SOP for Incorporating Anti-Inflammatory Agents in Nanoparticle Formulations

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

of the anti-inflammatory agent from the nanoparticles over time.

4.5 Stability Testing

4.5.1 Stability Study

4.5.1.1 Conduct stability testing under various storage conditions to confirm that the nanoparticles maintain their size and release characteristics over time.

4.6 Storage

4.6.1 Storage Conditions

4.6.1.1 Store the nanoparticles in sterile containers at 4°C or room temperature, depending on the stability data.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
NSAIDs: Nonsteroidal Anti-Inflammatory Drugs

6) Documents, if any

Anti-Inflammatory Nanoparticle Formulation Logbook

7) References, if any

Protocols for nanoparticle formulations with anti-inflammatory agents

8) SOP Version

Version 1.0

Annexure

Anti-Inflammatory Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Anti-Inflammatory Agent
    Particle Size
    Drug Release Rate
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Drug Name
    Size in nm
    Rate (mg/hr)
    Operator Name
    QA Name