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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients, maintaining...
In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
Modified-Release Drug Delivery Systems: Overview01:19

Modified-Release Drug Delivery Systems: Overview

Modified-release dosage forms are designed to address the limitations of drugs with short biological half-lives. These forms maintain stable therapeutic drug concentrations over extended periods, reducing the need for frequent dosing. A consistent drug level helps minimize peak-trough fluctuations, which can reduce adverse effects, lower the risk of drug resistance, and improve overall treatment effectiveness.One common type of modified-release form is the extended-release (ER) formulation. ER...
Modified-Release Drug Delivery Systems: Influencing Factors01:20

Modified-Release Drug Delivery Systems: Influencing Factors

Modified-release drug delivery systems are designed to optimize the therapeutic effect of drugs by minimizing side effects, reducing the dosage required, and controlling drug release to align with pharmacokinetic and pharmacodynamic needs. The system depends on two key factors: the drug's release from the formulation and its movement through the body to the target site. Unlike conventional dosage forms, where absorption is the limiting step, the rate of drug release is the key determinant in...
Modified-Release Drug Delivery Systems: Drug Release Characteristics01:22

Modified-Release Drug Delivery Systems: Drug Release Characteristics

Drug release from modified-release dosage forms is designed to achieve specific therapeutic effects by controlling the rate and extent of drug release. The classification of these drug release systems is based on key pharmacokinetic assumptions: drug disposition follows first-order kinetics, drug release is the rate-limiting step in absorption, and the released drug is rapidly and completely absorbed.There are four major models of drug release patterns. The first model is the slow zero-order...
Oral Drug Delivery Systems: Delayed-Release Systems01:11

Oral Drug Delivery Systems: Delayed-Release Systems

Delayed-release drug delivery systems are specialized pharmaceutical formulations designed to postpone the release of active compounds until the drug reaches a specific region of the gastrointestinal (GI) tract, typically the intestine. These systems are essential for drugs that may cause gastric irritation, are unstable in acidic environments, or need to exert therapeutic effects locally in the intestinal or colonic regions.The core feature of delayed-release systems is the use of enteric...

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Updated: Jul 5, 2026

Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study
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Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study

Published on: August 15, 2016

Model-Supported dissolution methods for Modified-Release Products: Enteric-coated versus extended-release ketoprofen

Mauricio A García1, Jozef Al-Gousous2, Pablo M González3

  • 1Departamento de Farmacia, Escuela de Química y Farmacia, Facultad de Química y de Farmacia, Pontificia Universidad Católica de Chile, Santiago, 7820436, Chile.

International Journal of Pharmaceutics
|March 28, 2025
PubMed
Summary

Dissolution testing for extended-release (XR) ketoprofen requires high buffer molarity for accurate in vitro-biopredictive results. Low molarity buffers do not fully capture the enhanced buffer capacity of XR dosage forms in vivo.

Keywords:
Enteric-coatedExtended-releaseModel-supported dissolutionSurrogate mediaSustained-release

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Formation of Dispersible Taohong Siwu Tablets
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Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

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Transport Properties of Ibuprofen Encapsulated in Cyclodextrin Nanosponge Hydrogels: A Proton HR-MAS NMR Spectroscopy Study
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05:44

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Physical Chemistry

Background:

  • Drug product development faces challenges, with dissolution testing crucial for predicting in vivo performance.
  • Poorly soluble ionizable drugs dissolve slower in biorelevant bicarbonate buffers due to a lowered effective pKa (pKa,eff).
  • This effect may differ for controlled-release formulations like enteric-coated (EC) and extended-release (XR) dosage forms.

Purpose of the Study:

  • To investigate and compare the in vitro dissolution profiles of enteric-coated (EC) and extended-release (XR) ketoprofen formulations.
  • To assess the biorelevance of in vitro dissolution data obtained in low molarity buffers mimicking intestinal conditions.
  • To elucidate the impact of formulation type and buffer conditions on drug dissolution and in vivo performance.

Main Methods:

  • In vitro dissolution studies of EC and XR ketoprofen formulations in low molarity buffers.
  • In vivo comparative bioavailability studies to confirm biorelevance.
  • Mass/charge balance modeling to gain mechanistic insights into dissolution behavior.

Main Results:

  • In vitro dissolution and in vivo absorption of EC tablets were influenced by coating polymer material.
  • In vitro dissolution of XR formulations showed formulation-dependent discrepancies in low molarity media, which were not observed in vivo.
  • Mechanistic modeling indicated that XR dosage forms exhibit enhanced buffer capacity in vivo due to slower diffusion and high liquid-to-solid ratios, which is not replicated by low molarity in vitro media.

Conclusions:

  • Dissolution testing in low molarity buffers may not accurately predict the in vivo performance of XR ketoprofen formulations.
  • Performing dissolution experiments at high buffer molarities is recommended to improve the biopredictivity of XR dosage forms.
  • Understanding the interplay between formulation design, buffer conditions, and dissolution mechanisms is key for successful drug product development.