Drug Product Testing, Methods and Stability Studies

Topical Drug Product Testing

Topical Drug Product Testing, Methods and Stability Studies

Topical drug product testing is a critical component of Dow Development Laboratories, LLC’s (DDL) comprehensive topical product development services, which are used develop products and then to bring products to the clinic and on to approval.

Topical Drug Product Testing

Depending on the specific dosage form, topical drug product testing at Dow Development Laboratories may include:

  • Quantitative assay of API and preservative
  • pH
  • Viscosity
  • Appearance
  • Water content
  • Light microscopy
  • Conductivity
  • Osmolality
  • Package compatibility
  • 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.

Testing Methods

Analytical methods are developed and then validated in a stage-appropriate manner as the product moves from R&D through clinical studies, with strict oversight by the quality assurance group.

Drug Product Stability Testing

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). DDL maintains both reach-in and walk-in chambers. Chambers maintained at -20oC are also available on-site.

Experience Specific to Topical Drug Product Testing

Our analytical team is well-versed in overcoming the unique challenges in method development and topical drug product testing, including:

  • 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

Testing Equipment

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
  • ELSD
  • Franz cell manifolds (IVRT)
  • Spectrophotometers, UV/Vis
  • Viscometers (Brookfield), osmometers, pH meters
  • Coulometric titrators for Karl Fisher analysis

For questions or inquiries as to how Dow Development Laboratories can help you with your topical product development needs, please contact us at khanley@dowdevelopmentlabs.com