Standard Operating Procedure for Preparation of Nanoparticles for Targeted Drug Delivery
1) Purpose
This SOP outlines the steps for preparing nanoparticles designed for targeted drug delivery, which can enhance therapeutic efficacy and minimize off-target effects of drugs.
2) Scope
This SOP applies to all personnel involved in the preparation of nanoparticles functionalized with targeting ligands for specific drug delivery applications.
3) Responsibilities
- Operators: Responsible for preparing targeted nanoparticles using the outlined protocols.
- QA: Ensures that the nanoparticles meet the required targeting and encapsulation specifications.
4) Procedure
4.1 Preparation of Nanoparticles
4.1.1 Selection of Polymer or Lipid
- 4.1.1.1 Select an appropriate polymer or lipid (e.g., PLGA, liposomes) to form the nanoparticle base.
4.2 Functionalization of Nanoparticles
4.2.1 Ligand Attachment
- 4.2.1.1 Conjugate the targeting ligands (e.g., antibodies, peptides) onto the surface of the nanoparticles using covalent or non-covalent interactions.
4.2.2 Drug Loading
- 4.2.2.1 Incorporate the therapeutic drug into the nanoparticles before or after ligand functionalization, depending on the formulation strategy.
4.3 Particle Size and Drug Release Testing
4.3.1 Dynamic Light Scattering (DLS)
- 4.3.1.1 Measure the particle size of the nanoparticles using DLS to ensure they are within the desired size range (typically 100–200 nm).
4.3.2 Drug Release Assay
- 4.3.2.1 Conduct in vitro drug release studies to confirm controlled and targeted drug release.
4.4 Storage of Targeted
Nanoparticles
4.4.1 Storage Conditions
- 4.4.1.1 Store the targeted nanoparticle formulations in sterile containers at 4°C.
5) Abbreviations, if any
- PLGA: Poly(lactic-co-glycolic acid)
- DLS: Dynamic Light Scattering
6) Documents, if any
- Targeted Nanoparticle Preparation Logbook
7) References, if any
- Protocols for targeted nanoparticle formulations
8) SOP Version
Version 1.0
Annexure
Targeted Nanoparticle Preparation Logbook Template
| Date | Batch Number | Polymer Type | Particle Size | Encapsulation Efficiency | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Polymer Type | Size in nm | % Encapsulation | Operator Name | QA Name |
