4.2 Selection of Components

SEDDS formulations typically consist of oils, surfactants, and co-surfactants. The selection of components is critical to ensure that the system self-emulsifies and improves drug solubility. Follow these steps to select the ingredients:

• 4.2.1 Select oils based on the solubility of the drug. Medium-chain triglycerides (MCT) or long-chain triglycerides (LCT) are commonly used as the lipid phase.
• 4.2.2 Choose surfactants with an appropriate hydrophilic-lipophilic balance (HLB), typically between 12 and 18, to promote the emulsification of the lipid phase in aqueous environments.
• 4.2.3 Select co-surfactants, such as ethanol or propylene glycol, to enhance the fluidity of the system and facilitate the self-emulsification process.

4.3 Formulation Process

4.3.1 Preparation of the Lipid Phase

• 4.3.1.1 Weigh the required amount of oil (e.g., MCT or LCT) according to the formulation protocol. Record the weight in the Batch Manufacturing Record (BMR).
• 4.3.1.2 Heat the oil phase to 40°C-60°C on a hot plate with a temperature controller.

4.3.2 Preparation of the Surfactant and Co-Surfactant

• 4.3.2.1 Weigh the surfactant and co-surfactant in the ratios specified by the formulation protocol. Record the weights in the BMR.
• 4.3.2.2 Heat the surfactant and co-surfactant mixture to 40°C-60°C, if necessary, to facilitate dissolution.

4.3.3 Mixing the Components

• 4.3.3.1 Gradually add the surfactant and co-surfactant mixture to the heated oil phase while stirring continuously with a magnetic stirrer.
• 4.3.3.2 Continue stirring until a homogeneous mixture is formed. The mixture should appear clear and uniform.
• 4.3.3.3 If the formulation requires finer droplets, use a homogenizer or ultrasonicator to further reduce droplet size.

4.4 Quality Control Testing

After preparing the SEDDS, it must undergo quality control tests to confirm that the formulation meets the required specifications for droplet size, stability, and self-emulsifying properties.

• 4.4.1 Measure the droplet size using a droplet size analyzer. The average droplet size should typically range between 50 and 200 nm.
• 4.4.2 Evaluate the self-emulsification properties by adding the formulation to simulated gastric fluid (SGF) or simulated intestinal fluid (SIF) and observing whether the mixture forms a stable emulsion.
• 4.4.3 Check the pH of the formulation using a calibrated pH meter. Adjust if necessary to meet the product specifications.
• 4.4.4 Conduct stability testing by storing the formulation at room temperature and accelerated conditions (e.g., 40°C) to assess long-term stability and droplet size retention.

4.5 Storage of SEDDS

The prepared SEDDS formulation should be stored in sterilized, airtight containers. Label the containers with the batch number, formulation date, and storage conditions. Store the formulation at room temperature, and periodically assess for stability and droplet size consistency.

5) Abbreviations, if any

• SEDDS: Self-Emulsifying Drug Delivery System
• HLB: Hydrophilic-Lipophilic Balance
• SGF: Simulated Gastric Fluid
• SIF: Simulated Intestinal Fluid
• QA: Quality Assurance
• QC: Quality Control

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Droplet Size Analysis Report
• pH Measurement Report
• Stability Test Report

7) References, if any

• ICH Q8: Pharmaceutical Development
• FDA Guidance for Lipid-Based Drug Delivery Systems

8) SOP Version

Version 1.0

Annexure

Annexure 1: Batch Manufacturing Record Template

  

    
Batch No.
    
Oil Phase
    
Surfactant
    
Co-Surfactant
    
Mixing Time
    
Operator Initials
    
QA Signature
  
  

    
Batch Number
    
Oil Type/Weight
    
Surfactant Name/Weight
    
Co-Surfactant Name/Weight
    
Minutes
    
Operator Name
    
QA Name