Modified release formulations containing a hypnotic agent
US6638535B2 · kind B2 · utility
Assignee
Inventors
Key dates
| Filing date | Apr 13, 2001 |
| Grant date | Oct 28, 2003 |
| Priority date | — |
| Expiry date | Apr 23, 2021 |
Classification
- Technology area (CPC A)Human Necessities
- CPC primaryA61K31/519
- WIPO fieldPharmaceuticals
- WIPO sectorChemistry
Abstract
Hypnotic pharmaceutical compositions are made from pellets and exhibit a modified release. Zolpidem or a pharmaceutically acceptable salt thereof is a typical hypnotic. The pellets are preferably spherical and exhibit a dissolution profile that includes 60% of the hypnotic agent being release from the pellet not earlier than 5 minutes from the start of a specified in vitro dissolution test. Although the modified release profile can include 50% of the hypnotic agent being released not earlier than 15 minutes after the start of the dissolution test, the pellet preferably does not contain a release rate controlling excipient or coating. Instead, microcrystalline cellulose and the active constitute the majority of the pellet, e.g. 90% or more. Spherical pellets are also made by a convenient method that is applicable to any pharmaceutically active agent.
Source: USPTO / EPO open patent data. Objective bibliographic and citation counts.