Sustained release formulation containing tacrolimus
US6884433B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Apr 14, 2003 |
| Grant date | Apr 26, 2005 |
| Priority date | — |
| Expiry date | Apr 14, 2023 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61P37/06
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.