Amorphous Solid Dispersions: An update for preparation, characterization, mechanism on bioavailability, stability, regulatory considerations and marketed products.

Amorphous solid dispersions (ASDs) are being employed frequently to improve bioavailability of poorly soluble molecules by enhancing the rate and extant of dissolution in drug product development process. These systems comprise of an amorphous active pharmaceutical ingredient stabilized by a polymer matrix to provide enhanced stability. This review discussed the methodologies of preparation and characterization of ASDs with an emphasis on understanding and predicting stability. Rational selection of polymers, preparation techniques with its advantages and disadvantages and characterization of polymeric amorphous solid dispersions have discussed. Stability aspects have been described as per ICH guidelines which intend to depend on selection of polymers and preparation methods of ASD. The mechanism involved on improvement of bioavailability also considered. Regulatory importance of ASD and current evolving details of QBD approach were reviewed. Amorphous products and particularly ASDs are currently most emerging area in the pharmaceutical field. This strategic approach presents huge impact and advantageous features concerning the overall improvement of drug product performance in clinical settings which ultimately lead to drug product approval by leading regulatory agencies into the market.

• Publication year

  2020

• Venue

  International journal of pharmaceutics

• Publication date

  2020-06-18

• Fields of study

  Medicine, Materials Science, Chemistry

• Identifiers
  DOI 10.1016/j.ijpharm.2020.119560PMID 32565285PMCID PMC8691091
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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