Role of rheology in formulation and process design of hot melt extruded amorphous solid dispersions.

Autor: Badruddoza AZM; Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA. Electronic address: abuzayedmd.badruddoza@pfizer.com., Moseson DE; Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA., Lee HG; Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA., Esteghamatian A; Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA., Thipsay P; Pharmaceutical Sciences Small Molecule, Worldwide Research and Development, Pfizer Inc., Groton, CT 06340, USA.
Jazyk: angličtina
Zdroj: International journal of pharmaceutics [Int J Pharm] 2024 Oct 25; Vol. 664, pp. 124651. Date of Electronic Publication: 2024 Aug 31.
DOI: 10.1016/j.ijpharm.2024.124651
Abstrakt: Hot melt extrusion (HME) has been widely used as a continuous and highly flexible pharmaceutical manufacturing process for the production of a variety of dosage forms. In particular, HME enables preparation of amorphous solid dispersions (ASDs) which can improve bioavailability of poorly water-soluble drugs. The rheological properties of drug-polymer mixtures can significantly influence the processability of drug formulations via HME and eventually the end-use product properties such as physical stability and drug release. The objective of this review is to provide an overview of various rheological techniques and properties that can be used to evaluate the flow behavior and processability of the drug-polymer mixtures as well as formulation characteristics such as drug-polymer interactions, miscibility/solubility, and plasticization to improve the HME processability. An overview of the thermodynamics and kinetics of ASD processing by HME is also provided, as well as aspects of scale-up and process modeling, highlighting rheological properties on formulation design and process development. Overall, this review provides valuable insights into critical rheological properties which can be used as a predictive tool to optimize the HME processing conditions.
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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