The effect of excipients on the stability and aerosol performance of salmon calcitonin dry powder inhalers prepared via the spray freeze drying process.
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).
Narges
N
Poursina
Alireza
A
Vatanara
Mohammad Reza
MR
Rouini
Kambiz
K
Gilani
Abdolhossein Rouholamini
AR
Najafabadi
D000073738:2-Hydroxypropyl-beta-cyclodextrin; D000280:Administration, Inhalation; D000336:Aerosols; D002116:Calcitonin / Q000008:administration & dosage* / Q000737:chemistry*; D002942:Circular Dichroism; D004339:Drug Compounding; D004355:Drug Stability; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005079:Excipients / Q000737:chemistry*; D005612:Freeze Drying; D008320:Maltose / Q000737:chemistry; D008855:Microscopy, Electron, Scanning; D010316:Particle Size; D011136:Polysorbates / Q000737:chemistry; D033362:Powder Diffraction; D011208:Powders; D055550:Protein Stability; D013050:Spectrometry, Fluorescence; D013056:Spectrophotometry, Ultraviolet; D013678:Technology, Pharmaceutical / Q000379:methods*; D014199:Trehalose / Q000737:chemistry; D047392:beta-Cyclodextrins / Q000737:chemistry*
D000336:Aerosols; D005079:Excipients; D011136:Polysorbates; D011208:Powders; D047392:beta-Cyclodextrins; D000073738:2-Hydroxypropyl-beta-cyclodextrin; D008320:Maltose; C028815:salmon calcitonin; D002116:Calcitonin; D014199:Trehalose