International Publisher of Science, Technology and Medicine

Journal of Pharmaceutical Sciences & Emerging Drugs

Research Article

Formulation Characterization of Parathyroid Hormone PTH (1-34)Coated on a Novel Transdermal Microprojection Delivery System:Water Determination

Mahmoud Ameri1*, Shelley C Fan1 and Yuh Fun Maa2
1Zosano Pharma, Inc., 34790 Ardentech Court, Fremont, CA 94555, USA
2Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA
Corresponding author : Mahmoud Ameri
Zosano Pharma, Inc., 34790 Ardentech Court, Fremont, CA 94555, USA
E-mail:
[email protected]
Received: October 25, 2016 Accepted: November 07, 2016 Published: November 15, 2016
Citation: Ameri M, Fan SC, Maa YF (2016) Formulation Characterization of Parathyroid Hormone PTH (1-34) Coated on a Novel Transdermal Microprojection Delivery System: Water Determination. J Pharm Sci Emerg Drugs 4:2. doi:10.4172/2380-9477.1000115

Abstract

This study assessed the feasibility of determining the water content of the PTH (1-34) formulation coated on a novel transdermal microprojection delivery system, ZP-PTH. Thermogravimetric analysis (TGA) and Karl Fischer (KF) titration were used for water analysis.Headspace moisture was determined by internal vapor analysis and a hand-held moisture sensor. The moisture sorption isotherm was established by moisture sorption analyzer. PTH (1-34) API and formulation showed several weight-loss phases in TGA thermograms. Water loss is not a single-phase event, occurring over a wide temperature range. The typical water amount in a single ZP-PTH coated array is below the sensitivity of TGA and KF titration. Combining 20 coated array samples together in a single extract made KF analysis is possible but impractical due to strenuous sample preparation requirements and controls. The moisture sorption isotherm allowed accurate prediction of water content when the headspace moisture level is known. We demonstrated that TGA and KF titration are not practically possible for determining the water content in ZP-PTH. Simple alternative approaches can ensure that the desired water content in the ZP-PTH coating is achieved without direct water measurement. This study provides scientific rationales to justify the application of unconventional approaches.

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