Functional Excipients for the Formulation of Solid Oral Dosage Forms
Fully Formulated Conventional and Modified Release Film Coating Systems
Information on a Variety of Applications to Enhance Food Products
Pharmaceutical Printing Inks
Alphabetical Listing of All Products
Products by Excipient Functionality
Formulation Information for Specific Applications
Technical Information for Solid Oral Dosage Manufacturing Processes
Useful Tools for the Pharmaceutical Formulator
Technical Formulation and Development Seminars and Forums
On-tablet Authentication and Brand Protection
Brand Enhancement Services for Tablets
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Useful Tools to Assist Pharmaceutical Product Development
Extensive Collection of Articles, Product Literature, Application Data and Regulatory Documents
Products
Acryl-EZE® Optimal Coating ParametersThis ADS was adapted from the 2000 AAPS poster outlining the optimum coating process parameters for Acryl-EZE dispersions.
The Influence of In Vitro Dissolution Method on Lansoprazole Release from Enteric Coated Mini-TabsADS adapted from 2009 CRS poster, The Influence of In Vitro Dissolution Method on Lansoprazole Release from Enteric Coated Mini-Tabs
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 BrochureIntroduction to the Acryl-EZE platform of delayed release coating systems.
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.
FDA Draft Guidance Document Comments on Use of Inks, Pigments, Flavors and Taggants to Guard Against CounterfeitingColocon Press Release, August 10, 2009.
The Influence of Molecular Weight on Drug Release from Ethylcellulose Barrier Membrane MultiparticulatesADS adapted from 2009 CRS poster, The Influence of Molecular Weight on Drug Release from Ethylcellulose Barrier Membrane Multiparticulates
ETHOCEL™ Product Information BrochureIntroduction to the ETHOCEL™ line of premium ethylcellulose polymers.
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 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.
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
Maintaining Similar Drug Release from Hypromellose Matrices with Identical Dimensions but Different Dose StrengthsThis poster reprint provides a method to maintain similar drug release, tablet shape and weight, from a METHOCEL™ matrix, while adjusting the drug dose.
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.
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.
Direct Compression Metformin HCl 500mg Extended Release Formula Based on HypromelloseThis poster reprint investigates the formulation of an extended release, direct compression Metformin HCl (500 mg) matrix tablet using METHOCEL™.
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.
Evaluation of Verapamil HCl (240 mg) Extended Release Matrix Formulations This article reprint investigates 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 poster reprint investigates the effect of hydro-alcoholic dissolution media on the textural properties of METHOCEL™ matrices, and rheological properties of METHOCEL solutions.
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™.
Investigation of a Venlafaxine HCl (37.5mg) Extended Release Formulation using Hypromellose (HPMC) MatricesPoster reprint 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 Effects of Hydro-Alcoholic Media on Rheological and Textural Properties of Various Grades of Hypromellose (HPMC)This poster reprint expands 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.
Mathematical Model for Simulation and Control of Drug Release from Hydrophilic MatricesThis poster reprint 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 EffectPoster reprint 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 poster reprint investigates swelling and coalescence behaviour 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.
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 Effect of Film Coating and Storage Conditions on the Performance of Metformin HCl 500 mg Extended Release Hypromellose MatricesThis poster reprint investigates 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 poster reprint examines 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 poster reprint summarizes 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 MatricesPoster reprint 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 poster reprint 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 poster reprint investigates 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 PolyersThe 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 poster reprint examines 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 PolymersThe purpose of this study was to evaluate 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.
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.
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.
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.
Delayed Release Coating of Garlic Tablets with Nutrateric in a 24" Fully Perforated side vented pan (Accela-Cota® type) Recommendations for the application of Nutrateric onto garlic tablets in a side-vented coating pan.
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
Delayed Release Coatings for Nutritional Supplements using Nutrateric® PigmentedOutline of the recommended dispersion mixing procedures, coating levels, and cleaning guidelines for Nutrateric.
Nutrateric® - Stability and Use GuidelinesSummary of Nutrateric dispersion characteristics and stability. Demonstration of enteric protection on garlic tablets.
Nutrateric® Sales BrochureIntroduction to the Nutrateric platform of delayed release coating systems.
Evaluation of a Continuous Coating Process for the Application of a Regulatory Compliant Nutritional Enteric Coating on Soft Gelatin CapsulesThe 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 poster reprint summarizes the performance of Nutrateric when applied to tablets or soft gelatin capsules.
The Influence of Plasticizers and a Stabilizer on Aqueous Delayed Release (DR) Coating Systems on Soft Gelatin CapsulesThis poster reprint 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®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 poster reprint investigates the application of Nutrateric on aspirin and caffeine cores to achieve enteric protection.
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.
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, 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 – 94 Series: Preparation & Use GuidelinesProduct Information for Opadry Enteric - 94 series - prep & use.
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 Sales BrochureIntroduction to the Opadry Enteric platform of PVAP (Phthalavin®) based, delayed release coating systems.
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.
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 poster 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 - ReconstitutionMixing procedure and holding instructions for Opadry II coating formulations.
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 - 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.
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.
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™ 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.
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.
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
POLYOX™ Product Information BrochureIntroduction to the POLYOX™ line of water soluble resins.
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 In-vitro Dissolution Method on the Release of a Highly Water Soluble Drug from Polyethylene Oxide and Hypromellose Hydrophilic Extended Release MatricesThe 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.
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
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.
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.
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.
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® used as a binder and disintegrant in high shear wet granulation. Comparison to PVP and Croscarmellose SodiumThis paper illustrates the benefits of utilizing Starch 1500 as both a disintegrant and binder in a high shear wet granulation application in the place of a polymeric binder and super 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
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.
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.
Lansoprazole (15mg) Delayed Release Capsule Formulation Using Acryl-EZE 93F19255 - English
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 16/18Product Information
SureSpheres 16/20Product Information
SureSpheres 18/20Product Information
SureSpheres 20/25Product Information
SureSpheres 25/30Product Information
SureSpheres 30/35Product Information
SureSpheres 14/18Product Information
SureSpheres Product Information BrochureSureSpheres features & benefits
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.
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.
Lansoprazole Delayed Release MultiparticulatesCharacterization of Delayed Release Lansoprazole Multiparticulates: Impact of Biorelevant Dissolution Media
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 ethylcellulose solution viscosity and consequent drug release from coated beads.
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
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.
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).
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.
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.
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.