SOP for Preparation of Nanoparticles for Nasal Delivery

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

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