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 |