SOP for Use of Surfactants in Nasal Formulations

Standard Operating Procedure for Use of Surfactants in Nasal Formulations

1) Purpose

The purpose of this SOP is to provide guidelines for the appropriate use of surfactants in nasal spray formulations to enhance solubility, stability, and absorption of the active ingredients.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays using surfactants at [Company Name].

3) Responsibilities

Operators: Responsible for adding surfactants and ensuring they are properly dispersed in the formulation.
QA: Verifies the surfactant concentration and checks that the formulation meets quality standards.

4) Procedure

4.1 Surfactant Selection

4.1.1 Types of Surfactants

Select the appropriate surfactant based on the formulation needs, such as Tween 80, polysorbate, or lecithin.
Ensure that the surfactants used are pharmaceutically acceptable and compatible with the active ingredients and excipients.

4.1.2 Weighing of Surfactants

Weigh the required amount of surfactants according to the formulation specifications.
Document all weights in the batch manufacturing record (BMR).

4.2 Incorporation of Surfactants

4.2.1 Dissolution

Dissolve the surfactant in the nasal spray solution while stirring continuously.
Ensure that the surfactant is completely dissolved to avoid phase separation or cloudiness in the

solution.

4.2.2 Mixing and Homogenization

Use a homogenizer to ensure uniform distribution of the surfactant in the formulation.

4.3 pH and Osmolality Testing

4.3.1 pH Testing

Measure the pH of the formulation after adding the surfactant and adjust as necessary.

4.3.2 Osmolality Testing

Check the osmolality of the solution to ensure it meets the required range for nasal sprays.

4.4 Filtration and Filling

4.4.1 Filtration

Filter the final solution through a 0.22-micron filter to ensure sterility.

4.4.2 Filling

Fill the sterile solution into nasal spray containers under aseptic conditions.

4.5 Documentation

Document all steps, including the type and amount of surfactant used, pH, and osmolality values in the batch manufacturing record (BMR).

5) Abbreviations, if any

QA: Quality Assurance
BMR: Batch Manufacturing Record

6) Documents, if any

Batch Manufacturing Record (BMR)
pH and Osmolality Log

7) References, if any

USP 39 – Surfactants in Drug Formulations

8) SOP Version

Version 1.0

Annexure

pH and Osmolality Log Template


  
    Date
    Formulation
    pH
    Osmolality (mOsm/kg)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    pH Value
    Osmolality
    Operator Name
    QA Name