A Compact Device for the Integrated Filtration, Drying, and Mechanical Processing of Active Pharmaceutical Ingredients.
J Pharm Sci
; 109(3): 1365-1372, 2020 03.
Article
em En
| MEDLINE
| ID: mdl-31866299
ABSTRACT
Recent changes in the pharmaceutical sector call for the development of novel manufacturing approaches to reduce costs and improve control over product quality. In this area, the development of compact, plug-and-play devices that fit in a continuous manufacturing system has gained interest in recent years. Most Nutsche filters offer a versatile solution as compact filtration and drying devices. However, conventional drying processes tend to generate a large amount of lumps, usually requiring further mechanical processing of the isolated drug substance before it can be formulated. In this work, we present a compact, automatable filtration device that takes advantage of a unique impeller design and in situ measurements of the drying heat duty to integrate mechanical processing into the drying step. By preventing the formation of dry lumps during drug substance drying, and breaking needle-like crystals through the developed agitation program, the resulting powder can be directly used for tablet formulation. This device, designed to fit in a compact continuous manufacturing module, has the potential to reduce manufacturing costs and footprint, while allowing for the low-shear mechanical processing of heat-sensitive compounds.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tecnologia Farmacêutica
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Dessecação
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
2020
Tipo de documento:
Article
País de publicação:
EEUU
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ESTADOS UNIDOS
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ESTADOS UNIDOS DA AMERICA
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EUA
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UNITED STATES
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UNITED STATES OF AMERICA
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US
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USA