SOP for Use of Bioadhesive Polymers in Nanoparticle Formulations

Standard Operating Procedure for Use of Bioadhesive Polymers in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for incorporating bioadhesive polymers into nanoparticle formulations, enhancing their adhesion to biological tissues and improving the residence time of the therapeutic agent at the target site.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of bioadhesive nanoparticle formulations used for drug delivery, particularly for mucosal or topical applications.

3) Responsibilities

Operators: Responsible for incorporating bioadhesive polymers into nanoparticle formulations as per this SOP.
QA: Ensures that bioadhesive formulations meet stability, adhesion, and release profile specifications.

4) Procedure

4.1 Selection of Bioadhesive Polymers

4.1.1 Common Polymers

4.1.1.1 Select bioadhesive polymers such as chitosan, polycarbophil, or alginate based on their compatibility with the nanoparticle and the intended route of administration.

4.2 Incorporation of Bioadhesive Polymers

4.2.1 Mixing Procedure

4.2.1.1 Add the selected bioadhesive polymer to the nanoparticle formulation during or after the nanoparticle preparation process, ensuring thorough mixing for uniform coating or incorporation.

4.3 Testing for Adhesion and Stability

4.3.1 In Vitro Adhesion Testing

4.3.1.1 Perform in vitro adhesion tests to measure the bioadhesive strength of the nanoparticles on mucosal or biological tissue models.

4.3.2 Stability Testing

4.3.2.1 Conduct stability tests under various environmental conditions to ensure that the bioadhesive

nanoparticles maintain their properties during storage and use.

4.4 Storage

4.4.1 Storage Conditions

4.4.1.1 Store bioadhesive nanoparticle formulations in sealed, sterile containers at 4°C to maintain stability and bioadhesion properties over time.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

Bioadhesive Nanoparticle Formulation Logbook

7) References, if any

Guidelines for bioadhesive polymer use in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Bioadhesive Nanoparticle Formulation Logbook Template


  
    Date
    Batch Number
    Bioadhesive Polymer Used
    Concentration
    Adhesion Test Results
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Polymer Name
    Concentration (w/v %)
    Pass/Fail
    Operator Name
    QA Name

Date	Batch Number	Bioadhesive Polymer Used	Concentration	Adhesion Test Results	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Polymer Name	Concentration (w/v %)	Pass/Fail	Operator Name	QA Name