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 preparing dendrimers, which are branched polymers used for drug delivery applications. Dendrimers provide controlled drug release and targeted delivery properties.

2) Scope

This SOP applies to laboratory personnel responsible for synthesizing and characterizing dendrimers for drug delivery systems.

3) Responsibilities

Operators: Responsible for the preparation of dendrimers as per the procedure described in this SOP.
QA: Ensures that the prepared dendrimers meet the required size and encapsulation specifications.

4) Procedure

4.1 Dendrimer Synthesis

4.1.1 Selection of Monomers

4.1.1.1 Select appropriate monomers (e.g., amines, esters) for the synthesis of dendrimers based on the desired generation and drug delivery application.

4.1.2 Polymerization

4.1.2.1 Initiate the polymerization reaction to form the dendritic structure by gradually adding the monomers under controlled temperature and stirring conditions.
4.1.2.2 Continue the polymerization reaction until the desired generation of dendrimer is achieved (e.g., generation 3 or 4).

4.2 Drug Loading

4.2.1 Drug Incorporation

4.2.1.1 Load the therapeutic agent into the dendrimer by passive or covalent attachment, depending on the drug and dendrimer chemistry.
4.2.1.2 Stir the drug-dendrimer mixture to ensure uniform drug encapsulation within the dendrimer cavities.

4.3 Particle Size and Drug Release Testing

4.3.1 Particle Size Measurement

4.3.1.1 Measure the particle size of

the dendrimer using dynamic light scattering (DLS) or another appropriate method.

4.3.2 Drug Release Studies

4.3.2.1 Perform in vitro drug release studies to evaluate the controlled release properties of the dendrimer formulation.

4.4 Storage

4.4.1 Storage Conditions

4.4.1.1 Store the dendrimer formulation in sealed containers at 4°C or room temperature, depending on the stability of the formulation.

5) Abbreviations, if any

DLS: Dynamic Light Scattering

6) Documents, if any

Dendrimer Preparation Logbook

7) References, if any

Protocols for dendrimer synthesis and drug encapsulation

8) SOP Version

Version 1.0

Annexure

Dendrimer Preparation Logbook Template


  
    Date
    Batch Number
    Monomer Type
    Generation
    Drug Encapsulation Efficiency
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Monomer Type
    Generation No.
    % Encapsulation
    Operator Name
    QA Name

Date	Batch Number	Monomer Type	Generation	Drug Encapsulation Efficiency	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Monomer Type	Generation No.	% Encapsulation	Operator Name	QA Name