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Granulation
Scale-Up Trials of Foam-Granulation Technology — High Shear (579 KB PDF)
The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulations equipment at the laboratory, pilot, and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
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METHOCEL as a Granulation Binding Agent for Immediate-Release Tablet and Capsule Products (146 KB PDF)
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Use of DOW Cellulose Ethers in Granulation - Initial Recommendations (13 KB PDF)
This one-page chart offers you a starting point guideline in selecting the appropriate METHOCEL* products for use in granulation applications.
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Aqueous Granulation of an Ethylcellulose Containing Inert Matrix Formulation (264 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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Investigation into the Mechanical Behavior of Selected Pharmaceutical Polymer Excipients as Binding Agents in Roller Compaction (235 KB PDF)
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Aqueous Granulation of an Ethylcellulose Containing Inert Matrix Formulation (264 KB PDF)
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Evaluation of the Use of METHOCEL in Fluid Bed Granulation As a Dry Binder - AAPS '95 (127 KB PDF)
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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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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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Hansen Solubility Parameters for Selected Cellulose Ether Derivatives and Their Use in Pharmaceutical Industry (81 KB PDF)
This paper describes a laboratory method used for determining the partial solubility parameters of five METHOCEL and six ETHOCEL* cellulose ether products. These laboratory derived values extend the data base of solubility parameters that have been used to understand phenomena like film coating adhesion, and cohesive and adhesive forces between substrates and polymeric binders in wet granulation processes. The paper characterizes the cellulose ethers in terms of non-polar, polar, and hydrogen bonding behavior. (1992)
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Granulation with Dow Cellulosic Polymers I. Fluid Bed Granulation (460 KB PDF)
A 24-page technical article that details model studies for fluid bed granulation using METHOCEL Premium products as binders. Performance of METHOCEL Premium cellulosic polymers in three model systems is reported. Numerous charts portray granulation properties, dissolution rates, friability and hardness measures, and other results from tests on model formulations. (Last Printed January 2001)
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Granulation with Dow Cellulosic Polymers II. High Shear Granulation (717 KB PDF)
A 26-page technical article that details model studies for high shear granulation using METHOCEL Premium products as binders. Performance of METHOCEL Premium cellulose polymers in three model systems is reported. Numerous charts portray granulation properties, dissolution rates, friability and hardness measures, and other results from tests on model formulations. (Last Printed January 2001)
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Granulation with Dow Cellulosic Polymers III. Low Shear Granulation (317 KB PDF)
This 28-page brochure reports on in-depth studies of the performance of various binder polymers in three model systems produced by low shear granulation. Polymers studied are methylcellulose, hypromellose, hydroxypropyl cellulose, povidones, acacia, and pregelatinized starch. The three model drug systems included acetaminophen (high-dose, low solubility), Vitamin C (high-dose, high solubility), and methazolamide (low-dose, low solubility). The study reports on many performance variables, including particle size distributions of the granulates, tablet hardnesses and friabilities, and tablet dissolution properties. (Last Printed May 1996)
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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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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 Containing 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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Polyethylene Oxide Matrix Tablets Prepared by Roller Compaction (606 KB PDF)
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Use of a Novel Foam Granulation Technique to Incorporate Low Drug Loading into Immediate Release Tablet Formulations (758 KB PDF)
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Foam Technology: The Development if a Novel Technique for the Delivery of Aqueous Binder Systems in High-shear and Fluid-Bed Wet-Granulation Applications (309 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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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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Scale-up of a Controlled-Release Tablet Formulation Based on Hypromellose and Manufactured Using Roll Compaction Technology (373 KB PDF)
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Investigation into the Mechanical Behavior of Selected Pharmaceutical Polymer Excipients as Binding Agents in Roller Compaction (235 KB PDF)
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Water Granulation with POLYOXTM WSR (175K PDF) (176 KB PDF)
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Salt-Enhanced Granulation of Matrix Tablets Prepared with POLYOX WSR Coagulant NF (686 KB PDF)
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† Previously referred to as hydroxypropyl methylcellulose or HPMC
®™*Trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow.
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