Dow Pharmaceutical Sciences, Inc. Topical Product Consulting
Topical Formulations Development
In Vitro Drug Penetration Studies
Analytical Sciences
Topicals Clinical Manufacturing
Clinical Labeling
Regulatory and Clinical Affairs
Clinical Research Units
Applications and Topical Dosage Forms

EXPERTS IN TOPICAL PRODUCT DEVELOPMENT SINCE 1977

The world's experts at developing stable, elegant topical products that deliver your drug to the target site as needed for your clinical indication.

Topical formulations have unique challenges

For your dermatological, ophthalmic, vaginal, transdermal or other topical application you want a stable, elegant, formulation that delivers drug to the target site and is scalable to commercial batch sizes. Topical dosage forms are unique and can present special problems during formulation development (incompatibility, solubility, stability, and penetration), during scale-up, or after long term storage (odor, discoloration, viscosity loss). Every API has different physical and chemical characteristics. Vehicles that could impact clinical results must be avoided, and the formulation used for nonclinical studies must be very similar to the commercial formulation.

 

32 years of topical product experience

By focusing exclusively on topical formulations for 32 years, Dow has developed more prescription topical formulations than any company in the world. We understand the problems and how to correct or prevent them. In the past 3 years alone, Dow successfully developed topical formulations for 65 companies of all sizes. These formulations penetrate as required, are scalable and disease compatible. Of the 23 topical product NDAs approved by the FDA in 2005-07, Dow developed the formulations for 9. By working with Dow you gain access to this expertise, and increase your chance of success.

Unique process for topical formulation development

Our formulation development and optimization process is unique. Experts in formulation, analytical, and drug transport collaborate to develop and optimize your formulation. Dow in vitro skin penetration models are used to screen multiple prototypes for release and penetration. Results are used to optimize until a lead formulation and back-up are selected.

Rapid feasibility and proof of concept data for Go/No Go decisions on your molecule

For this you need penetration, stability, and clinical proof-of-concept (POC) data. We work with you to streamline the development plan to obtain POC data quickly. For this we use our in vitro penetration models, accelerated stability studies and, where appropriate, unique human POC models available at our bioskin® subsidiary.

All services in one location

Coordinated by a Dow project manager, a full team of specialists in all required disciplines – formulation, in vitro testing, method development, stability, GMP clinical manufacturing, clinical labeling and distribution – work with you to reduce product development time.

Beyond product development – regulatory approval

We are experienced with regulatory planning and FDA submissions. Because we interact so frequently with the FDA Dermatology Division, we understand what it takes to get a product approved. Dow filed 4 NDAs in 2003-04; all 4 were approved in 2005-6. We develop non-clinical and clinical plans, and we file submissions electronically using our Core Dossier software system.