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Polar drug of prodrug compositions with extended shelf-life storage and a method of making thereof

Patent 6133248 Issued on October 17, 2000. Estimated Expiration Date: Icon_subject June 12, 2018. 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

Water soluble cyclodextrin polymers substituted by ionic groups and process for the preparation thereof
Patent #: 4535152
Issued on: 08/13/1985
Inventor: Szejtli ,   et al.

Stable pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester
Patent #: 4925860
Issued on: 05/15/1990
Inventor: Herbranson, et al.

Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
Patent #: 5134127
Issued on: 07/28/1992
Inventor: Stella, et al.

Cyclodextrin/drug complexation
Patent #: 5324718
Issued on: 06/28/1994
Inventor: Loftsson

Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof Patent #: 5376645
Issued on: 12/27/1994
Inventor: Stella, et al.

Inventor

Assignee

Application

No. 096747 filed on 06/12/1998

US Classes:

514/58, Dextrin or derivative514/169, Cyclopentanohydrophenanthrene ring system DOAI514/385, 1,3-diazoles536/103Dextrin or derivative

Examiners

Primary: Lee, Howard C.

Attorney, Agent or Firm

Foreign Patent References

  • 0 163 433 A2 EP. 12/13/1985
  • 0 188 821 A2 EP. 07/13/1986
  • 0 213 514 A2 EP. 03/13/1987
  • 0 839 528 A1 EP. 05/13/1998
  • 39 38 227 C1 DE. 05/13/1991
  • WO 94/02518 WO. 02/13/1994

International Classes

A61K 031/715
A61K 031/56
A61K 031/415

Abstract

The present invention is drawn to pharmaceutical composition comprising cyclodextrin and a pharmaceutically active agent or prodrug, wherein the cyclodextrin is present at less than 75% equimolar amounts of the above agent or prodrug. The present invention is further drawn to a method of extending the shelf-life of a pharmaceutically active agent or prodrug by adding one or more cyclodextrins a less than 75% equimolar amounts to said pharmaceutically active agent or prodrug.

Other References

  • Rajewski et al. "Preliminary Safety Evaluation f Parenterally Administered Sulfoalkyl Ether beta-Cyclodextrin Derivatives", Journal of Pharmaceutical Sciences, vol. 84(8): 927-932, Aug. 1995
  • Kazuto Okimoto et al. "The Interaction of Charged and Uncharged Drugs with Neutral (HP-B-CD) and Anionically Charged (SBE7-B-CD) B-Cyclodextrins", Pharmaceutical Research, vol. 13, No. 2 (1996) pp. 256-264
  • Thorsteinn Loftsson et al. "Pharmaceutical Applications of Cyclodextrins. 1. Drug Solubilization and Stabilization", Journal of Pharmaceutical Sciences, vol..85, No. 10 (Oct. 1996) pp. 1017-1025
  • S.A. Varia et al. "Phenytoin Prodrugs IV: Hydrolysis of Various 3-(Hydroxymethyl) phenytoin Esters", Journal of Pharmaceutical Sciences, vol. 73, No. 8 (Aug. 1984) pp. 1074-1080
  • Loftsson et al., "Effects of cyclodextrins on the chemical stability of drugs in aqueous solutions", Drug Stability, vol. 1, No. 1 (1995) pp. 22-33
  • Menard et al., "Studies of the Effect of pH, Temperature and Ring Size on the Complexation of Phenytoin with Cyclodextrins", Pharmaceutica Acta Helvetiae, vol. 63, No. 11 (1988) pp. 303-308
  • Stella, "A case for prodrugs: Fosphenytoin", Advanced Drug Delivery Reviews, vol. 19, No. 2. (1996) pp. 311-330
  • Muller et al., "Determination of the position of the ester bond in a micellar prodrug of phenytoin", International Journal of Pharmaceutics, vol. 102 (1994) pp. 109-11
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