XenoSkin P BM 25 mm Disk - Dermatomed Porcine Buccal Mucosa Model for in vitro oral Permeation Testing IVPT TG428 MDR 2017/745

Art. No.: PBM-D20D-25

25mm Ø Disk - Frozen Dermatomed Pig Buccal Mucosa

Product Description
Documents (2)

XenoSkin P BM is an ex vivo Porcine dermatomed Buccal Mucosa disc for in vitro mucosa permeation tests, absorption or penetration safety studies of chemicals, agrochemicals, pharmaceuticals, cosmetics or biocides and pesticides. The mucosa explants are also used as in vitro method for the evaluation of the barrier properties of medical devices for cutaneous use according Regulation 2017/745, Rule 21. The discs can be used for the safety assessment according to OECD 428, EFSA, EMA, FDA guidelines. XenoSkin P BM mucosa models are also used in place of colon mucosa or vaginal mucosa models and are replacing test animals.

XenoSkin H discs and porcine mucosas are excellent in vitro models for selecting drug candidates for dermal application, characterization of topical dosage forms, quality and safety assessment, selecting a suitable transdermal vehicle. XenoSkin H explants are replacing test animals.

Characteristics for in vitro dermal Permeation Testing

abdominal or face ex vivo skin
average age donor 45 years
aproved for absence of HBV, HCV, HIV-1, HIV-2
time form surgery to lab < 6 hours
macroscopic examination for absence of scars, surgical markers or pubic hairs
mean thickness 700 - 900 µm
in line with 3Rs (Reduce, Refine, Replace), replacing animal tests
many different sizes available
in line with OECD 428, EU Regulation 2017/745, Rule 21 for classification of medical devices, EFSA, EMA and FDA guidelines
Skin Absorption/Permeation study services available on skin explants or on 3D organotypic tissue models (skin, oral, vaginal, corneal, bladder, colorectal, nasal, intestinal tissues), please contact info@xenometrix.ch
for prices please contact info@xenometrix.ch