Standard Operating Procedure for Preparation of Nanoparticles for Ocular Delivery
1) Purpose
This SOP outlines the procedure for preparing nanoparticles intended for ocular delivery. These nanoparticles are designed to deliver therapeutic agents directly to the eye, targeting the anterior or posterior segments of the eye for sustained release and improved bioavailability.
2) Scope
This SOP applies to personnel involved in the formulation and characterization of nanoparticles for ocular drug delivery in pharmaceutical or ophthalmic research settings.
3) Responsibilities
- Operators: Responsible for preparing and characterizing nanoparticles for ocular delivery as per this SOP.
- QA: Ensures that nanoparticle formulations meet the required specifications for sterility, particle size, and drug release.
4) Procedure
4.1 Selection of Polymers and Drugs
4.1.1 Polymer Selection
- 4.1.1.1 Use biodegradable polymers like chitosan, hyaluronic acid, or PLGA to enhance the residence time of nanoparticles in the eye and ensure sustained drug release.
4.1.2 Drug Loading
- 4.1.2.1 Load the therapeutic agent into the nanoparticles, optimizing for efficient drug release while minimizing irritation to the ocular tissues.
4.2 Nanoparticle Preparation
4.2.1 Emulsification or Nanoprecipitation Method
- 4.2.1.1 Prepare nanoparticles using emulsification or nanoprecipitation methods, targeting particle sizes between 100–200 nm to allow for easy administration and sustained release in ocular tissues.
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 the drug release profile using in vitro drug release studies to ensure prolonged drug delivery to the eye.
4.3.2 In Vitro Ocular Irritation Testing
- 4.3.2.1 Perform in vitro ocular irritation testing using corneal or conjunctival cells to ensure the nanoparticle formulation is non-irritating to ocular tissues.
4.4 Sterility and Storage
4.4.1 Sterility Testing
- 4.4.1.1 Sterilize the nanoparticle suspension by filtration through a 0.22-micron sterile filter and perform sterility testing according to standard ophthalmic protocols.
4.4.2 Storage Conditions
- 4.4.2.1 Store the nanoparticles in sterile, sealed containers at 4°C to maintain stability and sterility until use.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- PLGA: Poly(lactic-co-glycolic acid)
6) Documents, if any
- Ocular Delivery Nanoparticle Formulation Logbook
7) References, if any
- Protocols for nanoparticle preparation for ocular drug delivery
8) SOP Version
Version 1.0
Annexure
Ocular Delivery Nanoparticle Formulation Logbook Template
| Date | Batch Number | Polymer Type | Drug Encapsulated | Particle Size | Ocular Irritation Test | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Type | Drug Name | Size in nm | Pass/Fail | Operator Name | QA Name |