Influence of temperature and relative humidity conditions on the pan coating of hydroxypropyl cellulose molded capsules

详细信息    查看全文

• 作者：Elena Macchi^a ; ^b ; ^{EMacchi@salud.unm.edu" class="auth_mail" title="E-mail the corresponding author} ; Lucia Zema^b ; ^{lucia.zema@unimi.it" class="auth_mail" title="E-mail the corresponding author} ; Preetanshu Pandey^c ; ^{Preetanshu.Pandey@bms.com" class="auth_mail" title="E-mail the corresponding author} ; Andrea Gazzaniga^b ; ^{andrea.gazzaniga@unimi.it" class="auth_mail" title="E-mail the corresponding author} ; Linda A. Felton^a ; ^{lfelton@unm.edu" class="auth_mail" title="E-mail the corresponding author}
• 关键词：HPC ; hydroxypropyl cellulose ; T ; temperature ; RH ; relative humidity ; SR ; spray rate ; Pf ; PyroButton data-logger fixed in the exhaust air plenum ; Pb ; PyroButton data-logger placed in the tablets bed ; Texh ; exhaust temperature read by the probe of the coating equipment ; t10% ; time to 10% drug release ; t90&ndash ; 10% ; time elapsed between 10% and 90% drug release
• 刊名：European Journal of Pharmaceutics and Biopharmaceutics
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：100
• 期：Complete
• 页码：47-57
• 全文大小：2225 K

文摘

In a previous study, hydroxypropyl cellulose (HPC)-based capsular shells prepared by injection molding and intended for pulsatile release were successfully coated with 10 mg/cm² Eudragit® L film. The suitability of HPC capsules for the development of a colon delivery platform based on a time dependent approach was demonstrated. In the present work, data logging devices (PyroButton®) were used to monitor the microenvironmental conditions, i.e. temperature (T) and relative humidity (RH), during coating processes performed under different spray rates (1.2, 2.5 and 5.5 g/min). As HPC-based capsules present special features, a preliminary study was conducted on commercially available gelatin capsules for comparison purposes. By means of PyroButton data-loggers it was possible to acquire information about the impact of the effective T and RH conditions experienced by HPC substrates during the process on the technological properties and release performance of the coated systems. The use of increasing spray rates seemed to promote a tendency of the HPC shells to slightly swell at the beginning of the spraying process; moreover, capsules coated under spray rates of 1.2 and 2.5 g/min showed the desired release performance, i.e. ability to withstand the acidic media followed by the pulsatile release expected for uncoated capsules. Preliminary stability studies seemed to show that coating conditions might also influence the release performance of the system upon storage.