Duramed Pharmaceuticals, Inc.

Other

Andrx Labs, LLC

Hallmark Pharmaceuticals, Inc.

Hallmark Pharmaceutical, Inc.

Guohua Zhang

Prasad Pinnamaraju

Muhammad Amzad Ali

Xiu Xiu Cheng

Manesh Dixit

Xiaohong Qi

A controlled release diltiazem dosage formulation comprising a plurality of diltiazem pellets and a gel-forming material where the time of maximum diltiazem blood plasma levels occurs more than 8 hours after administration and preferably more than 10 hours after administration.

Diltiazem controlled release formulation and method of manufacture

Depot drug formulations include the pharmaceutical itself and a three component release rate controlling matrix composition. The three components of the matrix composition are (1) a pH dependent gelling polymer such as an alginate component, (2) an enteric polymer component, such as Eudragit&reg; L or S, and (3) a pH independent gelling polymer, such as hydroxy propyl methyl cellulose or polyethylene oxide. The drug release rate can be adjusted by changing the amount of one or more of these components of the composition.

Sustained release formulation containing three different types of polymers and tablet formed therefrom

Sustained release drug formulations contain the pharmaceutical itself and a three component release rate controlling matrix composition. The three components of the matrix composition are (1) water insoluble polymer, such as ethyl cellulose, (2) pH dependent gelling polymer, such as sodium alginate, and (3) a pH independent gelling polymer, such as hydroxypropyl methylcellulose. The drug release rate can be adjusted by changing the amount of one or more of these components of the composition.

Water insoluble polymer based sustained release formulation

Depot drug formulations include the pharmaceutical itself and a three component release rate controlling matrix composition. The three components of the matrix composition are (1) a pH dependent gelling polymer such as an alginate component, (2) an enteric polymer component, such as Eudragit.RTM. L or S, and (3) a pH independent gelling polymer, such as hydroxy propyl methyl cellulose or polyethylene oxide. The drug release rate can be adjusted by changing the amount of one or more of these components of the composition.

Sustained release formulation containing three different types of

Verapamil depot drug formulations include the pharmaceutical itself and a three component release rate controlling matrix composition. The three components of the matrix composition are (1) an alginate component, such as sodium alginate, (2) an enteric polymer component, such as methacrylic acid copolymer, and (3) a pH independent gelling polymer, such as hydroxypropyl methylcellulose or polyethyleneoxide. The drug release rate can be adjusted by changing the amount of one or more of these components of the composition.

The subject invention is a process to manufacture a sustained release pharmaceutical tablet. The process includes granulation of inactive ingredients, such as hydroxypropyl cellulose, with active ingredients, such as nifedipine; followed by micronization of the granules. Additional granulation of further active or inactive ingredients is done with or without the micronized granules formed in the first step. All of the granules are then dried if necessary, lubricated, and compressed into tablets which slowly release the active ingredient over a controlled length of time.

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Parsippany, NJ, United States of America

Guohua Zhang