4.2 Selection of Ingredients

Choose excipients and APIs that ensure the stability and bioavailability of the emulsion for oral delivery. Follow these steps to select the appropriate ingredients:

• 4.2.1 Select the oil phase based on the solubility of the API and its compatibility with oral formulations. Oils such as medium-chain triglycerides (MCT) or long-chain triglycerides (LCT) are commonly used.
• 4.2.2 Choose emulsifiers with an appropriate hydrophilic-lipophilic balance (HLB) value to stabilize the emulsion. Typically, emulsifiers with an HLB of 8-18 are suitable for oil-in-water emulsions used in oral delivery.
• 4.2.3 If necessary, add stabilizers or co-emulsifiers to enhance the stability and prolong the shelf life of the emulsion.

4.3 Preparation of the Emulsion

4.3.1 Preparation of the Oil and Water Phases

• 4.3.1.1 Weigh the required amounts of oil phase, water phase, and API(s) according to the formulation protocol. Record the weights in the Batch Manufacturing Record (BMR).
• 4.3.1.2 Dissolve the API in the appropriate phase. Lipophilic APIs are dissolved in the oil phase, while hydrophilic APIs are dissolved in the aqueous phase.
• 4.3.1.3 Heat both the oil and water phases to the required temperature (typically 40°C-60°C) to ensure complete solubility of the API and emulsifiers.

4.3.2 Emulsion Formation

• 4.3.2.1 Slowly add the oil phase to the water phase while mixing with a high-shear mixer. The mixing speed and time should be adjusted according to the formulation protocol to ensure the formation of a coarse emulsion.
• 4.3.2.2 Continue mixing until the API is uniformly distributed throughout the emulsion.
• 4.3.2.3 Pass the emulsion through a homogenizer to reduce droplet size and improve the stability and bioavailability of the final emulsion.

4.4 Quality Control Testing

After preparing the emulsion, perform quality control tests to ensure the API is properly encapsulated and the emulsion is suitable for oral delivery. The following tests are recommended:

• 4.4.1 Measure the droplet size using a droplet size analyzer. The average droplet size should typically range between 100 nm and 5 µm for oral emulsions.
• 4.4.2 Perform API content uniformity testing using an appropriate analytical method (e.g., HPLC) to ensure consistent API distribution within the emulsion.
• 4.4.3 Conduct stability testing by storing the emulsion at room temperature and accelerated conditions (e.g., 40°C) and monitoring for droplet size changes, phase separation, and API content over time.
• 4.4.4 Check the pH of the emulsion using a calibrated pH meter to ensure it is within the acceptable range for oral formulations (typically pH 4.0-7.0).

4.5 Storage of Oral Emulsions

The prepared oral emulsion should be stored in sterilized, airtight containers. Label the containers with the batch number, preparation date, and storage conditions. Store the emulsion at room temperature or as specified in the formulation protocol, and periodically test for stability and API content retention.

5) Abbreviations, if any

• API: Active Pharmaceutical Ingredient
• HLB: Hydrophilic-Lipophilic Balance
• QA: Quality Assurance
• QC: Quality Control

6) Documents, if any

• Batch Manufacturing Record (BMR)
• Droplet Size Analysis Report
• API Content Uniformity Report
• Stability Test Report

7) References, if any

• ICH Q8: Pharmaceutical Development Guidelines
• FDA Guidance for Oral Emulsion Drug Products

8) SOP Version

Version 1.0

Annexure

Annexure 1: Batch Manufacturing Record Template

  

    
Batch No.
    
Oil Phase
    
Water Phase
    
API Type
    
Mixing Time
    
Homogenization Time
    
Operator Initials
    
QA Signature
  
  

    
Batch Number
    
Oil Type/Weight
    
Water Type/Volume
    
API Name
    
Minutes
    
Minutes
    
Operator Name
    
QA Name