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US Patent 4891230 - Diltiazem formulation

US Patent Issued on January 2, 1990
Estimated Patent Expiration Date: Icon_subject November 16, 2007Estimated 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.
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Abstract

A diltiazem pellet formulation for oral administration comprises a core of diltiazem or a pharmaceutically acceptable salt thereof in association with an organic acid, and a multi-layer membrane surrounding the core and containing a major proportion of a pharmaceutically acceptable film-forming, water insoluble synthetic polymer and a minor proportion of a pharmaceutically acceptable film-forming, water soluble synthetic polymer. The number of layers in the membrane and the ratio of the water soluble to water insoluble polymer being effective to permit release of diltiazem from the pellet at a rate allowing controlled absorption thereof over a twelve hour period following oral administration. The pellet has a dissolution rate in vitro which when measured in a dissolution apparatus (Paddle) according to U.S. Pharmacopoeia XXI in 0.05 M KCl at pH 7.0 results in not more than 35% of the total diltiazem being released after 2 hours of measurement. Not more than 80% of the total diltiazem is released after six hours of measurement and not less than 85% of the total diltiazem is released after 13 hours of measurement.

Other References

  • Chemical Abstracts, vol. 100, No. 18, Apr. 30, 1984, p. 367, abstract 145016

Inventors

Assignee

Application

No. 120952 filed on 11/16/1987

US Classes:

424/461, Containing polysaccharide (e.g., cellulose sugars, etc.)424/459, Organic coatings424/462, Containing solid synthetic polymers424/470, Where particles are granulated424/493, Containing polysaccharides (e.g., sugars)424/494, Cellulose derivatives424/495, Ethyl cellulose424/497Containing solid synthetic polymers

Field of Search

424/461, Containing polysaccharide (e.g., cellulose sugars, etc.)424/462, Containing solid synthetic polymers424/489, Particulate form (e.g., powders, granules, beads, microcapsules, and pellets)424/474, Coated pills or tablets424/470, Where particles are granulated424/477, Containing proteins or derivatives thereof424/479, Containing polysaccharide (e.g., sugar, etc.)424/481, Containing natural gums or resins424/482, Containing solid synthetic polymers424/490, Coated (e.g., microcapsules)424/494, Cellulose derivatives424/493, Containing polysaccharides (e.g., sugars)424/495, Ethyl cellulose424/497Containing solid synthetic polymers

Examiners

Primary: Page, Thurman K.

Attorney, Agent or Firm

US Patent References

3965255, Controlled drug releasing preparations
Issued on: 06/22/1976
Inventor: Bloch ,   et al.
4230687, Encapsulation of active agents as microdispersions in homogeneous natural polymeric matrices
Issued on: 10/28/1980
Inventor: Sair ,   et al.
4263273, Pharmaceutical preparation comprising a cardiac glycoside with a polymer coating
Issued on: 04/21/1981
Inventor: Appelgren ,   et al.
4361546, Retard form of pharmaceuticals with insoluble porous diffusion coatings
Issued on: 11/30/1982
Inventor: Stricker ,   et al.
4432966, Compressed tablets for disintegration in the colon comprising an active ingredient containing nucleus coated with a first layer containing microcrystalline cellulose which is coated with an enteric organic polymer coating
Issued on: 02/21/1984
Inventor: Zeitoun ,   et al.
4496558, Pharmaceutical compositions and methods for producing alpha antagonism
Issued on: 01/29/1985
Inventor: DeMarinis ,   et al.
4499066, Pharmaceutical sustained-release compositions
Issued on: 02/12/1985
Inventor: Moro ,   et al.
4555399, Aspirin tablet
Issued on: 11/26/1985
Inventor: Hsiao
4592753, Drug delivery device
Issued on: 06/03/1986
Inventor: Panoz
4600645, Process for treating dosage forms
Issued on: 07/15/1986
Inventor: Ghebre-Sellassie ,   et al.
4606909, Pharmaceutical multiple-units formulation
Issued on: 08/19/1986
Inventor: Bechgaard ,   et al.
4609542, New pharmaceutical forms for administration of medicaments by oral route, with programmed release
Issued on: 09/02/1986
Inventor: Panoz ,   et al.
4610870, Controlled release formulation
Issued on: 09/09/1986
Inventor: Jain ,   et al.
4666702, Dosage units for controlled release of active material
Issued on: 05/19/1987
Inventor: Junginger
4684516, Sustained release tablets and method of making same
Issued on: 08/04/1987
Inventor: Bhutani
4756911Controlled release formulation
Issued on: 07/12/1988
Inventor: Drost ,   et al.

Foreign Patent References

  • 0013262 EP. 07/22/1980
  • 0077956 EP. 05/22/1983
  • 0173928 EP 03/22/1986
  • 2313915 FR. 01/22/1977
  • 2039737 GB 08/22/1980

International Classes

A61K 009/62
A61K 009/16
A61K 009/26

Foreign Application Priority Data

1983-12-22 IE

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