Standard Operating Procedure for Use of Antioxidants in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for incorporating antioxidants into nanoparticle formulations to improve stability, reduce oxidative stress, and enhance the therapeutic effects of nanoparticles used in drug delivery or other biomedical applications.

2) Scope

This SOP applies to personnel involved in the preparation and formulation of nanoparticles intended for therapeutic purposes, specifically those incorporating antioxidants to maintain stability and prevent degradation.

3) Responsibilities

• Operators: Responsible for adding antioxidants and preparing nanoparticle formulations as per this SOP.
• QA: Ensures that antioxidant levels and formulations meet the required specifications for stability and efficacy.

4) Procedure

4.1 Selection of Antioxidants

4.1.1 Common Antioxidants

• 4.1.1.1 Select antioxidants such as ascorbic acid, glutathione, or tocopherol based on the formulation type and intended therapeutic application.

4.1.2 Concentration Optimization

• 4.1.2.1 Determine the optimal concentration of antioxidants to ensure adequate protection against oxidative damage without compromising nanoparticle structure or drug release profile.

4.2 Incorporation of Antioxidants

4.2.1 Addition to Nanoparticle Suspension

• 4.2.1.1 Dissolve the selected antioxidant in an appropriate solvent and mix it thoroughly with the nanoparticle suspension to ensure even distribution.
• 4.2.1.2 Perform gentle stirring or ultrasonication, if necessary, to enhance antioxidant incorporation into the nanoparticles.

4.3 Testing for Stability and Efficacy

4.3.1 Oxidative Stability Testing

• 4.3.1.1 Conduct