SOP for Use of Polymeric Micelles in Nanoparticle Formulations

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

within the micelles using UV-Vis spectroscopy or HPLC.

4.5 Stability Testing

4.5.1 Stability Study

4.5.1.1 Perform stability testing to ensure that the micelles retain their size and structure in biological environments over time.

4.6 Storage

4.6.1 Storage Conditions

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

5) Abbreviations, if any

DLS: Dynamic Light Scattering
PEG: Polyethylene Glycol
PLA: Poly(lactic acid)
PPO: Poly(propylene oxide)

6) Documents, if any

Polymeric Micelle Formulation Logbook

7) References, if any

Protocols for polymeric micelle formulation for drug delivery

8) SOP Version

Version 1.0

Annexure

Polymeric Micelle Formulation Logbook Template


  
    Date
    Batch Number
    Polymer Type
    Particle Size
    Drug Loading Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer Type
    Size in nm
    Loading Efficiency (%)
    Operator Name
    QA Name

Date	Batch Number	Polymer Type	Particle Size	Drug Loading Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Polymer Type	Size in nm	Loading Efficiency (%)	Operator Name	QA Name