Information about the solubility, permeability, dissolution, and pharmacokinetics of a drug substance and drug product are considered when defining dissolution acceptance criteria as part of the drug approval process.
Dissolution rate determines how much of a dosage form such as a tablet, capsule or sachet dissolves in terms of quantity and at what rate in terms of time.
The bioavailability and therapeutic efficacy of a drug depend on its dissolution.The dissolution rate of tablets or capsules is crucial for the effectiveness of an oral dosage, as the rate of dissolution varies depending on the ability of the tablets or capsules to dissolve in their own midgut fluids before absorption for distribution.
To assess the release performance of pharmaceutical products in the gastrointestinal tract (in vivo), laboratory dissolution profiles 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 established specifications demonstrates consistent product quality and performance.
The applied dissolution technique is determined based on the dosage form characteristics and the intended route of administration.
When developing a procedure for dissolution rate determination analysis there are several parameters that must be evaluated to obtain a robust method.
- Device type providing molecular selectivity
- Product form-specific apparatus (according to pharmacopoeia)
- Dissolution medium
- Mixing speed
- Temperature determination
- Filter selection
All such factors must be evaluated and appropriate for the product being tested.
Dissolution rate determination is one of the most important analytical applications to achieve 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.