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Formulations for the Skin

The skin is a complex organ that provides:

Protection from physical, chemical, and biological challenges
Moisture retention
Thermoregulation
Metabolic and immunological functions
Sensory perception

Formulations designed for the skin are optimized to control drug release and delivery. This includes the use of solvents and non-solvents to manage drug thermodynamic activity, along with both passive and active permeation enhancement strategies.

Formulation composition, microstructure, and changes after application, such as evaporation of volatile excipients, can significantly influence drug stability and delivery. These factors are evaluated throughout development.

Topical skin formulations range from:

Single-phase systems such as gels, liquids, and sprays
Multi-phase emulsions such as creams and foams
Patches such as drug in adhesive or in-situ forming films (such as MedSpray)

MedPharm typically selects excipients already approved for the intended route of delivery, such as those listed in the FDA Inactive Ingredient Database. This approach minimizes safety concerns, reduces regulatory risk, and limits the need for extensive in vivo safety studies.

Additional selection factors include:

  • Excipient concentration
  • Irritation potential
  • Dosing requirements
  • Target population and indication
  • Intended marketing territories

High-Throughput Flow-Through Diffusion Cells vs Franz Cells

To address limitations of commercially available diffusion cells, MedPharm developed MedFlux-HT®, a proprietary high-throughput flow-through diffusion system for evaluating skin and tissue permeation and penetration.

MedFlux-HT® uses a continuous-flow design with an optimized flow path that enables:

  • More accurate and detailed flux profiles
  • Improved sink conditions
  • Shorter study timelines
  • Enhanced analysis of lipophilic compounds without receiver-fluid additives

The system is thermostatically controlled to maintain physiological temperature, and receiver-fluid collection is automated to support higher throughput and improved reproducibility.

MedFlux-HT® also uses smaller dosing areas, allowing a greater number of replicates from limited human tissue supplies.

MedPharm's Static Franz Cell

  • Widely used in the industry
  • Manual sample collection
  • Static system
  • Receiver fluid may require additives to ensure sink conditions
  • Meets IVRT/SUPAC criteria
  • Ideal for skin penetration studies
  • Larger dosing areas enable increased exposure of the skin to the formulation
  • Ideal for regulatory submissions
  • Study duration 6-8 weeks

MedPharm's MedFlux-HT System

  • Proprietary high-throughput system
  • Automated sample collection
  • Flow-through design with rapid local clearance
  • Sink conditions easily achieved with biologically relevant receiver fluid
  • Ideal for skin permeation studies
  • More accurate permeation profiles and fluxes over more data points
  • Smaller dosing areas enable larger formulation screens
  • Ideal for early development and screening
  • Study duration 2-3 weeks

Easy Access to Human Skin

MedPharm provides rapid access to high-quality human skin tissue, including:

Repository of more than 100 frozen human skin samples stored at −80°C
IRB-approved sample collection
Normal, healthy, and diseased skin
Optimized collection, shipping, handling, and storage protocols to minimize variability
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