Amorphous Solid Dispersions (ASDs): The Influence of Material Properties, Manufacturing Processes and Analytical Technologies in Drug Product Development
| Autor: | Vesna Petrovska Jovanovska, Tilen Huzjak, Raman Mahadevan Iyer, Manuel Sanchez-Felix, Miha Jaklič, Cornelius Harlacher, Katja Berginc, Flavio Fabiani |
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| Rok vydání: | 2021 |
| Předmět: |
novel stabilizing polymers
chemistry.chemical_classification Materials science business.industry Pharmaceutical Science Nanotechnology Polymer Article Dosage form Amorphous solid Characterization (materials science) RS1-441 manufacturing processes Pharmacy and materia medica chemistry characterization amorphous solid dispersions Solubility material properties business Dispersion (chemistry) Dissolution Pharmaceutical industry |
| Zdroj: | Pharmaceutics Volume 13 Issue 10 Pharmaceutics, Vol 13, Iss 1682, p 1682 (2021) |
| ISSN: | 1999-4923 |
| DOI: | 10.3390/pharmaceutics13101682 |
| Popis: | Poorly water-soluble drugs pose a significant challenge to developability due to poor oral absorption leading to poor bioavailability. Several approaches exist that improve the oral absorption of such compounds by enhancing the 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 formulation strategies, the conversion to amorphous form has been successfully deployed across the pharmaceutical industry, accounting for approximately 30% of the marketed products that require solubility enhancement and making it the most frequently used technology from 2000 to 2020. This article discusses the underlying scientific theory and influence of the active compound, the material properties and manufacturing processes on the selection and design of amorphous solid dispersion (ASD) products as marketed products. Recent advances in the analytical tools to characterize ASDs stability and ability to be processed into suitable, patient-centric dosage forms are also described. The unmet need and regulatory path for the development of novel ASD polymers is finally discussed, including a description of the experimental data that can be used to establish if a new polymer offers sufficient differentiation from the established polymers to warrant advancement. |
| Databáze: | OpenAIRE |
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