Percutaneous absorption tests
Now carry out your analysis on endocrine disruptors in cosmetic raw materials and finished products
Do you need to evaluate the degree of absorption through the skin or mucosae of a product or substance designed for topical or oral use?
Abich - Lifeanalytics Laboratories perform in vitro absorption tests using Franz cells and protocols tailored for customer needs (USP <1724>, OECD 428 and OECD 156 - draft).
Within the new UE 2017/745 (MDR) regulatory framework for medical devices, the evaluation of the degree of percutaneous absorption is required for the classification of substance-based medical devices.
A strong rationale supporting the design of absorption studies and its results allows manufacturer to support the correct placement of their product as a medical device and its classification in an appropriate category.
The skin or mucosae models employed by our laboratories are derived from a human source and include in vitro reconstructed 3D tissues (epidermis + derma, damaged skin, vaginal, oral or gingival mucosae, etc.) or ex vivo tissue (skin from surgical procedures). In specific cases, such as for comparative evaluations or screenings, the use of synthetic membranes simulating the human skin and its thickness, composition and properties is also possible.
Lifeanalytics, your safest choice in the Medical Devices field
Abich – Lifeanalytics, the Group’s Competence Center for the Pharmaceutical and Cosmetic sectors, developed and offered its customers substantial quality services for percutaneous absorption studies designed to verify the absorption profile of any type of product or formulation designed for contact with the skin or mucosae.
Available Models
- In vitro reconstructed human epidermis;
- in vitro reconstructed oral epithelium;
- In vitro reconstructed vaginal epithelium;
- In vitro reconstructed gingival epithelium;
- In vitro reconstructed damaged epidermis (wounded skin);
- In vivo epidermis + derma from plastic surgery explants;
- In vitro reconstructed epidermis + derma;
- In vitro reconstructed bladder epithelium;
- In vitro reconstructed intestinal epithelium (colon or small intestine).
Screening Protocols
- Evaluation of rationale for the identification of molecules and protocol design
- Standardized dissolution tests in compliance with EP/USP requirements.
- Gradual release dissolution tests in compliance with EP/USP requirements.
- Absorption test – Shotgun analysis
Percutaneous absorption studies
- Percutaneous absorption kynetics
- Mucosal absorption kynetics
- Intestinal absorption kynetics (either with or without pre-simulated digestion)
- Film generation or barrier effect test by measurement of absorption markers
Medical Devices according to the UE 2017/745 (MDR) Regulatory framework
The regulation introduced the concept of substance-based medical devices and defined their classification according to the new rule 21 (annex VIII).
What does rule 21 imply
medical devices composed of substances or combinations of substances and that are intended to be introduced into the human body through a body orifice or applied to the skin and that are absorbed by or locally dispersed into the human body are classified as:
- Class III if said medical devices or their metabolic derivatives are absorbed systemically by the human body in order to achieve their designed effect
- Class III if they achieve their designed effect in the stomach or in the lower gastrointestinal tract, and if they or their metabolic products are absorbed systemically by the human body
- Class IIa if they are applied on the skin, or inside the nasal or oral cavities down to the pharynx, and achieve their designed effect on said cavities
- Class IIb in all other cases
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Lifeanalytics S.r.l.
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