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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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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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Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
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From lab-to-clinic with model informed formulation development: a case study of hydroxyzine SR tablets.

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Summary
This summary is machine-generated.

Model Informed Formulation Development (MIFD) utilized physiologically based pharmacokinetic (PBPK) modeling to create a sustained-release Hydroxyzine formulation. This approach successfully reduced peak plasma concentrations and confirmed efficacy through bioequivalence studies.

Keywords:
GastroPlusTM modellingbioequivalencecontrolled releasedifferentiated productdissolutionfood effect(s)in vitro/in vivo (IVIVC) correlation(s)model informed formulation development (MIFD)physiologically based pharmacokinetic (PBPK) modelling

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Area of Science:

  • Pharmacokinetics and Drug Delivery
  • Computational Modeling in Pharmaceutical Science

Background:

  • Model Informed Formulation Development (MIFD) integrates physiologically based pharmacokinetic (PBPK) modeling and in silico tools for efficient new product development.
  • Hydroxyzine, an antihistamine, has a significant side effect of sedation, necessitating optimized drug delivery to manage its therapeutic profile.

Purpose of the Study:

  • To develop a sustained-release formulation for Hydroxyzine using MIFD to reduce peak plasma concentrations and minimize sedation.
  • To validate the developed formulation's performance through in vivo bioequivalence studies and in silico predictions.
  • To establish clinically relevant dissolution specifications and assess the food effect for the modified-release Hydroxyzine product.

Main Methods:

  • Development of a preliminary PBPK absorption model using immediate-release Hydroxyzine data.
  • In silico evaluation of various hypothetical dissolution profiles to guide formulation design.
  • Manufacturing of a sustained-release formulation using Matrixealâ„¢ technology.
  • Conducting preliminary and confirmatory bioequivalence (BE) studies in human volunteers.
  • Refinement of the PBPK model based on bioequivalence study results.

Main Results:

  • A sustained-release Hydroxyzine formulation was successfully developed, demonstrating reduced peak plasma concentrations.
  • Virtual BE studies accurately predicted the performance of the modified formulation.
  • Confirmatory BE studies in 70 volunteers under fasting conditions validated the new formulation.
  • Clinically relevant dissolution specifications were established, and the food effect was assessed.

Conclusions:

  • PBPK modeling is a valuable tool for the development of modified-release drug products, as demonstrated by the Hydroxyzine sustained-release formulation.
  • MIFD enables efficient product development by predicting in vivo performance and guiding formulation optimization.
  • The developed Hydroxyzine formulation offers a potentially improved therapeutic profile with reduced sedation.