SOP for Incorporation of Solubility Enhancers in Lyophilized Products

Standard Operating Procedure for Incorporation of Solubility Enhancers in Lyophilized Products

1) Purpose

This SOP outlines the procedure for incorporating solubility enhancers into lyophilized products to improve the solubility of poorly soluble drugs upon reconstitution.

2) Scope

This SOP applies to all personnel involved in the preparation of lyophilized products requiring solubility enhancers, including formulation scientists, production operators, and QA personnel.

3) Responsibilities

Formulation Scientists: Responsible for selecting solubility enhancers based on the solubility requirements of the drug.
Operators: Responsible for incorporating solubility enhancers as outlined in the Batch Manufacturing Record (BMR).
QA: Responsible for verifying the incorporation of solubility enhancers and ensuring proper documentation.

4) Procedure

4.1 Selection of Solubility Enhancers

4.1.1 Criteria for Selection

4.1.1.1 Solubility enhancers must improve the dissolution rate of the active ingredient without affecting its stability. Common enhancers include cyclodextrins, surfactants, and hydrotropes.

4.2 Incorporation of Solubility Enhancers

4.2.1 Weighing and Dispensing

4.2.1.1 Weigh the solubility enhancers using a calibrated balance as specified in the BMR.
4.2.1.2 Add the enhancers to the formulation solution while stirring to ensure 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 solubility enhancers.
4.2.2.2 Homogenize the mixture if necessary 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 as per the BMR for lyophilization.

4.4 Documentation

Record all steps, including the addition of solubility enhancers, filtration, and lyophilization parameters, in the Solubility Enhancer Incorporation Logbook and ensure QA verification.

5) Abbreviations

BMR: Batch Manufacturing Record

6) Documents

Solubility Enhancer Incorporation Logbook

7) References

Pharmacopoeial guidelines for the use of solubility enhancers in lyophilized formulations

8) SOP Version

Version 1.0

Annexure

Solubility Enhancer Incorporation Logbook Template


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

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