Modified release formulations containing a hypnotic agent

Patent 6638535 Issued on October 28, 2003. Estimated Expiration Date:

April 13, 2021. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.

Abstract Claims Description Full Text

Patent References

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Inventors

Assignee

Synthon BV

Application

No. 09/833662 filed on 04/13/2001

US Classes:

424/489, Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)424/464, Tablets, lozenges, or pills424/465, With claimed perfecting feature in contents (e.g., excipient, lubricant, etc.)424/490, Coated (e.g., microcapsules)514/300, Plural hetero atoms in the bicyclo ring system514/781Cellulose or derivative

Examiners

Primary: Page, Thurman K.
Assistant: Pulliam, Amy E

Attorney, Agent or Firm

Fleshner & Kim, LLP

International Classes

A61K 9/16 (20060101)
A61K 31/4353 (20060101)
A61K 31/437 (20060101)
A61K 31/519 (20060101)

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.

Other References

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