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 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

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