SOP for Preparation of Nanoparticles for Ocular Delivery

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

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