Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2005-09-20
2005-09-20
Spear, James M. (Department: 1618)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S474000, C424S475000, C424S477000, C424S480000, C424S482000, C424S491000, C424S493000, C424S494000, C424S495000, C424S497000
Reexamination Certificate
active
06946146
ABSTRACT:
The present invention is directed to a coating composition for coating a solid dosage form of a medicament, where the coating composition controls the release of the medicament, said coating composition comprising (a) at least 50% (w/w) by dry weight of a water insoluble polymer insoluble in both acidic, basic and neutral pH, present in the form of an aqueous latex dispersion, (b) a water soluble non-polymeric component present in a weight ratio of about 5 to about 50% (w/w) by dry weight of the coating, having a molecular weight of less than about 15,000 daltons and water solubility in excess of 5 grams per 100 grams of water at room temperature at 1 atm pressure, said water soluble non-polymeric component being organic and either solid or liquid; said ratio of water insoluble polymer to water soluble non-polymeric component ranging from about 95:5 to about 1:1, the solid content in the coating composition ranges from about 5% to about 25%, said water soluble component being completely dissolved in the aqueous latex dispersion. The present invention is also directed to a system for the controlled release of an active medicament comprising a substrate and a coating, said substrate comprising a therapeutically effective amount of a medicament in association with a pharmaceutical carrier in solid unit dosage form, said substrate being uniformly coated with the aforesaid coating composition.
REFERENCES:
patent: 4330338 (1982-05-01), Banker
patent: 4963365 (1990-10-01), Samejima et al.
patent: 5126146 (1992-06-01), Seminoff et al.
patent: 5595762 (1997-01-01), Derrieu et al.
patent: 6251432 (2001-06-01), Mazer et al.
Nostrum Pharmaceuticals Inc.
Scully Scott Murphy & Presser
Spear James M.
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