Standard Operating Procedure for Dissolution Method Development for Sustained Release Tablets
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/102/2025 |
| Supersedes | SOP/TAB/102/2022 |
| Page No. | Page 1 of 7 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for developing dissolution testing methods for sustained release tablets, ensuring that the release of the active pharmaceutical ingredient (API) is consistent and reproducible.
2. Scope
This SOP applies to the development of dissolution methods specifically for sustained release tablet formulations. It covers method selection, validation, and optimization to ensure proper release of the API under simulated physiological conditions.
3. Responsibilities
- Quality Control (QC): Responsible for developing and optimizing the dissolution testing method for sustained release tablets and ensuring that the method meets the necessary specifications and regulatory requirements.
- Quality Assurance (QA): Reviews and approves the dissolution method development process to ensure compliance with regulatory standards and company policies.
- Laboratory Personnel: Responsible for carrying out the dissolution method development, performing tests, recording results, and ensuring that all necessary equipment is calibrated and functioning properly.
4. Accountability
The QC Manager is accountable for ensuring the accurate execution and development of the dissolution method for sustained release tablets. The QA Manager is responsible for reviewing and approving the developed methods.
5. Procedure
5.1 Method Selection
- Select the appropriate dissolution method based on the formulation characteristics of the sustained release tablets. Consider factors such as API solubility, release mechanism, and the intended therapeutic use of the tablet.
- Choose the dissolution medium, based on the pH and ionic strength that simulates the physiological conditions in the gastrointestinal tract (e.g., pH 1.2, 4.5, or 6.8 depending on the type of sustained release tablet).
- Determine the appropriate dissolution apparatus, such as USP Apparatus 1 (baskets) or USP Apparatus 2 (paddles), based on the tablet characteristics.
5.2 Method Development
- Optimize the dissolution method by testing various parameters, including the dissolution medium, paddle speed, and temperature. Ensure that the dissolution test conditions mimic the tablet’s intended release profile.
- Perform dissolution tests using a minimum of 6 tablets to ensure representative results, ensuring the integrity and uniformity of the sustained release mechanism.
- Record the time points at which the dissolution samples will be collected (e.g., 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr) and analyze the release profiles accordingly.
5.3 Method Validation
- Validate the dissolution method by performing multiple tests with tablets from different batches, ensuring the reproducibility and accuracy of the dissolution profiles across all batches.
- Ensure that the dissolution method meets the acceptance criteria for sustained release tablets, such as the percentage of API released within a specified time range (e.g., 80% API released in 12 hours or as specified).
- Perform method robustness testing by varying the dissolution test parameters (e.g., temperature, paddle speed) and observing any changes in dissolution results.
- Compare the dissolution profiles with the drug release specifications to ensure they meet the target release profile.
5.4 Data Recording and Calculation
- Record the dissolution results, including the amount of API released at each time point, in the batch record (Annexure-1).
- Calculate the cumulative percentage of the API released at each time point and compare it to the target dissolution profile.
- Document the dissolution results, including the time points, apparatus settings, and any deviations or anomalies during the test process.
5.5 Acceptance Criteria
- Ensure that the sustained release tablets meet the dissolution specifications defined in the product development report or regulatory guidelines (e.g., 80% drug release in 12 hours, or as specified).
- If the dissolution results do not meet the specified release criteria, investigate and document the findings in the deviation report (Annexure-2). Consider adjusting the formulation or method as necessary and perform re-testing.
5.6 Documentation and Record-Keeping
- Document all dissolution test results, including the setup parameters, time points, and calculated release profiles in the batch record (Annexure-1).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
- Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.
5.7 Post-Test Cleanup
- Clean all equipment used in the dissolution testing, including dissolution vessels, paddles, and collection vials, according to the cleaning SOP.
- Ensure that all equipment is properly maintained and calibrated for future use in dissolution tests.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- API: Active Pharmaceutical Ingredient
- HPLC: High-Performance Liquid Chromatography
- USP: United States Pharmacopeia
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <711> – Dissolution Testing of Tablets
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Dissolution Testing Guidelines
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Record
| Batch Number | Tablet Sample | Dissolution Method | API Released at 1 Hour (%) | API Released at 12 Hours (%) | Result |
|---|---|---|---|---|---|
| Batch 001 | Tablet Sample | Apparatus 2 | 25% | 80% | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Release profile did not meet specifications | Optimized formulation and re-tested | John Doe |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated Dissolution Method | Refined dissolution testing for sustained release | QA Head |