Industry White Paper: Contemporary Opportunities and Challenges in Characterizing Crystallinity in Amorphous Solid Dispersions.
J Pharm Sci
; 111(6): 1543-1555, 2022 06.
Article
em En
| MEDLINE
| ID: mdl-35041831
ABSTRACT
Members of the IQ Consortium â³Working Group on Characterization on Amorphous Solid Dispersionsâ³ shares here a perspective on the analytical challenges, and limitations of detecting low levels of crystalline drug substance in amorphous solid dispersions (ASDs) and associated drug products. These companies aim to employ highly sensitive commercially available analytical technologies to guide development, support control strategies, and enable registration of quality products. We hope to promote consistency in development and registration approaches and guide the industry in development of "characterization best practices" in the interest of providing high quality products for patients. The first half of this perspective highlights the unique challenges of analytical methodologies to monitor crystalline drug substance in ASDs and their associated drug products. Challenges around use of limit tests, analyte spiking experiments, and method robustness are also underscored. The latter half describes the merits and limitations of the diverse analytical "toolbox" (such as XRPD, NIR and DSC), which can be readily applied during development and, in some cases, considered for potential application and validation in the commercial QC setting when necessary.
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Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Química Farmacêutica
Tipo de estudo:
Guideline
Limite:
Humans
Idioma:
En
Revista:
J Pharm Sci
Ano de publicação:
2022
Tipo de documento:
Article