Topical Product Development Consulting Services

Expertise to assist you in selecting drug candidates, dosage forms, packaging, and evaluating and optimizing formulations.

Whether an early-stage start-up or a mature company, you will face challenges related to selection of an appropriate drug candidate for a topical product, choice of dosage form to promote release and delivery of your drug to the target tissue while maintaining its stability, and development of a robust process which maximizes drug stability.

After 30 years in the topical product development business, Dow has faced most of the challenges that may confront your topical program, and can help you avoid potential pitfalls so as to speed your development timeline and decrease your costs.

Drug Candidate Selection

Dow can provide guidance early in your program with evaluation of multiple candidate compounds based on their structure and physiochemical properties such as solubility, pK, and stability, to support your choice of lead drug for a particular indication. The potential commercial viability of the particular drug for the chosen indication can also be assessed by Dow early in your program.

Dosage Form and Packaging Recommendations

Based on your target indication and the physical/chemical properties of your active compound, our clinical, formulation, and skin biology experts can help you select the most appropriate and commercially viable dosage forms (gel, cream, ointment, solution, etc.) Recommendations for appropriate clinical and commercial packaging can also be made by Dow.

Formulation Evaluation & Process Critique

If you have already developed a topical formulation, Dow can assess the solvent system and other excipients and provide recommendations for changes to improve drug release and delivery, chemical and physical stability, cosmetic elegance, and/or potential for FDA approval. Increased delivery of drug to the target tissue will decrease the concentration needed, thereby decreasing the cost of goods while potentially improving the toxicology profile. Dow also evaluates the formulation process and may suggest changes to improve the chemical and physical stability and thus extend the shelf life of the product and improve commercial viability.

CMC Review

A CMC (chemistry, manufacturing and controls) section is needed for regulatory filings. Our CMC team will review your documents and provide input regarding drug substance characterization, formulation composition, formulation process, stability data and analytical methodology. We often prepare these sections for our clients.

Manufacturing Support

While we offer manufacturing of Phase 1 and 2 clinical supplies, we do not offer commercial manufacturing. Thus we have considerable experience helping our clients scale-up their products at several commercial manufacturers, and we can help to identify and select a commercial manufacturer and then provide technology transfer and trouble-shooting services.

For assistance with development of non-clinical and clinical product development plans, please see Dow’s Regulatory & Clinical Affairs.

To Learn More

Please contact Karen Hanley, Associate Director of Business Development, Tel 707.665.4665 for additional information. We encourage you to visit our facilities. Tel: 707.793.2600 to schedule an appointment.