Accelerate development of topical cream drug product using a common platform base formulation

Area of Science:

• Pharmaceutical Sciences
• Formulation Development

Background:

• Topical drug product development is time-consuming and resource-intensive.
• Establishing chemically and physically stable formulations is critical for early-stage drug development.
• Accelerating the development of first-time in human (FTIH) formulations for new chemical entities is a key objective.

Purpose of the Study:

• To identify stable topical platform cream formulations (placebo) to expedite drug product development.
• To establish criteria for stable cream formulations, including consistency, droplet size (<1 μm), and instability index (<0.1).
• To screen emulsifier and solvent systems to identify optimal platform cream bases.

Main Methods:

• Developed formulations using six emulsifier systems across three solvent systems.
• Screened emulsifier ratios to optimize formulation stability.
• Characterized formulations using microscopy, separation index, and consistency analysis.

Main Results:

• Identified three effective emulsifier combinations: PEG 40 stearate:GMS, S21:S2, and PEG 40 stearate:Span 60.
• Nine platform cream formulations (F4, F15, F33, F40, F52, F69, F77, F87, F106) met the stability criteria.
• The selected formulations demonstrated consistency, sub-micron droplet size, and minimal separation.

Conclusions:

• Stable topical platform cream formulations can be developed by controlling key quality attributes.
• These platform formulations significantly reduce early-stage topical drug development timelines by 3-6 months.
• The use of pre-validated platform bases streamlines the formulation process for new chemical entities.