Injectable Emulsion Dosage Form

Injectable emulsion is a sterile biphasic liquid dosage form in which two immiscible liquids (oil and water) are made miscible with one another, one as the disperse phase in other phase using an emulsifying agent.

Preformulation Studies

Assess the physicochemical properties of the drug and its compatibility with excipients.

• Solubility Assessment: Determine the solubility of the active pharmaceutical ingredient (API) in various solvents to identify suitable oil phases.
• Excipient Compatibility: Evaluate potential interactions between the API and excipients to prevent instability.
• Stability Profiling: Conduct stress testing under different conditions (e.g., pH, temperature) to predict degradation pathways.
• Viscosity and Surface Tension Measurements: Ensure the flow properties of the formulation are suitable for injection.

Prototype Development

Create an initial formulation that meets the desired specifications.

• Emulsification Technique Selection: Choose between high shear mixing (HSM) and high-pressure homogenization (HPH) based on the desired droplet size and stability.
• Excipient Optimization: Select emulsifiers and stabilizers that ensure the desired stability and compatibility.
• Formulation Screening: Prepare multiple formulations with varying concentrations of API and excipients to identify the optimal combination.
• Preliminary Stability Testing: Conduct short-term stability studies to assess physical and chemical stability.

Manufacturing Process Development

Scale up the formulation from laboratory to commercial production.

• Process Optimization: Refine emulsification and homogenization parameters to ensure consistent droplet size and stability.
• Equipment Selection: Choose appropriate equipment (e.g., homogenizers, mixers) that can handle the scale and maintain product quality.
• Aseptic Processing: Implement sterile techniques to prevent contamination during manufacturing.
• Filling and Packaging: Develop procedures for filling vials or syringes and ensure packaging maintains product integrity.