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 |