SOP for Use of Polyols in Lyophilized Formulations

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

and fill into vials for lyophilization as per the BMR.

4.4 Documentation

Record all steps, including the addition of polyols, filtration, and lyophilization parameters, in the Polyol Incorporation Logbook and ensure QA verification.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Polyol Incorporation Logbook

7) References

Pharmacopoeial guidelines for the use of polyols in lyophilized formulations

8) SOP Version

Version 1.0

Annexure

Polyol Incorporation Logbook Template


  
    Date
    Polyol Name
    Batch No.
    Quantity
    Operator Initials
    QA Verification
  
  
    DD/MM/YYYY
    Polyol Name
    Batch Number
    Quantity (grams)
    Operator Name
    QA Initials