SOP Guide for Pharma

Nanoparticle Formulation : SOP for Development of Nanoparticle Formulations for Oral Delivery

SOP for Development of Nanoparticle Formulations for Oral Delivery

Standard Operating Procedure for Development of Nanoparticle Formulations for Oral Delivery

1) Purpose

The purpose of this SOP is to outline the procedure for developing nanoparticle-based formulations for oral drug delivery. Nanoparticles offer improved bioavailability, protection of the active pharmaceutical ingredient (API) from the harsh gastrointestinal (GI) environment, and targeted drug release.

2) Scope

This SOP applies to personnel involved in the development, formulation, and characterization of nanoparticles intended for oral drug delivery, particularly in pharmaceutical research and formulation development settings.

3) Responsibilities

4) Procedure

4.1 Selection of Materials

4.1.1 Polymer and Lipid Selection

4.1.2 Drug Selection

4.2 Nanoparticle Preparation

4.2.1 Emulsification or Nanoprecipitation Method

4.2.2 Encapsulation of Drug

4.3 Characterization and Testing

4.3.1 Particle Size and Surface Charge

4.3.2 Drug Loading and Encapsulation Efficiency

4.3.3 In Vitro Release Studies

4.3.4 Stability Testing

4.4 Formulation Optimization

4.4.1 Coating for GI Protection

4.4.2 Process Optimization

4.5 Sterility and Storage

4.5.1 Sterilization

4.5.2 Storage Conditions

5) Abbreviations, if any

6) Documents, if any

7) References, if any

8) SOP Version

Version 1.0

Annexure

Nanoparticle Oral Delivery Formulation Logbook Template

Date Batch Number Nanoparticle Material Drug Encapsulated Particle Size Drug Loading Efficiency Operator Initials QA Initials
DD/MM/YYYY Batch Number Material Name Drug Name Size in nm Efficiency (%) Operator Name QA Name
           
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