Controlled absorption diltiazen pharmaceutical formulation

Patent 4721619 Issued on January 26, 1988. Estimated Expiration Date:

January 26, 2005. 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

Controlled drug releasing preparations
Patent #: 3965255
Issued on: 06/22/1976
Inventor: Bloch , et al.

Encapsulation of active agents as microdispersions in homogeneous natural polymeric matrices
Patent #: 4230687
Issued on: 10/28/1980
Inventor: Sair , et al.

Pharmaceutical preparation comprising a cardiac glycoside with a polymer coating
Patent #: 4263273
Issued on: 04/21/1981
Inventor: Appelgren , et al.

Retard form of pharmaceuticals with insoluble porous diffusion coatings
Patent #: 4361546
Issued on: 11/30/1982
Inventor: Stricker , et al.

Pharmaceutical sustained-release compositions
Patent #: 4499066
Issued on: 02/12/1985
Inventor: Moro , et al.

Aspirin tablet
Patent #: 4555399
Issued on: 11/26/1985
Inventor: Hsiao

Drug delivery device
Patent #: 4592753
Issued on: 06/03/1986
Inventor: Panoz

Process for treating dosage forms
Patent #: 4600645
Issued on: 07/15/1986
Inventor: Ghebre-Sellassie , et al.

New pharmaceutical forms for administration of medicaments by oral route, with programmed release
Patent #: 4609542
Issued on: 09/02/1986
Inventor: Panoz , et al.

Controlled release formulation Patent #: 4610870
Issued on: 09/09/1986
Inventor: Jain , et al.

Inventors

Assignee

Elan Corporation p.l.c. (IE)

Application

No. 06/684661 filed on 12/20/1984

US Classes:

424/459, Organic coatings424/462, Containing solid synthetic polymers424/468, Sustained or differential release type424/473, With porous, perforated, apertured, or sieved layer (e.g., dialyzing layer, microporous layer, etc.)424/490, Coated (e.g., microcapsules)424/497, Containing solid synthetic polymers514/965Discrete particles in supporting matrix

Examiners

Primary: Griffin, Ronald W.

Attorney, Agent or Firm

Hubbard, Thurman, Turner & Tucker

International Classes

A61K 9/50 (20060101)
A61K 31/55 (20060101)
A61K 31/554 (20060101)

Foreign Application Priority Data

1983-12-22 IE

Abstract

A controlled absorption diltiazem formulation for oral administration comprises a pellet having a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid and a lubricant, and an outer membrane which permits release of diltiazem in an aqueous medium at a controlled rate which is substantially pH independent. The pellet has a dissolution rate in vitro, which when measured according to the Paddle Method of U.S. Pharmacopoeia XX, is not more than 10% of the total diltiazem after 2 hours of measurement in a buffered medium. Not more than 30% of the total diltiazem is released after a total of 4 hours measurement and not more than 40% of the total diltiazem is released after a total of 6 hours. 100% release is achieved after 12 hours, with a maximum of 80% of the total diltiazem being released after 8 hours.