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Use of Low Viscosity Polymers for Pharmaceutical Solid Dosage Forms

IP.com Disclosure Number: IPCOM000191494D
Publication Date: 2010-Jan-05
Document File: 4 page(s) / 103K

Publishing Venue

The IP.com Prior Art Database

Abstract

Beyond the use of low viscosity HPMC, MC, and other water soluble film forming polymers for increased coating throughput, a variety of coating and matrix properties can result from utilization of low viscosity HPMC, MC, and other water soluble film forming polymers.

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                                                                                                                        Dec 15, 2009

Use of Low Viscosity Polymers for Pharmaceutical Solid Dosage Forms

-disclosed anonymously

Water-soluble cellulose ethers are commonly used as a film coating material on pharmaceutical solid dosage forms. As is often the case with any film coated product, the quality and function of the product, including its performance characteristics, may be influenced by: the nature of the substrate, the conditions of the coating process, and the type and quantity of the coating applied.  As used herein pharmaceutical solid dosage forms includes, for example, powders, granules, capsules, tablets, beads, films, microspheres, microencapsulated drugs, multi tablet systems, etc. Recently low viscosity hydroxypropylmethylcellulose, HPMC, and methylcellulose, MC, have become preferred polymers for use in high performance coating applications for pharmaceutical solid dosage forms due to the specific advantages in the coating process obtained by using lower molecular weight HPMC or MC.  The present disclosure is also directed to various methods for producing pharmaceutical solid dosage forms from compositions containing low viscosity HPMC or MC.   

The molecular weight of these polymers is typically characterized by measuring the solution viscosity and can typically range from about 1.2 to about 50 cps for a 2% solution measured at 20°C using a Ubellohde type viscometer according to the method described in ASTM, D-1347 for MC or ASTM D-2363 for HPMC.  The polymer materials at the lower end of the viscosity range allow for higher solids loading (e.g., fillers, plasticizers, surfactants, lubricants, polishing agents, coloring agents, opacifiers, anti-tack agents and glidants, etc) at lower overall formulation viscosities, improving the solids content of typical low viscosity based coating.  Instead of coating at typical 17-20% solids, the lower viscosity material allows one to coat for example at a higher range of 20-30% solids.

An example of a cellulose ether may be a high-hydroxypropyl cellulose ether or a low- hydroxypropyl cellulose ether.  As used herein, a “high-hydroxypropyl cellulose ether” is a hydroxypropylmethylcellulose having 28-30% by weight methoxyl groups and 7.0-12.0% by weight hydroxypropoxyl groups.  A “low-hydroxypropyl cellulose ether” is a hydroxypropylmethylcellulose having 27-30% by weight methoxyl groups and 4.0-7.5% by weight hydroxypropxyl groups.  Another example of a cellulose ether is a methylcellulose ether.  As used herein, a methyl cellulose ether has a methoxy substitution of about 21 - 42 % by weight methoxyl groups.

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