Using METHOCEL* Cellulose Ethers for Controlled Release of Drugs in Hydrophilic Matrix Systems (2 MB PDF)
When METHOCEL Premium hypromellose† is used in controlled-release matrix systems, strong, fast-forming, highly viscous gels result. Here is a 32-page technical brochure that gives formulation guidelines and a detailed discussion of system variables and highly reliable polymer effects. These include solution viscosity and hydration rates, tablet dissolution, polymer-drug excipient interactions, effects of drug solubility, effect of pH…as well as other formulation and manufacturing considerations.
Japanese version (2.2MB)
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Introducing METHOCEL™ DC Grade Hypromellose Polymers for Direct Compression of Controlled Release Dosage Forms (438 KB PDF)
Overview brochure that describes a direct compression (DC) Dow Wolff Cellulosics excipient for pharmaceutical applications: METHOCEL™ Premium DC Grade Hypromellose Polymers for Direct Compression of Controlled Release Dosage Forms. This is a water-soluble METHOCEL Premium methylcellulose that can eliminate the need for wet granulation and provides excellent tablet processing, physical properties, and dissolution profiles. The brochure summarizes the major technical advantages and lab data for two grades of this product in pharmaceutical formulations and provides a starting point for product selection. Includes direct comparisons to formulations containing METHOCEL Premium Controlled Release Grades.
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Drug Formulation Studies Using a New Grade of Hypromellose Excipient Designed for Direct-Compression, Controlled-Release Applications (231 KB PDF)
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| Supplements to above Controlled Release Brochure |
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Stability of Physical Properties and Drug Release of Controlled-Release Matrix Tablet Formulations Containing METHOCEL Cellulose Ethers (187 KB PDF)
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Roll Compaction Granulation of a Controlled Release Matrix Tablet Formulation Containing METHOCEL K4M Premium Ethers (276 KB PDF)
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| Additional literature and technical information |
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Effect of Filler Type on the Stability of Polyethylene Oxide in a Hydrophlic Matrix Tablet (124 KB PDF)
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A New Hypromellose Excipient for Direct Compression Controlled Release (768 KB PDF)
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Evaluation of Formulations Produced via Hot Melt Extrusion that Contain High API Loading and Exhibit Controlled Release (318 KB PDF)
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A Re-examination of the Contributions of Diffusion and Polymer Erosion to Overall Drug Release from Hydrophilic Matrix Tablets (210 KB PDF)
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Designed Studies on the Effects of Hypromellose Substitution Levels on Sustained Drug Release from Hydrophilic Matrix Tablets (780 KB PDF)
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Application of the Stationary Basket in the USP Type II Dissolution Apparatus to the Study of Hydrophilic Matrix Tablets (81 KB PDF)
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Effects of PEO Particle Size Distribution on CR Tablets by Direct Compression Method (94 KB PDF)
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Modeling and Experimental Validation of Drug and Polymer Release from Hypromellose-Drug Compacts (625 KB PDF)
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Application of QSPR to Modeling of Drug Release from Hypromellose-Drug Compacts (568 KB PDF)
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Investigation of the Influence of Polyethylene Oxide in a Compression-Coated, Controlled-Release Tablet Containing a Water-Soluble Active (66 KB PDF)
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Solid Solution of a Poorly Soluble Model Drug in a Phase-Separated Polymer Matrix: Melt Prepared Dispersions Based on POLYOXTM WSR (419 KB PDF)
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ETHOCEL* FP Polymers Product Specification Sheet (195 KB PDF)
This literature provides an introduction to the use of ETHOCEL Premium Fine Particle (FP) grade polymers in solvent-free pharmaceutical applications. Provides an overview of the use of these polymers in controlled release matrix systems. Includes product specifications for ETHOCEL 7 FP, ETHOCEL 10 FP, and ETHOCEL 100 FP Premium polymers, as well as United States regulatory information.
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Ethylcellulose Controlled Release Coating: Effects of Plasticizers, Additives and Solvents (530 KB PDF)
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Development of a Controlled Release Matrix Tablet Containing a Water-Soluble Drug Utilizing Hypromellose and Ethylcellulose (374 KB PDF)
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Influence of the Particle Size of the Inert Polymer in a Compression Coated Controlled Release Tablet (446 KB PDF)
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Polyethylene Oxide Matrix Tablets Prepared by Roller Compaction (606 KB PDF)
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Ethylcellulose Controlled Release Coating: Effects of Plasticizers, Additives and Solvents (606 KB PDF)
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Application of the "Sequential Layer" Model to Drug Release Profiles (187 KB PDF)
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Implementation of the "Sequential Layer" Controlled Release Model (179 KB PDF)
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Investigation of the Influence of Polyethylene Oxide in a Compression-Coated, Controlled-Release Tablet Containing a Water-Soluble Active (66 KB PDF)
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Development of a Controlled Release Matrix Tablet Containing a Water-Soluble Drug Utilizing Hypromellose and Ethylcellulose (111 KB PDF)
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Effect of Process Conditions on Various Sustained Release Formulations During Wet Granulation (2 MB PDF)
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Development of a Compaction Process to Enhance Dissolution of Poorly Water-Soluble Drugs Utilizing Hypromellose† (771 KB PDF)
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A Designed Study of Compression Parameters for a Sustained-Release Hydrophilic Matrix Tablet Formulation (469 KB PDF)
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Direct Compression of Sustained-release Hydrophilic Matrix Tablets Containing Hypromellose and MCC: Effects of a Lubricant (311 KB PDF)
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Investigation of the Effect of Surface Area/Volume on Drug Release From Hypromellose Controlled Release Tablets (690 KB PDF)
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Lab-Scale to Full Production Scale Evaluation of a Controlled Release Formulation Based on Hypromellose and Manufactured Using Roller Compaction Technology (489 KB PDF)
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Direct Compression of Sustained-Release Hydrophilic Matrix Tablets Containing Hypromellose and MCC Part II: Effects of Silicified MCC Grades and a Glidant on Powder Flow (744 KB PDF)
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A study of Polymer Blending and Polymer Erosion of Different Viscosity Grades of Hypromellose for Hydrophilic Matrix Tablets (440 KB PDF)
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Direct Compression of Sustained-Release Hydrophilic Matrix Tablets Containing Hypromellose and MCC - Part I: Initial Powder Flow and Tablet Physical Properties with Lactose Filler (335 KB PDF)
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Scale-up of a Controlled-Release Tablet Formulation Based on Hypromellose and Manufactured Using Roll Compaction Technology (373 KB PDF)
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Influence of the Particle Size of the Inert Polymer in a Compression Coated Controlled Release Tablet (446 KB PDF)
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Polymer Erosion of Hydrophilic Matrices (238 KB PDF)
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A Comparison Study of the Effect of Polymer Characteristics and Applied Coating Level on Controlled Release Matrix Systems (388 KB PDF)
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The Effect of Dissolution Media on Drug Release from CR Tablets (138 KB PDF)
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The Effect of Polymer Level, Polymer Viscosity, and Film Coating Level on a Controlled-Release Matrix Tablets (581 KB PDF)
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Influence of Filler/Binder Composition on the Properties of an Inert Matrix Controlled Release System (79 KB PDF)
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Initial Evaluation of Selected Variables Affecting the "Robustness" of Matrix Controlled-Release Tablet Formulations Containing Hypromellose Polymers (780 KB PDF)
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Evaluation of Granulation, Excipient Characteristics, and Drug Solubility in the Preparation of Hydrophilic Controlled-Release Matrix Tablets (146 KB PDF)
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Evaluation of Fine Particle Size ETHOCEL Polymer for use in Controlled-Release Matrix Drug Delivery - CRS '96 (374 KB PDF)
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Effects of Dissoultion Media pH on Drug Release from Controlled-Release Matrix Tablets Containing Hypromellose and Acidic and Basic Additives - AAPS '95 (148 KB PDF)
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Evaluation of FP Size ETHOCEL Polymer for Use in Controlled Release Matrix Drug Delivery - CRS '95 (374 KB PDF)
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Investigation of the Effect of Tablet Surface Area/Volume on Drug Release from Hydroxypropylmethylcellulose Controlled-Release Matrix Tablets (2 MB PDF)
This ten page article was originally published in Drug Development and Industrial Pharmacy in 2002. The purpose of this study was to investigate the influence of tablet surface area/volume (SA/Vol) on drug release from controlled-release matrix tablets containing hydroxypropylmethylcellulose (HPMC).
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A Compaction Process to Enhance Dissolution of Poorly Water-Soluble Drugs Using Hydroxypropyl Methylcellulose (Hypromellose) (704 KB PDF)
This is an eleven page article, which was originally published in the International Journal of Pharmaceutics. The purpose of this study was to develop a technique to enhance the dissolution rate of poorly water-soluble drugs with Hydroxypropyl Methylcellulose (Hypromellose) without the use of solvent or heat addition.
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The Effects of Roll Compaction Equipment Variables, Granulation Technique and Hypromellose Polymer level on a Controlled-Release Matrix Model Drug Formulation (177 KB PDF)
This journal article, reprinted from Pharmaceutical Technology Europe, describes a study of the effects of roll compaction equipment variables, roll design, granulation technologies, and concentration of hypromellose polymer on the physical properties of a model controlled-release drug formulation. This article also appeared in Pharmaceutical Technology in March 1999.
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Roll Compaction Granulation of a Controlled-Release Matrix Tablet Formulation Containing Hypromellose†: Effect of Process Scale-up on Robustness of Tablets, Tablet Stability, and Predicted In Vivo Performance (151 KB PDF)
This journal article, reprinted from the November 2000 issue of Pharmaceutical Technology, details a study of the effects on a theophylline controlled release formulation which is dry granulated in a laboratory-scale roller compactor and then scaled up to pilot-scale and to full production-scale. Physical property, drug dissolution, drug-release, and stability testing are thoroughly discussed.
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Roll Compaction Granulation of a Controlled-Release Matrix Tablet Formulation Containing Hypromellose†: Effect of Process Scale-up on Robustness of Tablets and Predicted In Vivo Performance (716 KB PDF)
This journal article, reprinted from a special insert on Tableting & Granulation from the October 1999 issue of Pharmaceutical Technology, details a study of the effects of roll compaction equipment scale-up on tablet robustness of a model matrix controlled-release formulation that contained hypromellose with theophylline as the model drug. The effects of scale-up from laboratory to pilot plant on granulation, tablet physical properties, and drug release of samples produced with roll compaction were compared with samples produced by direct compression.
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The Effects of Roll Compaction Equipment Variables, Granulation Technique and Hypromellose Polymer level on a Controlled-Release Matrix Model Drug Formulation (177 KB PDF)
This journal article, reprinted from Pharmaceutical Technology Europe, describes a study of the effects of roll compaction equipment variables, roll design, granulation technologies, and concentration of hypromellose polymer on the physical properties of a model controlled-release drug formulation. This article also appeared in Pharmaceutical Technology in March 1999.
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Comparison of Low-Shear and High-Shear Wet Granulation Techniques and the Influence of Percent Water Addition in the Preparation of a Controlled-Release Matrix Tablet Containing Hypromellose and a High-Dose, Highly Water-Soluble Drug (180 KB PDF)
This eight-page report was originally published in Pharmaceutical Technology magazine. The authors studied the effects of granulation technique and water addition levels on the physical properties of, and subsequent drug release from, tablets made from a controlled-release matrix formulation containing hypromellose and a high-dose, highly water-soluble drug (niacinamide). The results indicated that the level of water addition and the method of wet granulation (low shear versus high shear) had little effect on tablet physical properties and drug release. However, increasing levels of water addition resulted in increasing densification of granules. (March 1996)
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Evaluation of Various Polymers As Dry Binders in the Preparation of an Immediate-Release Tablet Formulation by Roller Compaction (167 KB PDF)
This 12-page article, which originally appeared in Pharmaceutical Technology magazine, describes an evaluation of nine commonly used polymers as dry binders for the manufacture of an immediate-release (IR) niacinamide tablet formulation using a roller compaction (dry granulation) process. Polymers studied were one methylcellulose, three hypromellose, two polyvinylpyrolidones, one pregelatinized cornstarch, and one microcrystalline cellulose. The study includes evaluations of tablet hardness and friability; granule particle sizes; and drug release rates for each of the polymers at three different levels. (October 1995)
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Effects of Lubricant Level, Method of Mixing, and Duration of Mixing on a Controlled-Release Matrix Tablet Coating Hypromellose (136 KB PDF)
Reprinted from Drug Development and Industrial Pharmacy, this 8-page article explores the effects of the lubricant magnesium stearate at different concentrations, mixing shear rates, and mixing times on the tablet properties and drug dissolution from controlled-release matrix tablets containing hypromellose 2208, USP, (METHOCEL K4M Premium). Studies were performed on diphenhydramine HCl and hydrochlorothiazide model drug formulations using spray-dried lactose and anhydrous dibasic calcium phosphate as the model excipient/fillers. The article provides data on resulting particle size distributions, crush strengths, friabilities, and dissolution characteristics of the various formulations. (1995)
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Use of Roller Compaction in the Preparation of Controlled-Release Hydrophilic Matrix Tablets Containing Methylcellulose and Hypromellose Polymers (121 KB PDF)
This journal article, reprinted from Pharmaceutical Technology, describes a study of roller compaction effects in the dry granulation of a controlled release matrix formulation containing methylcellulose or hypromellose. The authors evaluated the effect of roller compaction variables on tablet physical characteristics and drug-release profiles. Detailed charts show the results. (September 1994)
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Reworkability of Sustained-Release Tablet Formulations Containing Hypromellose Polymers (114 KB PDF)
Originally published in Pharmaceutical Technology magazine, this article evaluates the ability of sustained-release tablet matrix systems containing hypromellose to physically withstand the mechanical processes involved in a reworking procedure. The article covers the influence of polymer chemistry (substitution), the rework procedure, powder reblending levels, and the compression force on particle size distribution, tablet friability, and tablet hardness characteristics. Also investigated were the impact of the milling, remixing, and recompression processes on the in vitro drug-release dissolution profiles for three model drugs: ascorbic acid, chlorpheniramine maleate, and meclizine dihydrochloride. (Last Printed March 2000)
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Empirical Modeling of Tablets Containing Hypromellose (51 KB PDF)
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The Effect of Nozzle Type and Atomization Conditions on High-shear Granulation of a Sustained Release Formulation Containing HPMC (317 KB PDF)
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