SOP for Preparation of Nanoemulsions

Standard Operating Procedure for Preparation of Nanoemulsions

1) Purpose

This SOP outlines the procedure for preparing nanoemulsions, which are used as drug delivery systems to enhance the solubility of poorly soluble drugs. The aim is to ensure a consistent and controlled method for nanoemulsion preparation.

2) Scope

This SOP applies to all laboratory personnel involved in the formulation and preparation of nanoemulsions for drug delivery applications.

3) Responsibilities

Operators: Responsible for following the SOP to accurately prepare nanoemulsions.
QA: Ensures that the nanoemulsions meet quality and size specifications.

4) Procedure

4.1 Preparation of Oil Phase

4.1.1 Oil and Surfactant Selection

4.1.1.1 Select an appropriate oil phase based on the solubility of the drug and the desired application of the nanoemulsion.
4.1.1.2 Dissolve the drug in the oil phase under continuous stirring at room temperature.

4.2 Preparation of Aqueous Phase

4.2.1 Stabilizer Selection

4.2.1.1 Select a stabilizer or surfactant suitable for the formation of stable nanoemulsions.
4.2.1.2 Prepare the aqueous phase by dissolving the stabilizer in distilled water under gentle stirring.

4.3 Emulsification

4.3.1 Formation of Nanoemulsion

4.3.1.1 Add the oil phase to the aqueous phase under high-speed stirring to form an emulsion.
4.3.1.2 Continue stirring for 10–15 minutes to ensure proper emulsification.

4.3.2 Particle Size Reduction

4.3.2.1 Use a high-pressure homogenizer or ultrasonicator to reduce the particle size of the emulsion droplets to the nanoscale (typically less than 200 nm).
4.3.2.2 Monitor the particle size using dynamic light scattering (DLS).

4.4 Storage and Stability

4.4.1 Storage of Nanoemulsions

4.4.1.1 Store the prepared nanoemulsion in sterile, sealed containers at 4°C to maintain stability.

4.4.2 Stability Testing

4.4.2.1 Periodically test the nanoemulsion for particle size and physical stability (e.g., phase separation, creaming) to ensure the formulation remains stable over time.

5) Abbreviations, if any

DLS: Dynamic Light Scattering

6) Documents, if any

Nanoemulsion Preparation Logbook

7) References, if any

Literature on nanoemulsion formulations and stability testing

8) SOP Version

Version 1.0

Annexure

Nanoemulsion Preparation Logbook Template


  
    Date
    Batch Number
    Oil Phase
    Particle Size
    Stability Test
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Oil Phase Used
    Size in nm
    Pass/Fail
    Operator Name
    QA Name

Date	Batch Number	Oil Phase	Particle Size	Stability Test	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Oil Phase Used	Size in nm	Pass/Fail	Operator Name	QA Name