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Co amorphous systems: A product development perspective.

Rahul B Chavan1, Rajesh Thipparaboina1, Dinesh Kumar2

  • 1Solid State Pharmaceutical Research Group (SSPRG), Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, India.

International Journal of Pharmaceutics
|November 6, 2016
PubMed
Summary
This summary is machine-generated.

Co-amorphous systems (CAMs) offer a promising alternative to polymeric amorphous solid dispersions for stabilizing amorphous drugs. CAMs improve drug solubility and physical stability, enhancing therapeutic efficacy.

Keywords:
Amorphous solid dispersionCo amorphous systemMiscibilityPhase separationPolymersStability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Drug amorphization addresses poor solubility of new chemical entities but requires stabilization due to recrystallization tendency.
  • Polymeric amorphous solid dispersions (PASD) are common but face limitations like polymer solubility and hygroscopicity.
  • Co-amorphous systems (CAMs) emerge as a novel strategy to stabilize amorphous drugs.

Purpose of the Study:

  • To review the development of co-amorphous systems (CAMs) as drug products.
  • To discuss co-former selection, preparation methods, characterization, stability, scale-up, and regulatory aspects of CAMs.

Main Methods:

  • Review of existing literature on co-amorphous system development.
  • Analysis of co-former selection criteria and preparation techniques.
  • Evaluation of characterization, stability, scale-up, and regulatory considerations.

Main Results:

  • CAMs are multi-component, single-phase amorphous systems offering improved aqueous solubility and physical stability.
  • Various excipients like amino acids, carboxylic acids, nicotinamide, and saccharine can be used in CAM preparation.
  • CAMs show potential for enhanced therapeutic efficacy compared to traditional formulations.

Conclusions:

  • Co-amorphous systems represent a promising advancement over PASD for stabilizing amorphous drugs.
  • Comprehensive understanding of CAM development, from selection to regulation, is crucial for successful drug product implementation.
  • CAMs offer a viable strategy to overcome solubility challenges and improve drug performance.