Standard Operating Procedure for Formulation of Sustained Release Nasal Sprays
1) Purpose
The purpose of this SOP is to outline the formulation process for sustained-release nasal sprays, ensuring prolonged drug release and improved therapeutic effects for patients.
2) Scope
This SOP applies to all personnel involved in the formulation, testing, and quality control of sustained-release nasal sprays at [Company Name].
3) Responsibilities
- Operators: Responsible for following the formulation procedure and ensuring correct preparation of the sustained-release formulation.
- QA: Ensures that the sustained-release profile is consistent and meets regulatory standards for safety and efficacy.
4) Procedure
4.1 Selection of Release-Controlling Agents
4.1.1 Polymers and Excipients
- Select suitable polymers (e.g., hydroxypropyl methylcellulose, carbopol) and excipients that provide controlled and sustained drug release.
- Ensure all excipients comply with pharmacopeial standards for sustained-release formulations.
4.1.2 Weighing of Ingredients
- Weigh the required quantities of release-controlling agents and excipients as per the formulation guidelines.
- Record all weights in the batch manufacturing record (BMR).
4.2 Mixing and Formulation
4.2.1 Solution Preparation
- Prepare the base solution by dissolving the API and release-controlling agents in the appropriate solvent.
- Mix the solution using a magnetic stirrer or
homogenizer until the components are fully dissolved and evenly distributed.
4.2.2 Homogenization
- If necessary, homogenize the solution at the specified speed and time to ensure uniform particle distribution for sustained release.
4.3 Release Profile Testing
4.3.1 Dissolution Testing
- Perform dissolution testing on the formulation using an appropriate dissolution apparatus to determine the release profile of the drug.
- Test the formulation at predefined intervals (e.g., 1 hour, 6 hours, 12 hours) to ensure that it meets the sustained-release criteria.
4.3.2 Release Profile Adjustment
- If the release profile does not meet the target specifications, adjust the concentration of release-controlling agents and retest the formulation.
4.4 Sterilization and Filling
4.4.1 Sterilization
- Filter the sustained-release nasal spray formulation through a 0.22-micron filter to ensure sterility.
4.4.2 Filling
- Fill the sterile solution into nasal spray containers using aseptic techniques under controlled conditions.
4.5 Documentation
- Record all formulation steps, including ingredient weights, release profile testing results, and final adjustments 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)
- Dissolution Testing Results
7) References, if any
- FDA Guidance for Industry – Dissolution Testing of Immediate and Sustained-Release Dosage Forms
8) SOP Version
Version 1.0
Annexure
Dissolution Test Results Log Template
| Date | Formulation | Initial Release (%) | Sustained Release (over time) | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Formulation Name | Release at 1 hour | Release over 12/24 hours | Operator Name | QA Name |