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In Vitro Drug Dissolution: Compendial Testing Models I

In Vitro Drug Dissolution: Compendial Testing Models I

Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...

In Vitro Drug Dissolution: Compendial Testing Models II

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 Methods

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...

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...

In Vitro Drug Release Testing: Overview, Development and Validation

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...

Factors Affecting Dissolution: Particle Size and Effective Surface Area

Factors Affecting Dissolution: Particle Size and Effective Surface Area

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 employed to...

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Updated: May 21, 2026

Formation of Dispersible Taohong Siwu Tablets

Formation of Dispersible Taohong Siwu Tablets

Published on: February 3, 2023

Dissolution testing of orally disintegrating tablets.

Johannes Kraemer¹, Jayachandar Gajendran, Alexis Guillot

¹PHAST GmbH, Homburg, Germany. jkraemer@phast.de

The Journal of Pharmacy and Pharmacology

|June 13, 2012

Summary

For orally disintegrating tablets (ODTs), dissolution testing may suffice for quality control, potentially eliminating the need for disintegration studies in select cases. This simplifies product quality assessment for ODTs.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Quality Control

Background:

Pharmaceutical dosage forms require quality and performance testing.
Current compendial tests (disintegration/dissolution) may not fully reflect oral solid dosage form performance.
Orally disintegrating tablets (ODTs) present unique challenges for general performance testing due to rapid release.

Purpose of the Study:

To review the current status of dissolution testing for ODTs.
To establish product quality standards for ODTs.
To investigate the relationship between disintegration and dissolution for ODTs.

Main Methods:

Review of current compendial requirements for oral solid dosage forms.
Analysis of the relationship between disintegration and dissolution for ODTs.
Evaluation of experimental results on ODT dissolution testing.

Main Results:

Disintegration is often a prerequisite for dissolution in conventional oral solid dosage forms (COSDFs).
Disintegration testing alone is insufficient for judging COSDF product performance.
Experimental data suggest dissolution testing may be adequate for certain ODTs, negating the need for disintegration studies.

Conclusions:

The fast disintegration of ODTs warrants closer examination of the disintegration-dissolution relationship.
Dissolution testing alone may be a feasible approach for quality control of selected ODTs.
This could simplify ODT quality standards and testing protocols.