Depending on the specific drug product, testing at Dow Development Laboratories may include:
- quantitative assay of API and preservative
- water content
- light microscopy
- package integrity
- in vitro release testing (IVRT)
DDL has extensive experience in testing a wide variety of topical products containing new chemical entities (NCEs) as well as approved drugs, combination products, oligonucleotides, peptides, proteins, hygroscopic molecules and light-sensitive molecules.
Analytical methods are developed and then validated in a stage-appropriate manner as the product moves from R&D to Good Laboratory Practices (GLP) and through Phase I and II clinical studies, with strict oversight by the quality assurance group.
Stability studies may be conducted in R&D chambers (25oC and 40oC) or in temperature- and humidity-controlled Good Manufacturing Practices (GMP) chambers at International Conference for Harmonization (ICH) conditions (5oC, 25oC/60% RH, 30oC/65% RH and 40oC/75% RH). Chambers maintained at -20oC are also available on-site.
Experience Specific to Topical Products
Our analytical team is well-versed in overcoming the unique challenges in method development and testing that topical products can present. This includes:
- resolution of active pharmaceutical ingredient (API) and preservative from the multiple excipients in a topical product
- efficient extraction of the API from the formulation (ointments, gels, creams and suspensions)
- techniques for improving sensitivity for drug products at low strengths
- combination products
Analytical testing equipment at DDL includes:
- HPLC and uHPLC, with refrigerated auto-samplers and Diode Array Detectors
- Triple Quadrupole LC/MS
- Thermo Trace 1310 GC
- Franz cell manifolds (IVRT)
- Spectrophotometers, UV/Vis
- Viscometers (Brookfield), osmometers, pH meters
- Coulometric titrators for Karl Fisher analysis