Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023

• Published in: International journal of pharmaceutics: X Vol. 7; p. 100259
• Main Authors: Moseson, Dana E., Tran, Trong Bien, Karunakaran, Bharathi, Ambardekar, Rohan, Hiew, Tze Ning
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.06.2024; Elsevier
• Subjects: Amorphous solid dispersion; Dose; Drug product design; Patient centricity; Research Paper; Therapeutic category; FDA; Patient centricity; FDC; SAS; HBA; HBD; PVP; DP; Amorphous solid dispersion; LBF; SD; ASD; QD; Drug product design; EMA; BID; Dose; Therapeutic category; OM; MgSt; ON; HME; xPVP; cPT; SSG; SSF; MW; MCC; TID; BDDCS; DCP; CCS; BCS; PEG; USP; RESS; SCF; HPMCAS; Ro5; HPC; PVA; PVPVA; bRo5; DPI; GRAS; L-HPC; HPMC

Forty-eight (48) drug products (DPs) containing amorphous solid dispersions (ASDs) have been approved by the U.S. Food and Drug Administration in the 12-year period between 2012 and 2023. These DPs comprise 36 unique amorphous drugs. Ten (10) therapeutic categories are represented, with most DPs con...