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
Learn more about DDL’s Drug Product Design and Development services:
