Sustained release microsphere preparation containing antipsychotic drug and production process thereof
AssigneeYoshitomi Pharmaceutical Industries, Ltd.
InventorsShigemi Kino, Tomonori Osajima, Hiroaki Mizuta
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Abstract
A sustained release microsphere preparation which is produced by including a hydrophobic antipsychotic drug such as bromperidol, haloperidol or the like into a base composed of a high molecular weight polymer having in vivo histocompatibility such as polylactic acid, poly(lactic-co-glycolic)acid or the like, and a process for the production thereof.
Claims4
An antipsychotic drug-containing sustained release microsphere preparation having an almost zero order rate of release when administered to a patient in need thereof and having an average particle size of about 15 to 50 .mu.m, wherein a drug bromperidol or haloperidol is in a form of microcrystals having an average particle size of about 0.5 to 5 .mu.m and is included in a base comprising a high molecular weight polymer having in vivo histocompatibility selected from the group consisting of polylactic acid and poly(lactic-co glycolic)acid.
A process for producing an antipsychotic drug-containing sustained release microsphere preparation having an almost zero order rate of release when administered to a patient in need thereof and having an average particle size of about 15 to 50 .mu.m which comprises making an oil layer comprising a high molecular weight polymer having in vivo histocompatibility selected from the group consisting of polylactic acid and poly(lactic-co-glycolic)acid containing bromperidol or haloperidol in the form of microcrystals having an average particle size of about 0.5 to 5 .mu.m, adding the oil layer to a water layer, subjecting the resulting mixture to an emulsification treatment to obtain an O/W type emulsion and subsequently removing the solvent in the oil layer by an in-water drying method.
Dependencies are inferred from the claim text.