An oral dosage form of azithromycin which does not exhibit an adverse food effect; Specific azithromycin oral dosage forms including tablets, powders for oral suspensions and unit dose packets; Methods of treating microbial infections with the dosage forms; And therapeutic packages containing the dosage forms.
Other References
Documents relating to the European Patent Office Opposition proceedings regarding EU Patent No. 0 679 400 (Opposition file).
Zithromax (Trademark of Pfizer Inc.) Tablet and Powder for Oral Suspension Package Insert for azithromycin tablets and powder for oral suspension dosage forms sold commercially in Italy (1992).
Russell, T. L., et al., Upper Gastrointestinal pH in Seventy-nine Healthy, Elderly North American Men and Women, Pharmaceutical Research, vol. 10, No. 2, pp. 187-196, (1993).
Toothaker, R. D., et al., The Effect of Food on Drug Bioavailability, Ann. Rev. Pharmacol, Toxicol., vol. 20, pp. 173-199, (1980).
Hopkins, S., Clinical Toleration and Safety of Azithromycin, The American Journal of Medicine, vol. 91 (Suppl. 3A), pp. 40S-45S, (1991).
Chu, S., et. al., Drug-Food Interaction Potential of Clarithromycin, a New Macrolide Antimicrobial, J. Clin. Pharmacol., vol. 32, pp. 32-36, (1992).
Drew, R. H., et. al. Azithromycin—Spectrum of Activity, Pharmacokinetics, and Clinical Applications, Pharmacotheraphy, vol. 12, No. 3, pp. 161-173, (1992).
Malmborg, A., Absorption of erthromycin stearate after oral administration, Curr. Med. Res. Opin., vol. 5, (Suppl. 2)., pp. 15-18, (1978).
Welling, P. G., et. al., Plasma Levels following Single and Repeated Doses of Erythromycin Estolate and Erythromycin Stearate, Journal of Pharmaceutical Sciences, vol. 68, No. 2, pp. 150-155, (1979).
Welling, P. G., et. al., Bioavailability of Erythromycin Stearate: Influence of Food and Fluid Volume, Journal of Pharmaceutical Sciences, vol. 67, No. 6, pp. 764-766, (1978).
Curatolo, et al., Perforated Coated Tablets for Controlled Release of Drugs at a Constant Rate, Journal of Pharmaceutical Sciences, vol. 77, No. 4, pp. 322-324, (1988).
Zithromax (Trademark of Pfizer, Inc.) Capsules Package Insert for azithromycin capsule dosage form sold commercially in U.S.