Aqueous nitroglycerin injection and manufacturing process

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Ester doai

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514970, A61K 3121

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active

048793086

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.

REFERENCES:
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patent: 4481220 (1984-11-01), Giesselmann et al.
patent: 4746506 (1988-05-01), Lynch
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. 255-263.

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