SOP for Preparation of Dendrimers for Drug Delivery

SOP for Preparation of Dendrimers for Drug Delivery

Standard Operating Procedure for Preparation of Dendrimers for Drug Delivery

1) Purpose

This SOP outlines the procedure for synthesizing dendrimers for drug delivery applications, which are highly branched, nanoscale polymers capable of carrying therapeutic agents through covalent attachment or encapsulation.

2) Scope

This SOP applies to personnel involved in the synthesis, characterization, and functionalization of dendrimers for pharmaceutical or biomedical applications.

3) Responsibilities

  • Operators: Responsible for synthesizing and characterizing dendrimers as per this SOP.
  • QA: Ensures that dendrimer formulations meet specifications for drug loading, particle size, and biocompatibility.
See also  SOP for Incorporation of Bioactive Molecules in Nanoparticle-Based Formulations

4) Procedure

4.1 Synthesis of Dendrimers

4.1.1 Divergent or Convergent Method

  • 4.1.1.1 Use a divergent or convergent synthesis method to build the dendrimer structure, ensuring precise control over its size, branching, and surface functional groups.

4.2 Functionalization for Drug Delivery

4.2.1 Drug Encapsulation or Attachment

  • 4.2.1.1 Functionalize the surface of the dendrimer with specific groups to enable the attachment or encapsulation of therapeutic agents.
  • 4.2.1.2 Ensure that the drug loading efficiency is optimized without compromising the dendrimer’s stability or targeting abilities.

4.3 Characterization of Dendrimers

4.3.1 Particle Size and Zeta Potential

  • 4.3.1.1 Measure the particle size and zeta potential of the dendrimers using dynamic light scattering (DLS) to confirm uniformity and stability in solution.
See also  SOP for Risk Assessment of Nanoparticle Manufacturing Processes

4.3.2 Drug Release Studies

  • 4.3.2.1 Perform in vitro drug release studies
to evaluate the release kinetics of the therapeutic agent from the dendrimer structure.

4.4 Storage

4.4.1 Storage Conditions

  • 4.4.1.1 Store the synthesized dendrimers in sterile containers at 4°C, ensuring they remain stable over time and retain their drug delivery properties.

5) Abbreviations, if any

  • DLS: Dynamic Light Scattering

6) Documents, if any

  • Dendrimer Synthesis Logbook

7) References, if any

  • Protocols for dendrimer synthesis and drug delivery applications

8) SOP Version

Version 1.0

Annexure

Dendrimer Synthesis Logbook Template

Date Batch Number Synthesis Method Drug Encapsulation Efficiency Particle Size Operator Initials QA Initials
DD/MM/YYYY Batch Number Divergent/Convergent Efficiency (%) Size in nm Operator Name QA Name
           
See also  SOP for Incorporation of Stabilizers in Nanoparticle-Based Formulations

Related Posts