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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 fromHypromellose MatricesCase study indicating that incorporation of Starch 1500® in ER formulation design can provide benefits in supporting Quality by Design (QbD) study and minimizing formulation variability.
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.
