Procedure for Developing Ointments with Sustained Release Properties
| Department | Research and Development (R&D)/Quality Assurance (QA)/Quality Control (QC)/Formulation Development |
|---|---|
| SOP No. | SOP/Ointment/181 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for developing ointments with sustained release properties. This ensures consistent drug delivery, enhanced therapeutic efficacy, and compliance with regulatory guidelines.
2. Scope
This SOP applies to all personnel involved in the formulation, development, testing, and validation of sustained release ointments in the Research and Development (R&D), Quality Assurance (QA), and Quality Control (QC) departments.
3. Responsibilities
- Formulation Scientist: Develops and optimizes the sustained release formulation.
- QA Officer: Ensures compliance with formulation development guidelines.
- QC Analyst: Conducts quality testing to verify sustained release properties.
- R&D Supervisor: Oversees the entire formulation and validation process.
4. Accountability
The R&D Manager is accountable for ensuring that all formulation development activities comply with GMP, FDA, ICH, WHO, and company policies.
5. Procedure
5.1 Selection of Active and Excipient Ingredients
- Identify the **active pharmaceutical ingredient (API)** with suitable solubility and stability.
- Choose excipients such as:
- Polymers (e.g., hydroxypropyl methylcellulose, ethylcellulose) for controlled release.
- Emulsifiers to ensure proper dispersion.
- Penetration enhancers to facilitate dermal absorption.
- Ensure **compatibility testing** between
API and excipients.
5.2 Formulation Development
- Determine the **release mechanism**:
- Diffusion-controlled release.
- Erosion-based release.
- Swelling and gel-based release.
- Prepare preliminary formulations and conduct **viscosity and homogeneity tests.**
- Optimize the formulation by **varying polymer concentrations** and assessing release profiles.
- Record all formulation trials in the **Formulation Development Log (Annexure-1).**
5.3 Manufacturing Process Development
- Develop an optimized **manufacturing process** with the following steps:
- API and excipient weighing.
- Melting and homogenization.
- Cooling and solidification.
- Final mixing and deaeration.
- Establish **critical process parameters (CPPs)** such as:
- Mixing speed.
- Temperature profile.
- Shear rate.
- Document process development data in the **Manufacturing Development Log (Annexure-2).**
5.4 Testing and Validation
- Conduct in vitro release studies using Franz diffusion cells.
- Perform stability testing under accelerated and real-time conditions.
- Assess microbial contamination to ensure sterility.
- Evaluate **pH, spreadability, viscosity, and particle size distribution.**
5.5 Regulatory Compliance and Documentation
- Ensure compliance with ICH Q8 guidelines on pharmaceutical development.
- Maintain records of all formulation trials and validation tests.
- Prepare **regulatory submission documents** for sustained release ointments.
5.6 Approval for Scale-Up
- Once the formulation passes validation, seek **QA approval** for scale-up.
- Transfer the optimized formulation to the **pilot batch production team.**
5.7 Periodic Review and Improvement
- Conduct **annual reviews** of formulation performance.
- Identify potential improvements in **drug release kinetics and stability.**
- Maintain records for **five years** for regulatory audits.
6. Abbreviations
- API – Active Pharmaceutical Ingredient
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- ICH – International Council for Harmonisation
- FDA – Food and Drug Administration
7. Documents
- Formulation Development Log (Annexure-1)
- Manufacturing Development Log (Annexure-2)
8. References
- ICH Q8 – Pharmaceutical Development Guidelines
- WHO Guidelines on Formulation Development
- FDA Guidance on Sustained Release Drug Products
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Formulation Development Log
| Date | API Name | Batch No. | Polymer Type | Release Profile | QC Review |
|---|---|---|---|---|---|
| 02/02/2025 | Drug X | FML-1001 | HPMC | 12-hour release | Approved |
Annexure-2: Manufacturing Development Log
| Date | Batch No. | Process Parameter | Target Value | Actual Value | QA Approval |
|---|---|---|---|---|---|
| 02/02/2025 | FML-1001 | Mixing Speed | 300 rpm | 305 rpm | Approved |
12. Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 02/02/2025 | 2.0 | Expanded Formulation Procedures | Improved Release Consistency | QA Head |