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.

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.

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

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