供雾化器用吸入液体制剂的质量研究及其综合评价
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摘要
本文从供雾化器用吸入液体制剂的特性研究、影响质量的其他关键因素、监管机构的技术要求3个方面对该剂型的质量研究展开综述。最后,对影响制剂疗效的因素做了简要的综合评价。
This review mainly focuses on the characterization of nebulizer formulation,critical quality attributes of nebulizer drug products,technical requirements of regulatory offices. Furthermore,we made a briefly comprehensive evaluation on the factors which influence the therapeutic effects of nebulizer drug products.
This review mainly focuses on the characterization of nebulizer formulation,critical quality attributes of nebulizer drug products,technical requirements of regulatory offices. Furthermore,we made a briefly comprehensive evaluation on the factors which influence the therapeutic effects of nebulizer drug products.
引文
[1] The United States Pharmacopeial Convention. The United States pharmacopeia,the national formulary[S]. USP40. NF35. United Book Press,218-239.
[2] JAUERNIG J,MITCHELL J,et al. Position paper:recommendation on the adoption of breathing patterns for infants and small children in general chapter 2. 9. 44. Preparations for nebulisation[J]. Pharmeuropa Scientific Notes,2008,2008(1):31.
[3]国家药典委员会.中华人民共和国药典[S]. 2015年版.第四部.北京:中国医药科技出版社,2015:125-130.
[4] HOU S,WU J,LI X,et al. Practical,regulatory and clinical considerations for development of inhalation drug products[J].Asian J Pharm Sci,2015,10(6):490-500.
[5] CARVALHO TC,MCCONVILLE JT. The function and performance of aqueous aerosol devices for inhalation therapy[J]. J Pharm Pharmacol,2016,68(5):556-578.
[6] FDA guidance for industry. Nasal spray and inhalation solution,suspension,and spray drug products-chemistry,manufacturing,and controls documentation[S]. 2002.
[7] CHAN JG,WONG J,ZHOU QT,et al. Advances in device and formulation technologies for pulmonary drug delivery[J]. AAPS Pharmscitech,2014,15(4):882-897.
[8]国家食品药品监督管理总局药品审评中心.化学药物(原料药和制剂)稳定性研究技术指导原则[S]. 2015.
[9] EMEA guideline on the pharmaceutical quality of inhalation and nasal products[S]. 2006.
[10] PILCER G,AMIGHI K. Formulation strategy and use of excipients in pulmonary drug delivery[J]. Int J Pharm,2010,392(1-2):1-19.
[11] FINLAY WH. Nebulizers for drug delivery to the lungs[J]. Expert Opin Drug Deliv,2015,12(6):1-12.
[2] JAUERNIG J,MITCHELL J,et al. Position paper:recommendation on the adoption of breathing patterns for infants and small children in general chapter 2. 9. 44. Preparations for nebulisation[J]. Pharmeuropa Scientific Notes,2008,2008(1):31.
[3]国家药典委员会.中华人民共和国药典[S]. 2015年版.第四部.北京:中国医药科技出版社,2015:125-130.
[4] HOU S,WU J,LI X,et al. Practical,regulatory and clinical considerations for development of inhalation drug products[J].Asian J Pharm Sci,2015,10(6):490-500.
[5] CARVALHO TC,MCCONVILLE JT. The function and performance of aqueous aerosol devices for inhalation therapy[J]. J Pharm Pharmacol,2016,68(5):556-578.
[6] FDA guidance for industry. Nasal spray and inhalation solution,suspension,and spray drug products-chemistry,manufacturing,and controls documentation[S]. 2002.
[7] CHAN JG,WONG J,ZHOU QT,et al. Advances in device and formulation technologies for pulmonary drug delivery[J]. AAPS Pharmscitech,2014,15(4):882-897.
[8]国家食品药品监督管理总局药品审评中心.化学药物(原料药和制剂)稳定性研究技术指导原则[S]. 2015.
[9] EMEA guideline on the pharmaceutical quality of inhalation and nasal products[S]. 2006.
[10] PILCER G,AMIGHI K. Formulation strategy and use of excipients in pulmonary drug delivery[J]. Int J Pharm,2010,392(1-2):1-19.
[11] FINLAY WH. Nebulizers for drug delivery to the lungs[J]. Expert Opin Drug Deliv,2015,12(6):1-12.