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A Comparison of Delayed Release Film Coating Systems for Pharmaceutical Dosage FormsThis ADS was adapted from the CRS 2010 poster to evaluate and compare the dispersion properties, film properties and enteric performance at varying pH conditions, of four commercially available aqueous,delayed release film coating systems.
Acryl-EZE® Optimal Coating ParametersThis ADS was adapted from the 2000 AAPS poster outlining the optimum coating process parameters for Acryl-EZE dispersions.
Application of Acryl-EZE® 93F on Rabeprazole Sodium Tablets (20 mg) This ADS was adapted from the 2006 AAPS poster demonstrating the successful use of Acryl-EZE 93F19255, when applied onto rabeprazole sodium tablets.
Application of Powder Layering Technology and Aqueous Enteric CoatingThis ADS was adapted from the AAPS 2006 poster demonstrating the successful use of Acryl-EZE® 93F19255, when applied onto dry powder layered lansoprazole multiparticulates.
Aqueous Enteric Coating Application on Non-Banded Hard Gelatin Capsules This ADS was adapted from the 2006 AAPS poster that investigates the delayed release performance of Acryl-EZE® 93F19255, when applied onto omeprazole filled, hard gelatin capsules.
Controlled Permeability Films for Programmable Drug ReleaseThis ADS was adapated from the 2006 CRS poster investigating the influence of sodium alginate or hypromellose (HPMC) as pore formers in a delayed release film coating to achieve modified enteric drug release.
Enteric Coating of Tablets with Debossed LogosThis ADS was adapated from the 2004 CRS poster demonstrating how to successfully enteric coat tablets which contain a debossed logo.
Formulation and Process Considerations for Delayed Release Multi-Particulates of Esomeprazole Magnesium This ADS was adapted from the 2008 AAPS poster. The objective of this study was to investigate and establish an application process for an enteric coating system, Acryl-EZE®, aqueous acrylic enteric system, on an esomeprazole magnesium trihydrate (40 mg) multi-particulate system.
Investigation of a Modified USP Disintegration Test Method for Enteric Coated TabletsThis ADS was adapted from a poster presented at AAPS – Nov 2005. The ADS outlines the method and rationale for the analysis of enteric-coated dosage forms in intermediate acidic pH conditions (pH 4.5).
New Coating Process for the Application of Enteric Coatings to Small Tablet SamplesThis ADS was adapted from the 2005 AAPS poster investigating the rapid application of an aqueous enteric coating system onto very small batch sizes of tablets using a novel coating process technology, the SUPERCELL™ process from Niro.
Performance Characteristics of Acryl-EZE®This ADS was adapted from the 2001 CRS poster comparing the performance of the Acryl-EZE fully formulated system versus a multiple step dispersion preparation of Eudragit L100-55.
Preparation of Robust, Enteric-Coated Dosage Forms Utilizing Acryl-EZE®This ADS was adapted from the 2002 AAPS poster providing solutions for the application of aluminum lake pigmented Acryl-EZE formulations onto various actives, to provide stable, reproducible drug release.
Preparation of Stable, Gastro-Resistant Diclofenac Sodium Tablets, Utilizing Optimized Film-Coating Combinations with Acryl-EZE®This ADS was adapted from the 2003 CRS poster demonstrating how to reduce your overall coating process time and achieve drug product stability, by incorporating pigments directly into the Acryl-EZE enteric film layer.
Preparation of an Enteric Dosage Form with a Water-Dispersible Acrylic Film Coating FormulationThis ADS was adapted from the 2001 AAPS poster providing stability information for the Acryl-EZE® formulation as well as Acryl-EZE, enteric-coated aspirin tablets.
Production-Scale Process and Performance Comparison of Two Fully-Formulated Aqueous Enteric Coating SystemsThis ADS was adapted from the 2001 AAPS poster summarizing the production scale evaluation of Acryl-EZE® and Sureteric® for coating process, enteric protection, and finished product stability.
The Effect of Superdisintegrant on Acid Resistance of Enteric Coated TabletsThis ADS was adapted from the 2005 AAPS poster investigating the influence of superdisintegrant type and level on the performance of two enteric coated tablet formulations.
The Influence of Gastric Media (In-Vitro) on the Performance of Delayed Release Proton Pump Inhibitor Dosage FormsThis ADS was adapated from the 2005 AAPS poster investigating the enteric performance of aqueous enteric-coated tablet formulations containing proton pump inhibitors (PPI’s) in bio-relevant media, which better simulates the gastric environment of a patient on a multiple dose regimen of PPI’s.
The Influence of Plasticizer Type and Concentration on Acid Resistance of Tablets Coated with a New Aqueous Delayed Release Film Coating SystemThis ADS was adapted from the 2007 CRS poster investigating the influence of plasticizer type and concentration on acid resistance, when added to Acryl-EZE® 93A, aqueous delayed-release (DR) film coating systems.
Acryl-EZE® 93A Product InformationFeatures and benefits of the Acryl-EZE 93A series of aqueous, acrylic enteric delayed release coating systems.
Acryl-EZE® Enteric Coating StabilityThis product data sheet provides stability information for Acryl-EZE coated, delayed release aspirin tablets, at ambient and accelerated storage conditions.
Acryl-EZE® MP Product InformationFeatures and benefits of the Acryl-EZE MP series of aqueous, acrylic enteric delayed release coating systems.
Acryl-EZE® Product StabilityThis product data-sheet provides stability information for reconstituted Acryl-EZE powder formulations at ambient and accelerated storage conditions.
Acryl-EZE® Coating ParametersRecommended coating process parameters for Acryl-EZE in laboratory, pilot, and production scale coating pans.
Acryl-EZE® MP Coating ParametersRecommended coating process parameters for Acryl-EZE MP in laboratory and pilot scale fluid bed coaters.
Acryl-EZE® 93A Preparation and Use SheetOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for the Acryl-EZE 93A series.
Acryl-EZE® MP Preparation and Use SheetOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for Acryl-EZE MP.
Acryl-EZE® Preparation and Use SheetOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for Acryl-EZE.
Acryl-EZE® Product Information BrochureIntroduction to the Acryl-EZE platform of delayed release coating systems.
AAPS 2010 - Effects of Core Tablet Size on the Functionality of Aqueous Delayed Release Coatings as Measured by SEM and LIBSThe aim of this work was to develop a correlation between tablet surface area (size) and the minimum amount of coating weight gain/thickness of a functional coating necessary for enteric protection of tablets. Acryl-EZE®, aqueous enteric coating system, was used and the film coat thickness was determined via scanning electron microscopy (SEM) and laser-induced breakdown spectroscopy (LIBS).
Evaluation of the Enteric Performance of Lansoprazole Mini-Tabs Coated in a Perforated PanThe focus of this study was to investigate the potential of successful manufacture and enteric coating of lansoprazole mini-tabs using methacrylic acid co-polymers in a perforated pan. Along with other findings, this study will show that the mechanical strength of the mini-tabs significantly improved upon application of a seal-coat.
In-vitro Dissolution Testing of Delayed Release Multi-Particulate SystemsThis poster study was to investigate the use of fumed silica as an anti-adherent agent to prevent potential agglomeration of multi-particulates in acid media.
Investigation of Enteric Coating of Min-tabs Using a Perforated Pan or a Fluid-bed MachineIn this study the feasibility of using a perforated coating pan was evaluated and compared to a fluid-bed machine. Differences between the two processes, in terms of coated tablet appearance, physical properties and enteric protection were studied.
The Influence of Plasticizer Type and Concentration on Acid Resistance of Tablets Coated with Acryl-EZE® 93AThis poster reprint investigates the influence of plasticizer type and concentration on acid resistance, when added to Acryl-EZE 93A, aqueous delayed-release (DR) film coating systems.
Brand Enhancement™ Product Information BrochureTablet Design Services from Colorcon.
Rmark® On-Dose ID™ - Customized On-Dose Authentication TechnologyOn-dose micro-tags for solid oral dosage forms.
FDA Draft Guidance Document Comments on Use of Inks, Pigments, Flavors and Taggants to Guard Against CounterfeitingColocon Press Release, August 10, 2009.
ETHOCEL™ Product Information BrochureIntroduction to the ETHOCEL™ line of premium ethylcellulose polymers.
CRS 2011 - The Influence of Dissolution Media pH on Drug Release from Ethylcellulose Coated MultiparticulatesIn order to achieve a consistent extended drug release, it may be necessary to maintain similar drug release while dosage form travels across the physiological pH range. The objective of this work was to carry out a comparative evaluation of drug release from ethylcellulose coated multiparticulates in both gastric and intestinal pH media for ionic or non-ionic drugs.
CRS 2011 - The Influence of Drug Solubility on Release from Ethylcellulose Barrier Membrane Coated MultiparticulatesThe objective of this work was to carry out a comparative evaluation of drug release from solvent coated ethylcellulose multiparticulates using the same model drugs. The addition of a pore-former yielded a faster drug release.
Investigation of Ethylcellulose in the Preparation of Theophylline Extended Release Inert Matrix TabletsThis research illustrates the influence of EC particle size and molecular weight on drug release from inert matrices containing a sparingly water soluble drug. The influence of varying the polymer concentration, filler choice and compression force on drug release was also evaluated.
Investigation of Venlafaxine HCl Release from Extruded and Spheronized Beads Coated with Ethylcellulose using Organic or Aqueous Coating SystemsThe objective of this study was to investigate the overall performance of an extruded and spheronized formulation containing venlafaxine HCl, a highly water soluble drug (572 mg/mL)(3), coated with ethylcellulose from organic or aqueous systems.
The Influence of Pore-Former on Drug Release from Ethylcellulose Coated MultiparticulatesThis poster was presented at the 2010 CRS meeting in Portland, OR. The objective of this work was to investigate the influence of HPMC as a pore-former on the release of chlorpheniramine maleate from multiparticulate beads coated with ethylcellulose from an organic solution.
The Influence of Solvent Type on Extended Release Coating with Ethylcellulose Barrier MembranesThe objective of this work was to investigate the influence of four acceptable solvent combinations on EC solution viscosity and consequent drug release from coated beads.
Bi-Phasic Drug Release from Drug Layered, Extended Release Hypromellose MatricesThis ADS was adapted from the 2007 AAPS poster summarizing a process utilized to achieve an immediate and extended release profile from an HPMC matrix system.
Direct Compression Metformin HCl 500mg Extended Release Formula Based on HypromelloseThis ADS was adapted from the 2005 CRS poster investigating the formulation of an extended release, direct compression Metformin HCl (500 mg) matrix tablet using METHOCEL™.
Effect of Processing Conditions on Hypromellose Matrix Formulations of Acetaminophen Prepared by a High Shear Wet Granulation ProcessThis ADS was adapted from the CRS 2010 poster providing processing guidelines for developing a hypromellose matrix formulation using a wet granulation process; with the extra-granular addition of HPMC and Starch 1500 resulting in increased tablet hardness.
Evaluation of Verapamil HCl (240 mg) Extended Release Matrix Formulations This ADS was adapted from the 2006 AAPS poster investigating the use of dissolution testing apparatus III and biorelevant dissolution media as a means to better understand the in-vivo release of drug from METHOCEL™ matrices.
Evaluation of the Effect of Hydroalcoholic Media on Textural and Rheological Characteristics of Hypromellose MatricesThis ADS was adapated from the 2007 CRS poster investigating the effect of hydro-alcoholic dissolution media on the textural properties of METHOCEL™ matrices, and rheological properties of METHOCEL solutions.
Investigation of Moisture-Activated Granulation of Hydrophilic Polymer Blends in Verapamil HCl Extended Release MatricesADS adapted from 2009 CRS poster, Investigation of Moisture-Activated Granulation of Hydrophilic Polymer Blends in Verapamil HCl Extended Release Matrices
Investigation of a Venlafaxine HCl (37.5mg) Extended Release Formulation using Hypromellose (HPMC) MatricesThis ADS was adapted from the 2006 CRS poster which provides a method to minimize a burst of drug release typically observed in the early phases of release of highly soluble actives from METHOCEL™ matrices. Granulation of the drug, and coating on top of the matrix, with Surelease, were investigated.
Investigation of the Effect of Tablet Geometry and Film Coating on Drug Release from Hypromellose Matrices at Constant Surface Area to Volume Ratio Using Two Model DrugsADS adapted from 2009 CRS poster, Investigation of the Effect of Tablet Geometry and Film Coating on Drug Release from Hypromellose Matrices at Constant Surface Area to Volume Ratio Using Two Model Drugs
Investigation of the Effects of Hydro-Alcoholic Media on Rheological and Textural Properties of Various Grades of Hypromellose (HPMC)This ADS was adapted from the 2007 AAPS poster expanding on previously reported work which investigated the effect of hydro-alcoholic dissolution media on the textural properties of METHOCEL™ matrices, and rheological properties of METHOCEL solutions.
Maintaining Similar Drug Release from Hypromellose Matrices with Identical Dimensions but Different Dose StrengthsThis ADS provides a method to maintain similar drug release, tablet shape and weight, from a METHOCEL™ matrix, while adjusting the drug dose.
Mathematical Model for Simulation and Control of Drug Release from Hydrophilic MatricesThis ADS was adapted from the 2007 CRS poster which utilizes mathematical modeling to summarize the influence of several formulation variables on drug release from METHOCEL™ matrices.
Modulation of Drug Release from Hypromellose (HPMC) Matrices: Suppression of the Initial Burst EffectThis ADS was adapted from the 2006 AAPS poster which provides a method to minimize a burst of drug release typically observed in the early phases of release of highly soluble actives from METHOCEL™ matrices.
Particle Swelling and Coalescence to Gel Layer FormationThis ADS was adapted from the 2005 AAPS poster investigating swelling and coalescence behavior of hydroxypropylmethyl cellulose (HPMC) and partially pregelatinised starch particles, in order to monitor the contribution to gel layer formation in mixed HPMC and Starch 1500® matrices.
The Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg Extended Release Hypromellose MatricesThis ADS was adapted from the 2006 CRS poster investigating the influence of three film coating systems on the performance of Metformin HCl (500mg) extended release (ER) Hypromellose matrices stored under different conditions up to 12 months.
The Effect of In Vitro Dissolution Parameters on the Release Rate of a Low Dose, Low Solubility Drug from Extended Release Hypromellose Matrix Formulations This ADS was adapted from the 2006 CRS poster examining the impact of dissolution testing parameters on a low dose, low solubility, METHOCEL™ matrix formulation, compared to a marketed reference product.
The Influence of Anionic Polymers on Hydrochlorothiazide Extended Release Hypromellose MatricesThis ADS was adapted from the 2007 AAPS poster summarizing the effect of blending anionic polymers (carbomer and polyvinyl acetate phthalate [PVAP, Phthalavin®]) with HPMC, on extending the release of a very slightly soluble drug (~1.0 mg/ml). The effects of varying the polymer blend ratio and excipient choice were studied in terms of drug release profile and textural properties of the hydrated matrix tablets.
The Influence of Film Coatings on Performance of Hypromellose MatricesThis ADS was adapated from the 2003 CRS poster which examines the influence of various immediate release film coatings on the drug release from METHOCEL™ matrices.
The Influence of Formulation Variables on Drug Release Kinetics from Hypromellose Extended Release MatricesThis ADS was adapted from the 2006 CRS poster which utilizes mathematical modeling to summarize the influence of several formulation variables on drug release from METHOCEL™ matrices.
The Influence of Hydro-Alcoholic Media on Hypromellose Matrix SystemsThis ADS was adapted from the 2006 AAPS poster investigating the effect of hydro-alcoholic dissolution media on the swelling and drug release properties of METHOCEL™ matrices.
The Influence of Hydrodynamic Conditions on Verapamil Hydrochloride Release from Hydrophilic Matrices Using Ionic and Non-Ionic PolyersThis ADS was adapted from the 2008 AAPS poster. The purpose of this study was to investigate the effects of hydrodynamic conditions on drug release rates from a matrix tablet with a soluble active ingredient, using different combinations of HPMC. The study will show that the combination of HPMC with ionic polymers in ER matrices provides robust formulations which are insensitive to hydrodynamic conditions.
The Relevance of USP Methodology in the Development of a Verapamil Hydrochloride (240mg) Extended Release FormulationThis ADS was adapted from the 2005 CRS poster examining the impact of the type of dissolution testing method on drug release from extended release verapamil hydrochloride METHOCEL™ matrices.
Use of Roller Compaction in the Preparation of Verapamil Hydrochloride Extended Release Matrix Tablets Containing Hydrophilic PolymersThis ADS was adapted from the 2008 CRS poster evaluating the effects of roller compaction on the flow and compressibility of blends of HPMC, polyvinyl acetate phthalate(PVAP) and carbomer [cross-linked poly (acrylicacid)]. Drug release of an ER verapamil HCl matrix formulation containing this blend was also evaluated.
An Introduction to METHOCEL™ Cellulose EthersA description of the METHOCEL line of premium cellulose ethers.
Blending for Intermediate ViscosityThis product data sheet demontrates how to blend existing viscosity grades of METHOCEL™ to obtain an intermediate viscosity grade.
General Properties of METHOCEL™ Premium Cellulose EthersThis product data sheet describes chemical and physical properties of METHOCEL premium cellulose ethers.
How to Prepare Aqueous Solutions of METHOCEL™This product data sheet describes how to prepare aqueous solutions of METHOCEL.
How to Prepare Solutions of METHOCEL™ in Nonaqueous SolventsThis product data sheet describes how to prepare solutions of METHOCEL from non-aqueous solvents.
HyperStart® Formulation Service: Predicting Performance and Accelerating DevelopmentIntroduction to the HyperStart formulation service for hydrophilic matrix systems.
Properties of Solutions of METHOCEL™This product data sheet describes the properties of METHOCEL solutions.
Using METHOCEL™ Cellulose Ethers for Controlled Release of Drugs in Hydrophilic Matrix SystemsThis product data summarizes the application of METHOCEL premium cellulose ethers in extended release, hydrophilic matrix formulations.
Controlled Release Alliance BrochurePromotional booklet which outlines the Colorcon/Dow Wolff Cellulosics Controlled Release Alliance.
METHOCEL™ Product Information BrochureIntroduction to the METHOCEL™ platform of water soluble cellulose ethers.
AAPS 2010 - Application of Quality by Design (QbD) Principles to the Formulation of Extended Release Propranolol Hydrochloride Hydrophilic Matrix TabletsThe objective of this study was to investigate the effects of variation in hypromellose physico-chemical properties on powder flow, tablet physical properties and in vitro drug release profiles, from an extended release hydrophilic matrix tablet using QbD principles.
AAPS 2010 - Effect of Filler Type on Low Dose Acetaminophen Hydrophilic Matrix Formulations Prepared by a High Shear Wet Granulation ProcessThe objective of this study was to investigate the effect of four commonly used fillers in formulation and processing of HPMC matrices utilizing a high shear wet granulation process.
AAPS 2011 - The Influence of Sodium Carboxymethylcellulose on Drug Release from Polyethylene Oxide and Hypromellose Extended Release MatricesTo investigate the influence of ionic polymer sodium carboxymethylcellulose (NaCMC) on the release of a freely water-soluble (572 mg/mL11) model drug, venlafaxine hydrochloride, from ER formulations containing non-ionic polymers, PEO or HPMC, as matrix formers. The performance of PEO and HPMC was compared. Additionally, the effect of polymer concentration (30 or 50% w/w) on drug release was studied.
CRS 2011 - Application of Quality by Design (QbD) Principles to the Formulation of Extended Release Theophylline Hydrophilic Matrix TabletsThe objective of this study was to investigate the effects of hypromellose physicochemical properties on powder flow, tablet physical properties and in vitro drug release profiles from an extended release hydrophilic matrix tablet using QbD principles.
Comparison of Swelling, Erosion, and Gel Strength of Polyethylene Oxide and HypromelloseThe objective of this study was to compare swelling, erosion, and gel strength of commonly used hydrophilic polymers for controlled release.
Drug Formulation Studies Using a New Grade of Hypromellose Excipient Designed for Direct-Compression, Controlled-Release ApplicationsA new grade of hypromellose targeted at direct compression tableting was developed. The hypromellose excipient exhibits improved powder flow while retaining the controlled-release performance of hypromellose. The effect of active pharmaceutical ingredient particle size and solubility on tablet properties and controlled-release performance of formulations using the new excipient grade is examined.
Investigation of a Directly Compressible Hypromellose Matrix Formulation for a Low Dose, Practically Insoluble DrugThis poster reprint investigates the formulation of an extended release, direct compression Indapamide (1.5 mg) matrix tablet using METHOCEL™.
Powder Flowability of a New Direct Compression Grade Hypromellose Using Limiting Flow Rate AnalysisThis study applies the concept of limiting flow rates to the new direct compression grade hypromellose and emphasizes its importance as a key measure of flowability for fine materials.
The Utility of Ultra-High Viscosity Hypromellose in Extended Release Matrix FormulationsThis ADS was adapted from the CRS 2010 poster showing that the use of ultra-high viscosity BENECEL K200M in an extended release matrix system did not show any advantage in drug release retardation compared to METHOCEL K100M.
Application of a Modeling System in the Formulation of Extended Release Hydrophilic MatricesThis article reprint describes a predictive formulation service that provides pharmaceutical scientists with a starting formula for hydrophilic matrix tablets.
Applications of Complementary Polymers in HPMC Hydrophilic Extended Release MatricesThis article examines the application of co-formulation of polymers in developing ER hydrophilic matrix systems.
Investigation of the Influence of Tablet Shape, Geometry & Film Coating on Drug Release From Hypromellose Extended-Release MatricesDrug Delivery Technology article published March 2010.
Modulation of Drug Release from Hydrophilic MatricesThis article examines the concept of synergies between hypromellose and other polymers to modulate the drug release rate from matrix dosage forms.
The Influence of Excipients on Drug Release from Hydroxypropyl Methylcellulose MatricesPublished article reprint that summarizes the influence of various excipient fillers on the drug release from METHOCEL™ matrices.
Protection and Processing of a Highly Hygroscopic Herbal Extract by Drug Layering and Film CoatingStudy of the stablity improvements for Echinacea Purpurea beads layered with a moisture PVA and HPMC based barrier film coating.
Nutraficient® Coating Process ParametersStarting process recommendations for use of Nutraficient.
Nutraficient® Coating Process Parameters - PVA-based, ClearStarting process recommendations for use of Nutraficient, PVA-based, clear systems.
Nutraficient® Coating Process Parameters - PVA-based, PigmentedStarting process recommendations for use of Nutraficient, PVA-based, pigmented formulations.
Nutraficient® - ReconstitutionMixing procedure and holding instructions for Nutraficient coating formulations.
Nutraficient® Product Information BrochureProduct features and benefits.
Evaluation of a Continuous Coating Process for the Application of a Regulatory Compliant Nutritional Enteric Coating on Soft Gelatin CapsulesThis ADS was adapted from the Supply Side West poster presented in October 2008. The purpose of the study was to evaluate a continuous coating process for the application of a delayed release coating system onto soft gelatin capsules.
New Enteric Coating System (Nutrateric®) for Nutritional SupplementsThis ADS was adapted from the CRS poster presented in June 2005, summarizing the performance of Nutrateric when applied to tablets or soft gelatin capsules.
Nutrateric® II Enteric Coating System for Nutritional SupplementsA case study to introduce Nutrateric II, a new generation of enteric film coating designed for nutritional, food and dietary supplements. The system delivers productivity improvements, of greater than 40%, in both coating dispersion preparation and process time without any compromise in enteric protection. This study compares the preparation and productivity to the first generation Nutrateric product.
Performance Comparison of Two Delayed Release Coating Systems for Dietary SupplementsThis ADS was adapted from the CRS 2010 poster comparing the DR performance of an aqueous ethylcellulose and pH dependent pore-former based coating, with a shellac-based coating on garlic tablets.
The Influence of Plasticizers and a Stabilizer on Aqueous Delayed Release (DR) Coating Systems on Soft Gelatin CapsulesThis ADS was adapted from the AAPS poster presented in November 2007 - investigates the influence of different plasticizers and a secondary stabilizer (hypromellose, HPMC) in Nutrateric on the delayed release performance of coated fish oil soft gelatin capsules.
The Influence of Pore Former Concentration and Coating Weight Gain on Drug Release from Multi-Particulates Coated with Nutrateric®This ADS was adapted from the AAPS poster presented in November 2008. The outcome of this study successfully illustrates the combination of a pH dependent pore former and an aqueous ethylcellulose dispersion resulted in the desired delayed drug release profiles from multi-particulate systems. Coating level and port former concentrations were tailored to alter the duration of the delay in drug release followed by rapid release in higher pH media.
The Influence of a pH Dependent Pore Former on Acid Protection from Tablets Coated with an Aqueous Ethylcellulose Barrier MembraneThis ADS was adapted from the CRS poster presented in July 2006 - investigating the application of Nutrateric on aspirin and caffeine cores to achieve enteric protection.
Delayed Release Coating of Garlic Tablets with Nutrateric® in a 24" Fully Perforated side vented pan (Accela-Cota type) This product information sheet provides recommendations for the application of Nutrateric onto garlic tablets in a side-vented coating pan.
Nutrateric® - Stability and Use GuidelinesSummary of Nutrateric dispersion characteristics and stability. Demonstration of enteric protection on garlic tablets.
Delayed Release Coatings for Nutritional Supplements using Nutrateric® ClearNurateric is an easy-to-use and reliable delayed release coating for nutritional supplements. This information sheet details the preparation, use and clean-up guidelines for this coating system.
Nutrateric® II Reconstitution Sheet Mixing procedure and holding instructions for Nutrateric II coating formulations.
Nutrateric® II Product Information BrochureIntroduction to the Nutrateric II platform of delayed release coating systems.
AAPS 2010 - ICH Stability of Dietary Supplements Coated with an Aqueous Ethylcellulose Based Delayed Release Coating for Nutraceutical ApplicationsThe purpose of this study was to evaluate the effects of long-term storage on delayed release (DR) performance of garlic tablets and fish oil softgels coated with Nutrateric.
AAPS 2011 - Pilot and Production Scale Evaluation of an Improved High Productivity Delayed Release Coating for Dietary SupplementsUsing a Design of Experiment (DOE) approach, this study evaluated the optimum ratio of Surelease to NS Enteric to provide protection in simulated gastric fluid (SGF) while allowing acceptable disintegration performance in simulated intestinal fluid (SIF). The effects of coating dispersion solids concentration and coating weight gain were also investigated.
Opadry® Coating ParametersStarting process recommendations for use of Opadry aqueous formulations.
Opadry® Coating Parameters - Organic FormulationsStarting process recommendations for use of Opadry formulations using an isopropyl alcohol/methylene chloride solvent solution.
Opadry® Reconstitution ProceduresMixing procedure and holding instructions for Opadry coating formulations.
Correlation of Free Salicylic Acid Content to the Water Vapor Transmission Properties of Aqueous Film Coating SystemsThis study investigates the water vapor transmission (WVTR) properties of common aqueous film coating polymers and fully formulated coating systems.
Effectiveness of Moisture Barrier Coatings on Various Tablet CoresEvaluation of Opadry® amb compared with alternative coating formulations and their effect on moisture uptake.
Opadry® amb - Coating ParametersStarting process recommendations for use of Opadry amb.
Opadry® amb - Moisture Vapor TransmissionEvaluation of Opadry amb compared with alternative coating formulations and their effect on moisture uptake.
Opadry® amb - Preparation and UseMixing procedure and holding instructions for Opadry amb coating formulations.
Opadry® amb Product Information BrochureProduct features and benefits.
Development of Diclofenac Sodium Delayed Release Tablets USP Opadry® Enteric (94 Series)This study highlights the use of an Opadry® Enteric film coating for producing delayed-release diclofenac tablet formulations which meet current USP specifications.
Development of USP Delayed Release Aspirin Tablets using Opadry® Enteric, Acrylic-Based Coating System The objective of this study was to develop aspirin delayed release tablets that comply with USP requirements.
Drug Release From Acrylic-Based Opadry® Enteric (94 Series) Coated TabletsOpadry® Enteric (94 Series), enteric coating system, is a fully formulated, delayed release coating system for solid oral dosage forms that is based on MAC, specifically the poly [methacrylic acid, methyl methacrylate (1:1), type A].
Opadry® Enteric 91, 94, 95 seriesOpadry Enteric is a family of fully formulated, delayed release coating systems for solid oral dosage forms, which are applied by organic or hydro-alcoholic processing techniques.
Opadry® Enteric Product InformationFeatures and benefits of the Opadry Enteric platform of PVAP (Phthalavin®) based, delayed release coating systems.
Opadry® Enteric Preparation and Use SheetOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for the Opadry Enteric 91 series.
Opadry® Enteric – 94 Series: Preparation & Use GuidelinesProduct Information for Opadry Enteric - 94 series - prep & use.
Opadry® Enteric Sales BrochureIntroduction to the Opadry Enteric platform of PVAP (Phthalavin®) based, delayed release coating systems.
AAPS 2010 - Comparative Evaluation of Enteric Film Coatings Applied in Organic SolventsThe purpose of this work was to carry out comparative evaluations of the acid-resistance and pH dependent solubility of four organic solvent coated enteric film coating systems.
AAPS 2010 - Physicochemical Characterization of Binary Ionic Polymer Blends: Polyvinyl Acetate Phthalate and Eudragit E POThe aim of this study was to investigate the possible interaction between an anionic polymer (polyvinyl acetate phthalate [PVAP]) and a cationic polymer (basic butylatedmethacrylate copolymer).
Hydro-Alcoholic Applications of Polyvinyl Acetate Phthalate (PVAP) for Oral Delayed Release Coating SystemsThe objective of this poster reprint was to examine the gastro-resistance and drug release of diclofenac sodium tablets and omeprazole multi-particulates (MP) coated with Opadry® Enteric, using hydro-alcoholic solutions.
The Influence of Solvent System on the Performance of Polyvinyl Acetate Phthalate (PVAP) Delayed Release Coating SystemsThis poster reprint provides the dispersion characteristics and coating process parameters for an Opadry® Enteric system, when prepared in different solvent mixtures.
Coating Moisture-Sensitive Products Influence of inlet temperature and airflow on moisture uptake by tablet cores using a PVA-based film coating system.
Determination of Trace Formic Acid and Formaldehyde in Film Coatings Comprising Polyvinyl Alcohol (PVA)This work describes the application of a methodology developed by Amgen to determine the amounts of formic acid and formaldehyde in PVA-based film coatings.
Effect of Coating Process Conditions and Coating Formula Type on the Quantity and Location of Water in Film Coated TabletsEffects of process conditions and formula type on tablet moisture gain.
Evaluation of Recent Advances in Continuous Film Coating Technology in Reducing or Eliminating Potential Product LossesThis study evaluates the performance of Opadry II in a continuous coating process and demonstrates that improvements in continuous coater designs have reduced the need for re-work or discarding of partially coated product.
Evaluation of a Film Coating that Produces Enhanced Tablet-to-Tablet Film Uniformity In this study, Opadry® II (85 series) Clear was shown to have lower coating weight gain standard deviations than a standard clear hypromellose based film coating. Pigmented Opadry II (85 series) achieved similar or better coating color uniformity with a 1/3 savings in processing time.
Film Coating Process Considerations for the Application of High Productivity, High Solids Concentration Film Coating FormulationsUsing a Design of Experiments (DOE) approach, this study examines the effect of solids concentration on color uniformity and coating weight variation (CWV) in a batch coating process.
Influence of Film Coating Process Parameters on the Gloss of Tablets Coated with Pigmented Aqueous Film Coating FormulationsThe purpose of this study was to examine the effects of coating process parameters and dispersion solids concentration on the gloss of tablets coated with single-step, pigmented aqueous film coating formulations.
Investigation into the Flow Properties of Coated and Uncoated Tablets and Its Relevance to Blister Packing Efficiency Reduce contamination and improve packaging line efficiency through the application of a fully formulated film coating. Realize improved yield when packaging pharmaceutical or dietary supplement products.
Maximizing the Gloss of PVA-Based Film Coating SystemsResults of this study reveal gloss level improvements when PVA-based pigmented film coatings are applied at lower solids content levels.
Modern Tablet Film Coatings and Influence on Ease of SwallowingThis Application Data Sheet is extracted from a study of esophageal transit times using uncoated and film-coated caplets,oval tablets, plus hard and soft-gelatin capsules. Reprint of poster presented at the American Association of Pharmaceutical Scientists Meeting, 2003.
Reducing Coated Tablet Defects from Laboratory Through Production Scale: Performance of Hypromellose Based and Polyvinyl Alcohol Based Aqueous Film Coating SystemsZero Defects, Less Time, Less Material as a result of Opadry® II coating innovation from Colorcon®.
Scuffing Measurement Methodology and Improved Film Coating SystemsThis study describes laboratory tests to measure scuffing on film coated tablets and provides process and maintenance recommendations to prevent the occurrence of scuffing.
The Influence of Film Coatings on Performance of Hypromellose MatricesThis application data sheet presents a study on the influence of three film coating systems on the performance of hypromellose sustained release matrices, stored under different conditions up to 12 months.
Opadry® II Coating Parameters - Clear (PVA-based) FormulationsStarting process recommendations for use of Opadry II, clear formulations.
Opadry® II Coating Parameters - Pigmented (PVA-based) FormulationsStarting process recommendations for Opadry II pigmented formulations.
Opadry® II - ReconstitutionMixing procedure and holding instructions for Opadry II coating formulations.
Opadry® II - Product Information BrochureImproved efficiency PVA and HPMC coating formulations reduce coating processing time by 25-30% compared with conventional systems. For use in Nutritional and Pharmacuetical applications.
AAPS 2010 - Stability of Six Model Drug Products Coated with PVA-Based Opadry®IIThe purpose of this study was to investigate the influence of PVA-based Opadry®II high performance film coating systems on stability and release of immediate release formulations containing six model drugs, after storage at accelerated conditions.
Opadry® NS - Coating Process Conditions - Clear FormulaStarting process recommendations for use of Opadry NS.
Opadry® NS - Coating Process Conditions - Pigmented FormulaStarting process recommendations for use of Opadry NS.
Opadry® NS - ReconstitutionMixing procedure and holding instructions for Opadry NS coating formulations.
AAPS 2010 - Stability Evaluation of Two Non-Synthetic Pigments for Use in Fully Formulated Film Coating SystemsThe purpose of this study was to evaluate the color stability of two non-synthetic pigments in model pre-formulated film coating systems under accelerated storage conditions.
Opadry® tm - Taste Mask ComparisonProduct technology summary including stability profile, film properties, color effects and regulatory guidelines.
Opadry® tm - Sales BrochureProduct features and benefits.
Taste Masking Performance and Stability of Opadry® tmTaste and dissolution profile studies of Bitrex and Caffeine tablet cores coated with Opadry tm.
Opadry® fx™ Enhanced Moisture Protection and Film PropertiesCharacterization of moisture vapor transmission rate and other film properties of Opadry fx.
Opadry® fx™ PropertiesProduct technology summary including stability profile, film properties, color effects and regulatory guidelines.
Opadry® fx™- Coating ParametersStarting process recommendations for use of Opadry fx
Reconstitution SheetMixing and holding instructions for Opadry® fx suspensions.
Opadry® fx™ Product Information BrochureProduct features and benefits.
Dissolution Comparison - Acetaminophen and Ibuprofen Cores Following Accelerated Storage Stability TestingComparative data for Opadry 200 and Opadry II following six months accelerated storage stability.
Performance Characterization of Opadry® 200In this study the performance of Opadry® 200, optimized film coatings, were conducted on coated and uncoated acetaminophen and Ibruprofen tablets. The document includes quantitative ingredient information, dispersion viscosity vs. solids analysis, disintegration and water vapor transmission plus dissolution information.
Opadry® 200 Coating Parameters - Clear FormulationsStarting process recommendations for use of Opadry 200, clear formulations.
Opadry® 200 Coating Parameters - Pigmented FormulationsStarting process recommendations for Opadry 200 pigmented formulations.
Opadry® 200 - Product ReconstitutionMixing procedure and holding instructions for Opadry 200 coating formulations.
Opadry® 200 - Product Information BrochureFully formulated, one-step, PVA (polyvinyl alcohol)-based film coatings that offer a high-level of protection combined with fast coating process times and improved final product stability.
AAPS 2010 - Novel Immediate Release Coating Offering Excellent Coating Productivity, Moisture Barrier and Drug Release Composition Based on PVA and an Acrylic PolymerThe aim of this study was to characterize a novel fully formulated film coating comprised of polyvinyl alcohol and an acrylic polymer. The novel film coating studied offers high productivity with enhanced moisture barrier functionality and no impact on drug release compared to uncoated tablets..
AAPS 2011 - Characterization of a Novel Film Coating System Based on a PVA Copolymer with Excellent Productivity and Barrier PerformanceThe aim of this study was to characterize Opadry® 300, optimized performance film coating, a fully formulated system available for use in Japan only, comprising a novel copolymer based on polyvinyl alcohol, methyl methacrylate and acrylic acid that offers a desirable combination of all these attributes.
Effect of Tablet Shape on the Perception of High Gloss Film Coating SystemsPoster study on the importance of tablet shape selection in the development of dosage forms with a high gloss finish.
Opaglos® 2 Gloss Units ComparisonGloss comparison of commercially available product compared with Opaglos 2 tablets.
Opaglos® 2 Powder Stability Summary of the analytical and microbiological stability data of Opaglos 2 dry powder.
Opaglos® 2 Reconstitution Procedure Mixing procedure and holding instructions for Opaglos 2 coating formulations.
Opaglos® 2 Sales BrochureProduct features and benefits.
Determination of Critical Process Parameters on the Application of an Aqueous, High Gloss Film Coating SystemCritical process parameters for achieving an elegant high-gloss film coating.
Enhanced Aesthetic and Functional Stability of Opaglos® 2 High Gloss Film Coating System vs. Sugar CoatingAchieving the elegance of a sugar coated dosage with an aqueous film coating.
Photostability of Pharmaceutical Colorants in Opaglos® 2Assesment of the relative color stability of Opaglos 2 formulations containing iron oxides or Red #40, Yellow #6, Blue #2 (Dye or Lakes).
Physical Properties and Stability of Opaglos® 2, a Pigmentable High Gloss Film Coating SystemStudy comparing free film performance, rheological properties and dissolution profiles of Opaglos 2 to other cellulosic polymer-based film coatings on both acetaminophen and ibuprofen coated tablet cores.
Stability of Acetaminophen 500mg Cores Coated with Opaglos® 2Disintegraton and dissolution stability results for Acetaminophen cores coated with Opaglos 2.
Stability of Ibuprofen 200mg Cores Coated with Opaglos® 2Disintegraton and dissolution stability results for Ibuprofen cores coated with Opaglos 2.
Opalux® Tablet Sealant CoatingProduct Overivew.
Application of Opadry® II, complete film coating system, on metformin HCl extended release matrices containing POLYOX™ water soluble resinApplication Data on Polyox
Dissolution Testing for POLYOX™ Extended Release MatricesApplication Data on Polyox
Evaluation of Various Materials for Cleaning of Processing Area and Equipment After Using POLYOX™ PolymersApplication Data for Polyox
Formulation of POLYOX™ ER Matrices for a Highly Soluble ActiveApplication Data
Physico-mechanical Characterization of POLYOX™ for Tablet ManufactureApplication Data on Polyox
The Influence of In Vitro Dissolution Method on the Release of a Highly Water Soluble Drug from Polyethylene Oxide and Hypromellose Hydrophilic Extended Release MatricesThis ADS was adapted from the 2008 AAPS poster. The objective of this study was to investigate the influence of different dissolution methods on the release of a high solubility drug from an ER matrix formulation containing either HPMC or PEO as the rate-controlling polymer.
POLYOX™ Product Information BrochureIntroduction to the POLYOX™ line of water soluble resins.
AAPS 2010 - The Influence of Hydro-Alcoholic Media on Drug Release from Polyethylene Oxide Extended Release Matrix TabletsThe aim of this study was to investigate the influence of hydro-alcoholic media on the release rate of two model APIs with various aqueous solubility (gliclazide and metformin HCl) from PEO ER matrices.
AAPS 2010 - The Influence of Polymer Concentration on Release of Poorly Soluble Drugs from Polyethylene Oxide Extended Release MatricesThe aim of this study was to investigate the influence of PEO concentration on the release of poorly water soluble APIs from ER matrices.
AAPS 2011 - Effect of Formulation and Granulation Processing Parameters on Performance of Push-Pull Osmotic Pump Tablets of a Practically Water Insoluble Model DrugPush-pull osmotic pumps (PPOP) of a practically insoluble model drug (Drug Y) were developed. The purpose is to evaluate the effect of tablet formulation and granulation processing on performance of PPOP tablets of this model drug.
AAPS 2011 - Effect of Semipermeable Coating Composition and Opadry® Top-Coating Systems on Performance of Push-Pull Osmotic Pump Tablets of a Practically Water Insoluble Model DrugThe objective of this study is twofold: (i) to investigate the effect of the semipermeable coating composition comprising cellulose acetate along with different grades of polyethylene glycol (PEG); and (ii) to evaluate the effect of various Opadry film coating systems, on performance of the developed PPOPs.
AAPS 2011 - The Effect of Film Coating on the Stability of Extended Release Metformin Hydrochloride POLYOX™ MatricesThe aim of this study was to investigate the effect of an Opadry® II film coating system on the stability of metformin HCl extended released (ER) polyethylene oxide (POLYOX™) matrix tablets.
CRS 2011 - Development of Push Pull Osmotic Pump Tablets for a Slightly Soluble Model DrugResults showed that irrespective of the multiple steps involved in manufacture of such dosage forms, developed tablets demonstrated equivalent performance to commercial tablets with respect to physical properties, drug release and push-pull pattern. The developed system could provide a platform to yield satisfactory results for similar drug candidates.
CRS 2011 - Effect of Different Processing Conditions on the Performance of Push Pull Osmotic Pump Tablets of a Slightly Soluble Model DrugPush-Pull Osmotic Pump (PPOP) tablets of a slightly water soluble model drug were developed. The effects of tablet mechanical strength, drying method of granules and methods of tablet manufacture (manual vs. rotary tablet press) on performance of PPOP tablets. The findings of this study showed a robust osmotic system which could yield satisfactory results for similar drug candidates.
CRS 2011 - The Influence of Film Coating and Storage on Propranolol Hydrochloride Release from Polyethylene Oxide Extended Release MatricesPolyethylene oxide (PEO) is prone to autoxidation, leading to chain cleavage and reduction of polymer viscosity on storage.Robust POLYOX™ ER matrices containing model drug propranolol HCl were produced, the mechanical strength of which was significantly improved by the application of 3% WG of an Opadry II® film coating.
CRS 2011 - The Influence of Sodium Carboxymethyl Cellulose on Drug Release from Polyethylene Oxide Extended Release MatricesPolyethylene oxide (POLYOX™) and sodium carboxymethyl cellulose can be used to modulate the release of various drugs. Potential synergistic interaction can be used to design new oral ER pharmaceutical dosage forms with more prolonged release using lower polymer amounts, which could be particularly beneficial for freely or very water-soluble drugs, where accommodation of high doses is required and once daily administration is preferred.
Development of Push Pull Osmotic Pump Tablets for a Slightly Soluble Model DrugResults showed that irrespective of the multiple steps involved in manufacture of such dosage forms, developed tablets demonstrated equivalent performance to commercial tablets with respect to physical properties, drug release and push-pull pattern. The developed system could provide a platform to yield satisfactory results for similar drug candidates.
Effect of Different Processing Conditions on the Performance of Push Pull Osmotic Pump Tablets of a Slightly Soluble Model DrugPush-Pull Osmotic Pump (PPOP) tablets of a slightly water soluble model drug were developed. The effects of tablet mechanical strength, drying method of granules and methods of tablet manufacture (manual vs. rotary tablet press) on performance of PPOP tablets. The findings of this study showed a robust osmotic system which could yield satisfactory results for similar drug candidates.
Effect of Filler Type on the Stability of Polyethylene Oxide in a Hydrophilic Matrix TabletThe effect of various fillers on the oxidative stability of polyethylene oxide (PEO) in a matrix tablet was studied. Tablet hardness, dissolution profiles, and polymer viscosity were studied over 3 months at accelerated aging conditions. Results indicate PEO stability can be affected by the type of filler used in the formulation.
The Influence of Hydro-Alcoholic Media on Drug Release from Polyethylene Oxide Extended-Release Matrix TabletsPublished article reprint that summarizes extended-release of PEO tablets of the practically water insoluble drug gliclazide (30 mg) and freely soluble metformin HCl (500 mg) when exposed to 5% and 40% w/v ethanol solutions for up to 12 h.
StarCap 1500® utilized in a direct fill Capsule Formulation of a high dose / High solubility active drug - Gabapentin Capsules 300mgDiscusses the formulation of a commercially viable gabapentin capsule formulation using StarCap 1500.
Starting Formulation - Formulation Used to Produce Gabapentin (300mg) Capsules
StarCap 1500® Information Sheet
AAPS 2007 Development of a Common Cyclobenzaprine Formulation for Both Encapsulation and Tabletting Using StarCap 1500®Feasiblity study of using a common formula that can be encapsulated into hard gelatin capsules for clinical trials and subsequently compressed into tablets for commercialization. Results show that the common formula has all the key properties required for the manufacture of hard gelatin capsules and film coated tablets by a direct blend/encapsulation and direct compression process.
AAPS 2010 - Application of StarCap 1500® as Filler/Binder/Disintegrant in a Roller Compaction Dry Granulation FormulationIn this study, the feasibility of using a combination of StarCap 1500®, co-processed starch excipient, and microcrystalline cellulose (MCC)in the development of a roller compaction formulation of a slightly soluble model drug was evaluated.
AAPS 2010 - Evaluation of StarCap 1500® as an Excipient in Extended Release Hydrophilic Matrix SystemsThe objective of the present study was to evaluate the use of StarCap 1500, a unique co-processed mixture of globally accepted excipients, corn starch and pregelatinized starch, as an alternative filler in hydrophilic matrices of HPMC or PEO using different model drugs.
Evaluation of StarCap 1500® in a Propranolol Hydrochloride CapsuleCompares the flow properties of StarCap 1500 to other excipients commonly used in capsule filling and evaluates the performance of StarCap 1500 in a hard gelatin capsule formulation.
Assessment of Low-Dose Content Uniformity of IndomethacinThis ADS was adapted from an academic poster comparing three excipients and their role in achieving content uniformity in a formula containing a very low dose of indomethacin.
DiBasic Calcium Phosphate replacement with Starch 1500® in a Direct Compression FormulaData showing the benefits of using Starch 1500 in a direct compression placebo formulation replacing DiCal.
Direct Compression Formula using Starch 1500® with Ranitidine HCL (150mg) Tablets, Film Coated with Opadry® II (85 Series)Data demonstrating the ability of a formulator challenged with a moisture sensitive active to produce a robust dosage with excellent physical and chemical stability utilizing Starch 1500 in the core and Opadry II as the film coat.
Direct Compression Formulation Used to Produce Loratadine (10 mg) TabletsData demonstrating the successful utilization of Starch 1500® in a lactose free, low dose active formulation (loratadine).
Dual Functionality of Starch 1500® as a Binder and Disintegrant in XCH (Xiaochaihu) Herbal Extract/Powder Tablet Formula by High-Shear Wet GranulationA high dose tablet formulation of XCH herbal extract/powder combination developed and evaluated using Starch 1500/MCC in a high-shear granulation process.
Fluid Bed Method for Increasing the Compactability of Echinacea Purpurea Powder using Starch 1500® and fumed silicaTreating a high dose, poorly compressible herbal powder with Starch 1500 and fumed silica to increase the compressibility of the powder.
Free and Bound Water in Starch 1500® compared to other commonly used excipientsComparison of Water Activity v LOD of commonly used excipients.
High Shear Granulation with Starch 1500®, Partially Pregelatinized Maize Starch - Evaluation of Process Parameters by Design of Experiments (DOE)ADS adapted from 2007 AAPS poster evaluating the impact of process variables and formulation on the granulation and tablet properties of formulations, utilizing Starch 1500®, partially pregelatinized maize starch, as a binder and disintegrant through Design of Experiments (DOE).
Investigation of Mini-Tab Capsule Filling Using a Zanasi Lab 16 MachineThis study investigated the possibility of filling 2 mm diameter coated placebo mini-tabs into capsules size 0, using a Zanasi Lab 16 (IMA) capsule filling machine.
Lactose Replacement with Starch 1500® in a direct compression formulaData showing that Starch 1500 produces a more robust, more stable placebo tablet via direct compression as compared to a similar lactose based formulation.
Starch 1500®, Partially Pregelatinized Maize Starch, Used as a Binder Disintegrant in High Shear Wet Granulation Comparison to Povidone and Croscarmellose SodiumThis study compares the high shear granulation and tablet properties of two formulations. One is based on a polymer granulation binder, PVP, in combination with a super disintegrant, croscarmellose sodium (CCS). This formulation was developed external to Colorcon. The other formulation utilized partially pregelatinized maize starch, Starch 1500, as both the binder and the disintegrant.
Starting Formulation - Direct Compression Formulation Used to Produce Multivitamin Tablets
Starting Formulation - A High Shear Wet Granulation formulation used to produce Guaifenesin
Starting Formulation - Direct Compression Formulation Used to Produce Aspirin (325mg) Tablets
Starting Formulation - Direct Compression Formulation Used to Produce Lactose free Loratadine (10mg) Tablets
Starting Formulation - Direct Compression Formulation Used to Produce Norfloxacin (400mg) Tablets
Starting Formulation - Direct Compression Formulation Used to Produce Ranitidine (400mg) Tablets
Starting Formulation - Direct Compression Formulation Used to Produce Theophylline (100mg) Tablets
Starting Formulation - Direct Compression Formulation used to Produce Chloropheniramine (4mg) Tablets
Starting Formulation - Direct Compression Formulation used to Produce Hydrochlorothiazide (50mg) Tablets
The Effect of Starch 1500® on the Stability of Aspirin Tablets Stored Under Accelerated ConditionsPresents data to suggest that Starch 1500 may be inhibiting water activity within the formulation and retarding moisture interaction with the aspirin.
Wet Granulation of Acetaminophen with Starch 1500® Highlights the performance improvements in tablet hardness and disintegration of Starch 1500 over PVP.
Starch 1500® Bulk Packaging Information
Starch 1500® G Product Information Sheet
Starch 1500® LM Product Information Sheet
Starch 1500® Product Information Sheet
Starch 1500® Brochure
AAPS 2010 - Influence of Filler Type in the Blend Uniformity of Micronized DrugsThe objective of this study was to investigate the influence of various fillers on blend uniformity of binary mixtures of fillers and a micronized model drug.
AAPS 2011 - Effect of Drug Particle Size on Blend Segregation and Content Uniformity of Low Dose TabletsA combination of Starch 1500 and MCC was selected as the filler. One of the objectives was to evaluate the effect of drug particle size on blend segregation of low dose formulations of micronized hydrochlorothiazide (HCTZ), a slightly water soluble model drug. The other objective was to study the effect of drug particle size and drug load on dissolution rate of micronized drug tablets; two concentrations, 1% and 10% of the micronized drug, were used in these studies.
CRS 2011 - Use of Starch 1500® to Minimize Variability on Drug Release from Hypromellose MatricesThe use of Starch 1500® as filler provided significantly more robust ER matrices indicated by similar release profiles despite variations in hypromellose properties. By comparison, matrices containing lactose as filler demonstrated dissimilar release profiles as hypromellose properties varied.
Control of Dissolution Rate of IR Tablets Containing Starch 1500® with Different Types and Grades of Methocel®To demonstrate the feasibility of using Methocel of different hydration rates, viscosity grades and concentrations to control the release rate of immediate release (IR) tablets.
Development of Common Formulations for Both Encapsulation and Tableting - Narrowing the Gap Between Clinical and Commercial FormulationsThe successful outcome of this study demonstrates the feasibility of developing a single formula that can be encapsulated into hard gelatin capsules for clinical studies and compressed into tablets for commercialization.
Development of Ultra High-Dose Formulation of Traditional Chinese Medicine (TCM) Extract Tablets by Fluid Bed Granulation ProcessThe use of Starch 1500 as a substitute for PVP and superdisintigrant minimizes the complexity of the formula and offers significant excipient cost reductions.
Evaluation of a Partially Pregelatinized Starch in Comparison with Superdisintegrants in a DC Hydrochlorothiazide FormulationThe goal of this study was to compare the tablet disintegration and drug dissolution effectiveness of a partially pregelatinized starch (Starch 1500®) in comparison with various superdisintegrants in a poorly soluble, hydrochlorothiazide direct compaction application.
Fluid Bed Granulation of Acetaminophen: Effect of Key Process Variables on Granule and Tablet CharacteristicsIllustrates the use of Design of Experiment (DOE) as a tool to access the effect of potential process parameter changes on product quality and overall process operation.
Formulation and Processing Options for an Amlodipine Besylate TabletStudy evaluating the effects of formulation and manufacturing process on an amlodipine besylate tablet. A base of microcrystalline cellulose and Starch 1500 produced an excellent product with high mechanical strength, fast dissolution, stable stablity, and good process flexibility that was superior to DCP in many aspects.
Influence of Fillers on Tabletting and Drug Release from HPMC MatricesTo investigate the influence of compression force on tableting and drug release from HPMC matrices formulated with three commonly used fillers.
Influence of Starch on Drug Release from HPMC MatricesTo investigate the influence of partially pregelatinized starch (Starch 1500®, Colorcon), in comparison to microcrystalline cellulose (MCC) and lactose, on drug release from hydroxypropylmethylcellulose (HPMC) sustained release matrix formulations.
Modulating Dissolution Profiles of Immediate Release Tablets Using METHOCEL™ E5 LV and a Direct Compression ProcessThis study investigates the ability of a single METHOCEL™ premium cellulose ether, E5 LV grade to modulate the dissolution profiles of immediate release tablets prepared by direct compression. The research will show that the dissolution rate of all tablets decreases with increasing concentration of METHOCEL™ E5 LV.
Optimizing Lubricant Usage in a Direct Compression Hyrochlorothiazide formulation containing a plastically deforming excipientThis study investigates the use of stearic acid as an alternative to magnesium stearate in the production of pharmaceutical tablets. Also provides guidance on selecting the optimum lubricant level and for a direct compression formulation.
Use of Starch 1500® to Improve the Uniformity of a Low Dose Direct Compression Chlorpheniramine FormulationThis study examines the effect of Starch 1500 as an agent for pre-blending a low dose active to ensure good uniformity in a direct compression chlorpheniramine maleate (4mg) formulation.
Excipient Update, Influence of fillers, compression force, film coating, and storage conditions on Performance of Hypromellose matricesInvestigates the influence of fillers, compression force, film coating, and storage conditions on performance of hypromellose matrices.
Formulating TCMs; East meets WestHow formulated coated tablets can make TCM's more palletable.
Formulation of Acetylsalicylic Acid Tablets for Aqueous Enteric Film CoatingThe goal of this study was to determine which combination of excipients would result in an Aspirin tablet core that would be suitable for use in an aqueous enteric film-coating process.
Formulation of Low Dose Medicines - Theory and PracticeAn article written by Hashim Ahmed, Ph.D. and Navnit Shah, Ph.D. of Hoffmann-LaRoche Inc. evaluating multiple excipients for content uniformity in a low dose application.
Multifunctional Excipients ArticleMultifunctional Excipients, Pharma Magazine.
Narrowing the Gap Between Clinical Capsule Formulations and Commercial Film-coated TabletsMay 2009 - Pharmaceutical Technology Europe Article
Overcoming Formulation DifficultiesHow does the pharmaceutical world meet the challenge of the ever-increasing pace in drug development? One shortcut solution for formulators is to use high-performing excipients.
Starch ContrastsKnowing the differences among pregelatinized starches will produce desired formulation release rates." Discusses differences between pregelatinized starches - morphology, particle size and the degree of modification effects on functionality.
The Effect of Core Design and Formulation on the Quality of Film Coated TabletsThis article examines the importance of core design and formulation on the quality of a film coated tablet.
Technical Evaluation of SureSpheres™ 20/25 Mesh (850-710 micron) as Drug Layering Substrates (Starter Seeds)SureSpheres Application Data - Technical Evaluation - 20/25 Mesh
The Influence of Plasticizer Type and Level on Drug Release from Ethylcellulose Barrier Membrane MultiparticulatesADS adapted from 2009 CRS poster, The Influence of Plasticizer Type and Level on Drug Release from Ethylcellulose Barrier Membrane Multiparticulates
SureSpheres Product Information BrochureSureSpheres features & benefits
Application of Surelease® in Preparation of Theophylline Extended Release Inert Matrix Tablets by Spray GranulationSurelease Application Data document
Investigation of Aqueous Ethylcellulose Dispersion in Extended Release Metformin Inert Matrices ADS adapted from 2009 CRS poster, Investigation of Aqueous Ethylcellulose Dispersion in Extended Release Metformin Inert Matrices
Stability of a Sparingly Soluble BCS Class I API Ethylcellulose Coated MultiparticulateThis ADS was adapted from the CRS 2010 poster investigating the long term stability, curing effects and release kinetics of a sparingly soluble BCS Class I API, layered on nonpareil beads and coated with aqueous Ethylcellulose dispersion.
The Influence of Hydrophilic Pore-Formers on Metoprolol Succinate Release from Mini-tabs Coated with Aqueous Ethylcellulose DispersionThis ADS was adapted from the CRS 2010 poster to investigate the influence of incorporating different levels of pore-former into aqueous EC system (Surelease) on the release of a freely water-soluble drug metoprolol succinate, from coated mini-tabs.
Surelease® E-7-19020 Product InformationFeatures and benefits of the Surelease E-7-19020, aqueous ethylcellulose coating system.
Surelease® E-7-19030 Product InformationFeatures and benefits of the Surelease E-7-19030, aqueous ethylcellulose coating system.
Surelease® E-7-19040 Product InformationFeatures and benefits of the Surelease E-7-19040, aqueous ethylcellulose coating system.
Surelease® E-7-19050 Product InformationFeatures and benefits of the Surelease E-7-19050, aqueous ethylcellulose coating system.
Surelease® Preparation and Use SheetOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for the Surelease platform of aqueous ethylcellulose dispersions.
Surelease® Sales BrochureIntroduction to the Surelease platform of aqueous ethylcellulose dispersions.
AAPS 2011 - Barrier Membrane Coating of Hydrophilic Matrices of Sparingly Soluble Drug, Acetaminophen: A Strategy to Reduce Possible Food EffectTo investigate the application of a barrier membrane (BM) coating on APAP matrices, consisting of an aqueous ethylcellulose dispersion (Surelease® E-7-19010) and a pore former (Opadry® film coating) as a strategy to reduce drug release variability and possible food effect when dealing with hydrophilic matrices of a sparingly soluble model drug.
Application of Ethylcellulose in Preparation of Extended Release Theophylline Inert Matrix Tablets by Wet GranulationThe outcome of this study illustrates that an aqueous ethylcellulose dispersion (Surelease™) was successfully utilized to formulate and manufacture extended release theophyllin inert matrices. The influence of varying polymer concentration, filler choice and compression force on drug release profiles were studied as well.
Application of an Aqueous Ethylcellulose Dispersion in Multiple-Unit Pellet Systems.The objective of this poster reprint was to investigate drug release from compressed multiple-unit pellet systems, coated with an aqueous ethylcellulose dispersion (Surelease® E-7-19040).
CRS 2011 - Barrier Membrane Coating of Hydrophilic Matrices: A Strategy to Reduce Drug Release Variability and Possible Food EffectThe objective of the present study was to investigate the application of BM coating consisting of an aqueous ethylcellulose dispersion (Surelease® E-7-19010) and a pore former (Opadry®) as a strategy to reduce drug release variability from hydrophilic matrices as a function of hydrodynamics. The effect of coating weight gain and level of pore-former in the BM coating were also evaluated.
CRS 2011 - Barrier Membrane Coating of Hydrophilic Matrices: Influence of Tablet Shape and Geometry on Drug ReleaseThe shape and geometry of the matrix tablet is one of the critical parameters in determining the release rate from hydrophilic matrices.Barrier membrane coating of different shaped hydrophilic matrix tablets offers an opportunity for drug release modulation and tailoring the drug release profile in addition to advantages such as rebranding of existing products, and creating distinctive formulations.
CRS 2011 - The Influence of Aqueous Ethylcellulose Coating on the Performance of Hydrophilic Polyethylene Oxide Mini-Matrices Containing a Freely Water Soluble DrugRelease of freely water soluble metoprolol succinate from uncoated and sealcoated mini-matrices occurred within 3 hours. An application of Surelease® barrier membrane to mini-tabs resulted in extending drug dissolution up to 24 hours. As the weight gain of ethylcellulose coating increased, the release profile shifted towards zero order.
Comparative Study of Theoretical Versus Actual Weight Gain for a Surelease® Barrier Membrane on Coated PelletsThis poster reprint outlines an analytical method to determine the quantity of ethylcellulose applied during coating, on multiparticulates.
Effect of Hypromellose as a Pore-Former in Aqueous Ethylcellulose Dispersion: Characterization of Dispersion PropertiesThis poster reprint investigates the effect of HPMC as a pore-former on: stability of aqueous EC dispersion (Surelease®); quality of the free films prepared from these mixtures, and interactions between the HPMC and EC dispersion.
Evaluation of Alternative Plasticizers for Surelease®, an Aqueous Ethylcellulose Dispersion for Modified Release Film-CoatingThis poster reprint examines the effects of various plasticizers on the thermal and physical properties of ethylcellulose.
Hypromellose as a Pore Former in Aqueous Ethylcellulose Dispersion: Stability and Film PropertiesThis poster reprint investigates the effect of HPMC as a pore-former on: stability of aqueous EC dispersion (Surelease®); quality of the free films prepared from these mixtures, and interactions between the HPMC and EC dispersion.
Identification and Influence of Critical Coating Process Parameters on Drug Release from a Fully Formulated Aqueous Ethylcellulose DispersionThe objective of this poster reprint was to identify and study the influence of critical film coating process parameters for Surelease® aqueous ethylcellulose dispersion, on drug release behavior and the output or response variables of that process.
Investigation of the Relationship between Formulation Variables and Drug Release in Aqueous Ethylcellulose CoatingThis poster reprint summarizes the effect of pore former on the drug release of various actives from drug layered beads coated with Surelease®, aqueous ethylcellulose dispersion.
Predictability of Drug Release from Multiparticulate Systems Coated with an Aqueous Ethylcellulose DispersionThis poster reprint examines drug release from drug layered beads varying in substrate size, and Surelease® coating level.
The Effect of Hypromellose as a Pore-Former on Drug Release from Aqueous Ethylcellulose Film-Coated Dipyridamole-Loaded Non-Pareil BeadsThis poster reprint investigates the influence of pore-formers on the release of a poorly water-soluble drug, dipyridamole, from non-pareil beads coated with an aqueous ethylcellulose dispersion (Surelease® NG E-7-19050).
The Influence of Hydrophilic Pore Formers on Dipyridamole Release from Aqueous Ethylcellulose Film-Coated PelletsThis poster reprint studies the effect of incorporating water-soluble polyvinyl alcohol (PVA) and polyethylene glycol (PEG) as a pore former into Surelease® films, and how they influence dipryridamole release from the pellets.
The Influence of Plasticizer Type on the Film Properties of a Fully-Formulated Aqueous Ethylcellulose DispersionThis poster reprint examines the impact of choice of plasticizer on the dispersion behavior and film properties of a fully formulated aqueous ethylcellulose dispersion.
The Influence of Post Coating Thermal Treatment on Film Properties and Drug Release from Ethylcellulose Barrier Membrane Coating SystemsThe results of this study demonstrate that post coating treatment can affect both physico-mechanical properties of EC films and drug release from EC-coated multi-particulates.
A Comparison of the Performance Characteristics of Delayed-Release Film Coating Systems A comparison of the performance of Sureteric® versus various other delayed release polymers or formulated systems.
Coating Tablets with Sureteric® Optimum coating process parameters for Sureteric in laboratory, pilot, and production scale coating pans.
Delayed Release Coating of Aspirin Granules with Sureteric®Optimum coating process parameters for Sureteric in laboratory, pilot, and production scale fluid bed units.
Effect of Dissolution Media pH on the Release of Aspirin from Sureteric® Coated TabletsInvestigation into the effect of dissolution media pH on drug release from Sureteric coated aspirin tablets.
Sureteric® 90G18506 Product InformationFeatures and benefits of Sureteric 90G18506 PVAP (Phthalavin®) based delayed release coating systems.
Sureteric® YAE-6-18107 Product InformationFeatures and benefits of Sureteric YAE-6-18107 PVAP (Phthalavin®) based delayed release coating systems.
Sureteric® Preparation and Use GuidelinesOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for the Sureteric platform of delayed release coating systems.
Sureteric® Sales BrochureIntroduction to the Sureteric platform of PVAP (Phthalavin®) based, delayed release coating systems.
