Pharmaceutical compositions in the form of beadlets and method

Patent 4808413 Issued on February 28, 1989. Estimated Expiration Date:

December 31, 2007. 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

Inventors

Assignee

E. R. Squibb & Sons, Inc.

Application

No. 07/140281 filed on 12/31/1987

US Classes:

424/458, Containing discrete coated particles pellets, granules, or beads424/469, Discrete particles in supporting matrix424/489, Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)424/499Contains proteins or derivative or polysaccharides or derivative

Examiners

Primary: Lusignan, Michael R.

Attorney, Agent or Firm

International Classes

A61K 9/16 (20060101)
A61K 9/16 (20060101)
A61K 9/50 (20060101)
A61K 9/50 (20060101)
A61K 31/40 (20060101)
A61K 31/40 (20060101)

Abstract

A pharmaceutical composition is provided which is in the form of a plurality of beadlets, adapted to be filled into pharmaceutical hard shell capsules, or compressed into tablets, which beadlets are formed of a pharmaceutical such as an ACE inhibitor, for example, captopril, a beta-blocker such as nadolol, propranolol or atenolol, a calcium channel blocker such as diltiazem or nifedipine or other pharmaceuticals including combinations thereof, binder such as microcrystalline cellulose, and at least 5% by weight of an acid processing aid, such as citric acid, which imparts plasticity to the wet mass needed for efficient extrusion and spheronization. A method for forming beadlets is also provided which includes the steps of extruding a composition as described above, and subjecting the resulting extrudate to a spheronization step wherein an acid processing aid such as citric acid is employed to improve processing and form improved beadlets.