Skip to content
  • Clinical Studies
  • Schedule M
  • Stability Studies
  • Pharma GMP
  • Pharma Tips
  • Pharma Books
  • Pharma Validation
  • Pharma Regulatory

SOP Guide for Pharma

The Ultimate Resource for Pharmaceutical SOPs and Best Practices

  • Home
  • Job Safety Analysis (JSA)
    • Oral Dosage Forms (Tablets & Capsules)
    • Oral Liquid Dosage Forms (Syrups, Elixirs, Suspensions, Emulsions)
    • Powder and Granule Dosage Forms
    • Topical Dosage Forms (Creams, Ointments, Gels, Lotions, Pastes)
    • Transdermal Dosage Forms (Patches)
  • Standard Test Procedures (STP)
  • SOP – Blog Post
  • Toggle search form

Nanoparticle Formulation : SOP for Use of Antioxidants in Nanoparticle Formulations

Posted on By

SOP for Use of Antioxidants in Nanoparticle Formulations

Standard Operating Procedure for Use of Antioxidants in Nanoparticle Formulations

1) Purpose

The purpose of this SOP is to outline the procedure for incorporating antioxidants in nanoparticle formulations. Antioxidants are used to prevent oxidative degradation of both the active pharmaceutical ingredients (API) and the carrier material, ensuring improved stability, bioavailability, and efficacy.

2) Scope

This SOP applies to personnel involved in the development, formulation, and characterization of nanoparticle-based drug delivery systems incorporating antioxidants to enhance stability and therapeutic performance.

3) Responsibilities

  • Operators: Responsible for preparing nanoparticle formulations with antioxidants according to this procedure.
  • QA: Ensures that antioxidant levels and their effects on the stability and efficacy of the nanoparticles meet the required specifications.

4) Procedure

4.1 Selection of Antioxidants

4.1.1 Common Antioxidants Used

  • 4.1.1.1 Select antioxidants such as tocopherol (Vitamin E), ascorbic acid (Vitamin C), or glutathione, which are commonly used in nanoparticle formulations for their ability to neutralize free radicals and protect the API from oxidative degradation.
See also  Nanoparticle Formulation : SOP for Nanoencapsulation Techniques for Drug Delivery

4.1.2 Compatibility with Nanoparticles

  • 4.1.2.1 Ensure the chosen antioxidant is compatible with the nanoparticle material (e.g., lipids, polymers) and does not interfere with the drug release profile or bioavailability.

4.2 Nanoparticle Preparation with Antioxidants

4.2.1 Emulsification or Nanoprecipitation Method

  • 4.2.1.1 Prepare the nanoparticles using standard emulsification, nanoprecipitation, or similar methods, ensuring
that the antioxidant is either co-encapsulated with the API or incorporated into the surface of the nanoparticles.

4.2.2 Loading the Antioxidant

  • 4.2.2.1 Add the selected antioxidant during the nanoparticle preparation process, either dissolved in the organic or aqueous phase depending on its solubility.
  • 4.2.2.2 Optimize antioxidant loading to achieve maximum protection without affecting nanoparticle stability or drug release properties.

4.3 Characterization and Testing

4.3.1 Particle Size and Antioxidant Distribution

  • 4.3.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate the distribution of the antioxidant within the nanoparticles using techniques such as UV-Vis spectrophotometry or high-performance liquid chromatography (HPLC).

4.3.2 Oxidative Stability Testing

  • 4.3.2.1 Conduct stability studies to assess the effectiveness of the antioxidant in preventing oxidative degradation of the API and the nanoparticle matrix under various conditions (e.g., temperature, humidity).

4.3.3 In Vitro Release Studies

  • 4.3.3.1 Perform in vitro drug release studies to ensure the presence of the antioxidant does not alter the desired release profile of the API from the nanoparticles.

4.4 Optimization and Storage

4.4.1 Antioxidant Concentration Optimization

  • 4.4.1.1 Adjust the concentration of the antioxidant based on stability testing results to achieve the optimal balance between protection and nanoparticle performance.

4.4.2 Storage Conditions

  • 4.4.2.1 Store the antioxidant-incorporated nanoparticle formulations in airtight containers at 4°C or room temperature, depending on the stability data, ensuring protection from light and oxygen.

5) Abbreviations, if any

  • API: Active Pharmaceutical Ingredient
  • DLS: Dynamic Light Scattering
  • HPLC: High-Performance Liquid Chromatography

6) Documents, if any

  • Nanoparticle Antioxidant Incorporation Logbook

7) References, if any

  • Guidelines for using antioxidants in nanoparticle formulations
  • FDA Guidance on Stability Testing for Nanoparticles

8) SOP Version

Version 1.0

Annexure

Nanoparticle Antioxidant Incorporation Logbook Template

Date Batch Number Antioxidant Used Concentration Particle Size Oxidative Stability Results Operator Initials QA Initials
DD/MM/YYYY Batch Number Antioxidant Name Concentration (w/v %) Size in nm Pass/Fail Operator Name QA Name
           
See also  SOP for Nanoparticle-Based Formulations for Cancer Therapy
Nanoparticle Formulation Tags:Nanoparticle biomedical applications SOP, Nanoparticle clinical trial SOP, Nanoparticle encapsulation SOP, Nanoparticle formulation SOP, Nanoparticle handling SOP, Nanoparticle preparation procedure, Nanoparticle production SOP, Nanoparticle quality control SOP, Nanoparticle size optimization SOP, Nanoparticle SOP, Nanoparticle stability testing SOP, Nanoparticle standard operating procedures, Nanoparticle sterilization SOP, Nanoparticle storage SOP, Nanoparticle surface modification SOP, Nanoparticle synthesis SOP, Nanoparticle toxicology SOP, SOP for nanomaterials, SOP for nanoparticle characterization, SOP for nanoparticle drug delivery, SOP for nanoparticle gene delivery, SOP for nanoparticle regulatory compliance, SOP for nanoparticle safety, SOP for nanoparticle scaling, SOP for targeted drug delivery nanoparticles

Post navigation

Previous Post: SOP for Hot Melt Extrusion Process for Nasal Powders
Next Post: SOP for Preparation of Liposomal Lyophilized Products

Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

Read SOPs in your Language:

 - 
Bengali
 - 
bn
English
 - 
en
Gujarati
 - 
gu
Hindi
 - 
hi
Malayalam
 - 
ml
Marathi
 - 
mr
Punjabi
 - 
pa
Tamil
 - 
ta
Telugu
 - 
te

NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

Copyright © 2025 SOP Guide for Pharma.

Powered by PressBook WordPress theme

Go to mobile version