Related Experiment Video
Updated: May 4, 2026
11:27
A Package of Established Analytical Tools to Investigate the Solid-State Alteration of Lipid-Based Excipients
Published on: August 9, 2022
1.8K
Drug release from semisolid dosage forms: a comparison of two testing methods.
Pharmaceutical Development and Technology
|December 17, 2013
Summary
This study compared Franz cell and modified USP systems for in-vitro drug release of diclofenac sodium from dermatological bases. The modified USP method generally offered more precise results for drug release studies.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Dermatological Formulations
Background:
- In-vitro drug release studies are crucial for evaluating dermatological formulations.
- Semisolid bases and non-impregnated cellulose acetate membranes were used in previous studies.
- Understanding drug release kinetics is essential for predicting in-vivo performance.
Purpose of the Study:
- To compare the performance of Franz cell and a modified USP apparatus for in-vitro drug release of diclofenac sodium from semisolid dermatological bases.
- To assess the in-vivo-in-vitro correlation for different dermatological bases using these methods.
- To evaluate the repeatability and reproducibility of the drug release measurements.
Main Methods:
- Utilized five different semisolid and two marketed preparations containing 1% diclofenac sodium.
- Employed both the Franz cell and a modified USP (mini paddle with ointment holding cell) systems for drug release testing.
- Analyzed complex, slightly non-linear release curves and measured diclofenac sodium release at 6 hours.
Main Results:
- Complex release curves were observed, attributed to co-diffusion of excipients affecting membrane and medium properties.
- Good qualitative and quantitative in-vivo-in-vitro correlations were found for certain dermatological bases.
- The modified USP method generally yielded more precise results compared to the Franz cell method.
Conclusions:
- The choice of in-vitro testing apparatus impacts the precision of drug release data for dermatological formulations.
- While not ideal for establishing in-vivo-in-vitro correlation, the tested model showed promise for specific formulation types.
- Excipient co-diffusion can dynamically alter membrane and receiving medium characteristics during drug release testing.
Related Concept Videos
01:09In Vitro Drug Dissolution: Compendial Testing Models II
686
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,...
686
01:14Drug Dissolution: Requirements and Profile Comparison
500
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...
500
01:17In Vitro Drug Dissolution: Alternative Methods
380
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...
380
01:13In Vitro Drug Dissolution: Compendial Testing Models I
560
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...
560
01:10In Vitro Drug Release Testing: Overview, Development and Validation
593
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...
593
01:22Modified-Release Drug Delivery Systems: Drug Release Characteristics
257
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...
257