Pharmaceutical compositions of sirolimus
AssigneeCadila Healthcare Limited
InventorsSunilendu Bhushan Roy, Sushrut Krishnaji Kulkarni, Kiritkumar Maulik Panchal, Shubhashchandra Shailendra Mandge
Life of this patent
Estimating the term…
Abstract
The present invention discloses a stable solid pharmaceutical matrix composition comprising sirolimus or pharmaceutically acceptable salts thereof along with one or more sugars.
Claims19
A stable solid pharmaceutical matrix composition comprising sirolimus or pharmaceutically acceptable salts thereof along with one or more sugars.
A stable solid pharmaceutical matrix composition comprising a core of sirolimus or pharmaceutically acceptable salts thereof and one or more sugars, wherein the composition retains at least 80% of the potency of the sirolimus when stored for three months at 40° C. and 75% relative humidity.
A stable pharmaceutical composition of sirolimus comprising:
- (a) about 0.75% w/w of sirolimus;
- (a) about 31.55% w/w of sucrose;
- (c) about 11.18% w/w of lactose monohydrate;
- (d) about 13.21% w/w of microcrystalline cellulose;
- (e) about 5.66% w/w of crospovidone;
- (f) about 0.47% w/w of poloxomer 188;
- (g) about 0.06% w/w of glyceryl mono oleate;
- (h) about 0.75% w/w of vitamin E acetate;
- (i) about 1.51% w/w of citric acid monohydrate;
- (j) about 1.70% w/w of povidone K30;
- and
- (k) about 1.51% w/w of talc.
A process for the preparation of stable pharmaceutical solid matrix composition comprising sirolimus or pharmaceutically acceptable salts thereof, the process comprising mixing or granulating the sirolimus or pharmaceutically acceptable salts thereof with one or more sugars.
A method of inhibiting organ or tissue transplant rejection in a mammal in need thereof, the method comprising administering to said mammal a stable solid pharmaceutical matrix composition comprising sirolimus or pharmaceutically acceptable salts thereof along with one or more sugars.
Dependencies are inferred from the claim text.