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Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
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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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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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Development of a Discriminative Dissolution Method, Using In-Silico Tool for Hydrochlorothiazide and Valsartan

Rosmery Merma Leon1, Michele Georges Issa1, Marcelo Dutra Duque2

  • 1Department of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo 05508-080, SP, Brazil.

Pharmaceutics
|June 28, 2023
PubMed
Summary

This study developed a dissolution method for fixed-dose combination tablets containing hydrochlorothiazide (HTZ) and valsartan (VAL). The optimized method uses in silico tools and demonstrates adequate discriminative power for assessing drug release.

Keywords:
DDDPlusdissolutionfactorial designhydrochlorothiazidein silicosimulationsvalsartan

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery and Formulation
  • Computational Chemistry

Background:

  • Hydrochlorothiazide (HTZ) and Valsartan (VAL) are poorly soluble drugs classified under BCS classes IV and II, respectively.
  • Fixed-dose combination tablets containing HTZ and VAL present formulation challenges due to poor solubility.
  • Evaluating the dissolution profiles of these poorly soluble drugs is critical for ensuring therapeutic efficacy.

Purpose of the Study:

  • To develop and validate a dissolution method for fixed-dose combination tablets of HTZ and VAL.
  • To utilize in silico tools for evaluating marketed products in Brazil and Peru.
  • To establish optimal conditions for assessing drug release and product performance.

Main Methods:

  • In vitro dissolution tests were conducted using a fractional factorial design (33-1).
  • In silico simulations were performed using DDDPlus™ with a complete factorial design (33).
  • Factors investigated included formulation, sinker use, and rotation speed, with dissolution efficiency (DE) as the primary response.

Main Results:

  • The optimal dissolution method conditions were determined as 900 mL of phosphate buffer (pH 6.8), 75 rpm rotation speed, and sinker use.
  • In silico analysis revealed that the reference product exhibited higher dissolution efficiency (DE) compared to other formulations.
  • Statistical analysis confirmed the significant effects and interactions of the tested factors on drug release.

Conclusions:

  • A robust and discriminative dissolution method was successfully established for HTZ and VAL fixed-dose combination tablets.
  • The developed method ensures complete drug release and can differentiate between formulations.
  • In silico modeling proved valuable in optimizing the dissolution method and evaluating marketed products.