Glycemic Profile in Rats After Pulmonary Administration of a Pure Insulin Powder
Francesca Buttini,1 Veronica Chierici1, Eride Quarta1, Lisa Flammini1, Adryana Rocha Clementino1, Susana Ecenarro2, Massimiliano Tognolini1, Elisabetta Barocelli1, Paolo Colombo1 & Ruggero Bettini1
1Food and Drug Department, University of Parma, Parco Area delle Scienze 27a, 43124, Parma, Italy
2Qualicaps Europe, S.A.U., Alcobendas, Madrid, Spain
The purpose of this study was to investigate the chemical stability and respirability of a pure insulin spray-dried (Ins_SD) powder. Moreover, the glycemic plasma profile of rats was measured after pulmonary insufflation of Ins_SD and Afrezza® at a dose of 10 IU/Kg.
The results of this study show that a pure insulin pulmonary powder (Ins_SD), produced by spray drying from an acid aqueous solution of the peptide, presented a high respirable fraction (FPF=91.5%) and favourable stability behaviour. The powder, filled into HPMC Quali-V®-I capsules together with the PVC-PVDC packaging material, showed long term stability at room temperature whilst maintaining good aerodynamic performance. The in vivo study was conducted in rats and the glycemic plasma profile was determined after pulmonary insufflation of Ins_SD and Afrezza® powder. These profiles resulted to be similar to each other when the powder was administered and both of them were similar to the glycemic plasma profile registered after the subcutaneous insulin solution administration.