Standard Operating Procedure for Optimization of Particle Size in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for optimizing particle size in nanoparticle formulations. Particle size is a critical factor influencing drug release, stability, and bioavailability, and must be optimized to meet the therapeutic objectives of the formulation.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of nanoparticle formulations, particularly those responsible for adjusting and controlling particle size during formulation.

3) Responsibilities

• Operators: Responsible for optimizing and measuring particle size in nanoparticle formulations following this SOP.
• QA: Ensures that particle size falls within the required specifications and meets stability and bioavailability targets.

4) Procedure

4.1 Methods for Optimizing Particle Size

4.1.1 Solvent Evaporation

• 4.1.1.1 Adjust the solvent evaporation process parameters (e.g., solvent type, evaporation rate) to control particle size during nanoparticle formation.

4.1.2 High-Pressure Homogenization

• 4.1.2.1 Utilize high-pressure homogenization to reduce particle size and create uniform nanoparticles, adjusting pressure and cycle number as necessary.

4.1.3 Sonication

• 4.1.3.1 Use sonication to break down larger particles and control the size of the nanoparticles, optimizing sonication time and power settings.

4.2 Particle Size Measurement

4.2.1 Dynamic Light Scattering (DLS)

• 4.2.1.1 Measure particle size using DLS to ensure the nanoparticles are within the desired size range, typically between 100–200 nm for drug delivery applications.

4.2.2 Scanning Electron Microscopy (SEM)

• 4.2.2.1 Use SEM to confirm the shape and size distribution of the nanoparticles, verifying uniformity and surface morphology.

4.3 Adjustments and Optimization

4.3.1 Process Optimization

• 4.3.1.1 Optimize the formulation process by adjusting the solvent, homogenization pressure, or sonication parameters to achieve the desired particle size and stability.

4.4 Stability Testing

4.4.1 Stability of Optimized Formulations

• 4.4.1.1 Conduct stability testing on the optimized nanoparticle formulations under various conditions (e.g., temperature, humidity) to ensure that the particle size remains stable over time.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• SEM: Scanning Electron Microscopy

6) Documents, if any

• Particle Size Optimization Logbook

7) References, if any

• Protocols for optimizing particle size in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Particle Size Optimization Logbook Template

  

    
Date
    
Batch Number
    
Method Used
    
Optimized Particle Size
    
Stability Results
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Method (Sonication, Homogenization, etc.)
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoparticles for Gene Delivery

1) Purpose

This SOP outlines the procedure for preparing nanoparticles intended for gene delivery. Nanoparticles are used to deliver nucleic acids (e.g., DNA, RNA) to cells, protecting the genetic material and enhancing cellular uptake for gene therapy applications.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of nanoparticles designed for gene delivery in pharmaceutical or genetic research settings.

3) Responsibilities

• Operators: Responsible for preparing gene delivery nanoparticles as per the outlined procedure.
• QA: Ensures the nanoparticles meet the required specifications for nucleic acid encapsulation, particle size, and gene transfection efficiency.

4) Procedure

4.1 Selection of Nucleic Acids and Nanoparticles

4.1.1 Nucleic Acid Selection

• 4.1.1.1 Choose the appropriate nucleic acid (e.g., plasmid DNA, siRNA, mRNA) based on the intended gene therapy application and ensure its stability during nanoparticle formulation.

4.1.2 Nanoparticle Material Selection

• 4.1.2.1 Select biodegradable and biocompatible polymers (e.g., chitosan, PLGA) or lipids for nanoparticle formation, optimizing for nucleic acid protection and cellular uptake.

4.2 Nucleic Acid Incorporation

4.2.1 Encapsulation or Complexation

• 4.2.1.1 Encapsulate or complex the nucleic acid with the nanoparticles using electrostatic interactions or entrapment within the nanoparticle matrix. Optimize for high encapsulation efficiency while maintaining nucleic acid activity.

4.3 Characterization

4.3.1 Particle Size and Encapsulation Efficiency

• 4.3.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate encapsulation efficiency using gel electrophoresis or spectrophotometry to ensure proper formulation.

4.3.2 Gene Transfection Efficiency

• 4.3.2.1 Perform in vitro transfection studies using target cells to assess the ability of the nanoparticles to successfully deliver the genetic material and express the gene of interest.

4.4 Stability and Storage

4.4.1 Storage Conditions

• 4.4.1.1 Store the gene delivery nanoparticles in sterile containers at 4°C or -20°C depending on stability data, ensuring the integrity of the nucleic acids is preserved over time.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• PLGA: Poly(lactic-co-glycolic acid)
• siRNA: Small Interfering RNA

6) Documents, if any

• Gene Delivery Nanoparticle Formulation Logbook

7) References, if any

• Protocols for nanoparticle preparation for gene delivery

8) SOP Version

Version 1.0

Annexure

Gene Delivery Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Nucleic Acid
    
Nanoparticle Material
    
Particle Size
    
Encapsulation Efficiency
    
Transfection Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Nucleic Acid Used
    
Material
    
Size in nm
    
Efficiency (%)
    
Transfection (%)
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Incorporation of Peptides in Nanoparticle-Based Formulations

1) Purpose

This SOP outlines the procedure for incorporating peptides into nanoparticle formulations for targeted delivery or therapeutic applications. Peptides can be used as therapeutic agents or as targeting ligands to enhance the specificity of nanoparticles.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of peptide-loaded nanoparticles in pharmaceutical and biomedical research settings.

3) Responsibilities

• Operators: Responsible for incorporating peptides into nanoparticle formulations following this SOP.
• QA: Ensures that peptide-loaded nanoparticles meet specifications for peptide loading, particle size, and stability.

4) Procedure

4.1 Selection of Peptides and Nanoparticles

4.1.1 Peptide Selection

• 4.1.1.1 Select peptides based on the therapeutic or targeting application. Peptides should be stable under formulation conditions and retain bioactivity after encapsulation.

4.1.2 Nanoparticle Material Selection

• 4.1.2.1 Choose appropriate nanoparticle materials (e.g., PLGA, liposomes, or polymeric micelles) that are compatible with peptide encapsulation and allow for sustained or targeted release.

4.2 Peptide Incorporation

4.2.1 Encapsulation or Surface Conjugation

• 4.2.1.1 Incorporate peptides into the nanoparticles by encapsulation within the particle matrix or conjugation to the surface, depending on the application (e.g., therapeutic or targeting).
• 4.2.1.2 Optimize peptide loading to balance efficacy and stability, ensuring that the peptide is not degraded during the formulation process.

4.3 Characterization

4.3.1 Particle Size and Peptide Stability

• 4.3.1.1 Measure the particle size using dynamic light scattering (DLS) and confirm the stability of the encapsulated or conjugated peptide using techniques like HPLC or mass spectrometry.

4.3.2 In Vitro Release Studies

• 4.3.2.1 Perform in vitro release studies to evaluate the release profile of the peptide from the nanoparticles and confirm sustained or targeted delivery over time.

4.4 Storage and Stability

4.4.1 Storage Conditions

• 4.4.1.1 Store the peptide-loaded nanoparticles in sterile containers at 4°C to maintain stability and prevent degradation of the peptides during storage.

5) Abbreviations, if any

• PLGA: Poly(lactic-co-glycolic acid)
• DLS: Dynamic Light Scattering
• HPLC: High-Performance Liquid Chromatography

6) Documents, if any

• Peptide-Loaded Nanoparticle Formulation Logbook

7) References, if any

• Protocols for incorporating peptides in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Peptide-Loaded Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Peptide Used
    
Nanoparticle Type
    
Particle Size
    
Peptide Stability
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Peptide Name
    
Nanoparticle Material
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Formulation of Protein-Based Nanoparticles

1) Purpose

This SOP outlines the procedure for formulating protein-based nanoparticles, which are used for the delivery of peptides, proteins, or therapeutic agents. Protein-based nanoparticles are biocompatible, biodegradable, and suitable for targeted drug delivery.

2) Scope

This SOP applies to personnel involved in the preparation and characterization of protein-based nanoparticles in pharmaceutical or biomedical research settings.

3) Responsibilities

• Operators: Responsible for preparing protein-based nanoparticles as per the outlined procedure.
• QA: Ensures the nanoparticle formulations meet specifications for size, drug loading, and protein stability.

4) Procedure

4.1 Selection of Proteins and Therapeutic Agents

4.1.1 Protein Selection

• 4.1.1.1 Use proteins such as albumin, gelatin, or casein for nanoparticle formulation. Ensure the protein is biocompatible and stable under formulation conditions.

4.1.2 Drug Loading

• 4.1.2.1 Incorporate the therapeutic agent or peptide into the protein matrix during nanoparticle formation, optimizing drug loading and release properties.

4.2 Nanoparticle Preparation

4.2.1 Coacervation or Desolvation Method

• 4.2.1.1 Prepare protein nanoparticles using the coacervation or desolvation method, adjusting the pH and ionic strength to induce protein aggregation and nanoparticle formation.

4.3 Characterization

4.3.1 Particle Size and Zeta Potential

• 4.3.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniform size distribution and charge stability.

4.3.2 Protein Stability Testing

• 4.3.2.1 Conduct protein stability testing to confirm the structural integrity of the protein after nanoparticle formation, using techniques like SDS-PAGE or circular dichroism.

4.4 Storage and Stability

4.4.1 Storage Conditions

• 4.4.1.1 Store the protein-based nanoparticles at 4°C in sealed containers to maintain stability and prevent protein degradation over time.

5) Abbreviations, if any

• DLS: Dynamic Light Scattering
• SDS-PAGE: Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis

6) Documents, if any

• Protein Nanoparticle Formulation Logbook

7) References, if any

• Protocols for protein-based nanoparticle formulation

8) SOP Version

Version 1.0

Annexure

Protein Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Protein Used
    
Therapeutic Agent
    
Particle Size
    
Stability Test Results
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Protein Name
    
Drug/Peptide Name
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoparticles for Ocular Delivery

1) Purpose

This SOP outlines the procedure for preparing nanoparticles intended for ocular delivery. These nanoparticles are designed to deliver therapeutic agents directly to the eye, targeting the anterior or posterior segments of the eye for sustained release and improved bioavailability.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of nanoparticles for ocular drug delivery in pharmaceutical or ophthalmic research settings.

3) Responsibilities

• Operators: Responsible for preparing and characterizing nanoparticles for ocular delivery as per this SOP.
• QA: Ensures that nanoparticle formulations meet the required specifications for sterility, particle size, and drug release.

4) Procedure

4.1 Selection of Polymers and Drugs

4.1.1 Polymer Selection

• 4.1.1.1 Use biodegradable polymers like chitosan, hyaluronic acid, or PLGA to enhance the residence time of nanoparticles in the eye and ensure sustained drug release.

4.1.2 Drug Loading

• 4.1.2.1 Load the therapeutic agent into the nanoparticles, optimizing for efficient drug release while minimizing irritation to the ocular tissues.

4.2 Nanoparticle Preparation

4.2.1 Emulsification or Nanoprecipitation Method

• 4.2.1.1 Prepare nanoparticles using emulsification or nanoprecipitation methods, targeting particle sizes between 100–200 nm to allow for easy administration and sustained release in ocular tissues.

4.3 Characterization and Testing

4.3.1 Particle Size and Drug Release

• 4.3.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate the drug release profile using in vitro drug release studies to ensure prolonged drug delivery to the eye.

4.3.2 In Vitro Ocular Irritation Testing

• 4.3.2.1 Perform in vitro ocular irritation testing using corneal or conjunctival cells to ensure the nanoparticle formulation is non-irritating to ocular tissues.

4.4 Sterility and Storage

4.4.1 Sterility Testing

• 4.4.1.1 Sterilize the nanoparticle suspension by filtration through a 0.22-micron sterile filter and perform sterility testing according to standard ophthalmic protocols.

4.4.2 Storage Conditions

• 4.4.2.1 Store the nanoparticles in sterile, sealed containers at 4°C to maintain stability and sterility until use.

5) Abbreviations, if any

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

6) Documents, if any

• Ocular Delivery Nanoparticle Formulation Logbook

7) References, if any

• Protocols for nanoparticle preparation for ocular drug delivery

8) SOP Version

Version 1.0

Annexure

Ocular Delivery Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Polymer Type
    
Drug Encapsulated
    
Particle Size
    
Ocular Irritation Test
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Type
    
Drug Name
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Incorporation of Targeting Ligands in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for incorporating targeting ligands, such as antibodies or peptides, into nanoparticle formulations to improve the specificity and efficacy of drug delivery by targeting diseased cells or tissues.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of targeted nanoparticle formulations for use in drug delivery and therapeutic applications.

3) Responsibilities

• Operators: Responsible for incorporating targeting ligands into nanoparticle formulations following the outlined procedure.
• QA: Ensures that the targeted nanoparticles meet the required specifications for ligand attachment and targeting efficacy.

4) Procedure

4.1 Selection of Targeting Ligands

4.1.1 Ligand Types

• 4.1.1.1 Choose appropriate targeting ligands such as antibodies (e.g., anti-EGFR), peptides (e.g., RGD peptide), or aptamers that bind specifically to receptors on diseased cells or tissues.

4.1.2 Ligand Conjugation

• 4.1.2.1 Use chemical or physical conjugation techniques (e.g., EDC/NHS coupling, thiol-maleimide reaction) to attach the targeting ligands to the nanoparticle surface.

4.2 Nanoparticle Preparation

4.2.1 Ligand-Conjugated Nanoparticles

• 4.2.1.1 Prepare ligand-conjugated nanoparticles by adding the targeting ligands to pre-formed nanoparticles and allowing the conjugation reaction to occur under controlled conditions.

4.3 Characterization

4.3.1 Ligand Density and Activity

• 4.3.1.1 Quantify the number of ligands conjugated to the nanoparticles using techniques such as ELISA or Western blotting to ensure the appropriate density of targeting molecules.
• 4.3.1.2 Perform binding assays to confirm that the targeting ligands retain their binding activity after conjugation to the nanoparticles.

4.4 Testing for Targeting Efficacy

4.4.1 In Vitro Targeting Studies

• 4.4.1.1 Conduct in vitro studies using cell lines expressing the target receptor to evaluate the specificity and efficacy of the targeted nanoparticles in binding to the desired cells or tissues.

4.5 Storage

4.5.1 Storage Conditions

• 4.5.1.1 Store the ligand-conjugated nanoparticles in sterile, sealed containers at 4°C to maintain stability and targeting efficacy.

5) Abbreviations, if any

• EDC: 1-Ethyl-3-(3-dimethylaminopropyl) carbodiimide
• NHS: N-Hydroxysuccinimide

6) Documents, if any

• Targeting Ligand Conjugation Logbook

7) References, if any

• Protocols for ligand conjugation in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Targeting Ligand Conjugation Logbook Template

  

    
Date
    
Batch Number
    
Targeting Ligand
    
Conjugation Method
    
Ligand Density
    
Binding Activity
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Ligand Name
    
Method Used
    
Density (mol/mol)
    
Activity (%)
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoparticles for Nasal Delivery

1) Purpose

This SOP outlines the procedure for preparing nanoparticles intended for nasal delivery. Nasal delivery provides a non-invasive route for administering drugs directly to the systemic circulation or central nervous system via the nasal cavity.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of nanoparticles for nasal drug delivery in pharmaceutical research and development.

3) Responsibilities

• Operators: Responsible for preparing nanoparticles optimized for nasal delivery following this SOP.
• QA: Ensures the nanoparticle formulations meet specifications for size, drug release, and nasal absorption.

4) Procedure

4.1 Selection of Polymers and Drugs

4.1.1 Polymer and Surfactant Selection

• 4.1.1.1 Choose biocompatible polymers (e.g., chitosan, PLGA) and mucoadhesive surfactants (e.g., poloxamer) to enhance the residence time and absorption of the drug in the nasal cavity.

4.1.2 Drug Loading

• 4.1.2.1 Load the therapeutic agent into the nanoparticles, ensuring it is protected from enzymatic degradation and optimized for nasal absorption.

4.2 Nanoparticle Preparation

4.2.1 Emulsification or Nanoprecipitation Method

• 4.2.1.1 Prepare nanoparticles using emulsification or nanoprecipitation methods, aiming for a particle size below 200 nm to ensure efficient nasal absorption and minimal mucociliary clearance.

4.3 Characterization and Testing

4.3.1 Particle Size and Drug Release

• 4.3.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate drug release profiles to ensure sustained drug delivery through the nasal mucosa.

4.3.2 In Vitro Nasal Permeation Studies

• 4.3.2.1 Conduct in vitro nasal permeation studies using excised nasal tissue or an appropriate model to evaluate the nanoparticles’ ability to cross the nasal epithelium.

4.4 Stability and Storage

4.4.1 Stability Testing

• 4.4.1.1 Perform stability tests under various environmental conditions (e.g., temperature, humidity) to assess the long-term stability of the nanoparticles.

4.4.2 Storage Conditions

• 4.4.2.1 Store the nasal delivery nanoparticle formulations in sterile containers at 4°C or room temperature, ensuring protection from moisture and contamination.

5) Abbreviations, if any

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

6) Documents, if any

• Nasal Delivery Nanoparticle Formulation Logbook

7) References, if any

• Protocols for nanoparticle preparation for nasal drug delivery

8) SOP Version

Version 1.0

Annexure

Nasal Delivery Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Polymer Type
    
Surfactant Used
    
Particle Size
    
Nasal Permeation Results
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Type
    
Surfactant Name
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Nanoparticle-Based Formulations for Cancer Therapy

1) Purpose

This SOP outlines the procedure for formulating nanoparticles designed for cancer therapy. These nanoparticles are used to deliver chemotherapeutic agents directly to cancer cells, improving efficacy and reducing systemic side effects.

2) Scope

This SOP applies to personnel involved in the preparation, characterization, and testing of nanoparticle formulations intended for cancer therapy in pharmaceutical or research settings.

3) Responsibilities

• Operators: Responsible for preparing nanoparticle-based cancer therapy formulations following this SOP.
• QA: Ensures that formulations meet specifications for drug loading, particle size, and targeting efficiency.

4) Procedure

4.1 Selection of Polymers and Drugs

4.1.1 Polymer Selection

• 4.1.1.1 Select biocompatible and biodegradable polymers such as PLGA or PEGylated lipids for nanoparticle formulation, ensuring minimal toxicity and prolonged circulation in the bloodstream.

4.1.2 Drug Loading

• 4.1.2.1 Incorporate the chemotherapeutic agent (e.g., doxorubicin, paclitaxel) into the nanoparticles during the preparation process, optimizing drug loading for efficient delivery to cancer cells.

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation Method

• 4.2.1.1 Use solvent evaporation or nanoprecipitation methods to prepare nanoparticles with a particle size between 100 and 200 nm, suitable for enhanced permeability and retention (EPR) effect in tumors.

4.3 Targeting and Surface Modification

4.3.1 Surface Functionalization

• 4.3.1.1 Modify the nanoparticle surface with targeting ligands such as antibodies or peptides (e.g., folic acid) to improve selective uptake by cancer cells.

4.4 Characterization

4.4.1 Particle Size and Drug Loading Efficiency

• 4.4.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate the drug loading efficiency using high-performance liquid chromatography (HPLC).

4.4.2 In Vitro Cytotoxicity Testing

• 4.4.2.1 Perform in vitro cytotoxicity assays on cancer cell lines to evaluate the efficacy of the nanoparticle formulation in killing cancer cells.

4.5 Storage

4.5.1 Storage Conditions

• 4.5.1.1 Store the nanoparticle formulations in sterile, sealed containers at 4°C to maintain stability and prevent degradation of the chemotherapeutic agent.

5) Abbreviations, if any

• PLGA: Poly(lactic-co-glycolic acid)
• PEG: Polyethylene Glycol
• DLS: Dynamic Light Scattering
• HPLC: High-Performance Liquid Chromatography

6) Documents, if any

• Cancer Therapy Nanoparticle Formulation Logbook

7) References, if any

• Protocols for nanoparticle-based cancer therapy formulations

8) SOP Version

Version 1.0

Annexure

Cancer Therapy Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Polymer Type
    
Targeting Ligand
    
Particle Size
    
Drug Loading Efficiency
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer Type
    
Ligand Used
    
Size in nm
    
Efficiency (%)
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Carbon-Based Nanomaterials

1) Purpose

This SOP outlines the procedure for preparing carbon-based nanomaterials, such as graphene, carbon nanotubes, and fullerenes, which are used in various applications including drug delivery, electronics, and energy storage.

2) Scope

This SOP applies to personnel involved in the synthesis and characterization of carbon-based nanomaterials for research or industrial purposes.

3) Responsibilities

• Operators: Responsible for synthesizing carbon-based nanomaterials and performing quality control tests.
• QA: Ensures that the nanomaterials meet the required specifications for purity, particle size, and structure.

4) Procedure

4.1 Synthesis of Carbon Nanomaterials

4.1.1 Chemical Vapor Deposition (CVD) Method

• 4.1.1.1 Use the CVD method to synthesize graphene or carbon nanotubes by depositing carbon atoms onto a substrate through the thermal decomposition of a carbon source (e.g., methane).

4.1.2 Arc Discharge Method

• 4.1.2.1 Alternatively, use the arc discharge method to synthesize fullerenes or multi-walled carbon nanotubes by vaporizing carbon electrodes in an inert atmosphere.

4.2 Purification and Characterization

4.2.1 Purification

• 4.2.1.1 Purify the synthesized carbon nanomaterials using acid treatments or thermal oxidation to remove any impurities or catalyst residues.

4.2.2 Characterization

• 4.2.2.1 Characterize the nanomaterials using techniques such as scanning electron microscopy (SEM), transmission electron microscopy (TEM), and Raman spectroscopy to determine their structure, purity, and size.

4.3 Stability and Storage

4.3.1 Stability Testing

• 4.3.1.1 Conduct stability studies under different environmental conditions (e.g., temperature, humidity) to assess the long-term stability of the nanomaterials.

4.3.2 Storage Conditions

• 4.3.2.1 Store the carbon-based nanomaterials in sealed, dry containers at room temperature to prevent oxidation or degradation.

5) Abbreviations, if any

• CVD: Chemical Vapor Deposition
• SEM: Scanning Electron Microscopy
• TEM: Transmission Electron Microscopy

6) Documents, if any

• Carbon Nanomaterial Synthesis Logbook

7) References, if any

• Protocols for carbon-based nanomaterial synthesis and characterization

8) SOP Version

Version 1.0

Annexure

Carbon Nanomaterial Synthesis Logbook Template

  

    
Date
    
Batch Number
    
Synthesis Method
    
Purity Level
    
Particle Size
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
CVD/Arc Discharge
    
Purity (%)
    
Size in nm
    
Operator Name
    
QA Name
  
  

    
 
    
 
    
 
    
 
    
 
    
 
  

Standard Operating Procedure for Preparation of Nanoparticles for Transdermal Delivery

1) Purpose

This SOP outlines the procedure for preparing nanoparticles specifically designed for transdermal drug delivery. Transdermal delivery systems aim to deliver therapeutic agents through the skin, providing a controlled and sustained release.

2) Scope

This SOP applies to personnel involved in the formulation and characterization of nanoparticles intended for transdermal drug delivery, which requires optimized skin permeation properties.

3) Responsibilities

• Operators: Responsible for preparing the nanoparticles and ensuring they meet the specifications for transdermal delivery.
• QA: Ensures the nanoparticles are characterized for particle size, skin permeation, and stability.

4) Procedure

4.1 Selection of Materials

4.1.1 Polymer or Lipid Selection

• 4.1.1.1 Choose biocompatible polymers or lipids such as PLGA, chitosan, or phospholipids that enhance skin permeation while protecting the drug from degradation.

4.1.2 Permeation Enhancers

• 4.1.2.1 Incorporate permeation enhancers such as oleic acid or ethanol to facilitate the movement of nanoparticles through the skin barrier.

4.2 Nanoparticle Preparation

4.2.1 Solvent Evaporation or Nanoprecipitation Method

• 4.2.1.1 Prepare the nanoparticles using solvent evaporation or nanoprecipitation methods, aiming for a particle size below 300 nm to improve skin permeation.

4.3 Characterization and Testing

4.3.1 Particle Size and Zeta Potential

• 4.3.1.1 Measure the particle size and zeta potential using dynamic light scattering (DLS) to ensure uniform size distribution and stability.

4.3.2 In Vitro Skin Permeation Studies

• 4.3.2.1 Perform in vitro skin permeation studies using Franz diffusion cells to assess the nanoparticles’ ability to penetrate through the skin.

4.4 Stability and Storage

4.4.1 Stability Testing

• 4.4.1.1 Conduct stability studies under different environmental conditions (e.g., temperature, humidity) to assess the long-term stability of the nanoparticles.

4.4.2 Storage Conditions

• 4.4.2.1 Store the nanoparticles in sterile containers at 4°C or room temperature based on stability data, ensuring protection from light and moisture.

5) Abbreviations, if any

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

6) Documents, if any

• Transdermal Nanoparticle Formulation Logbook

7) References, if any

• Protocols for preparing nanoparticles for transdermal drug delivery

8) SOP Version

Version 1.0

Annexure

Transdermal Nanoparticle Formulation Logbook Template

  

    
Date
    
Batch Number
    
Polymer/Lipid Type
    
Permeation Enhancer
    
Particle Size
    
Permeation Test Results
    
Operator Initials
    
QA Initials
  
  

    
DD/MM/YYYY
    
Batch Number
    
Polymer/Lipid Type
    
Enhancer Used
    
Size in nm
    
Pass/Fail
    
Operator Name
    
QA Name