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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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Protein Based Amorphous Solid Dispersion: a Case Study Investigating Different Whey Proteins at High Drug Loading.

Donglei Leng1, Bulut Bulduk1, Toni Widmer2

  • 1Zerion Pharma A/S, Fruebjergvej 3, 2100, Copenhagen, Denmark.

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|May 26, 2023
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Summary

Whey protein isolate (WPI) and its components show potential for amorphous solid dispersions (ASDs) with poorly soluble drugs. Beta-lactoglobulin (BLG) demonstrated superior stability and dissolution enhancement at high drug loadings up to 70%.

Keywords:
amorphousbeta-lactoglobulin, poorly soluble drugs, dissolutionsolid dispersionwhey-proteins

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Biochemistry

Background:

  • Whey protein isolate (WPI) is a promising excipient for amorphous solid dispersions (ASDs) at 50% drug loading.
  • WPI comprises beta-lactoglobulin (BLG), alpha-lactalbumin (ALA), and casein glycomacropeptides (CGMP), but their individual roles in ASD performance are unknown.
  • The performance of WPI-based ASDs at drug loadings exceeding 50% remains unexplored.

Purpose of the Study:

  • To investigate the individual contributions of BLG, ALA, and CGMP to ASD performance.
  • To evaluate ASDs formulated with WPI and its components at high drug loadings (50%, 60%, and 70%).
  • To assess the feasibility of developing ASDs with poorly water-soluble drugs (Compound A and Compound B) at increased loadings.

Main Methods:

  • Formulation of ASDs using BLG, ALA, CGMP, and WPI with Compound A and Compound B at 50%, 60%, and 70% drug loadings.
  • Solid-state characterization of the formulated ASDs.
  • Analysis of dissolution rates and physical stability of the ASDs.

Main Results:

  • All ASD formulations were amorphous and exhibited enhanced dissolution rates compared to their crystalline drug counterparts.
  • BLG-based ASDs, particularly for Compound A, showed superior performance in terms of physical stability, dissolution enhancement, and solubility increase.
  • The study successfully developed amorphous solid dispersions at drug loadings up to 70%.

Conclusions:

  • Whey proteins, including individual components like BLG, are effective excipients for developing amorphous solid dispersions (ASDs).
  • ASDs can be successfully developed with poorly water-soluble drugs at high drug loadings up to 70%.
  • BLG emerges as a particularly promising component for enhancing the stability and dissolution of ASDs.