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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Hot-melt extrusion--basic principles and pharmaceutical applications.

Bo Lang1, James W McGinity, Robert O Williams

  • 1Division of Pharmaceutics, College of Pharmacy, The University of Texas at Austin , Austin, TX , USA.

Drug Development and Industrial Pharmacy
|February 14, 2014
PubMed
Summary
This summary is machine-generated.

Hot-melt extrusion (HME) is a viable pharmaceutical manufacturing technique for drug delivery. This review details HME formulation, process development, and material science principles for successful drug product development.

Keywords:
Amorphous solid dispersionco-crystalcontrolled releasefilmimplantmelt extrusionpolymer selectionprocess developmentscale-up

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Hot-melt extrusion (HME), originally from the plastics industry, is increasingly adopted for pharmaceutical drug delivery.
  • FDA-approved HME products confirm its commercial viability.
  • Limited reviews focus on the fundamental formulation and process development principles of HME.

Purpose of the Study:

  • To provide a comprehensive analysis of formulation and processing aspects of HME.
  • To discuss the influence of drug and excipient physicochemical properties on HME formulation from a materials science perspective.
  • To cover process development, scale-up, and recent applications of HME in various dosage forms.

Main Methods:

  • Literature review focusing on formulation and processing principles of HME.
  • Analysis of material science considerations for drug substances and excipients in HME.
  • Discussion of process development, scale-up strategies, and interplay of formulation-process attributes.

Main Results:

  • HME is a feasible technology for pharmaceutical processing with commercial success.
  • Physicochemical properties of materials significantly impact HME formulation development.
  • Understanding the interplay between formulation and process parameters is crucial for successful scale-up and application.

Conclusions:

  • This review consolidates key formulation and process development principles for HME.
  • It highlights the importance of material science in optimizing HME drug delivery systems.
  • It provides insights into recent advancements and applications of HME across diverse pharmaceutical dosage forms.