Fmc Corporation

E. R. Squibb Sons, Inc.

George E Reier

Michael Augello

Sheila M Dell

Nemichand B Jain

Thomas A Ruszkay

Howard J Stamato

George A Agyilirah

Lynn M DiMemmo

Joseph D Drost

Michael Auguello

The present invention describes the use of croscarmellose sodium to coat bitter-tasting active agents in a manner that will mask the bitter taste of these materials, taste masked pharmaceutical compositions in which the particles of pharmaceutically active agent are coated with croscarmellose sodium, taste masked pharmaceutical tablets made therefrom, in which the rapid disintegration of tablets that is imparted by croscarmellose sodium is preserved, and to a method for preparing such coated particles by preparing them in a fluidized bed coating process.

Croscarmellose taste masking

The present invention discloses an improved excipient composition for use as an excipient/binder for wet granulation of pharmaceuticals, a process for preparing the excipient composition, its use in granular pharmaceutical compositions, and compressed pharmaceutical tablets made from the granular pharmaceutical compositions. The excipient composition comprises a dried aqueous slurry of microcrystalline cellulose wetcake and a low viscosity alginate.

Microcrystalline cellulose/alginate wet granulation excipient/binder

Rapidly disintegrating and readily suspendible tablets and their method of preparation are disclosed in which there is a therapeutic amount of a pharmacologically active ingredient, 1 to 6 percent croscarmellose sodium, 10 to 50 percent microcrystalline cellulose, and 10 to 50 percent of a coprocessed additive consisting essentially of 75 to 95 percent microcrystalline cellulose and 5 to 25 percent calcium, sodium alginate complex. The tablets are suitable for oral administration of measured-dose suspensions of either water soluble or water insoluble pharmaceuticals.

Pharmaceutical suspension tablet compositions

Particulate pharmaceutical tablet excipient compositions comprising co-processed microcrystalline cellulose and particulate USP calcium carbonate having a particle size distribution of 7 to 22 .mu.m wherein the range of calcium carbonate to microcrystalline cellulose is 70:30 to 90:10.

Co-processed products

A controlled release pharmaceutical formulation which undergoes substantially or approaches zero order release of active drug is provided, preferably in the form of a coated tablet, containing a core portion from which medicament, such as procainamide hydrochloride, is slowly released over a controlled length of time. The core also includes one or more primary hydrocolloid gelling agents which is a hydropropylmethyl cellulose having a viscosity of within the range of from about 1,000 to about 6,000 centipoises in 2% solution at 20.degree. C., and a methoxyl content of 28-30%, optionally a secondary hydrocarbon gelling agent, such as hydroxypropyl cellulose and/or methyl cellulose, one or more non-swellable binders and/or wax binders (where the medicament and/or hydrocolloid gelling agents are non-compressible), one or more inert fillers or excipients, one or more lubricants, and optionally one or more anti-adherents such as silicon dioxide and water. The above-described core is coated with a pharmaceutical coating composition containing a hydrophobic polymer and a hydrophilic polymer.

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Somerset, NJ, United States of America

George E Reier