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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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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Mechanistic study of carvacrol processing and stabilization as glassy solid solution and microcapsule.

Markus W Tackenberg1, Carola Geisthövel2, Andreas Marmann3

  • 1Institute of Process Engineering in Life Sciences, Section I: Food Process Engineering, Karlsruhe Institute of Technology, Karlsruhe, Germany; Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Duesseldorf, Germany.

International Journal of Pharmaceutics
|December 16, 2014
PubMed
Summary

This study explored microencapsulation (MC) and glassy solid solutions (GSS) for carvacrol. Glassy solid solutions achieved significantly higher carvacrol stabilization compared to microcapsules.

Keywords:
CarbohydratesCarvacrolCarvacrol (PubChem CID: 10364)Glassy solid solutionMaltodextrin (PubChem CID: 107526)Methylene chloride (PubChem CID: 66344)MicroencapsulationPVPPlasticizationPolyvinylpyrrolidone (PubChem CID: 6917)Sodium hydroxide (PubChem CID: 14798)Sucrose (PubChem CID: 5988)

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Microencapsulation improves stability and handling of liquid active pharmaceutical ingredients (APIs).
  • Glassy solid solutions (GSS) offer a single-phase system as an alternative formulation strategy.
  • Carvacrol was used as a model API to investigate formulation approaches.

Purpose of the Study:

  • To compare microcapsule (MC) and glassy solid solution (GSS) formulation strategies for carvacrol.
  • To determine the stabilization capacity of different excipients for carvacrol.
  • To evaluate the plasticizing effect of carvacrol on matrix materials.

Main Methods:

  • Solubility parameter approach to select matrix materials (polyvinylpyrrolidone for GSS; maltodextrin and sucrose for MC).
  • Differential scanning calorimetry (DSC) to assess thermal properties and plasticization.
  • Batch mixing, crushing, and sieving to prepare GSS and MC formulations.

Main Results:

  • Polyvinylpyrrolidone (PVP) was identified as a suitable matrix for GSS due to carvacrol's plasticizing effect.
  • Glassy solid solutions stabilized up to 16.3% carvacrol, significantly higher than the 4.5% in microcapsules.
  • Grinding processes resulted in a carvacrol loss of up to 30%.

Conclusions:

  • Glassy solid solutions represent a highly effective method for stabilizing high concentrations of liquid APIs like carvacrol.
  • The choice of excipient and formulation strategy significantly impacts API loading and stability.
  • Further optimization of processing methods is needed to minimize API loss during post-processing steps.