Standard Operating Procedure for Solvent Evaporation Method for Nanoparticles

1) Purpose

This SOP provides the detailed steps for the solvent evaporation method used in nanoparticle preparation. The purpose is to ensure consistency and control in the formation of nanoparticles for drug delivery applications.

2) Scope

This SOP applies to laboratory staff involved in the formulation of nanoparticles using the solvent evaporation method.

3) Responsibilities

• Operators: Responsible for carrying out the solvent evaporation technique as per this SOP.
• QA: Ensures quality control by verifying particle size and encapsulation efficiency.

4) Procedure

4.1 Polymer Dissolution

4.1.1 Solvent Selection

• 4.1.1.1 Select a suitable organic solvent (e.g., dichloromethane) and dissolve the polymer (e.g., PLGA) under gentle stirring.

4.1.2 Drug Loading

• 4.1.2.1 Dissolve or suspend the drug in the polymer solution based on its solubility profile.

4.2 Formation of Emulsion

4.2.1 Emulsification

• 4.2.1.1 Add the polymer-drug solution into an aqueous phase containing a surfactant (e.g., PVA) under continuous stirring to form an emulsion.
• 4.2.1.2 Use a high-speed homogenizer to reduce the size of emulsion droplets.

4.3 Solvent Evaporation

4.3.1 Solvent Removal

• 4.3.1.1 Evaporate the solvent under reduced pressure or stirring at room temperature, leading to nanoparticle formation as the polymer solidifies.
• 4.3.1.2 Continue until no solvent remains in the suspension.

4.4 Washing and Collection of Nanoparticles

4.4.1 Centrifugation

• 4.4.1.1 Centrifuge the nanoparticle suspension to collect the solid particles and discard the supernatant.
• 4.4.1.2 Wash the particles with distilled water and repeat the centrifugation process.

4.5 Particle Size Measurement

4.5.1 Dynamic Light Scattering (DLS)

• 4.5.1.1 Use DLS or another method to measure the particle size of the nanoparticles and ensure they meet the desired specifications (e.g., 100–200 nm).

4.6 Storage

4.6.1 Storage Conditions

• 4.6.1.1 Store the nanoparticles in sterile, sealed containers at 4°C or freeze-dry them for long-term stability.

5) Abbreviations, if any

• PLGA: Poly(lactic-co-glycolic acid)
• PVA: Polyvinyl Alcohol
• DLS: Dynamic Light Scattering

6) Documents, if any

• Solvent Evaporation Method Logbook

7) References, if any

• Formulation protocols for nanoparticles using solvent evaporation

8) SOP Version

Version 1.0

Annexure

Solvent Evaporation Method Logbook Template

  

    
Date
    
Batch Number
    
Polymer Used
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Type
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoparticle Suspensions

1) Purpose

This SOP outlines the procedure for preparing stable nanoparticle suspensions used in drug delivery, diagnostics, and other applications. The goal is to ensure that nanoparticles are uniformly dispersed in the suspension and maintain stability over time.

2) Scope

This SOP applies to laboratory personnel responsible for the preparation of nanoparticle suspensions in a sterile and controlled environment.

3) Responsibilities

• Operators: Responsible for following the SOP to prepare stable nanoparticle suspensions.
• QA: Ensures that nanoparticle suspensions meet the required size, stability, and quality parameters.

4) Procedure

4.1 Preparation of Nanoparticles

4.1.1 Nanoparticle Selection

• 4.1.1.1 Select the desired type of nanoparticles based on the specific application (e.g., polymeric, metallic, or lipid-based nanoparticles).

4.2 Preparation of Suspension Medium

4.2.1 Solvent Selection

• 4.2.1.1 Prepare a suspension medium using distilled water, saline solution, or a buffer depending on the application.

4.2.2 Stabilizers

• 4.2.2.1 Add a stabilizer (e.g., PVA, Tween 80) to the suspension medium to prevent nanoparticle aggregation.

4.3 Suspending the Nanoparticles

4.3.1 Dispersion

• 4.3.1.1 Add the nanoparticles to the suspension medium under gentle stirring.
• 4.3.1.2 Use an ultrasonic bath or homogenizer to ensure uniform dispersion of the nanoparticles in the suspension.

4.3.2 Monitoring Particle Size

• 4.3.2.1 Measure the particle size using dynamic light scattering (DLS) to ensure the nanoparticles remain in the desired size range (typically less than 200 nm).

4.4 Storage and Stability Testing

4.4.1 Storage

• 4.4.1.1 Store the nanoparticle suspension in sterile, sealed containers at 4°C.

4.4.2 Stability Testing

• 4.4.2.1 Periodically test the suspension for particle size, zeta potential, and any signs of aggregation or sedimentation.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• PVA: Polyvinyl Alcohol

6) Documents, if any

• Nanoparticle Suspension Preparation Logbook

7) References, if any

• Relevant literature on the preparation and stabilization of nanoparticle suspensions

8) SOP Version

Version 1.0

Annexure

Nanoparticle Suspension Preparation Logbook Template

  

    
Date
    
Batch Number
    
Particle Type
    
Particle Size
    
Stabilizer Used
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Type of Nanoparticles
    
Size in nm
    
Stabilizer Name
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoemulsions

1) Purpose

This SOP outlines the procedure for preparing nanoemulsions, which are used as drug delivery systems to enhance the solubility of poorly soluble drugs. The aim is to ensure a consistent and controlled method for nanoemulsion preparation.

2) Scope

This SOP applies to all laboratory personnel involved in the formulation and preparation of nanoemulsions for drug delivery applications.

3) Responsibilities

• Operators: Responsible for following the SOP to accurately prepare nanoemulsions.
• QA: Ensures that the nanoemulsions meet quality and size specifications.

4) Procedure

4.1 Preparation of Oil Phase

4.1.1 Oil and Surfactant Selection

• 4.1.1.1 Select an appropriate oil phase based on the solubility of the drug and the desired application of the nanoemulsion.
• 4.1.1.2 Dissolve the drug in the oil phase under continuous stirring at room temperature.

4.2 Preparation of Aqueous Phase

4.2.1 Stabilizer Selection

• 4.2.1.1 Select a stabilizer or surfactant suitable for the formation of stable nanoemulsions.
• 4.2.1.2 Prepare the aqueous phase by dissolving the stabilizer in distilled water under gentle stirring.

4.3 Emulsification

4.3.1 Formation of Nanoemulsion

• 4.3.1.1 Add the oil phase to the aqueous phase under high-speed stirring to form an emulsion.
• 4.3.1.2 Continue stirring for 10–15 minutes to ensure proper emulsification.

4.3.2 Particle Size Reduction

• 4.3.2.1 Use a high-pressure homogenizer or ultrasonicator to reduce the particle size of the emulsion droplets to the nanoscale (typically less than 200 nm).
• 4.3.2.2 Monitor the particle size using dynamic light scattering (DLS).

4.4 Storage and Stability

4.4.1 Storage of Nanoemulsions

• 4.4.1.1 Store the prepared nanoemulsion in sterile, sealed containers at 4°C to maintain stability.

4.4.2 Stability Testing

• 4.4.2.1 Periodically test the nanoemulsion for particle size and physical stability (e.g., phase separation, creaming) to ensure the formulation remains stable over time.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering

6) Documents, if any

• Nanoemulsion Preparation Logbook

7) References, if any

• Literature on nanoemulsion formulations and stability testing

8) SOP Version

Version 1.0

Annexure

Nanoemulsion Preparation Logbook Template

  

    
Date
    
Batch Number
    
Oil Phase
    
Particle Size
    
Stability Test
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Oil Phase Used
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for High-Pressure Homogenization in Nanoparticle Production

1) Purpose

This SOP outlines the high-pressure homogenization method used for reducing particle size in nanoparticle production, a technique commonly employed to achieve nanoparticles for drug delivery and other applications.

2) Scope

This SOP applies to all operators using high-pressure homogenizers to reduce the particle size of nanoparticles in formulations.

3) Responsibilities

• Operators: Responsible for setting up and operating the high-pressure homogenizer.
• QA: Ensures the final nanoparticles meet quality and size specifications.

4) Procedure

4.1 Preparation of Sample

4.1.1 Sample Preparation

• 4.1.1.1 Prepare the nanoparticle suspension as per formulation guidelines, ensuring that the starting particle size is suitable for homogenization.
• 4.1.1.2 Transfer the suspension into the homogenizer feed tank.

4.2 High-Pressure Homogenization

4.2.1 Equipment Setup

• 4.2.1.1 Calibrate the high-pressure homogenizer according to the manufacturer’s instructions.
• 4.2.1.2 Set the operating pressure between 500 and 1500 bar, depending on the formulation needs.

4.2.2 Particle Size Reduction

• 4.2.2.1 Pass the nanoparticle suspension through the homogenizer for multiple cycles (usually 3–5 passes) until the desired particle size is achieved.
• 4.2.2.2 Monitor the particle size during the process using dynamic light scattering (DLS) or a similar technique.

4.3 Cleaning and Maintenance

4.3.1 Cleaning of Equipment

• 4.3.1.1 Clean the homogenizer thoroughly after each batch using sterile water and a cleaning solution to remove any residual particles or contaminants.

4.4 Storage of Nanoparticles

4.4.1 Storage Conditions

• 4.4.1.1 Store the nanoparticle suspension in sealed, sterile containers at 4°C, or freeze-dry for long-term storage if necessary.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• QA: Quality Assurance

6) Documents, if any

• High-Pressure Homogenization Process Logbook

7) References, if any

• Manufacturer’s instructions for high-pressure homogenizer

8) SOP Version

Version 1.0

Annexure

High-Pressure Homogenization Process Logbook Template

  

    
Date
    
Batch Number
    
Pressure (bar)
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Pressure Used (e.g., 1000 bar)
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Nanoprecipitation Method in Nanoparticle Formulation

1) Purpose

This SOP outlines the nanonprecipitation method for preparing nanoparticles, typically used to create polymer-based nanoparticles for drug delivery. The technique allows for the formation of nanoparticles by precipitation from a solution.

2) Scope

This SOP applies to laboratory personnel responsible for the formulation of nanoparticles using the nanonprecipitation method.

3) Responsibilities

• Operators: Responsible for following the nanonprecipitation protocol and ensuring accurate nanoparticle formation.
• QA: Ensures the nanoparticles meet the required quality standards.

4) Procedure

4.1 Polymer Solution Preparation

4.1.1 Polymer Selection

• 4.1.1.1 Select an appropriate polymer (e.g., PLGA) and dissolve it in a water-miscible organic solvent (e.g., acetone or ethanol).
• 4.1.1.2 Stir until the polymer is completely dissolved.

4.2 Precipitation Process

4.2.1 Addition of Polymer Solution

• 4.2.1.1 Slowly add the polymer solution into an aqueous phase containing stabilizers under gentle stirring to form nanoparticles by precipitation.
• 4.2.1.2 Maintain the stirring rate until the nanoparticles have formed, typically over a period of 10–15 minutes.

4.2.2 Particle Size Control

• 4.2.2.1 Monitor particle size using dynamic light scattering (DLS) to ensure the nanoparticles are within the desired size range.

4.3 Washing and Purification

4.3.1 Centrifugation

• 4.3.1.1 Centrifuge the nanoparticle suspension at 10,000 g to collect the nanoparticles and discard the supernatant.
• 4.3.1.2 Wash the nanoparticles with distilled water and repeat the centrifugation process.

4.4 Drying and Storage

4.4.1 Drying

• 4.4.1.1 Freeze-dry or vacuum-dry the nanoparticles, depending on the formulation requirements.

4.4.2 Storage

• 4.4.2.1 Store the dried nanoparticles in sterile containers at 4°C or room temperature.

5) Abbreviations, if any

• PLGA: Poly(lactic-co-glycolic acid)
• DLS: Dynamic Light Scattering

6) Documents, if any

• Nanoprecipitation Process Logbook

7) References, if any

• Guidelines for nanoprecipitation methods in nanoparticle formulation

8) SOP Version

Version 1.0

Annexure

Nanoprecipitation Process Logbook Template

  

    
Date
    
Batch Number
    
Polymer Type
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Name
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Supercritical Fluid Techniques in Nanoparticle Preparation

1) Purpose

This SOP outlines the use of supercritical fluid techniques for the preparation of nanoparticles, which allow for controlled particle size and purity. The supercritical fluid method is commonly used to prepare drug nanoparticles with enhanced solubility.

2) Scope

This SOP applies to all laboratory personnel involved in the use of supercritical fluids for the preparation of nanoparticles.

3) Responsibilities

• Operators: Responsible for following the supercritical fluid technique protocol accurately.
• QA: Ensures that nanoparticles prepared using supercritical fluids meet the required quality standards.

4) Procedure

4.1 Setup of Supercritical Fluid Apparatus

4.1.1 Equipment Preparation

• 4.1.1.1 Ensure that the supercritical fluid apparatus is cleaned, calibrated, and properly set up according to the manufacturer’s guidelines.
• 4.1.1.2 Check for leaks and ensure that all safety protocols are in place for handling supercritical CO₂ or other fluids.

4.1.2 Solvent and Drug Preparation

• 4.1.2.1 Dissolve the drug or active ingredient in a solvent appropriate for the supercritical fluid process (e.g., ethanol, acetone).
• 4.1.2.2 Set up the drug solution and supercritical fluid for introduction into the apparatus.

4.2 Supercritical Fluid Process

4.2.1 Introduction of Supercritical Fluid

• 4.2.1.1 Slowly introduce the supercritical fluid (e.g., CO₂) into the system at the specified temperature and pressure conditions.
• 4.2.1.2 Ensure that the flow rates of both the drug solution and supercritical fluid are consistent and as per the process requirement.

4.2.2 Particle Formation

• 4.2.2.1 As the supercritical fluid expands, nanoparticles are formed as the solvent evaporates and the drug precipitates.
• 4.2.2.2 Collect the formed nanoparticles in the collection chamber.

4.3 Washing and Drying

4.3.1 Washing with Solvent

• 4.3.1.1 Wash the nanoparticles using a suitable solvent to remove any residual supercritical fluid or impurities.

4.3.2 Drying of Nanoparticles

• 4.3.2.1 Dry the nanoparticles under vacuum or in a desiccator to ensure complete removal of solvent residues.

4.4 Characterization

4.4.1 Particle Size Analysis

• 4.4.1.1 Use dynamic light scattering (DLS) or similar techniques to measure the particle size of the nanoparticles.
• 4.4.1.2 Record the particle size and ensure it meets the required specifications.

4.5 Storage of Nanoparticles

4.5.1 Storage Conditions

• 4.5.1.1 Store the nanoparticles in sterile, sealed containers and maintain them at room temperature or 4°C depending on the stability of the formulation.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• CO₂: Carbon Dioxide
• QA: Quality Assurance

6) Documents, if any

• Supercritical Fluid Process Logbook

7) References, if any

• Relevant literature on supercritical fluid techniques in nanoparticle preparation

8) SOP Version

Version 1.0

Annexure

Supercritical Fluid Process Logbook Template

  

    
Date
    
Batch Number
    
Fluid Used
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Fluid (e.g., CO2)
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Emulsification-Solvent Evaporation in Nanoparticle Formulations

1) Purpose

This SOP outlines the emulsification-solvent evaporation technique, commonly used to prepare nanoparticles for drug delivery systems. The goal is to standardize the process to ensure consistent nanoparticle size and encapsulation efficiency.

2) Scope

This SOP applies to all laboratory personnel responsible for preparing nanoparticle formulations using the emulsification-solvent evaporation technique.

3) Responsibilities

• Operators: Responsible for following the emulsification-solvent evaporation protocol to prepare nanoparticles.
• QA: Ensures compliance with protocols and verifies the final product quality.

4) Procedure

4.1 Preparation of Organic Phase

4.1.1 Solubilization of Polymer and Drug

• 4.1.1.1 Dissolve the polymer (e.g., PLGA) and drug in a volatile organic solvent (e.g., dichloromethane) under constant stirring.
• 4.1.1.2 Continue stirring until the polymer and drug are fully dissolved.

4.2 Emulsification

4.2.1 Preparation of Aqueous Phase

• 4.2.1.1 Prepare an aqueous phase containing a stabilizer (e.g., PVA) to prevent nanoparticle aggregation.

4.2.2 Formation of Emulsion

• 4.2.2.1 Slowly add the organic phase into the aqueous phase under high-speed stirring to form an emulsion.
• 4.2.2.2 Continue stirring for 15–20 minutes to ensure stable emulsion formation.

4.3 Solvent Evaporation

4.3.1 Removal of Organic Solvent

• 4.3.1.1 Allow the volatile organic solvent to evaporate under reduced pressure or by stirring at room temperature, leading to nanoparticle formation as the polymer solidifies.
• 4.3.1.2 Monitor the evaporation process until no solvent remains.

4.4 Nanoparticle Collection

4.4.1 Centrifugation

• 4.4.1.1 Centrifuge the nanoparticle suspension at 10,000–15,000 g for 30 minutes to collect the nanoparticles.
• 4.4.1.2 Wash the nanoparticles with distilled water to remove any unencapsulated drug or residual stabilizers.

4.5 Characterization of Nanoparticles

4.5.1 Particle Size Measurement

• 4.5.1.1 Use dynamic light scattering (DLS) or similar methods to measure the particle size of the nanoparticles.
• 4.5.1.2 Record the average size and polydispersity index (PDI) to ensure the nanoparticles meet the required specifications.

4.6 Storage of Nanoparticles

4.6.1 Storage Conditions

• 4.6.1.1 Transfer the nanoparticle suspension into sterile, labeled containers and store at 4°C or freeze-dry for long-term stability.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• PDI: Polydispersity Index

6) Documents, if any

• Emulsification-Solvent Evaporation Logbook

7) References, if any

• Formulation protocols for nanoparticles using the emulsification-solvent evaporation method

8) SOP Version

Version 1.0

Annexure

Emulsification-Solvent Evaporation Logbook Template

  

    
Date
    
Batch Number
    
Polymer Type
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Name
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanocrystals for Drug Delivery

1) Purpose

This SOP describes the process for preparing drug nanocrystals, which enhance the solubility and bioavailability of poorly water-soluble drugs. The goal is to standardize the preparation of nanocrystals for drug delivery applications.

2) Scope

This SOP applies to all laboratory staff involved in the formulation and preparation of drug nanocrystals for pharmaceutical and drug delivery purposes.

3) Responsibilities

• Operators: Responsible for following the SOP to prepare nanocrystals according to the specified protocols.
• QA: Ensures compliance with the protocol and verifies the quality of prepared nanocrystals.

4) Procedure

4.1 Preparation of Drug Solution

4.1.1 Drug Selection and Dissolution

• 4.1.1.1 Select the poorly water-soluble drug to be formulated into nanocrystals.
• 4.1.1.2 Dissolve the drug in an organic solvent or a mixture of organic solvents suitable for the nanocrystal formulation.

4.2 Nanocrystal Formation

4.2.1 Precipitation Method

• 4.2.1.1 Add the drug solution dropwise into an aqueous phase containing stabilizers while continuously stirring to precipitate the drug nanocrystals.
• 4.2.1.2 Maintain stirring for 15–30 minutes until nanocrystals are formed.

4.2.2 High-Pressure Homogenization

• 4.2.2.1 Homogenize the suspension at high pressure to reduce the particle size and achieve nanoscale dimensions.
• 4.2.2.2 Monitor the size reduction using dynamic light scattering (DLS) or another particle-sizing method.

4.3 Washing and Collection of Nanocrystals

4.3.1 Filtration

• 4.3.1.1 Filter the nanocrystal suspension using a filtration unit to remove any remaining organic solvents.
• 4.3.1.2 Wash the nanocrystals with distilled water to remove any excess stabilizers or solvents.

4.3.2 Centrifugation

• 4.3.2.1 Centrifuge the suspension to collect the nanocrystals, discarding the supernatant.
• 4.3.2.2 Repeat the washing and centrifugation process as needed to ensure the purity of the nanocrystals.

4.4 Characterization of Nanocrystals

4.4.1 Particle Size Measurement

• 4.4.1.1 Measure the particle size using DLS or other appropriate methods to confirm that the nanocrystals meet the desired size specifications.

4.5 Storage of Nanocrystals

4.5.1 Storage Conditions

• 4.5.1.1 Store the nanocrystals in sterile containers, preferably under refrigeration (4°C) or freeze-drying for long-term stability.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• QA: Quality Assurance

6) Documents, if any

• Nanocrystal Preparation Logbook

7) References, if any

• Good Manufacturing Practice (GMP) guidelines for drug formulation

8) SOP Version

Version 1.0

Annexure

Nanocrystal Preparation Logbook Template

  

    
Date
    
Batch Number
    
Drug Name
    
Particle Size
    
Encapsulation Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Drug Name
    
Size in nm
    
% Encapsulation
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Metal Nanoparticles

1) Purpose

This SOP describes the process for preparing metal nanoparticles, such as gold, silver, and iron oxide nanoparticles, for various applications, including drug delivery, catalysis, and biomedical imaging.

2) Scope

This SOP applies to all laboratory personnel involved in the synthesis and preparation of metal nanoparticles.

3) Responsibilities

• Operators: Responsible for following the SOP to prepare metal nanoparticles accurately and safely.
• QA: Ensures compliance with the preparation protocols and verifies the quality of the metal nanoparticles.

4) Procedure

4.1 Preparation of Metal Salt Solution

4.1.1 Selection of Metal Salt

• 4.1.1.1 Select a metal salt (e.g., gold chloride, silver nitrate) based on the desired metal nanoparticle.
• 4.1.1.2 Dissolve the metal salt in distilled water or another suitable solvent under gentle stirring.

4.2 Reduction Process

4.2.1 Reduction Using Chemical Reducing Agents

• 4.2.1.1 Add a reducing agent (e.g., sodium citrate, sodium borohydride) to the metal salt solution under constant stirring.
• 4.2.1.2 Continue stirring the solution until the reaction is complete and nanoparticles are formed, as indicated by a color change (e.g., gold nanoparticles produce a red/pink color).

4.2.2 Thermal or Photochemical Reduction

• 4.2.2.1 Alternatively, perform a thermal or photochemical reduction by exposing the metal salt solution to heat or UV light, leading to nanoparticle formation.

4.3 Stabilization of Nanoparticles

4.3.1 Use of Capping Agents

• 4.3.1.1 To stabilize the metal nanoparticles, add a capping agent (e.g., polyvinyl alcohol, thiols) to the solution.
• 4.3.1.2 Stir the solution to ensure the capping agent uniformly coats the nanoparticles.

4.4 Washing and Purification

4.4.1 Centrifugation

• 4.4.1.1 Centrifuge the metal nanoparticles to collect them and remove excess salts or reagents.
• 4.4.1.2 Wash the nanoparticles by resuspending them in distilled water and repeating the centrifugation process.

4.5 Characterization

4.5.1 UV-Vis Spectroscopy

• 4.5.1.1 Use UV-Vis spectroscopy to monitor the optical properties of the metal nanoparticles, confirming their formation and size.

4.6 Storage

4.6.1 Storage Conditions

• 4.6.1.1 Store the metal nanoparticles in sterile containers at 4°C or at room temperature, depending on their stability.

5) Abbreviations, if any

• UV-Vis: Ultraviolet-Visible Spectroscopy
• QA: Quality Assurance

6) Documents, if any

• Metal Nanoparticle Synthesis Logbook

7) References, if any

• Material Safety Data Sheets (MSDS) for metal salts and reagents

8) SOP Version

Version 1.0

Annexure

Metal Nanoparticle Synthesis Logbook Template

  

    
Date
    
Batch Number
    
Metal Type
    
Reduction Method
    
Particle Size
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Metal (e.g., Gold, Silver)
    
Reduction Method Used (e.g., Chemical, Photochemical)
    
Size in nm
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

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