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Processes
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.
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.
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.
Acryl-EZE® Coating ParametersRecommended coating process parameters for Acryl-EZE in laboratory, pilot, and production scale coating pans.
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.
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.
Opadry® amb - Moisture Vapor TransmissionEvaluation of Opadry amb compared with alternative coating formulations and their effect on moisture uptake.
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.
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.
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.
Opadry® fx™ Enhanced Moisture Protection and Film PropertiesCharacterization of moisture vapor transmission rate and other film properties of Opadry fx.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
Wet Granulation of Acetaminophen with Starch 1500® Highlights the performance improvements in tablet hardness and disintegration of Starch 1500 over PVP.
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.
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.
