In Vitro permeation testing (IVPT) studies across biological membranes for formulations that are applied to the skin or in the eye are vital to guide product development and establish product bioequivalence. Combined with QbD-guided formulation development and robust IVRT methodologies, Absorptions Systems’ optimized and validated IVPT testing can provide the “totality of evidence” required to enable the highest degree of success for your NCE, ANDA or 505(b)(2) filing.
IVPT Study Design
Optimization of study conditions: analytical, receiver buffer, time-point selection and dose amount
Establishment of sensitivity and selectivity
Qualification of the optimized assay parameters
Validation: Analytical method validation and test system validation including recovery, mass balance, and dose depletion
Pivotal bioequivalence comparison with statistical evaluation: Parallel, single-dose, and multiple donors
Permeation Testing Utility
The Importance of Permeation Testing with a Reliable Source
IVPT is fundamental to understanding the ability of the formulation to reach its intended site of action and elicit its therapeutic effect, providing guidance to formulation development and establishing product bioequivalence
Over 15 complex ophthalmic and 25 complex topical products currently have no marketed generics. IVPT testing can be combined with IVRT testing and robust product development to formulate a “totality of evidence” approach to ANDA approval
Using dermal tissue or rabbit cornea and conjunctiva, IVPT can be used in lieu of in vivo testing that utilizes clinical endpoint or pharmacokinetic studies
Besides permeation, IVPT studies can also be used to study drug accumulation in different layers of dermal or ophthalmic tissue
BIOEQUIVALENCE ASSESSMENT OF LOCALLY ACTING TOPICAL DOSAGE FORMS IS CHALLENGING.