Compositions and methods for enhanced mucosal delivery of...

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

Reexamination Certificate

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C424S045000, C128S200230

Reexamination Certificate

active

07435720

ABSTRACT:
Pharmaceutical compositions and methods are described comprising at least a parathyroid hormone peptide (PTH) preferably PTH1-34and one or more mucosal delivery-enhancing agents for enhanced nasal mucosal delivery of PTH, for treating or preventing osteoporosis or osteopenia in a mammalian subject, preferably a human.

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FDA's CDRH Final Guidance for Neublizers, Metered Dose Inhalers, Spacers, and Actuators (issued on Oct. 1, 1993), pp. 1-12 (also available on the Internet at www.fda.gov/cdrh/ode/784.html).
Codrons, V.; Vanderbist, F.; Verbeeck, R. K.; Arras, M.; Lison, D.; Preat, V. and Vanbever, R., “Systemic Delivery of Parathyroid Hormone (1-34) Using Inhalation Dry Powders in Rats,”Journal of Pharmaceutical Sciences, May 2003:92 (5) pp. 938-950.
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