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Related Concept Videos

Drug Product Stability01:16

Drug Product Stability

The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
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A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
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Physicochemical Stability of Compounded Creams Containing a-Hydroxy Acids.

M M de Villiers1, K Narsai, J G van der Watt

  • 1Research Institute for Industrial Pharmacy Potchefstroom University for CHE Potchefstroom, South Africa.

International Journal of Pharmaceutical Compounding
|August 30, 2013
PubMed
Summary
This summary is machine-generated.

The stability of alpha-hydroxy acid (AHA) creams was assessed using freeze-thaw cycles. Hydrophilic ointment bases yielded the most stable AHA formulations, though preservative levels decreased.

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Published on: September 20, 2017

Area of Science:

  • Cosmetic Science
  • Pharmaceutical Formulation
  • Dermatology

Background:

  • Alpha-hydroxy acids (AHAs) like lactic and glycolic acid are popular skincare ingredients.
  • Extemporaneous compounding of AHA creams requires careful consideration of formulation stability.
  • Understanding the impact of freeze-thaw cycles on AHA cream stability is crucial for product shelf-life.

Purpose of the Study:

  • To evaluate the stability of creams containing lactic acid and glycolic acid after freeze-thaw cycles.
  • To compare the stability of AHA creams formulated with aqueous cream, BP and hydrophilic ointment, USP.
  • To investigate the effect of AHAs on preservative efficacy and potential hydrolysis.

Main Methods:

  • Creams with alpha-hydroxy acids (AHAs) were prepared using aqueous cream, BP or hydrophilic ointment, USP.
  • Formulations underwent five freeze-thaw cycles between -4°C and 40°C.
  • Stability parameters including pH, viscosity, spreadability, density, appearance, and potency were measured post-cycle.

Main Results:

  • Creams compounded with hydrophilic ointment, USP exhibited superior stability.
  • The addition of AHAs significantly reduced preservative (methylparaben, propylparaben) levels.
  • Preservative hydrolysis was prevented in hydrophilic creams when AHAs were neutralized to a pH above 3.5.

Conclusions:

  • Hydrophilic ointment, USP is a suitable base for stabilizing AHA-containing creams.
  • Formulators must address potential preservative depletion when incorporating AHAs.
  • Partial neutralization of AHAs to pH > 3.5 can maintain preservative integrity in hydrophilic formulations.