Mesalamine suppository
US8436051B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Dec 16, 2009 |
| Grant date | May 7, 2013 |
| Priority date | — |
| Expiry date | Mar 23, 2031 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K31/136
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
The present invention relates to a mesalamine rectal suppository designed to provide improved comfort of use. One embodiment of the invention is a mesalamine rectal suppository comprising mesalamine and one or more pharmaceutically acceptable excipients, wherein the drug load of the suppository ranges from 35% to 50%. Yet another embodiment of the invention is a mesalamine rectal suppository comprising mesalamine having a tap density ranging from about 600 to about 800 g/L (as measured by USP <616>) and a hard fat having an ascending melting point of 32 to 35.5° C. Yet another embodiment is a mesalamine rectal suppository comprising mesalamine particles and one or more pharmaceutically acceptable excipients, where the mesalamine particles have a surface area of from about 0.1 m2/g to about 2.8 m2/g (e.g., from about 0.1 m2/g to about 1.3 m2/g). Methods of preparing and methods of treatment with mesalamine suppositories are also provided. The invention further provides a method of determining a dissolution parameter (such as dissolution rate) of a mesalamine rectal suppository, such as a 1 g mesalamine suppository, by measuring its dissolution with USP Apparatus #2 at 40° C. and a p…
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.