Information about the solubility, permeability, dissolution and pharmacokinetics of a drug substance and drug product is taken into account when defining dissolution acceptance criteria as part of the drug approval process
The dissolution rate determines how long a dosage form, such as tablets, capsules or sachets, is dissolved in quantity and at what speed for a period of time.
The bioavailability and therapeutic efficacy of a drug depend on its dissolution. Since the effectiveness of an oral dosage form varies according to the ability of the gastrointestinal tract to dissolve the drug in its own fluids before it is absorbed for circulation, the dissolution rate of the tablet or capsule is very important for this process.
To assess the release performance of pharmaceutical products in the gastrointestinal tract (in vivo), dissolution profiles in the laboratory environment can be simulated by determining the rate and extent of release in various environments similar to gastric and intestinal solutions (pH 0.1 and pH 6.8) through in vitro studies. Comparison of the dissolution profiles of pharmaceutical drug forms and their compliance with determined specifications demonstrates consistent product quality and performance.
The dissolution technique applied is determined based on the dosage form characteristics and the intended route of administration
There are several parameters that need to be evaluated to obtain a robust method when developing a dissolution rate determination analysis procedure.
- Type of a device that provides molecule-specific selectivity
- Product form-specific apparatus (according to pharmacopoeia)
- Dissolution media
- Stirring rate
- Selection of the filter
All such factors must be evaluated and suitable for the tested product.
Dissolution rate determination is one of the most important analytical applications for ensuring pharmaceutical quality control. Pharmacokinetic factors must be determined robustly and accurately during pharmaceutical development. Determining dissolution rates for products in various dosage forms allows for better sample understanding and development, while also supporting dissolution profile analysis and method development and validation studies.