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