If you are interested in exploring how Tioga Research might best help you advance your skin-applied product program, please contact us at info@tiogaresearch.com. 

Minimally, we may be able to help you in your planning process.

Tioga Research delivers CRO services in the research and early development of skin-applied products, specializing in formulation innovation and skin permeation screening. With more than a decade of experience, we offer CRO services in support of topical drug products, transdermal drug products, prestige cosmetics, personal care products, and skin-applied medical device fields. Should we be tasked by a client with development of a new skin-applied drug product, from concept through to investigational new drug application (“IND”) filing, the process would typically entail (for a 505(b)(2) submission): 

Areas Addressed

Concept assessment: Evaluation of commercial appeal (based on estimates of development timelines and costs, sales potential, and risks) and technical feasibility of prospective new topical or transdermal drug product. 

Target product profile: Development of a detailed description of a prospective new drug product, in terms of indication, active pharmaceutical ingredient (“API”) nature and strength, formulation format, delivery requirements, development and regulatory paths, competitive products, differentiating benefits etc. 

Preformulation & analytical: Virtual feasibility assessment; analytical method development and verification; assessments of ingredient compatibilities; solubility measurements; gauging of competitive product performances.

Formulation innovation: Assessment & improvement of a current skin-applied formulation; formulation concept & library design; formulation discovery & refinement (with formulations innovation coupled closely with performance screening); spanning solutions, gels, creams, lotions, ointments, lacquers, foams, patches etc.

Skin permeation and delivery measurements: Measurements of skin permeation and retention using traditional diffusion cells (Franz and other designs); employing human cadaver skin (IVPT), porcine skin, nail, sebum, mucosal membranes, synthetic membranes (IVRT) etc.; from cream, gel, foam, solution, emulsion, lacquer, ointment, patch etc. formats; under finite or infinite dose conditions; permitted to work with Schedule II-V and Schedule I drug code 7360 (Cannabidiols etc.) controlled substances; and using analytics by HPLC, LC-MS, (LC-MS/MS with partner), liquid scintillation counting, ELISA etc.

High Throughput Experimentation: Tioga also provides skin delivery screening services using patented, patent pending and trade-secret high throughput experimentation (“HTE”) platforms including the award-winning INSIGHT™, and STORM™, FUROR™, TEMPEST™, and TORNADO™.

Formulation optimization: Adjustments to formulation composition and preparative procedures to optimize performance attributes; quality by design experiments and assessment of formulation robustness; excipient sourcing; platinum-standard skin permeation & retention measurements.

Measurements of product attributes, such as esthetics: Physical property measurements; subjective assessment of esthetics by panels.

Patent support: Formulation engineering to enable freedom to operate by circumventing protected compositions; patenting strategy input; support in application drafting; accumulation of experimental data to support claims (such as more comprehensive examples and claims support using proprietary high throughput experiment (“HTE”) platforms).

Stability:  Informal and formal assessments of formulation stability under normal (25°C) and accelerated (40°C) conditions, in qualified stability chambers.