11.01.19
Absorption Systems has been awarded a 2-year contract for a total amount of approximately $300,000 by the U.S. Food and Drug Administration (FDA). The funding mechanism is a Broad Agency Announcement, or BAA. The ultimate goal is to streamline FDA approval of generic versions of orally administered drugs.
Under the terms of the contract, Absorption Systems will use its proprietary In Vitro Dissolution Absorption System (IDAS) to evaluate the effects of excipients (inactive ingredients in a finished drug product) on the absorption of a particular class of drug product.
According to the most recent FDA guidance on the Biopharmaceutics Classification System (BCS), Class 3 drugs (high solubility, low permeability) are eligible for biowaivers, meaning that, for a generic version of a drug, a clinical bioequivalence study comparing it to the corresponding branded drug may not be required. However, the FDA has found that the biowaiver option is under-utilized for BCS Class 3 drugs, one reason being that the current requirements for similarity of the generic formulation (i.e., the identity and amount of excipients) to that of the branded drug are tight.
The studies to be conducted by Absorption Systems are intended to uncover whether the acceptance criteria for formulation similarity can be relaxed without affecting the absorption of the drug substance (the active pharmaceutical ingredient). Ultimately, fulfillment of this contract will help ensure that safe, effective, and high-quality generic oral drugs are more readily available to the public.
IDAS is a unique, patented device that combines a conventional dissolution vessel with a bio-relevant barrier (a monolayer of polarized human intestinal cells) to enable the simultaneous assessment of drug product dissolution and drug substance permeation. This is similar to what happens in the body, but distinct from the prevailing paradigm in drug product development, where the processes of dissolution and permeation are evaluated separately, mainly because, prior to IDAS, there was no other way to perform concurrent analyses. In multiple instances, in vitro studies with IDAS were able to predictin vivo (clinical) drug dissolution and absorption, including some cases where no other in vitro tool could have reproduced the results. The studies proposed under the BAA contract will expand the range of IDAS to include the effects of excipients.
"It has been gratifying to watch IDAS grow, over recent years, from an idea to a prototype, to a testing platform that is now in great demand,” said Ismael Hidalgo, chief scientific officer and co-founder of Absorption Systems. “This next-generation, integrated, and innovative formulation characterization tool can elevate the fundamental understanding of how formulation properties, known as the critical quality attributes (CQAs), affect local and/or systemic pharmacokinetics and/or pharmacodynamics and help establish better in vitro-in vivo correlations. We look forward to working hand-in-hand with the FDA to study the effect of excipients, because the end goal is always to make safer, more cost-effective drugs available to patients quicker."
Under the terms of the contract, Absorption Systems will use its proprietary In Vitro Dissolution Absorption System (IDAS) to evaluate the effects of excipients (inactive ingredients in a finished drug product) on the absorption of a particular class of drug product.
According to the most recent FDA guidance on the Biopharmaceutics Classification System (BCS), Class 3 drugs (high solubility, low permeability) are eligible for biowaivers, meaning that, for a generic version of a drug, a clinical bioequivalence study comparing it to the corresponding branded drug may not be required. However, the FDA has found that the biowaiver option is under-utilized for BCS Class 3 drugs, one reason being that the current requirements for similarity of the generic formulation (i.e., the identity and amount of excipients) to that of the branded drug are tight.
The studies to be conducted by Absorption Systems are intended to uncover whether the acceptance criteria for formulation similarity can be relaxed without affecting the absorption of the drug substance (the active pharmaceutical ingredient). Ultimately, fulfillment of this contract will help ensure that safe, effective, and high-quality generic oral drugs are more readily available to the public.
IDAS is a unique, patented device that combines a conventional dissolution vessel with a bio-relevant barrier (a monolayer of polarized human intestinal cells) to enable the simultaneous assessment of drug product dissolution and drug substance permeation. This is similar to what happens in the body, but distinct from the prevailing paradigm in drug product development, where the processes of dissolution and permeation are evaluated separately, mainly because, prior to IDAS, there was no other way to perform concurrent analyses. In multiple instances, in vitro studies with IDAS were able to predictin vivo (clinical) drug dissolution and absorption, including some cases where no other in vitro tool could have reproduced the results. The studies proposed under the BAA contract will expand the range of IDAS to include the effects of excipients.
"It has been gratifying to watch IDAS grow, over recent years, from an idea to a prototype, to a testing platform that is now in great demand,” said Ismael Hidalgo, chief scientific officer and co-founder of Absorption Systems. “This next-generation, integrated, and innovative formulation characterization tool can elevate the fundamental understanding of how formulation properties, known as the critical quality attributes (CQAs), affect local and/or systemic pharmacokinetics and/or pharmacodynamics and help establish better in vitro-in vivo correlations. We look forward to working hand-in-hand with the FDA to study the effect of excipients, because the end goal is always to make safer, more cost-effective drugs available to patients quicker."
