Back to results
US 12,702,647 B2Granted
Enteric bisacodyl softgel capsule
AssigneeR.P. Scherer Technologies, LLC
InventorsKarunakar Sukuru, Qi Fang, Haitao Li, Yafei Lyu
Life of this patent
Estimating the term…
Abstract
Softgel capsules comprise a fill material and a shell composition, wherein the fill composition includes bisacodyl and the shell composition includes a film forming material and an enteric polymer. The softgel capsules further include 5 parts by weight of bisacodyl based on 100 parts by weight of the fill material. A method for producing the softgel capsule using a gel conversion is also provided.
Claims22
A softgel capsule comprising:
- (a) a fill material comprising bisacodyl or a pharmaceutically acceptable salt, a lipid comprising soybean oil, and a suspending agent comprising hydrogenated vegetable oil;
- and (b) a shell composition comprising a film forming material, a plasticizer comprising sorbitol and sorbitan, and an enteric polymer comprising pectin;
- wherein the fill material comprises about 5 parts by weight to about 10 parts by weight of bisacodyl based on 100 parts by weight of the fill material;
- wherein the fill material comprises from about 90 wt % to about 95 wt % of lipid based on a total composition of the fill material;
- wherein the softgel capsule remains intact for at least about 15 minutes when a disintegration test is performed in a USP Apparatus II with paddles at a speed of 50 rpm in pH 1.2 medium;
- and
- wherein the softgel capsule has an assay stability of at least about 90% when tested at 40° C./75% RH at 1 month.
4 more elements
Dependencies are inferred from the claim text.