Pharmaceutical compositions for intranasal spray administration

Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid

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424434, 424484, 424485, 424487, 424488, 424489, 424491, 514958, A61L 914

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active

060903686

ABSTRACT:
A pharmaceutical composition of a water soluble drug admixed with an aqueous bioadhesive cellulosic polymer containing microcrystalline particles. When sprayed (via a conventional spray device) into the nose, drug molecules are retained in contact with the nasal membrane. The drug composition comprises ketorolac tromethamine in an aqueous nasal polymeric spray formulation that without the addition of any permeation enhancer will promote drug absorption and provides absolute drug bioavailability greater than 90%.

REFERENCES:
patent: 5639738 (1997-06-01), Falk et al.
patent: 5736161 (1998-04-01), Garces et al.
Santus et al. Nasal formulations of ketorolac tromethamine-technological evaluation--bioavailability and tolerabil;ity in rabbits. FARMCO. vol. 48(12). pp. 1709-1723, 1993.
Dondeti et al. Biadhesive and formulation parameters affecting nasal absorption. International Journal of Pharmaceuticlas. vol. 126. 115-133, 1996.
Santus et al. Nasal Formulations of ketorolac tromethamine-technological evaluation--bioavailability and tolerability in rabbits. FARMCO, vol. 48 (12). pp. 1709-1723, 1993.
Dondeti etal. Bioadhesive and formulation parameters affecting nasal absorption. International Journal of Pharmaceutics. vol. 126. 115-133, 1996.
The influence of tonicity and viscosity on the intranasal absorption of salmon calcitonin in rabbits, Ramneik Dua et al., International Journal of Pharmaceutics, 174 (1997) 233-242.
Bioadhesive and formulation parameters affecting nasal absorption, Polireddy Dondeti et al., International Journal of Pharmaceutics, 127 (1996) 115-133.
In vivo evaluation of spray formulations of human insulin for nasal delivery, Polireddy Dondeti et al., International Journal of Pharmaceutics, 122 (1995) 91-105.
Ketorolac as a rapid and effective treatment of migraine headache: evaluations by patients, Charles P. Davis, et al., American Journal of Emergency Medicine, vol. 11, No. 6, Nov. 1993, 573-575.
Ketorolac in acute headache management, R. Norman Harden, et al., Headache, 31:463-464, 1991.
Self-administration of parenteral ketorolac tromethamine for head pain, L. Jay TurkeWitz et al., Headache, 1992; 32: 452-454.
Recent advances in the acute management of migraine and cluster headaches, Kusum L. Kumar, Clinical Review, 339-348, 1994.
Ketorolac tromethamine in cancer pain, Suayib Yalcin et al., Acta Oncologica, vol. 36, No. 2, pp. 231-232, 1997.
Recommendations for the emergency treatment of migraine headache, Bob L. Lobo et al., Feb., 1994, 53-54.
The use of ketorolac in the management of postoperative pain, J. Robin DeAndrade, et al., Review, vol. 17, No. 2, Feb 1994, 157-166.

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