David P Otto

US Patent:

59359390, Aug 10, 1999

Filed:

Sep 9, 1996

Appl. No.:

8/709708

Inventors:

Tugrul T. Kararli - Skokie IL
David Otto - Vernon Hills IL
Stanley C. Penzotti - Green Oaks IL
James E. Truelove - Libertyville IL

Assignee:

G. D. Searle & Co. - Chicago IL

International Classification:

A61K 3170

US Classification:

514 54

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.