Standard Operating Procedure for Preparation of Nanoparticles with Controlled Release Properties
1) Purpose
This SOP outlines the procedure for preparing nanoparticles with controlled release properties, designed to release a drug or therapeutic agent over an extended period.
2) Scope
This SOP applies to personnel involved in the preparation and optimization of nanoparticle formulations that provide sustained or controlled drug release for pharmaceutical applications.
3) Responsibilities
- Operators: Responsible for preparing controlled release nanoparticles following this SOP.
- QA: Ensures the formulation meets specifications for drug release rate and stability.
4) Procedure
4.1 Selection of Materials
4.1.1 Polymer Selection
- 4.1.1.1 Select biodegradable polymers (e.g., PLGA or PCL) that can provide controlled drug release through degradation or diffusion.
4.2 Nanoparticle Formation
4.2.1 Solvent Evaporation or Nanoprecipitation
- 4.2.1.1 Prepare the nanoparticles using either the solvent evaporation or nanoprecipitation method, ensuring uniform dispersion of the drug within the polymer matrix.
4.3 Drug Loading
4.3.1 Incorporation of Drug
- 4.3.1.1 Load the therapeutic agent into the nanoparticles either during the formation process or post-formation through adsorption techniques.
4.4 Controlled Release Testing
4.4.1 In Vitro Release Study
- 4.4.1.1 Conduct in vitro drug release studies to evaluate the release profile of the drug over time and ensure it meets the desired controlled release characteristics.
4.5 Particle Size and Stability Testing
4.5.1 Dynamic Light Scattering (DLS)
- 4.5.1.1 Measure the particle size of the nanoparticles using DLS to ensure they are in the desired size range for controlled release (typically 100–300 nm).
4.6 Storage
4.6.1 Storage Conditions
- 4.6.1.1 Store the nanoparticles in sealed containers at 4°C or room temperature, depending on stability data.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- PLGA: Poly(lactic-co-glycolic acid)
- PCL: Polycaprolactone
6) Documents, if any
- Controlled Release Nanoparticle Formulation Logbook
7) References, if any
- Protocols for controlled release nanoparticle formulations
8) SOP Version
Version 1.0
Annexure
Controlled Release Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer Type | Particle Size | Drug Release Rate | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Type | Size in nm | Rate (mg/hr) | Operator Name | QA Name |