SOP for Incorporation of Taste-Masking Agents in Lyophilized Products

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