Standard Operating Procedure for Incorporation of Taste-Masking Agents in Lyophilized Products
1) Purpose
This SOP outlines the process of incorporating taste-masking agents into lyophilized products, ensuring palatability while maintaining product efficacy and stability.
2) Scope
This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products requiring taste-masking agents.
3) Responsibilities
- Formulation Scientists: Responsible for selecting appropriate taste-masking agents based on the product’s active ingredients.
- Operators: Responsible for incorporating taste-masking agents into the formulation as per the Batch Manufacturing Record (BMR).
- QA: Responsible for verifying the incorporation of taste-masking agents and ensuring proper documentation.
4) Procedure
4.1 Selection of Taste-Masking Agents
4.1.1 Criteria for Selection
- 4.1.1.1 The taste-masking agents must effectively mask the bitter or unpleasant taste of the active ingredient without altering its stability or efficacy.
- 4.1.1.2 Commonly used agents include flavoring agents, sweeteners (e.g., aspartame), or coating techniques such as microencapsulation.
4.2 Incorporation of Taste-Masking Agents
4.2.1 Weighing and Dispensing
- 4.2.1.1 Weigh the taste-masking agents using a calibrated balance as specified in the BMR.
- 4.2.1.2 Add the agents to the formulation solution during the appropriate stage of preparation.
4.2.2 Mixing and Homogenization
- 4.2.2.1 Stir the solution using a mechanical stirrer to ensure the taste-masking agents are evenly distributed.
- 4.2.2.2 Homogenize the mixture if required to ensure uniformity.
4.3 Filtration and Filling
- 4.3.1 Filter the solution using a sterile 0.22-micron filter and fill into vials for lyophilization as per the BMR.
4.4 Documentation
Record all steps, including taste-masking agent incorporation, filtration, and lyophilization parameters, in the Taste-Masking Agent Logbook and ensure QA verification.
5) Abbreviations
- BMR: Batch Manufacturing Record
6) Documents
- Taste-Masking Agent Incorporation Logbook
7) References
- Pharmacopoeial guidelines for the use of taste-masking agents in pharmaceutical formulations
8) SOP Version
Version 1.0
Annexure
Taste-Masking Agent Incorporation Logbook Template
| Date | Taste-Masking Agent Name | Batch No. | Quantity | Operator Initials | QA Verification |
|---|---|---|---|---|---|
| DD/MM/YYYY | Agent Name | Batch Number | Quantity (grams) | Operator Name | QA Initials |