An Experimental-Based Approach to Construct the Process Design Space of a Freeze-Drying Process: An Effective Tool to Design an Optimum and Robust Freeze-Drying Process for Pharmaceuticals.

Assegehegn, Getachew; Brito-de la Fuente, Edmundo; Franco, José M; Gallegos, Críspulo

Assegehegn, Getachew; Brito-de la Fuente, Edmundo; Franco, José M; Gallegos, Críspulo.

Afiliação

Assegehegn G; Fresenius-Kabi Deutschland GmbH, Product and Process Engineering Center, Global Manufacturing Pharmaceuticals, Bad Homburg, Germany. Electronic address: getachew.assegehegn@fresenius-kabi.com.
Brito-de la Fuente E; Fresenius-Kabi Deutschland GmbH, Product and Process Engineering Center, Global Manufacturing Pharmaceuticals, Bad Homburg, Germany.
Franco JM; Departamento de Ingeniería Química, Pro2TecS-Chemical Product and Process Technology Research Centre, Complex Fluid Engineering Laboratory, Universidad de Huelva, Huelva, Spain.
Gallegos C; Fresenius-Kabi Deutschland GmbH, Product and Process Engineering Center, Global Manufacturing Pharmaceuticals, Bad Homburg, Germany.

J Pharm Sci ; 109(1): 785-796, 2020 01.

Article em En | MEDLINE | ID: mdl-31288035

Assuntos

Modelos Químicos; Sacarose/química; Tecnologia Farmacêutica; Trealose/química; Composição de Medicamentos; Liofilização; Pressão; Temperatura

Palavras-chave

formulation; freeze-drying; lyophilization; mathematical models(s); processing; quality-by-design

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Sacarose / Trealose / Tecnologia Farmacêutica / Modelos Químicos Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2020 Tipo de documento: Article

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