How to Develop a Dissolution Method?
A logical five-step approach mentioned below for dissolution method development:
1. Conduct a Solubility Test
Begin by assessing the solubility of the product’s maximum daily dose in various media. This establishes a foundational understanding of the product’s solubility profile.
2. Select Dissolution Media
Based on the solubility data, determine the appropriate dissolution media volume and pH. Ensure the product does not require a challenging medium. If no challenges are present, proceed to the next step.
3. Perform Comparative Dissolution Profile (CDP) Testing
Evaluate the dissolution behavior in the three standard USP media (pH 1.2, pH 4.5, and pH 6.8). Establish the most suitable dissolution medium for your product while ensuring proper sinking conditions.
4. Define the Q Value
Using the results from step 3, set the Q value by referring to the ICH dissolution decision tree. This ensures alignment with regulatory guidelines.
5. Address Low Solubility APIs
For poorly soluble APIs, consider incorporating a surfactant to enhance solubility. The type and concentration of the surfactant must be justified using the solubility data from step 1.
Key Insights
By following these five steps, you can logically and systematically develop a dissolution method. Each step provides a clear rationale and flexibility for further refinement if necessary.
From my experience, developing and performing dissolution tests is relatively straightforward. However, interpreting the results can be significantly more challenging, requiring a deep understanding of the test’s nuances and implications.
Read also:
- Common Interview Questions and Answers on Analytical Development
- Importance of pKa Value in Selection of Dissolution Media
Resource Person: Lyes Reguieg
