SOP for Use of Permeation Enhancers in Nasal Formulations

Standard Operating Procedure for Use of Permeation Enhancers in Nasal Formulations

1) Purpose

The purpose of this SOP is to outline the process for incorporating permeation enhancers in nasal spray formulations to improve drug absorption and bioavailability.

2) Scope

This SOP applies to all personnel involved in the formulation of nasal sprays with permeation enhancers at [Company Name].

3) Responsibilities

Operators: Responsible for incorporating permeation enhancers into the formulation and ensuring proper dispersion.
QA: Verifies the concentration of permeation enhancers and checks for consistency in formulation.

4) Procedure

4.1 Selection of Permeation Enhancers

4.1.1 Types of Permeation Enhancers

Select appropriate permeation enhancers based on the drug’s physicochemical properties (e.g., bile salts, fatty acids, surfactants).

4.1.2 Weighing of Enhancers

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

4.2 Incorporation of Permeation Enhancers

4.2.1 Mixing

Mix the permeation enhancer into the formulation under constant stirring to ensure uniform distribution.

4.2.2 Homogenization

If required, homogenize the formulation to ensure even distribution of the permeation enhancers.

4.3 Testing

4.3.1 pH and Osmolality Testing

Measure the pH and osmolality of the formulation after the addition of permeation enhancers.

4.4 Sterilization and Filling

4.4.1 Filtration

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

4.4.2 Filling

Fill the sterilized formulation into nasal spray containers using aseptic techniques.

4.5 Documentation

Document all steps, including the concentration of permeation enhancers used and results of pH and osmolality testing, 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

ICH Q6A – Specifications for Drug Substances and Products

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