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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Amorphous solid dispersions: Rational selection of a manufacturing process.

Teófilo Vasconcelos1, Sara Marques2, José das Neves3

  • 1BIAL-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.

Advanced Drug Delivery Reviews
|January 31, 2016
PubMed
Summary

Amorphous solid dispersions enhance drug bioavailability. This review proposes guidelines for selecting manufacturing processes to ensure robust development and production of these pharmaceutical products.

Keywords:
Amorphous productsDrug deliveryIndustrial scaleLaboratorial scaleMelting processSolid dispersionsSolvent evaporation process

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Area of Science:

  • Pharmaceutical Science
  • Materials Science

Background:

  • Amorphous solid dispersions (ASDs) are a key area in pharmaceuticals.
  • ASDs significantly improve drug bioavailability.
  • Developing robust and reproducible manufacturing processes for ASDs is crucial.

Purpose of the Study:

  • To review laboratorial and industrial scale manufacturing processes for amorphous solid dispersions.
  • To propose guidelines for the rational selection of these manufacturing processes.
  • To ensure adequate development and GMP-compliant production of ASDs.

Main Methods:

  • Review of existing literature on amorphous solid dispersion manufacturing.
  • Analysis of laboratorial and industrial scale processes.
  • Development of selection guidelines based on process characteristics.

Main Results:

  • Overview of various manufacturing techniques including solvent evaporation and melting processes.
  • Identification of key factors for selecting appropriate manufacturing methods.
  • Proposed guidelines for scaling up ASD production.

Conclusions:

  • The selection of appropriate manufacturing processes is critical for successful ASD development.
  • Guidelines facilitate the transition from laboratorial to industrial scale production.
  • Optimized ASD manufacturing impacts process validation and the drug development pipeline.