Standard Operating Procedure for Nanoencapsulation Techniques
1) Purpose
This SOP outlines the standard procedures for performing nanoencapsulation techniques, commonly used in drug delivery systems to improve bioavailability and targeted delivery of pharmaceutical compounds.
2) Scope
This SOP applies to all laboratory personnel involved in the preparation of nanoencapsulated drug formulations.
3) Responsibilities
- Operators: Responsible for following the SOP to prepare nanoencapsulated drug formulations correctly.
- QA: Ensures compliance with the preparation protocols and verifies the quality of the final product.
4) Procedure
4.1 Material Preparation
4.1.1 Preparation of Drug Substance
- 4.1.1.1 Accurately weigh the drug substance using a calibrated balance.
- 4.1.1.2 Dissolve the drug in a suitable solvent based on the drug’s solubility characteristics.
4.1.2 Preparation of Encapsulation Matrix
- 4.1.2.1 Select an appropriate encapsulating material (e.g., polymer, lipid) based on the desired release profile and compatibility with the drug.
- 4.1.2.2 Dissolve the encapsulating material in an organic solvent or aqueous medium under stirring.
4.2 Encapsulation Techniques
4.2.1 Emulsification-Solvent Evaporation
- 4.2.1.1 Mix the drug solution with the encapsulating material under high-speed homogenization to form an emulsion.
- 4.2.1.2 Allow the solvent to evaporate, leading to the formation of nanoencapsulated particles as the polymer or lipid solidifies.
4.2.2 Nanoprecipitation
- 4.2.2.1 Add the drug-encapsulating material to a non-solvent under continuous stirring, causing the polymer or lipid to precipitate and encapsulate
the drug.
4.2.2.2 Continue stirring until the nanoprecipitation process is complete and particles are formed.
4.3 Washing and Collection of Nanoparticles
4.3.1 Centrifugation
- 4.3.1.1 Centrifuge the nanoencapsulated particles to collect them, discarding the supernatant.
- 4.3.1.2 Wash the particles by resuspending them in distilled water and centrifuging again to remove any residual solvents.
4.4 Particle Size Analysis
4.4.1 Dynamic Light Scattering (DLS)
- 4.4.1.1 Use DLS or a similar technique to measure the particle size and distribution of the nanoencapsulated particles.
- 4.4.1.2 Record the average particle size and ensure it meets the desired specifications.
4.5 Storage
4.5.1 Storage Conditions
- 4.5.1.1 Transfer the nanoencapsulated drug formulations to sterile containers and store them at 4°C or lower, depending on the stability of the formulation.
5) Abbreviations, if any
- DLS: Dynamic Light Scattering
- QA: Quality Assurance
6) Documents, if any
- Nanoencapsulation Process Logbook
7) References, if any
- Relevant literature on nanoencapsulation techniques and their applications in drug delivery
8) SOP Version
Version 1.0
Annexure
Nanoencapsulation Process Logbook Template
| Date | Batch Number | Encapsulation Technique | Particle Size | Encapsulation Efficiency | Operator Initials | QA Initials |
|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Technique Used (e.g., Emulsification, Nanoprecipitation) | Size in nm | % Encapsulation | Operator Name | QA Name |