Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1993-12-10
1996-06-18
Phelan, D. Gabrielle
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424493, 424494, 424495, 424498, A61K 916
Patent
active
055275451
ABSTRACT:
Disclosed is a liquid-suspension controlled-release enteric-coated pharmaceutical formulation for the administration of naproxen, comprising (a) microgranules of naproxen and an excipient; (b) four successive coats of polymeric hydrophilic and hydrophobic materials, at least the innermost of said coats imparting controlled-release properties to said naproxen according to a predetermined release profile, and at least the outermost of said coats imparting resistance to dissolution in gastric fluids; and (c) a liquid administration vehicle. This composition enables the oral administration of naproxen as a single daily dose the adjustment of the dosage to a patient's requirements, and avoids detrimental effects of prolonged contact of naproxen with the gastric mucosa thus aiding oral intake and minimizing the drug's typical side effects.
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Cramer, J. A. et al., JAMA 261:3273-7. 1989.
Day, R. O. et al., Clin. Pharm. Ther. 31(6): 733-40, 1982.
Gibaldi, M. et al., Pharmacokinetics (Marcel Dekker, New York) pp. 451-7, 1982.
United States Pharmacopeia Edition XXII, NF XVII, pp. 1578-83, 1990.
Bilato Ettore
Bottoni Giuseppe
Santus Giancarlo
Phelan D. Gabrielle
Recordati S.A. Chemical and Pharmaceutical Company
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