Statistical tools and control of internal lubricant content of inhalation grade HPMC capsules during manufacture

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• 作者：Guillermo Ayala^a ; ^{Guillermo.Ayala@uv.es" class="auth_mail" title="E-mail the corresponding author} ; Fernando Dí ; ez^b ; ^{Fdiez@qualicaps.es" class="auth_mail" title="E-mail the corresponding author} ; Marí ; a T. Gassó ; ^c ; ^{mgasso@mat.upv.es" class="auth_mail" title="E-mail the corresponding author} ; Brian E. Jones^d ; ^{JBE2@cardiff.ac.uk" class="auth_mail" title="E-mail the corresponding author} ; Rafael Martí ; n-Portugué ; s^b ; ^{Rmartin-portugues@qualicaps.es" class="auth_mail" title="E-mail the corresponding author} ; Juan Ramiro-Aparicio^b ; ^{jraparicio@qualicaps.es" class="auth_mail" title="E-mail the corresponding author}
• 关键词：HPMC capsules ; Internal lubricant ; Aerosolization ; Dry powder inhaler (DPI) ; Linear models
• 刊名：International Journal of Pharmaceutics
• 出版年：2016
• 出版时间：30 April 2016
• 年：2016
• 卷：503
• 期：1-2
• 页码：36-40
• 全文大小：481 K

文摘

The internal lubricant content (ILC) of inhalation grade HPMC capsules is a key factor to ensure good powder release when the patient inhales a medicine from a dry powder inhaler (DPI). Powder release from capsules has been shown to be influenced by the ILC. The characteristics used to measure this are the emitted dose, fine particle fraction and mass median aerodynamic diameter. In addition the ILC level is critical for capsule shell manufacture because it is an essential part of the process that cannot work without it. An experiment has been applied to the manufacture of inhalation capsules with the required ILC. A full factorial model was used to identify the controlling factors and from this a linear model has been proposed to improve control of the process.