Standard Operating Procedure for Incorporation of Controlled Release Agents in Lyophilized Products
1) Purpose
This SOP outlines the procedure for incorporating controlled release agents into lyophilized products, ensuring prolonged release of the active ingredients over a specific duration while maintaining product stability.
2) Scope
This SOP applies to all personnel involved in the formulation, preparation, and testing of lyophilized products with controlled release agents, including formulation scientists, production operators, and QA personnel.
3) Responsibilities
- Formulation Scientists: Responsible for selecting appropriate controlled release agents and designing the release profile for the formulation.
- Operators: Responsible for incorporating the controlled release agents as per the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying the incorporation and release testing of the controlled release agents, ensuring documentation accuracy.
4) Procedure
4.1 Selection of Controlled Release Agents
4.1.1 Criteria for Selection
- 4.1.1.1 The selected controlled release agents must be compatible with the active ingredients and should ensure a consistent release profile. Commonly used agents include polymers such as hydroxypropyl methylcellulose (HPMC) or poly(lactic-co-glycolic acid) (PLGA).
4.2 Incorporation of Controlled Release Agents
4.2.1 Weighing and Dispensing
- 4.2.1.1 Weigh the controlled release agents using a calibrated balance as specified in the BMR.
- 4.2.1.2 Add the controlled release agents to the formulation
solution and stir until fully dissolved or dispersed.
4.2.2 Mixing and Homogenization
- 4.2.2.1 Stir the solution using a mechanical stirrer to ensure the controlled release agents are evenly distributed.
- 4.2.2.2 Homogenize the mixture if necessary to ensure uniformity across the entire solution.
4.3 Filtration and Filling
- 4.3.1 Filter the solution using a sterile 0.22-micron filter and fill into sterile vials as per the BMR for lyophilization.
4.4 Controlled Release Testing
- 4.4.1 After lyophilization, perform release testing using in vitro dissolution methods to monitor the release profile of the active ingredients over time.
- 4.4.2 Ensure that the release profile meets the specifications outlined in the BMR.
4.5 Documentation
Record all steps, including weighing, controlled release agent addition, filtration, and release testing, in the Controlled Release Agent Incorporation Logbook. All entries must be verified by QA personnel.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Controlled Release Agent Incorporation Logbook
7) References
- Pharmacopoeial guidelines for controlled release drug products and testing methods
8) SOP Version
Version 1.0
Annexure
Controlled Release Agent Incorporation Logbook Template
| Date | Formulation Name | Batch No. | Controlled Release Agent | Release Profile | Operator Initials | QA Verification |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Batch Number | Agent Name | Release Profile Result | Operator Name | QA Initials |