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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
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Modulating Shape of Polyester Based Polymersomes using Osmotic Pressure
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Amorphous Drug-Polymer Salts.

Xin Yao1, Amy Lan Neusaenger1, Lian Yu1

  • 1School of Pharmacy and Department of Chemistry, University of Wisconsin-Madison, Madison, WI 53705, USA.

Pharmaceutics
|August 28, 2021
PubMed
Summary
This summary is machine-generated.

Amorphous drug formulations can be stabilized against tropical conditions using drug-polymer salts. This approach enhances solubility and bioavailability, crucial for global health medicines.

Keywords:
amorphouscoatingcrystallizationdrug–polymer saltglobal healthpolyelectrolytestropical conditions

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous formulations enhance drug solubility and bioavailability.
  • Medicines for global health require stability under tropical conditions (high temperature and humidity).
  • High drug loading is often necessary for amorphous medicines.

Purpose of the Study:

  • To explore the use of drug-polymer salts for stabilizing amorphous drug formulations.
  • To improve the resistance of amorphous medicines to crystallization under stressful environmental conditions.
  • To maintain or enhance dissolution rates while improving physical stability.

Main Methods:

  • Utilizing drug-polymer salt formation to create ultra-thin polyelectrolyte coatings on amorphous drug surfaces.
  • Forming amorphous drug-polymer salts throughout the bulk of the formulation.
  • Evaluating the stability of formulations against crystallization under high temperature and humidity.
  • Assessing wetting and dissolution properties of the coated and bulk-stabilized particles.

Main Results:

  • Local salt formation creates a polyelectrolyte coating that immobilizes surface molecules and inhibits crystal growth.
  • Coated amorphous drug particles exhibit improved wetting and dissolution characteristics.
  • Bulk amorphous drug-polymer salt formation significantly enhances stability against crystallization under tropical conditions.
  • Dissolution rates were not compromised by the enhanced physical stability.

Conclusions:

  • Drug-polymer salts offer a viable strategy for developing stable amorphous formulations for global health.
  • Both surface coating and bulk salt formation effectively prevent crystallization under challenging conditions.
  • This approach addresses key challenges in amorphous drug stabilization, improving drug performance and applicability.