Standard Operating Procedure for Preparation of Nanoparticles for Ocular Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles for ocular drug delivery. These formulations are designed to deliver drugs to the eye with enhanced penetration, controlled release, and reduced systemic side effects.
2) Scope
This SOP applies to laboratory personnel involved in the preparation of nanoparticle formulations for ocular applications in drug delivery.
3) Responsibilities
- Operators: Responsible for preparing nanoparticles for ocular delivery as per the procedure in this SOP.
- QA: Ensures the prepared nanoparticles meet quality, sterility, and particle size requirements for ocular administration.
4) Procedure
4.1 Material Selection
4.1.1 Polymer or Lipid Selection
- 4.1.1.1 Select suitable materials for ocular nanoparticle formulations, such as chitosan, PLGA, or liposomes, based on biocompatibility with ocular tissues.
4.2 Nanoparticle Preparation
4.2.1 Solvent Evaporation Method
- 4.2.1.1 Dissolve the polymer or lipid in a suitable organic solvent and mix with an aqueous phase containing a surfactant (e.g., Poloxamer).
- 4.2.1.2 Use high-speed stirring or homogenization to create an emulsion, then evaporate the solvent under reduced pressure to form nanoparticles.
4.3 Sterilization
4.3.1 Filtration Sterilization
- 4.3.1.1 Sterilize the nanoparticle suspension by passing it through a 0.22 μm filter to remove any microbial contamination.
4.4 Drug Loading
4.4.1 Incorporation of Drug
- 4.4.1.1 Load the therapeutic agent into the nanoparticles during the preparation process or post-formation through adsorption or encapsulation techniques.
4.5 Characterization
4.5.1 Particle Size Measurement
- 4.5.1.1 Measure the particle size using dynamic light scattering (DLS) to confirm that the nanoparticles are within the desired size range (100–300 nm) for ocular delivery.
4.5.2 Drug Release Profile
- 4.5.2.1 Conduct in vitro release studies to determine the release rate of the drug from the nanoparticles over time.
4.6 Storage
4.6.1 Storage Conditions
- 4.6.1.1 Store the sterile nanoparticle formulation in sealed, sterile containers at 4°C to maintain stability and sterility.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- PLGA: Poly(lactic-co-glycolic acid)
6) Documents, if any
- Ocular Nanoparticle Preparation Logbook
7) References, if any
- Protocols for nanoparticle formulations in ocular drug delivery
8) SOP Version
Version 1.0
Annexure
Ocular 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 |