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Multiple unit oral pharmaceutical formulations

Patent 5955104 Issued on September 21, 1999. Estimated Expiration Date: Icon_subject July 18, 2017. 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.

Patent References

Sustained-release pharmaceutical tablet and process for preparation thereof
Patent #: 4415547
Issued on: 11/15/1983
Inventor: Yu ,   et al.

Multilayer sustained release granule
Patent #: 5093200
Issued on: 03/03/1992
Inventor: Watanabe, et al.

Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets
Patent #: 5260072
Issued on: 11/09/1993
Inventor: Roche, et al.

Multilayered controlled release pharmaceutical dosage form
Patent #: 5395626
Issued on: 03/07/1995
Inventor: Kotwal, et al.

Powder-layered morphine sulfate formulations
Patent #: 5411745
Issued on: 05/02/1995
Inventor: Oshlack, et al.

Multilayered controlled release pharmaceutical dosage form
Patent #: 5474786
Issued on: 12/12/1995
Inventor: Kotwal, et al.

Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level Patent #: 5478577
Issued on: 12/26/1995
Inventor: Sackler, et al.

Inventors

Assignee

Application

No. 896629 filed on 07/18/1997

US Classes:

424/458, Containing discrete coated particles pellets, granules, or beads424/457, Sustained or differential release424/459, Organic coatings424/461, Containing polysaccharide (e.g., cellulose sugars, etc.)424/462, Containing solid synthetic polymers424/468, Sustained or differential release type424/494, Cellulose derivatives424/495, Ethyl cellulose424/496, Containing natural gums/resins424/497, Containing solid synthetic polymers514/781, Cellulose or derivative514/782Natural gum or resin

Examiners

Primary: Spear, James M.

Attorney, Agent or Firm

International Classes

A61K 009/22
A61K 009/54
A61K 009/60
A61K 009/62

Foreign Application Priority Data

1996-07-25 DE

Abstract

A multiple unit oral pharmaceutical dosage form having a plurality of pellets in a water soluble capsule or in a tablet compressed from the pellets, wherein each pellet contains (a) a substantially inert core, (b) an active ingredient layer over the inert core, and containing (i) a pharmacologically active particulate active ingredient, (ii) a nonembedding amount of a binder for adhering the active ingredient over the inert core, and optionally (iii) a pharmaceutically acceptable, inert adjuvant, such as colloidal silica, and (c) a coating over the active ingredient layer for retarding the release of the active ingredient from the active ingredient layer into an aqueous body fluid solvent in situ, the nonembedding amount of the binder is suitably from about 1% wt. to about 10% wt. based on the active ingredient layer, the binder in the active ingredient layer is suitably a mixture of ethylcellulose and shellac, in a weight proportion suitably of from about 1:9 to about 9:1, the coating for retarding the release suitably contains from about 70% wt. to about 95% wt. based on the coating, of a substantially water-insoluble, pharmacologically inert, particulate material, and a binder; the pharmacologically inert, particulate material is suitably talcum, and the binder in the active ingredient layer is suitably identical to the binder in the coating.

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