U.S. patents available from 1976 to present.
U.S. patent applications available from 2005 to present.

Low steroid dose dry pharmaceutical preparation

Patent 5382434 Issued on January 17, 1995. Estimated Expiration Date: Icon_subject March 22, 2014. 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

3423507

3568828

3626063

3671633

3802914

Method for contraception by the application of combination-type sequential preparations
Patent #: 3957982
Issued on: 05/18/1976
Inventor: Lachnit-Fixson ,   et al.

Compositions and method of treating with stereoisomeric mixtures of 2-unsymmetrical 16,17-methylenedioxy steroids
Patent #: 3983233
Issued on: 09/28/1976
Inventor: Brattsand ,   et al.

Method of contraception
Patent #: 4143136
Issued on: 03/06/1979
Inventor: De Jage ,   et al.

Triphasic oral contraceptive
Patent #: 4628051
Issued on: 12/09/1986
Inventor: Pasquale

Spray-dried lactose formulation of micronized glyburide
Patent #: 4916163
Issued on: 04/10/1990
Inventor: Ni

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Inventors

Assignee

Application

No. 216236 filed on 03/22/1994

US Classes:

424/465, With claimed perfecting feature in contents (e.g., excipient, lubricant, etc.)424/464, Tablets, lozenges, or pills514/169, Cyclopentanohydrophenanthrene ring system DOAI514/171, With additional active ingredient514/174, -O-C-O- is part of a hetero ring (e.g., acetonide, etc.)514/175, -C(=O)-O-is part of a hetero ring (e.g., lactone, etc.)514/960SIGNIFICANT, TABLET FORMULATION (E.G., DESIGNATED EXCIPIENT, DISINTEGRANT, GLYDENT OR LUBRICANT, ETC.)

Examiners

Primary: Cintins, Marianne M.
Assistant: Criares, T. J.

Attorney, Agent or Firm

Foreign Patent References

  • 0036229 EP. 09/13/1981

International Classes

A61K 009/20
A61K 031/56
A61K 031/585

Foreign Application Priority Data

1991-03-12 EP

Abstract

Disclosed are dry pharmaceutical preparations containing potent steroidal medicinal agents in combination with an excipient capable of binding the agent to an extent greater than 80% and a having a demixing potential of less than 10% for said agent. Such excipients include spray-dried polyalcohols, granulated ଱-lactose monohydrate, or mixtures thereof. Also disclosed is a process of manufacturing stable tablets containing nearly identical amounts of at least one steroidal medicinal agent present in each tablet in an amount varying from 0.005 to 0.5 percent by weight of the tablet. Also disclosed is a dry mix consisting essentially of 1 to 100 parts, by weight, of at least one medicinal agent uniformly distributed throughout 2000 to 20,000 parts, by weight, of the described excipients. The mixture can be used to make dry dosage forms such as capsules, tablets, powders, and slugged granulates.

Other References

  • "Martindale, The Extra Pharmacopoeia" 28th edition; (1982); p. 54
  • J. N. Staniforth, "Advances in Powder Mixing and Segregation in Relation to Pharmaceutical Processing," Int. J. Pharm. & Prod. Mfr., vol. 3 (Suppl.) pp. 1-12, 1982, London, England
  • J. N. Staniforth, "Advances in excipient technology Powder and tableting characteristics," S.T. P. Pharma, vol. 6, No. 3, pp. 162-168, 1990
  • L. S. C. Wan et al., "Incorporation and Distribution of a low dose drug in granules" International Journal of Pharmaceutics, 88 (1992) pp. 159-163, no date
  • Chase et al., Remington's Pharmaceutical Sciences, pp. 1553-1576 (16th ed. 1980, Mack Publ. Co., Easton, Pa., USA
  • Thiel et al., "Content Uniformity of microdose Tablets (dosage lug-10 mg) Produced by Fluid Bed Granulation of Interactive Mixtures", J. Pharmacol., 38:335-343 (1986)
  • Thiel and Nguyen, "Fluidized Bed Granulation of an Ordered Powder Mixture", J. Pharm. Pharmacol., 34:692-699 (1982)
  • Thiel et al. "Fluidised Bed Granulation of an Ordered Powder Mixture Reduces the Potential for Ordered Unit Segregation", Powder Technology, 34:75-80 (1983)
  • Nikolakakis & Newton, "Solid State Adsorption of Antibiotics onto Sorbiton" J. Pharm. Pharmacol., 41:145-148 (1989)
  • Schmidt & Benke, "Ubersattigte Geordnete Mischungen auf der Basis von Sorbit", Pharm. ind., 46(2):193-198 (1984)
  • Cartillier and Moes, "Influence dy Type de Lactose sur Cohesif et Faiblement Dose", S.T.P. Pharma, 5(3):152-159 (1989
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