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

Abstract

The aim of this work was to identify stable topical platform cream formulations (placebo creams without active drug substance) using the quality attributes of cream consistency, droplet size distribution (<1 μm), and separation or instability index of <0.1 to accelerate the development of topical cream drug product. The formulations were developed with six emulsifier systems that were screened in three different solvent systems across a range of emulsifier ratios. Each formulation was characterized by microscopy, separation index, and consistency. The results showed that there are three emulsifier combination (PEG 40 stearate:GMS, S21:S2, and PEG 40 stearate:Span 60) that works well with the solvent systems. Platform cream formulations F4, F15, F33, F40, F52, F69, F77, F87, and F106 were found to meet the three criteria for a long-term stable platform cream formulation. Formulation development for topical administered drug product can be very time consuming, expensive, and resourceful in identifying a chemically and physically stable product. In early development, where it can take 1–2 years to develop a first time in human (FTIH) formulation for a new chemical entity. The use of the platform base cream formulations will expedite the early development timeline for new chemical entity by 3–6 months.

Keywords:

• Topical cream
• emulsion
• formulation
• first time in human (FTIH)
• stability
• consistency

Acknowledgements

The authors thank Dr. Stephanie Lam for generating the viscosity and microscopic images on the platform formulations and Dr. Muralikrishnan Angamuthu for his invaluable review and suggestions on the manuscript.

Disclosure statement

No potential conflict of interest reported by author(s).