期刊
ADVANCED DRUG DELIVERY REVIEWS
卷 100, 期 -, 页码 85-101出版社
ELSEVIER
DOI: 10.1016/j.addr.2016.01.012
关键词
Amorphous products; Solid dispersions; Solvent evaporation process; Melting process; Laboratorial scale; Industrial scale; Drug delivery
资金
- Fundacao para a Ciencia e a Tecnologia (FCT), Portugal [SFRH/BPD/92934/2013, SFRH/BPD/75905/2011]
- European Regional Development Fund (ERDF) through the Programa Operacional Factores de Competitividade-COMPETE
- Portuguese funds through FCT-Fundacao para a Ciencia e a Tecnologia - North Portugal Regional Operational Programme (ON.2-O Novo Norte) [UID/BIM/04293/2013, 4293]
- National Strategic Reference Framework (NSRF) [SAESCTN-PIICDT/2011]
- Fundação para a Ciência e a Tecnologia [SFRH/BPD/92934/2013] Funding Source: FCT
Amorphous products and particularly amorphous solid dispersions are currently one of the most exciting areas in the pharmaceutical field. This approach presents huge potential and advantageous features concerning the overall improvement of drug bioavailability. Currently, different manufacturing processes are being developed to produce amorphous solid dispersions with suitable robustness and reproducibility, ranging from solvent evaporation to melting processes. In the present paper, laboratorial and industrial scale processes were reviewed, and guidelines for a rationale selection of manufacturing processes were proposed. This would ensure an adequate development (laboratorial scale) and production according to the good manufacturing practices (GMP) (industrial scale) of amorphous solid dispersions, with further implications on the process validations and drug development pipeline. (c) 2016 Elsevier B.V. All rights reserved.
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