Standard Operating Procedure for Use of Polymeric Micelles in Nanoparticle Formulations

1) Purpose

This SOP describes the procedure for preparing polymeric micelles, which are used in nanoparticle formulations to solubilize poorly water-soluble drugs, improve bioavailability, and provide controlled drug release.

2) Scope

This SOP applies to laboratory personnel involved in the formulation of polymeric micelles for drug delivery applications.

3) Responsibilities

• Operators: Responsible for preparing polymeric micelles as per the protocols in this SOP.
• QA: Ensures that the micelle formulations meet quality and particle size specifications.

4) Procedure

4.1 Selection of Polymers

4.1.1 Polymer Selection

• 4.1.1.1 Select amphiphilic block copolymers (e.g., PEG-PLA or PEO-PPO) that can self-assemble into micelles in aqueous solutions.

4.2 Micelle Formation

4.2.1 Solubilization and Micellization

• 4.2.1.1 Dissolve the polymer in an organic solvent, then slowly add it to water under stirring to form polymeric micelles.

4.3 Drug Loading

4.3.1 Drug Incorporation

• 4.3.1.1 Load the hydrophobic drug into the core of the micelles during the self-assembly process, ensuring uniform drug distribution.

4.4 Characterization

4.4.1 Particle Size Measurement

• 4.4.1.1 Measure the particle size of the polymeric micelles using dynamic light scattering (DLS) to ensure uniformity and that they fall within the desired range (10–100 nm).

4.4.2 Drug Loading Efficiency

• 4.4.2.1 Analyze the drug loading efficiency by determining the amount of drug encapsulated