Patent number: 5935939
Abstract: The present invention provides for stabilization of misoprostol in solid dispersions using amorphous excipients or excipients which have been converted to an amorphous state such as hydroxypropyl cellulose, methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, cellulose acetate phthalate, cellulose acetate butyrate, hydroxyethyl cellulose, ethyl cellulose, polyvinyl alcohol, polyethylene glycol, starch, polypropylene, dextrans, dextrins, hydroxypropyl .beta.-cyclodextrin chitosan, co-(lactic/glycolic)copolymers, poly(orthoester), polyvinyl chloride, polyvinyl acetate, ethylene vinyl acetate, lectins, carbopols, silicon elastomers, cyclodextrins, polyacrylic polymers, maltodextrins, lactose, fructose, inositol, trehalose, maltose, and raffinose, (and other mono-, di- and tri- saccharides) and .alpha.-, .beta.- and .gamma.-cyclodextrins, and more preferably the excipients which are used are dextran, maltodextrin, hydroxypropyl .beta.-cyclodextrin and maltose.
Type:
Grant
Filed:
September 9, 1996
Date of Patent:
August 10, 1999
Assignee:
G. D. Searle & Co.
Inventors:
Tugrul T. Kararli, David Otto, Stanley C. Penzotti, Jr., James E. Truelove