SOP for Preparation of Nanoparticles for Sublingual Administration

Standard Operating Procedure for Preparation of Nanoparticles for Sublingual Administration

1) Purpose

This SOP outlines the procedure for preparing nanoparticles for sublingual drug delivery, allowing for rapid absorption of drugs through the mucosal tissues under the tongue, bypassing first-pass metabolism and providing faster therapeutic effects.

2) Scope

This SOP applies to personnel involved in the preparation and formulation of nanoparticles specifically designed for sublingual administration.

3) Responsibilities

Operators: Responsible for preparing nanoparticles for sublingual drug delivery as per this SOP.
QA: Ensures that the formulations meet particle size, stability, and drug release specifications for sublingual administration.

4) Procedure

4.1 Selection of Materials

4.1.1 Polymer or Lipid Selection

4.1.1.1 Select suitable materials for nanoparticle formulation, such as chitosan, PLGA, or liposomes, that provide good bioadhesion to sublingual mucosa.

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation Method

4.2.1.1 Prepare nanoparticles using solvent evaporation or nanoprecipitation methods, optimizing the formulation for a particle size of 100–300 nm to ensure efficient mucosal adhesion and absorption.

4.3 Drug Loading

4.3.1 Drug Incorporation

4.3.1.1 Incorporate the active pharmaceutical ingredient (API) into the nanoparticles during the preparation or post-formation through adsorption or encapsulation techniques.

4.4 Characterization and Testing

4.4.1 Particle Size and Drug Release Testing

4.4.1.1 Measure the particle size using dynamic light scattering (DLS) to ensure that nanoparticles are in the optimal size range for sublingual delivery.
4.4.1.2 Conduct in vitro drug release studies to evaluate the release profile of the drug from the nanoparticles.

4.5 Storage

4.5.1 Storage Conditions

4.5.1.1 Store the nanoparticles in sterile containers at 4°C to maintain stability and prevent aggregation.

5) Abbreviations, if any

PLGA: Poly(lactic-co-glycolic acid)
DLS: Dynamic Light Scattering

6) Documents, if any

Sublingual Nanoparticle Preparation Logbook

7) References, if any

Protocols for sublingual nanoparticle delivery systems

8) SOP Version

Version 1.0

Annexure

Sublingual 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