The objective of the study was to investigate the effects of different devices and capsules on the respirable fraction of capreomycin oleate (CO) powder. CO powder was produced by a simple method using the Büchi nano spray-dryer B90. HandiHaler (Boehringer Ingelheim), the monodose DPI model 8 and RS01 model 7 (Plastiape) devices were evaluated in this study. HPMC capsules (Vcaps, Capsugel and QualiV, Qualicaps) were chosen since highly suitable for dry powder formulations due to their low water content with respect to gelatin capsules and Lactohale LH200 (Domo) was used as carrier. A glass twin stage impinger has been employed to evaluate the emitted fraction (EF) and the respirable fraction of the nominal dose (RFN) according to the European Pharmacopoeia specifications. The highest EF (85%) was obtained using the HandiHaler with the Vcaps or the RS01 model 7 with the QualiV, while the highest RFN (~ 26%) was obtained with the QualiV using both the model 8 and RS01 model 7. It is very interesting to observe that the choice of the capsule had a strong influence on the EF using the HandiHaler and the RS01 model 7 but not the model 8. Therefore, it can be stated the model 8 device performances were not affected by the capsules, while Vcaps were ideal for the HandiHaler and QualiV for the RS01 model 7. In conclusion, this study allowed to evidence the importance of the optimal combination between device and capsule in the performance of pulmonary delivery.
Pulmonary delivery of capreomycin supergenerics: effects of device and capsule
SCHOUBBEN, Aurelie Marie Madeleine;BLASI, PAOLO;GIOVAGNOLI, Stefano;RICCI, Maurizio
2012
Abstract
The objective of the study was to investigate the effects of different devices and capsules on the respirable fraction of capreomycin oleate (CO) powder. CO powder was produced by a simple method using the Büchi nano spray-dryer B90. HandiHaler (Boehringer Ingelheim), the monodose DPI model 8 and RS01 model 7 (Plastiape) devices were evaluated in this study. HPMC capsules (Vcaps, Capsugel and QualiV, Qualicaps) were chosen since highly suitable for dry powder formulations due to their low water content with respect to gelatin capsules and Lactohale LH200 (Domo) was used as carrier. A glass twin stage impinger has been employed to evaluate the emitted fraction (EF) and the respirable fraction of the nominal dose (RFN) according to the European Pharmacopoeia specifications. The highest EF (85%) was obtained using the HandiHaler with the Vcaps or the RS01 model 7 with the QualiV, while the highest RFN (~ 26%) was obtained with the QualiV using both the model 8 and RS01 model 7. It is very interesting to observe that the choice of the capsule had a strong influence on the EF using the HandiHaler and the RS01 model 7 but not the model 8. Therefore, it can be stated the model 8 device performances were not affected by the capsules, while Vcaps were ideal for the HandiHaler and QualiV for the RS01 model 7. In conclusion, this study allowed to evidence the importance of the optimal combination between device and capsule in the performance of pulmonary delivery.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
