Standard Operating Procedure for Incorporating Anti-Inflammatory Agents in Nanoparticle Formulations

1) Purpose

This SOP outlines the process for incorporating anti-inflammatory agents into nanoparticle formulations to enhance their bioavailability and therapeutic efficacy.

2) Scope

This SOP applies to personnel involved in the formulation of nanoparticles designed to deliver anti-inflammatory drugs for therapeutic applications.

3) Responsibilities

• Operators: Responsible for incorporating anti-inflammatory agents into nanoparticle formulations as per the procedure outlined in this SOP.
• QA: Ensures the formulation meets quality and particle size specifications.

4) Procedure

4.1 Selection of Anti-Inflammatory Agents

4.1.1 Drug Selection

• 4.1.1.1 Select an appropriate anti-inflammatory agent (e.g., NSAIDs such as ibuprofen or corticosteroids) based on the intended application and compatibility with the nanoparticle matrix.

4.2 Nanoparticle Formation

4.2.1 Solvent Evaporation or Nanoprecipitation

• 4.2.1.1 Prepare the nanoparticles using either solvent evaporation or nanoprecipitation, incorporating the anti-inflammatory agent during the formation process to ensure uniform dispersion.

4.3 Drug Loading

4.3.1 Drug Incorporation

• 4.3.1.1 Ensure that the anti-inflammatory agent is loaded into the nanoparticle matrix or adsorbed onto the surface of the nanoparticles after formation.

4.4 Characterization

4.4.1 Particle Size Measurement

• 4.4.1.1 Measure the particle size of the nanoparticles using dynamic light scattering (DLS) to ensure uniformity in size (typically 100–200 nm).

4.4.2 Drug Release Profile

• 4.4.2.1 Perform in vitro release studies to evaluate the release profile