SOP for Development of Nanoparticle Formulations for Oral Delivery

Standard Operating Procedure for Development of Nanoparticle Formulations for Oral Delivery

1) Purpose

This SOP outlines the procedure for developing nanoparticle formulations intended for oral delivery, ensuring that the nanoparticles are stable in the gastrointestinal tract and can deliver the therapeutic agent effectively.

2) Scope

This SOP applies to personnel involved in the formulation, characterization, and optimization of nanoparticles for oral administration in pharmaceutical and research settings.

3) Responsibilities

Operators: Responsible for preparing and optimizing nanoparticles for oral delivery following the procedures outlined in this SOP.
QA: Ensures that oral nanoparticle formulations meet specifications for stability, drug release, and gastrointestinal compatibility.

4) Procedure

4.1 Selection of Polymers and Stabilizers

4.1.1 Polymer Types

4.1.1.1 Select biodegradable and gastro-resistant polymers such as chitosan, PLGA, or Eudragit to protect the nanoparticles and drug from the acidic environment of the stomach.

4.1.2 Stabilizers and Surfactants

4.1.2.1 Incorporate stabilizers or surfactants such as Tween 80 or poloxamer to prevent nanoparticle aggregation and enhance bioavailability.

4.2 Nanoparticle Preparation

4.2.1 Nanoprecipitation or Emulsification Method

4.2.1.1 Prepare the nanoparticles using nanoprecipitation or emulsification methods, optimizing for size, stability, and drug loading for oral delivery.

4.3 Gastrointestinal Stability Testing

4.3.1 Simulated Gastrointestinal Fluids (SGF and SIF)

4.3.1.1 Perform stability tests in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF)

to evaluate the nanoparticles’ resistance to degradation and release in different pH environments.

4.4 Drug Release Profile

4.4.1 In Vitro Release Studies

4.4.1.1 Conduct in vitro drug release studies using conditions that mimic the gastrointestinal environment to determine the release profile of the encapsulated drug.

4.5 Storage and Packaging

4.5.1 Storage Conditions

4.5.1.1 Store the oral nanoparticle formulation in airtight containers at room temperature or refrigerated conditions to maintain stability over time.

5) Abbreviations, if any

PLGA: Poly(lactic-co-glycolic acid)
SGF: Simulated Gastric Fluid
SIF: Simulated Intestinal Fluid

6) Documents, if any

Oral Nanoparticle Formulation Logbook

7) References, if any

Protocols for developing nanoparticle formulations for oral delivery

8) SOP Version

Version 1.0

Annexure

Oral Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Polymer Type
    Stability in SGF/SIF
    Drug Release Profile
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer Type
    Pass/Fail
    Release (mg/hr)
    Operator Name
    QA Name