Fluidised bed granulation of two APIs: QbD approach and development of a NIR in-line monitoring method.

Gavan, Alexandru; Iurian, Sonia; Casian, Tibor; Porfire, Alina; Porav, Sebastian; Voina, Ioana; Oprea, Alexandru; Tomuta, Ioan

Gavan, Alexandru; Iurian, Sonia; Casian, Tibor; Porfire, Alina; Porav, Sebastian; Voina, Ioana; Oprea, Alexandru; Tomuta, Ioan.

Afiliação

Gavan A; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.
Iurian S; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.
Casian T; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.
Porfire A; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.
Porav S; National Institute for Research and Development of Isotopic and Molecular Technologies, Cluj-Napoca 400293, Romania.
Voina I; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.
Oprea A; S.C. Laropharm SRL, Bragadiru 077025, Romania.
Tomuta I; Faculty of Pharmacy, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca 400012, Romania.

Asian J Pharm Sci ; 15(4): 506-517, 2020 Jul.

Article em En | MEDLINE | ID: mdl-32952673

Palavras-chave

Design space; Fluid bed granulation; MicroNIR; Process analytical technology; Quality by design; Risk assessment

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Asian J Pharm Sci Ano de publicação: 2020 Tipo de documento: Article

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PubMed Links

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: Asian J Pharm Sci Ano de publicação: 2020 Tipo de documento: Article