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Open AccessArticle

Excipient Interactions in Glucagon Dry Powder Inhaler Formulation for Pulmonary Delivery

1
Department of Pharmaceutics, School of Pharmacy, King Khalid University, Abha, Aseer 62529, Saudi Arabia
2
Pharmacy Discipline, School of Clinical Sciences, Faculty of Health, Queensland University of Technology, Brisbane, QLD 4000d, Australia
3
School of Chemistry, Physics and Mechanical Engineering, Science and Engineering Faculty, Queensland University of Technology, Brisbane, QLD 4000d, Australia
4
Pharmacy Program, School of Health and Biomedical Sciences, College of Science, Engineering & Health, RMIT University, Bundoora, VIC 308, Australia
5
Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, QLD 4000d, Australia
*
Authors to whom correspondence should be addressed.
Pharmaceutics 2019, 11(5), 207; https://doi.org/10.3390/pharmaceutics11050207
Received: 19 March 2019 / Revised: 11 April 2019 / Accepted: 29 April 2019 / Published: 1 May 2019
(This article belongs to the Special Issue Advances in Pulmonary Drug Delivery)
Purpose: This study describes the development and characterization of glucagon dry powder inhaler (DPI) formulation for pulmonary delivery. Lactose monohydrate, as a carrier, and L-leucine and magnesium stearate (MgSt) were used as dispersibility enhancers for this formulation. Methods: Using Fourier-transform infrared (FTIR) spectroscopy, Differential Scanning Calorimetry (DSC), and Raman confocal microscopy, the interactions between glucagon and all excipients were characterized. The fine particle fractions (FPFs) of glucagon in different formulations were determined by a twin stage impinger (TSI) using a 2.5% glucagon mixture, and the glucagon concentration was measured by a validated LC-MS/MS method. Results: The FPF of the glucagon was 6.4%, which increased six-fold from the formulations with excipients. The highest FPF (36%) was observed for the formulation containing MgSt and large carrier lactose. The FTIR, Raman, and DSC data showed remarkable physical interactions of glucagon with leucine and a minor interaction with lactose; however, there were no interactions with MgSt alone or mixed with lactose. Conclusion: Due to the interaction between L-leucine and glucagon, leucine was not a suitable excipient for glucagon formulation. In contrast, the use of lactose and MgSt could be considered to prepare an efficient DPI formulation for the pulmonary delivery of glucagon. View Full-Text
Keywords: glucagon; dry powder inhaler formulation; pulmonary drug delivery; excipients interactions; fine particle fractions; FTIR; DSC glucagon; dry powder inhaler formulation; pulmonary drug delivery; excipients interactions; fine particle fractions; FTIR; DSC
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Rashid, M.A.; Elgied, A.A.; Alhamhoom, Y.; Chan, E.; Rintoul, L.; Allahham, A.; Islam, N. Excipient Interactions in Glucagon Dry Powder Inhaler Formulation for Pulmonary Delivery. Pharmaceutics 2019, 11, 207.

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