Standard Operating Procedure for Formulation of Sustained Release Nasal Sprays

1) Purpose

The purpose of this SOP is to provide guidelines for the formulation of sustained-release nasal sprays to ensure prolonged drug release and effective therapeutic action.

2) Scope

This SOP applies to all personnel involved in the formulation and testing of sustained-release nasal sprays at [Company Name].

3) Responsibilities

• Operators: Responsible for preparing the sustained-release formulation according to the specified protocol.
• QA: Verifies the release profile and ensures the formulation meets quality standards.

4) Procedure

4.1 Selection of Release-Controlling Agents

4.1.1 Polymers and Excipients

• Select suitable polymers and excipients (e.g., hydroxypropyl methylcellulose, carbopol) that provide sustained drug release.
• Ensure the excipients meet pharmacopeial standards for sustained-release applications.

4.1.2 Weighing of Ingredients

• Weigh the required amount of polymers and excipients as per the formulation guidelines.
• Document all weights in the batch manufacturing record (BMR).

4.2 Formulation Process

4.2.1 Mixing

• Mix the polymers, excipients, and active pharmaceutical ingredients in the formulation base, ensuring even distribution.

4.2.2 Homogenization

• Use a homogenizer to ensure uniform particle size and dispersion in the sustained-release formulation.

4.3 Release Profile Testing

4.3.1 Dissolution Testing

• Test the sustained-release formulation