Related Experiment Video
Updated: May 7, 2026
09:59
Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
Published on: July 4, 2014
19.0K
Dissolution criticality in developing solid oral formulations: from inception to perception
Riddhish Patadia1, Chintan Vora, Karan Mittal
1Pharmacy Department, Faculty of Technology and Engineering, The Maharaja Sayajirao University of Baroda, Kalabhavan, Vadodara-390001, Gujarat State, India.
Critical Reviews in Therapeutic Drug Carrier Systems
|October 9, 2013
Summary
Simple dissolution testing is crucial for assessing oral dosage form performance and can serve as a biowaiver for bioequivalence studies, reducing costs and benefiting patients.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Dissolution testing is vital for evaluating solid oral dosage form performance.
- Simple dissolution apparatus is gaining favor over complex analytical instruments.
- Understanding dissolution parameters is key for accurate formulation analysis.
Purpose of the Study:
- To provide a comprehensive review of dissolution testing.
- To guide formulation scientists, especially generic manufacturers, in developing dissolution methodologies.
- To highlight the importance of dissolution science in product development and regulatory processes.
Main Methods:
- Review of historical and contemporary dissolution testing practices.
- Analysis of parameters influencing dissolution testing (apparatus, medium, agitation).
- Examination of regulatory guidelines and their impact on dissolution studies.
Main Results:
- Simple dissolution testing offers a cost-effective alternative to complex analyses.
- In vitro dissolution data can support biowaiver recommendations, reducing the need for bioequivalence studies.
- Adherence to regulatory guidelines is essential for successful product development.
Conclusions:
- Dissolution science is a key factor for success in generic drug development.
- Properly designed dissolution testing aids in overcoming product development challenges.
- This review serves as a guide for navigating dissolution complexities and improving prospects.
Related Concept Videos
01:27Factors Influencing Drug Absorption: Drug Dissolution
1.8K
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...
1.8K
01:20Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
738
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...
738
01:23Factors Affecting Dissolution: Particle Size and Effective Surface Area
1.9K
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...
1.9K
01:14Drug Dissolution: Requirements and Profile Comparison
504
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...
504
01:28Factors Influencing Drug Absorption: Pharmaceutical Parameters
836
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...
836
01:15Theories of Dissolution: Diffusion Layer Model
2.1K
Dissolution, the process by which drug particles dissolve in a solvent, is explained by the diffusion layer model, a theoretical framework that simulates the absorption of oral drugs and allows us to analyze experimental data.
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
This process starts with a thin layer, saturated with the drug, forming at the interface between the solid and liquid. The solute then diffuses from this layer into the main solution. The Noyes-Whitney equation suggests that the rate of dissolution relies on the diffusion...
2.1K