Standard Operating Procedure for Preparation of Nanoparticles for Nasal Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles intended for nasal delivery. Nasal delivery provides a non-invasive route for administering drugs directly to the systemic circulation or central nervous system via the nasal cavity.
2) Scope
This SOP applies to personnel involved in the formulation and characterization of nanoparticles for nasal drug delivery in pharmaceutical research and development.
3) Responsibilities
- Operators: Responsible for preparing nanoparticles optimized for nasal delivery following this SOP.
- QA: Ensures the nanoparticle formulations meet specifications for size, drug release, and nasal absorption.
4) Procedure
4.1 Selection of Polymers and Drugs
4.1.1 Polymer and Surfactant Selection
- 4.1.1.1 Choose biocompatible polymers (e.g., chitosan, PLGA) and mucoadhesive surfactants (e.g., poloxamer) to enhance the residence time and absorption of the drug in the nasal cavity.
4.1.2 Drug Loading
- 4.1.2.1 Load the therapeutic agent into the nanoparticles, ensuring it is protected from enzymatic degradation and optimized for nasal absorption.
4.2 Nanoparticle Preparation
4.2.1 Emulsification or Nanoprecipitation Method
- 4.2.1.1 Prepare nanoparticles using emulsification or nanoprecipitation methods, aiming for a particle size below 200 nm to ensure efficient nasal absorption and minimal mucociliary clearance.
4.3 Characterization and Testing
4.3.1 Particle Size and Drug Release
- 4.3.1.1 Measure the particle size using dynamic light scattering
(DLS) and evaluate drug release profiles to ensure sustained drug delivery through the nasal mucosa.
4.3.2 In Vitro Nasal Permeation Studies
- 4.3.2.1 Conduct in vitro nasal permeation studies using excised nasal tissue or an appropriate model to evaluate the nanoparticles’ ability to cross the nasal epithelium.
4.4 Stability and Storage
4.4.1 Stability Testing
- 4.4.1.1 Perform stability tests under various environmental conditions (e.g., temperature, humidity) to assess the long-term stability of the nanoparticles.
4.4.2 Storage Conditions
- 4.4.2.1 Store the nasal delivery nanoparticle formulations in sterile containers at 4°C or room temperature, ensuring protection from moisture and contamination.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- DLS: Dynamic Light Scattering
6) Documents, if any
- Nasal Delivery Nanoparticle Formulation Logbook
7) References, if any
- Protocols for nanoparticle preparation for nasal drug delivery
8) SOP Version
Version 1.0
Annexure
Nasal Delivery Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer Type | Surfactant Used | Particle Size | Nasal Permeation Results | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Type | Surfactant Name | Size in nm | Pass/Fail | Operator Name | QA Name |