Topical Formulations Development

29 NDAs for prescription topical dermatological products were approved by the FDA during 2005-09: 10 of these formulations were developed at Dow.

Experience is Important

Whether your API is a new chemical entity (NCE) or a classical drug substance, you benefit from our 33 years of topical product experience. We develop for our clients stable, elegant topical formulations that deliver drug to the target site for the specific disease. Dow focuses only on topical products; thus, we know how to overcome or prevent problems that occur with topical dosage forms, which can include difficulty with API solubility, chemical or physical stability, API release from the formulation and penetration of the target tissue. Dow successfully developed topical formulations for hundreds of companies of all sizes . These included dermatological, ophthalmic, vaginal, transdermal and buccal formulations.

Unique Formulation Process & Teamwork

You benefit from our unique formulation development process wherein Dow scientists from formulations, analytical and the drug transport laboratory collaborate as a team. Our process includes pre-formulation (drug solubility, excipient and solvent compatibility) evaluations, formula design and development of multiple prototypes. Multiple prototypes based on different systems are developed to maximize success for chemical and physical stability, release from the formulation and penetration into the skin or tissue as desired.

Formulation Optimization and Cost Savings

Multiple formulation prototypes are evaluated for API release and penetration in our in vitro drug transport laboratory, and are then optimized for maximum delivery. Increased penetration means less API is required in your formulation (lower strength), which can result in a substantial reduction in cost of goods if your API is expensive. A formulation optimized for penetration also gives your product the best chance for success in the clinic because the API is released from the formulation and delivered to the desired site.

Disease Compatible Formulations

Our formulation scientists understand which topical dosage forms (cream, gel, lotion, ointment, etc.) are preferred for a specific indication, and they know which excipients should be avoided for patient acceptance. In addition, we can help you avoid preservative issues or formulation vehicle effects which could confound your clinical results. This knowledge only comes from years of experience with topical products.

Scalable Formulations

A successful product must have a scalable manufacturing process. With topical products, scale-up issues can occur in moving from small batch sizes to large commercial batch sizes. Our formulation scientists are keenly aware of potential scalability problems and consider them when they are developing the formulation and the manufacturing process.

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.

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