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Related Concept Videos

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Co-processed MCC-Eudragit® E excipients for extrusion-spheronization.

Alvaro Goyanes1, Consuelo Souto, Ramón Martínez-Pacheco

  • 1Departamento de Farmacia y Tecnología Farmacéutica, Facultad de Farmacia, Universidad de Santiago de Compostela, Santiago de Compostela, Spain.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|September 28, 2011
PubMed
Summary
This summary is machine-generated.

This study shows that co-processed microcrystalline cellulose and Eudragit® E with sorbitol can create effective drug delivery pellets. Higher sorbitol content significantly increases the dissolution rate of hydrochlorothiazide (HCT) from these pellets.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Optimizing drug dissolution is crucial for low water-solubility drugs.
  • Co-processed excipients offer enhanced functionality in pharmaceutical formulations.
  • Sorbitol serves as a soluble filler and disintegrant in pellet formulations.

Purpose of the Study:

  • To evaluate the extrusion-spheronization performance of microcrystalline cellulose (MCC) and Eudragit® E co-processed excipients with sorbitol.
  • To investigate the dissolution rate of hydrochlorothiazide (HCT) from pellets formulated with these excipients.
  • To determine the influence of Eudragit® E content and sorbitol proportion on drug release.

Main Methods:

  • Extrusion-spheronization technique was employed to prepare drug-loaded pellets.
  • Formulations included co-processed MCC-Eudragit® E and varying concentrations of sorbitol.
  • Pellet properties (morphology, flow, mechanical strength) and drug dissolution profiles were assessed.
  • Hydrochlorothiazide (HCT) was used as a model low water-solubility drug.

Main Results:

  • All tested pellet formulations exhibited satisfactory morphological, flow, and mechanical characteristics.
  • Drug dissolution rate was found to be dependent on both Eudragit® E content and sorbitol proportion.
  • Pellets containing 50% sorbitol demonstrated a significantly high dissolution rate for HCT.
  • Pellets with higher sorbitol content underwent rapid disintegration in the dissolution medium.

Conclusions:

  • Co-processed MCC-Eudragit® E and sorbitol are suitable excipients for producing pellets with good physical properties.
  • The combination of co-processed MCC-Eudragit® E and sorbitol effectively enhances the dissolution of poorly soluble drugs like HCT.
  • Optimizing sorbitol content in these formulations can lead to rapid drug release and disintegration, beneficial for specific therapeutic applications.