SOP for Formulation of Sustained Release Nasal Sprays

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