作者
Teófilo Vasconcelos, Sara Marques, José das Neves, Bruno Sarmento
发表日期
2016/5/1
来源
Advanced drug delivery reviews
卷号
100
页码范围
85-101
出版商
Elsevier
简介
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.
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T Vasconcelos, S Marques, J das Neves, B Sarmento - Advanced drug delivery reviews, 2016