title: Amorphous solid dispersions: Rational selection of a manufacturing process.
abstract: 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.
authors.affiliation: BIAL-Portela & Cª, S.A., Avenida da Siderugia Nacional, 4745-457 Trofa, Portugal; Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Rua de Jorge Viterbo Ferreira, n° 228, 4050-313 Porto, Portugal; I3S-Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal; INEB-Instituto de Engenharia Biomédica, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal.
authors.forename: Teófilo
authors.initials: T
authors.lastname: Vasconcelos
authors.affiliation: CIBIO/InBIO-UP-Research Centre in Biodiversity and Genetic Resources, University of Porto, Rua Padre Armando Quintas, n° 7, 4485-661 Vairão, Portugal.
authors.forename: Sara
authors.initials: S
authors.lastname: Marques
authors.affiliation: I3S-Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal; INEB-Instituto de Engenharia Biomédica, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal.
authors.forename: José
authors.initials: J
authors.lastname: das Neves
authors.affiliation: I3S-Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal; INEB-Instituto de Engenharia Biomédica, Universidade do Porto, Rua do Campo Alegre, 823, 4150-180 Porto, Portugal; Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde and Instituto Universitário de Ciências da Saúde, CESPU, Rua Central de Gandra 1317, 4585-116 Gandra, Portugal. Electronic address: Bruno.sarmento@ineb.up.pt.
authors.forename: Bruno
authors.initials: B
authors.lastname: Sarmento
mesh_terms: D001682:Biological Availability; D002626:Chemistry, Pharmaceutical; D016503:Drug Delivery Systems; D015203:Reproducibility of Results; D012995:Solubility
keywords: Amorphous products; Drug delivery; Industrial scale; Laboratorial scale; Melting process; Solid dispersions; Solvent evaporation process