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.
Keywords: Amorphous products; Permeability; Regulatory; Solubility; Stability.
Published by Elsevier B.V.