Acta Pharm. 66 (2016) 207-218
Original research paper
The effect of excipients on the stability and aerosol
performance of salmon calcitonin dry powder inhalers prepared via spray freeze drying process
NARGES POURSINA,
ALIREZA VATANARA, MOHAMMAD REZA ROUINI, KAMBIZ GILANI and ABDOLHOSSEIN
ROUHOLAMINI NAJAFABADI
Department
of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences,
Tehran, Iran
Accepted October 15, 2015
Published online May 11, 2016
Spray freeze
drying was developed to produce dry powders suitable for applications such as
inhalation delivery. In the current study, the spray freeze drying technique
was employed to produce inhalable salmon calcitonin microparticles. Effects of the
carrier type, concentration of hydroxyl propyl-β-cyclodextrin and the
presence of Tween 80 on the chemical and structural stability, as well as on
the aerosol performance of the particles were investigated. The results
indicated that hydroxyl propyl-β-cyclodextrin had the most important
effect on the chemical stability of the powder and strongly increased its stability
by increasing its concentration in the formulation. Chemically stable
formulations (over 90 % recovery) were selected for further examinations.
Fluorescence spectroscopy and circular dichroism suggested that the
formulations were structurally stable. Aerosol performance showed that the
Tween-free powders produced higher fine particle fraction values than the
formulations containing Tween (53.7 vs.
41.92 % for trehalose content and 52.85 vs.
43.06 % for maltose content).
Keywords: salmon
calcitonin, inhalation, spray freeze drying, hydroxypropyl-β-cyclodextrin,
fine particle fraction, stability