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 |