SOP Guide for Pharma

Tablets: SOP for Dissolution Method Development for Sustained Release Tablets – V 2.0

Auditor

Tablets: SOP for Dissolution Method Development for Sustained Release Tablets – V 2.0

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

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.

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5. Procedure

5.1 Method Selection

  1. 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.
  2. 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).
  3. 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

  1. 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.
  2. Perform dissolution tests using a minimum of 6 tablets to ensure representative results, ensuring the integrity and uniformity of the sustained release mechanism.
  3. 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

  1. 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.
  2. 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).
  3. Perform method robustness testing by varying the dissolution test parameters (e.g., temperature, paddle speed) and observing any changes in dissolution results.
  4. Compare the dissolution profiles with the drug release specifications to ensure they meet the target release profile.
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5.4 Data Recording and Calculation

  1. Record the dissolution results, including the amount of API released at each time point, in the batch record (Annexure-1).
  2. Calculate the cumulative percentage of the API released at each time point and compare it to the target dissolution profile.
  3. Document the dissolution results, including the time points, apparatus settings, and any deviations or anomalies during the test process.

5.5 Acceptance Criteria

  1. 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).
  2. 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

  1. Document all dissolution test results, including the setup parameters, time points, and calculated release profiles in the batch record (Annexure-1).
  2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
  3. Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.

5.7 Post-Test Cleanup

  1. Clean all equipment used in the dissolution testing, including dissolution vessels, paddles, and collection vials, according to the cleaning SOP.
  2. Ensure that all equipment is properly maintained and calibrated for future use in dissolution tests.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

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
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