Ex Vivo Tissue Permeability Services

Rugged and Validated Predefined and Custom Designed Assays

Absorption Systems' ex vivo tissue permeability service offers mechanistic models to assess drug permeability and absorption. The isolation of specific tissues eliminates interference from other physiological factors present in conventional in vivo pharmacokinetic studies. These models can be used in early-stage preclinical studies to compare different formulations of your drug or can be used post-marketing to evaluate new formulations and determine the feasibility of various dose routes.

Ex Vivo Tissue Permeability Assays
Unidirectional Permeability through Intestinal Tissue
Bidirectional Permeability through Intestinal Tissue
Unidirectional Permeability across Porcine Buccal Tissue
Unidirectional Permeability through Porcine Nasal Epithelium
Unidirectional Permeability through Excised Human Skin
Unidirectional Permeability through Excised Human Vaginal Tissue
Unidirectional Permeability through Excised Rabbit Vaginal Tissue
Unidirectional Permeability Through Rabbit Cornea or Conjunctiva Level 1
Unidirectional Permeability Through Rabbit Cornea or Conjunctiva Level 2
Ocular Penetration Assessment
Penetration Assessment

Ocular Permeability
Porcine Nasal/Buccal
Tissue Permeability
Dermal Permeability
and Metabolism
   
Intestinal Permeability
and Metabolism
Vaginal Permeability
and Metabolism

Answer drug permeability and metabolism questions with unique, tissue-based models

Our scientists have expertise in:
• Decisions to help derive IVIVCs
• Skilled and perfected excision and preparation of tissues
• Unique models created to tackle developers' challenges

Tour the Tissue Lab

Ex Vivo Tissue Permeability Tabbed Module

Intestinal and ocular tissue permeability studies are performed using a vertical Ussing chamber. 
Excised tissue is mounted in the chamber, and blank buffer is added to the receiver compartment. Buffer containing test compound and reference compounds is added to the donor compartment. Co-administration with the reference compounds is performed in order to ensure tissue functionality and integrity remains intact. Samples are taken at various time points in order to calculate permeability of the test compound across the tissue.

Buccal, nasal and dermal permeability studies are performed using a Franz cell.
The Franz cell creates an air interface that mimics physiologically relevant conditions and allows for dosing of cream and gel formulations. Excised tissue is mounted in the chamber, and blank buffer is added to the receiver compartment. Formulated test compound, or buffer containing test compound and reference compounds, is applied to the tissue in the donor compartment. In instances where co-administration with reference compounds is not possible, an additional control treatment is performed in parallel in order to ensure that tissue functionality and integrity remains intact. Samples are taken at various time points in order to calculate permeability of the test compound across the tissue.

EA205 Unidirectional Permeability through Intestinal Tissue
EA206 Bidirectional Permeability through  Intestinal Tissue
EA207 Permeability across Porcine Buccal
EA208 Unidirectional Permeability through Porcine Nasal Epithelium
EA209 Unidirectional Permeability through Excised Human Skin
EA210 Unidirectional Permeability through Excised Human Vaginal Tissue
EA214 Unidirectional Permeability through Excised Rabbit Vaginal Tissue
EA215 MatTek EpiOral® Permeability
EA226 Unidirectional Permeability through Rabbit Cornea or Conjunctiva (Level 1)
EA227 Unidirectional Permeability through Rabbit Cornea or Conjunctiva (Level 2)

>> View all assays

EA216 Corneal Penetration Assessment
EA217 Conjunctival Penetration Assessment

EA411 MS-Intestinal Microsomes

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Goosen C, et al., A comparative study of an in situ adapted diffusion cell and an in vitro Franz diffusion cell method for transdermal absorption of doxylamine. Eur J Pharm Sci. 2001 May; 13(2):169-77.

Gotoh Y, et al., The advantages of the Ussing chamber in drug absorption studies. J Biomol Screen. 2005 Aug; 10(5):517-23.

Korinth G, et al., Is the permeability coefficient Kp a reliable tool in percutaneous absorption studies?. Arch Toxicol. 2005 Mar; 79(3):155-9. Epub 2004 Dec 31

Nicolazzo JA, et al., The effect of various in vitro conditions on the permeability characteristics of the buccal mucosa. J Pharm Sci. 2003 Dec; 92(12):2399-410.

Ponchel G, et al., In vitro studies on enhancing effect of sodium glycocholate on transbuccal permeation of morphine hydrochloride. J Control Release. 1998 Feb 12; 51(2-3):107-13.

Wadell C, et al., Permeability of porcine nasal mucosa correlated with human nasal absorption. Eur J Pharm Sci. 2003 Jan; 18(1):47-53.

In Vitro and In Vivo Rabbit Models of Ocular Drug Absorption (Poster #T2086, AAPS 2010)

Evaluation of Corneal Orbs Created from Human Stem Cells as an In Vitro Model for Studying Ocular Drug Absorption (Poster #T2085, AAPS 2010)

In Vitro Corneal Model for Prediction of In Vivo Ocular Absorption Following Topical Administration (Poster, AAPS 2009)

Hydrolysis of Latanoprost in Rabbit Ocular Tissues (Poster, ISSX 2008)

Characterization of Excised Rabbit Cornea and Conjunctiva as In Vitro Models for Ocular Drug Absorption Studies (Poster, AAPS 2008)

Evaluation of the effect of 4-aromatic substitution on metabolic stability and metabolite profiles of 2AT using in vitro and ex vivo models (Poster, AAPS 2008)

Metabolizing Activities in Rabbit Cornea and Conjunctiva (Poster, ISSX 2007)

>> Resource Library

How long will the study take to complete?
This depends on the tissue to be procured and the number of donor tissues needed to execute the study protocol. Typically intestinal tissue studies take the longest, because we recommend using at least 3 different tissue donors and because the availability of donor tissue is unpredictable. However, we'll issue updates after each donor tissue has been assayed so that the sponsor can see how the study is progressing and modify the protocol, if necessary prior to running the next donor tissue.

Can you monitor for metabolites as well as the orginal test article and you determine tissue accumulation of test article and metabolites?
Absolutely. We have developed sensitive LC/MS/MS assays of monitoring compound levels in all the tissue matrices we use. In addition, we also have the capability of using radio-labelled compounds and monitoring labelled metabolites.

Ex vivo human tissues represent a more realistic model for studying drug transport and metabolism because all the basic pathways that participate remain intact. Therefore, the contribution of each individual pathway, e.g. oxidation by CYPs or uptake by OATPs, can be assessed in a pharmacologically relevant context in the target tissue of interest; intestine, skin, etc. Absorption Systems has investigated these pathways extensively and can provide its customers with both historical and control data verifying the physiological performance of the tissues used in any of its studies.

Absorption Systems uses transplant quality human tissues for all of its ex vivo studies assuring the quality and traceability of its tissue sources.

Absorption Systems dedicated ex vivo tissue Study Directors have advanced degrees and years of experience in these types of studies, guaranteeing that the highest quality research will be performed.

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