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Related Concept Videos

Methods for Studying Drug Absorption: In vitro01:16

Methods for Studying Drug Absorption: In vitro

191
In vitro experiments are crucial for understanding the transport and absorption of drugs through biological materials. These studies employ varied methods such as the diffusion cell method, the everted sac technique, and the everted ring technique.
The diffusion cell method uses a two-compartment cell, including a donor compartment with the drug solution, which simulates the environment where the drug is applied, and a receptor compartment with a buffer solution, which simulates the environment...
191
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

164
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
164
Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

395
The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
395
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

112
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...
112
Methods for Studying Drug Absorption: In situ01:09

Methods for Studying Drug Absorption: In situ

193
In situ experiments, such as the Doluisio method and Single-Pass Perfusion technique, provide critical insights into drug uptake by simulating in vivo conditions for drug absorption.
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
193
Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

276
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...
276

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In Vitro-In Vivo Correlation Of Amorphous Solid Dispersion Enabled Itraconazole Tablets.

Ana L Coutinho1, Asmita Adhikari1,2, Samuel Krug1

  • 1Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, 20 Penn Street, Room 623, HSF2 Building, Baltimore, MD, 21201, USA.

Pharmaceutical Research
|March 12, 2025
PubMed
Summary

This study developed an FDA Level A in vitro-in vivo correlation (IVIVC) for itraconazole spray-dried dispersion tablets. This model successfully predicts human pharmacokinetics (PK) from dissolution data, aiding drug development.

Keywords:
amorphouscorrelationdispersiondissolutionhumanitraconazolepharmacokinetics

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Pharmacokinetics

Background:

  • Limited reports exist on in vitro-in vivo correlation (IVIVC) for immediate-release (IR) formulations.
  • Few studies investigate the impact of formulation and processing on spray-dried dispersion (SDD)-based tablets' human pharmacokinetics (PK).
  • Commercial successes highlight the need to understand bioavailability enhancement in SDD tablets.

Purpose of the Study:

  • To explore formulation and process factors influencing bioavailability enhancement of IR itraconazole SDD tablets.
  • To establish an FDA Level A IVIVC for predicting in vivo PK performance from in vitro dissolution.

Main Methods:

  • Employed a direct, differential-equation-based IVIVC model.
  • Utilized an oral solution for post-dissolution disposition analysis.
  • Tested Fast-, Medium-, and Slow-release tablets with specific in vitro dissolution conditions (USP simulated intestinal fluid, pH 6.4).

Main Results:

  • The developed IVIVC met FDA internal predictability standards for Level A correlation.
  • In vitro dissolution involved particle trituration to simulate in vivo disintegration differences.
  • Model credibility was assessed through verification and validation, considering context and risk.

Conclusions:

  • This is the first study to successfully develop an FDA Level A IVIVC for an amorphous solid dispersion.
  • Assessed the influence of polymer grades, disintegrant levels, and dry granulation on SDD tablet performance.
  • The findings provide a robust model for predicting human PK of itraconazole SDD tablets.