Standard Operating Procedure for Development of Nanoparticle Formulations for Oral Delivery

1) Purpose

This SOP outlines the procedure for developing nanoparticle formulations intended for oral delivery, ensuring that the nanoparticles are stable in the gastrointestinal tract and can deliver the therapeutic agent effectively.

2) Scope

This SOP applies to personnel involved in the formulation, characterization, and optimization of nanoparticles for oral administration in pharmaceutical and research settings.

3) Responsibilities

• Operators: Responsible for preparing and optimizing nanoparticles for oral delivery following the procedures outlined in this SOP.
• QA: Ensures that oral nanoparticle formulations meet specifications for stability, drug release, and gastrointestinal compatibility.

4) Procedure

4.1 Selection of Polymers and Stabilizers

4.1.1 Polymer Types

• 4.1.1.1 Select biodegradable and gastro-resistant polymers such as chitosan, PLGA, or Eudragit to protect the nanoparticles and drug from the acidic environment of the stomach.

4.1.2 Stabilizers and Surfactants

• 4.1.2.1 Incorporate stabilizers or surfactants such as Tween 80 or poloxamer to prevent nanoparticle aggregation and enhance bioavailability.

4.2 Nanoparticle Preparation

4.2.1 Nanoprecipitation or Emulsification Method

• 4.2.1.1 Prepare the nanoparticles using nanoprecipitation or emulsification methods, optimizing for size, stability, and drug loading for oral delivery.

4.3 Gastrointestinal Stability Testing

4.3.1 Simulated Gastrointestinal Fluids (SGF and SIF)

• 4.3.1.1 Perform stability tests in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF)