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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Hot Melt Extruded High-Dose Amorphous Solid Dispersions Containing Lumefantrine and Soluplus.

Shu Li1, Zi'an Zhang1, Wenjie Gu1

  • 1School of Pharmacy, Queen's University Belfast, 97 Lisburn Rd, Belfast BT9 7BL, NI UK.

International Journal of Pharmaceutics
|September 10, 2024
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Summary

This study developed a new formulation for artemether/lumefantrine using amorphous solid dispersions to improve lumefantrine solubility and dissolution. This approach aims to enhance drug delivery and potentially reduce adverse effects in malaria treatment.

Keywords:
Amorphous solid dispersionsAnti-malarialDrug enablementHigh doseHot melt extrusionLumefantrineSoluplus

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Paediatric artemisinin-based combination therapies face challenges with patient compliance and drug dissolution.
  • Poor solubility of lumefantrine in gastrointestinal fluids hinders the effectiveness of artemether/lumefantrine combinations.
  • Existing formulations require high-fat meals and exhibit variable dissolution.

Purpose of the Study:

  • To develop amorphous solid dispersions of lumefantrine using Soluplus® and hot melt extrusion.
  • To enhance the dissolution and apparent solubility of lumefantrine.
  • To investigate the impact of extrusion parameters on the stability and performance of the dispersions.

Main Methods:

  • Manufacturing amorphous solid dispersions of lumefantrine in Soluplus® matrices via hot melt extrusion.
  • Investigating drug loading capacity and in-vitro dissolution performance.
  • Examining the influence of varying extrusion conditions (temperature, scale) on physical stability.

Main Results:

  • Successful creation of amorphous solid dispersions of lumefantrine within Soluplus®.
  • Demonstrated improved in-vitro dissolution of lumefantrine from the dispersions.
  • Identified the role of extrusion conditions in the stability and performance of supersaturated amorphous solid dispersions.

Conclusions:

  • Hot melt extrusion of amorphous solid dispersions is a viable strategy to improve lumefantrine solubility and dissolution.
  • Optimized extrusion processes can lead to stable formulations with enhanced drug performance.
  • This approach may enable lower drug dosing, reducing the risk of adverse effects in malaria treatment.