Topical Drug Product Design and Development Services

Dow Development Labs, LLC (DDL), a specialty contract development and manufacturing organization, provides drug product design and development services for pharmaceutical and biotech companies. We leverage our significant experience in formulation development, method development and manufacturing to move topical drug products quickly towards regulatory approval.

Topical Formulation Design and Development

Pre-formulation studies (solubility, excipient compatibility, pH profiles)
Prototype formulation design, development, and optimization specific for the disease state
Accelerated stability and packaging compatibility studies (pH, viscosity, conductivity, water content, microscopy)
Process development and scale-up
IVRT (in vitro release testing)

Analytical Methods and Testing

Method development for assay of API in drug product (HPLC, UPLC, LC/MS)
Analytical method validation (phase-appropriate from GLP through Phase III/commercial stage)
In-process and finished product release testing
Identification and quantitation of degradation products/related substances

Drug Product Manufacturing (gels, creams, ointments, solutions, sprays, pastes)

Supplies for GLP studies (up to ~40 Kg)
Supplies for GMP clinical studies (Phase I/II) with filling (tubes, vials, bottles, syringes)

Clinical Trial Material Services

Clinical supplies packaging, labeling, and distribution (kit design, random code generation)
Inventory management, returns accountability, and destruction

Drug Product Stability Studies

GMP stability studies (temperature- and humidity-controlled storage, ICH conditions)
Accelerated stability testing, tables, and reports
Extrapolation for shelf-life determination

Services