4 years ago

Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels

Investigation on the aerosol performance of dry powder inhalation hypromellose capsules with different lubricant levels
HPMC capsules are made by a dipping process and a surface lubricant for the mould pins is an essential processing aid for removing dried capsules shells. For the purpose of this study, the level was determined by quantifying methyloleate (MO) a component found in the lubricant but not in the hypromellose capsules. Here we investigated the influence of the lubricant, low (10.81μg/capsule=60mg/kg MO), medium (15.97μg/capsule=90mg/kg MO) and high (23.23μg/capsule=127mg/kg MO) content on powder (binary mixture of salbutamol: lactose, 1:50 w/w) aerosolization properties was investigated. Results indicated significantly lower emitted dose from capsules with 60mg/kg MO. Furthermore, the 90 and 127mg/kg MO level of lubricant capsules produced almost double the Fine Particle Dose & Fine Particle Fraction compared with the low level of lubricant. The data indicates that lubricant level within capsules has an influence on deposition profiles and amount of drug remaining in capsule and inhaler device after actuation. It is suggested lubricant levels greater than 60mg/kg MO per capsule are required to minimise powder retention within capsules and maximise deposition profiles. AFM (atomic force microscopy) data suggest that internal surface roughness may be related with this phenomena.

Publisher URL: www.sciencedirect.com/science

DOI: S0378517315300491

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