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13. SOP for Preparation of Nanoparticles for Intranasal Delivery
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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 |