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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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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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Developing Soluplus®-Based Microparticle Amorphous Solid Dispersions with High Drug Loading for Enhanced Celecoxib

Fan Fan1,2, Feng Zhou1,2, Jiayu Zhang3

  • 1Laboratory of Advanced Theranostic Materials and Technology, Ningbo Institute of Materials Technology and Engineering, Chinese Academy of Sciences, Ningbo, 315201, China.

AAPS Pharmscitech
|January 29, 2025
PubMed
Summary
This summary is machine-generated.

Electrospraying created stable amorphous solid dispersions (ASDs) of celecoxib (CEL) and Soluplus® (SOL) with high drug loading. These microparticle ASDs significantly enhanced CEL dissolution, offering a promising alternative for poorly water-soluble drugs.

Keywords:
amorphous solid dispersions (ASDs)electrosprayinghigh drug loadingssolubility enhancementsoluplus®-based microparticles

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous solid dispersions (ASDs) improve drug dissolution but often have low drug loadings.
  • Poorly water-soluble drugs like celecoxib (CEL) require enhanced dissolution for better therapeutic efficacy.
  • Developing stable ASDs with high drug content is crucial for effective oral drug formulations.

Purpose of the Study:

  • To develop Soluplus® (SOL)-based microparticle ASDs of celecoxib (CEL) with high drug loading (up to 60% w/w).
  • To achieve long-term physical stability (≥16 months) of the CEL-SOL ASDs.
  • To enhance the in vitro dissolution rate of CEL using electrospraying technology.

Main Methods:

  • Electrospraying was employed to fabricate SOL-CEL microparticle ASDs.
  • X-ray diffraction (XRD) and differential scanning calorimetry (DSC) were used to confirm the amorphous nature.
  • Fourier transform infrared spectroscopy (FTIR) analyzed drug-excipient interactions (hydrogen bonding).

Main Results:

  • Electrosprayed SOL-CEL microparticles were confirmed to be amorphous.
  • FTIR analysis revealed hydrogen bonding between SOL and CEL, contributing to ASD stabilization.
  • In vitro dissolution studies showed an 8.2-fold increase in CEL dissolution rate compared to the crystalline form.

Conclusions:

  • Electrospraying is a viable method for producing high-loaded, stable CEL-SOL ASDs.
  • The developed ASDs significantly enhance the dissolution of poorly water-soluble celecoxib.
  • Electrospraying offers advantages over traditional methods like HME and SD for ASD production.