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Aqueous nitroglycerin injection and manufacturing process

Patent 4879308 Issued on November 7, 1989. Estimated Expiration Date: Icon_subject August 11, 2007. 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

Percutaneous administration of nitroglycerine
Patent #: 4322433
Issued on: 03/30/1982
Inventor: Leslie ,   et al.

Aqueous solution of nitroglycerin
Patent #: 4323577
Issued on: 04/06/1982
Inventor: Ohkuma ,   et al.

Water-soluble composition for forming an aqueous isotonic nitroglycerine solution and the nitroglycerine solution formed
Patent #: 4481220
Issued on: 11/06/1984
Inventor: Giesselmann ,   et al.

Organic nitrate drug mixtures resistant to detonation by fire Patent #: 4746506
Issued on: 05/24/1988
Inventor: Lynch

Inventors

Assignee

Application

No. 084631 filed on 08/11/1987

US Classes:

514/509, (O=)N(=O)-O-C containing (e.g., nitrate ester, etc.)514/970CONTAINING DESIGNATED INGREDIENT TO STABILIZE AN ACTIVE INGREDIENT

Examiners

Primary: Howard, Jacqueline V.

Attorney, Agent or Firm

Foreign Patent References

  • 116944 EP 08/13/1984

International Class

A61K 031/21

Abstract

Nitroglycerin injection that is free of the customary organic solvents and has an extended shelf life of at least 1 year, consisting essentially of water, lactose, and nitroglycerin. Sodium chloride or dextrose may be added during manufacture or upon diluting with an infusion. Commerically safe manufacture and stable dispersion are assured by mixing lactose adsorbate, containing nitroglycerin, with water at high shear so that no nitroglycerin droplets coalesce. Stability is maintained by filtering and filling operations using nonreactive, nonleaching, nonadsorptive materials.

Other References

  • D. M. Baaske, A. H. Amann, D. M. Wagenknecht, M. Mooers, J. E. Carter, H. J. Hoyt and R. G. Stoll, "Nitroglycerin Compatibility with Intravenous Fluid Filters, Containers and Admininstration Sets", American Journal of Hospital Pharmacy, vol. 37, Feb. 1980, pp. 201-205
  • A. J. Clarke and R. E. Watkins, "Nitroglycerin Injection Manufactured by a Hospital Pharmacy", American Journal of Hospital Pharmacy, vol. 42, Jul. 1985
  • B. L. McNiff, E. F. McNiff and Ho-Leung Fung, "Potency and Stability of Extemporaneous Nitroglycerin Infusions", American Journal of Hospital Pharmacy, vol. 36, Feb. 1979, pp. 173-177
  • D. M. Wagenknecht, D. M. Baaske, A. S. Alam, J. E. Carter and J. Shah, "Stability of Nitroglycerin Solutions in Polyolefin and Glass Containers", American Journal of Hospital Pharmacy, vol. 41, Sep. 1984, pp. 1807-1811
  • A. Yacobi, A. H. Amann and D. M. Baaske, "Pharmaceutical Considerations of Nitroglycerin ", Drug Intelligence and Clinical Pharmacy, vol. 17, Apr. 83, pp. 255-26
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