Iyer, Raman, Vesna, petrovska jovanovska, Sanchez-Felix, Manuel, Fabiani, Flavio, Harlacher, Cornelius, Huzjak, Tilen, Berginc, Katja and Jaklič, Miha (2021) Amorphous Solid Dispersions (ASDs) – “The influence of material properties, manufacturing processes and technologies in drug product development". Pharmaceutics Journal, 13(10) (10). pp. 1682-1696.

Abstract

Poorly water-soluble drugs pose a significant challenge in developability due to poor oral absorption leading to poor bioavailability. Several approaches exist that improve oral absorption of such compounds by enhancing aqueous solubility and/or dissolution rate of the drug. These include chemical modifications such as salts, co-crystals or prodrugs and physical modifications such as complexation, nanocrystals or conversion to amorphous form. Among these, the conversion to amorphous form has gained a lot of attention over the last decades for its underlying scientific merit, innovative scope in adaptation of technologies and transformative ability in the performance of new medicines for patients. However, since amorphous forms are thermodynamically unstable, the materials and technologies utilized to enable the conversion of crystalline drug into amorphous state, and finally into the desired dosage form and the methods of characterization of these systems play a critical role in defining the quality, stability, processability and in-vivo performance of the amorphous formulation and have been extensively studied in drug development. Several successfully launched ASD based drug products point to an industrial relevance and increasing maturity of technologies for ASD development.

This article discusses the influence of various material properties, manufacturing processes and technologies in the development of ASD , and recent advances in the analytical tools to characterize their stability and ability to be processed into suitable, patient-centric dosage forms. The unmet need for the development of novel polymers for ASDs is also discussed.

Item Type:	Article
Date Deposited:	02 Nov 2021 00:45
Last Modified:	02 Nov 2021 00:45
URI:	https://oak.novartis.com/id/eprint/45132