13. SOP for Preparation of Nanoparticles for Intranasal Delivery
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SOP for Preparation of Nanoparticles for Intranasal Delivery

Standard Operating Procedure for Preparation of Nanoparticles for Intranasal Delivery

1) Purpose

The purpose of this SOP is to outline the procedures for preparing nanoparticles for intranasal delivery, ensuring optimal particle size, stability, and bioavailability.

2) Scope

This SOP applies to all personnel involved in the preparation, characterization, and testing of nanoparticles intended for intranasal drug delivery at [Company Name].

3) Responsibilities

Operators: Responsible for preparing and characterizing nanoparticles according to this SOP.
QA: Verifies particle size, stability, and ensures that the process adheres to quality standards.

4) Procedure

4.1 Preparation of Nanoparticles

4.1.1 Selection of Materials

Select appropriate polymers and surfactants (e.g., PLGA, chitosan) for nanoparticle formation.
Ensure that all materials meet pharmaceutical standards for intranasal drug delivery.

4.1.2 Solvent Preparation

Prepare a solution of the drug and polymer in an organic solvent (e.g., acetone or ethanol) based on the formulation guidelines.

4.2 Nanoparticle Formation

4.2.1 Emulsification

Add the drug-polymer solution into an aqueous phase containing surfactants under stirring to form an emulsion.
Ensure constant stirring to maintain stability

of the emulsion.

4.2.2 Solvent Evaporation

Remove the organic solvent by evaporating under reduced pressure or using a rotary evaporator to solidify the nanoparticles.

4.3 Characterization of Nanoparticles

4.3.1 Particle Size Measurement

Measure the particle size using dynamic light scattering (DLS) or nanoparticle tracking analysis (NTA) to ensure the particles fall within the target range (e.g., 50-200 nm).

4.3.2 Zeta Potential Testing

Test the zeta potential of the nanoparticles to evaluate surface charge and stability.

4.4 Sterilization and Storage

4.4.1 Sterilization

If necessary, sterilize the nanoparticle suspension using a 0.22-micron filter or an appropriate sterilization method.

4.4.2 Storage

Store the nanoparticle suspension in sterilized containers at controlled temperature conditions to maintain stability.

4.5 Documentation

Document all steps in the preparation process, including particle size, zeta potential values, and sterilization records in the batch manufacturing record (BMR).

5) Abbreviations, if any

DLS: Dynamic Light Scattering
PLGA: Poly(lactic-co-glycolic acid)
BMR: Batch Manufacturing Record
QA: Quality Assurance

6) Documents, if any

Batch Manufacturing Record (BMR)
Particle Size and Zeta Potential Log

7) References, if any

FDA Guidance for Industry – Nanomaterials in Drug Products

8) SOP Version

Version 1.0

Annexure

Particle Size and Zeta Potential Log Template


  
    Date
    Formulation
    Particle Size (nm)
    Zeta Potential (mV)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Formulation Name
    Size
    Potential
    Operator Name
    QA Name