Standard Operating Procedure for Preparation of Nanoparticles for Nasal Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles for nasal drug delivery, which provides a non-invasive route for systemic drug delivery with rapid onset of action.
2) Scope
This SOP applies to personnel involved in the formulation and preparation of nanoparticles for nasal administration, ensuring the drug is delivered effectively via the nasal mucosa.
3) Responsibilities
- Operators: Responsible for preparing nanoparticles for nasal delivery following this SOP.
- QA: Ensures that the formulations meet quality, stability, and particle size requirements.
4) Procedure
4.1 Selection of Materials
4.1.1 Polymer or Lipid Selection
- 4.1.1.1 Select suitable biocompatible polymers or lipids (e.g., PLGA, chitosan, liposomes) for nanoparticle formation, based on the intended drug and nasal delivery route.
4.2 Nanoparticle Preparation
4.2.1 Solvent Evaporation or Nanoprecipitation
- 4.2.1.1 Prepare nanoparticles using the solvent evaporation or nanoprecipitation method. Dissolve the polymer or lipid in an organic solvent and mix with the aqueous phase containing a surfactant.
- 4.2.1.2 Evaporate the solvent under controlled conditions to form nanoparticles.
4.3 Drug Loading
4.3.1 Drug Incorporation
- 4.3.1.1 Incorporate the drug into the nanoparticles during formulation or by post-loading techniques, depending on the drug solubility and stability.
4.4 Size Reduction and Homogenization
4.4.1 Homogenization
- 4.4.1.1 Use high-pressure homogenization or ultrasonication to reduce particle size to the nanoscale (100–300 nm), ensuring effective delivery through the nasal mucosa.
4.5 Particle Size and Drug Release Testing
4.5.1 Particle Size Measurement
- 4.5.1.1 Measure particle size using dynamic light scattering (DLS) to confirm nanoparticles are within the desired range for nasal delivery.
4.5.2 Drug Release Assay
- 4.5.2.1 Perform in vitro drug release studies to evaluate the release profile and ensure sustained or controlled release from the nanoparticles.
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 the stability requirements.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- DLS: Dynamic Light Scattering
6) Documents, if any
- Nasal Delivery Nanoparticle Preparation Logbook
7) References, if any
- Guidelines for nanoparticle-based nasal drug delivery systems
8) SOP Version
Version 1.0
Annexure
Nasal Delivery Nanoparticle Preparation Logbook Template
| Date | Batch Number | Polymer/Lipid Type | Particle Size | Drug Release Rate | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer/Lipid Type | Size in nm | Rate (mg/hr) | Operator Name | QA Name |