Standard Operating Procedure for Use of Polyols in Lyophilized Formulations

1) Purpose

This SOP outlines the procedure for incorporating polyols (e.g., mannitol, sorbitol) into lyophilized formulations to enhance stability and act as bulking agents, cryoprotectants, or stabilizers.

2) Scope

This SOP applies to formulation scientists, production operators, and QA personnel involved in the preparation of lyophilized products using polyols.

3) Responsibilities

• Formulation Scientists: Responsible for selecting appropriate polyols based on the formulation’s stability requirements.
• Operators: Responsible for incorporating the polyols as outlined in the Batch Manufacturing Record (BMR).
• QA: Responsible for verifying the incorporation of polyols and ensuring proper documentation.

4) Procedure

4.1 Selection of Polyols

4.1.1 Criteria for Selection

• 4.1.1.1 Polyols must be compatible with the active ingredient and should not interfere with the lyophilization process. Commonly used polyols include mannitol, sorbitol, and glycerol.

4.2 Incorporation of Polyols

4.2.1 Weighing and Addition

• 4.2.1.1 Weigh the polyols using a calibrated balance as specified in the BMR.
• 4.2.1.2 Dissolve or disperse the polyols into the formulation solution, ensuring even distribution.

4.2.2 Mixing and Homogenization

• 4.2.2.1 Stir the solution using a mechanical stirrer to ensure uniform distribution of the polyols.
• 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