ArticleInternational journal of pharmaceutics: X2024
Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023.
Article in International journal of pharmaceutics: X, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
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Who cites it
28 citing papers in PubMed.
- Thermoresponsive Solid Dispersion to Enhance Dissolution Profile of Atorvastatin Calcium: An Industrially Sustainable Alternative to Conventional Approaches.Pharmaceutics · 2026Article
- Crystallization Inhibition and Solid-State Stability in High Drug Loaded Amorphous Drug-Polymer Dispersions Above the Overlap Concentration.Pharmaceutical research · 2026Review
- Full vibrational spectroscopy for simultaneous mechanical, structural and chemical analysis.Nature communications · 2026Article
- The expanding role of formulations to enable oral delivery of poorly water-soluble drugs.Nature reviews. Drug discovery · 2026Review
- From Chemistry to Clinic: Amorphous Solid-State Modification Strategies for Oral Azole Antifungals.ACS omega · 2026Review
- Unlocking the potential of alkaline polymethacrylates via ionic crosslinking in amorphous solid dispersions.International journal of pharmaceutics: X · 2026Article
- Double action of HPMCAS as a dry binder and precipitation inhibitor in ASD tablet formulations of nifedipine prepared by hot-melt extrusion.International journal of pharmaceutics: X · 2026Article
- Preparation and recrystallization of amorphous l-glutamic acid.RSC advances · 2026Article
- Nanoparticulate protectants for the dry storage of protein therapeutics.Nanomedicine (London, England) · 2026Review
- Supersaturated Lipid-Based Formulations of Moderately Lipophilic Neutral Drug: Impact of Formulation type, Colloidal Behaviour and Precipitation Inhibition on In Vitro-In Vivo Performance.AAPS PharmSciTech · 2026Article
- Prediction of Solvent Penetration Rate-Limited Release of Drug from Amorphous Solid Dispersion Discs of Various Geometries.Molecular pharmaceutics · 2026Article
- High-Contrast X-Ray Computed Tomography for Quantifying Amorphous Content in Melt-Quenched Acetaminophen.AAPS PharmSciTech · 2026Article
- High Bioavailability Resveratrol Delivery System: A Novel Nutritional Strategy for the Prevention and Alleviation of Rheumatoid Arthritis.Food science & nutrition · 2026Article
- Dissolution-permeation approach for biopharmaceutical evaluation: a feasibility study using naproxen.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2026Article
- Article
- Advancing amorphous solid dispersions through empirical and hybrid modeling of drug-polymer solubility and miscibility: A case study using Ibuprofen.International journal of pharmaceutics: X · 2025Article
- Article
- Recent Techniques to Improve Amorphous Dispersion Performance with Quality Design, Physicochemical Monitoring, Molecular Simulation, and Machine Learning.Pharmaceutics · 2025Review
- The More the Better?─Vitamin E TPGS as a Release Enhancer for Ritonavir/PVPVA Amorphous Solid Dispersions.Molecular pharmaceutics · 2025Article
- Mechanistic Investigation into the Phase Separation Behavior of Soluplus in the Presence of Biorelevant Media.Molecular pharmaceutics · 2025Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 containing antiviral and antineoplastic agents. The most common ASD polymers are copovidone (49%) and hypromellose acetate succinate (30%), while spray drying (54%) and hot melt extrusion (35%) are the most utilized manufacturing processes to prepare the ASD drug product intermediate (DPI). Tablet dosage forms are the most common, with several capsule products available. Line extensions of several DPs based on flexible oral solids and powders for oral suspension have been approved which provide patient-centric dosing to pediatric and other patient populations. The trends in the use of common excipients and film coating types are discussed. Eighteen (18) DPs are fixed-dose combinations, and some contain a mixture of amorphous and crystalline drugs. The DPs have dose/unit of amorphous drug ranging from <5 mg up to 300 mg, with the majority being ≤100 mg/unit. This review details several aspects of DPI and DP formulation and manufacturing of ASDs, as well as trends related to therapeutic category, dose, and patient-centricity.
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