In Vitro Dissolution Absorption System (IDAS)
The In Vitro Dissolution Absorption System (IDASTM) combines traditional dissolution testing with a means to determine and quantify interactions with a bio-relevant membrane. The characterized and validated system allows for multiple dissolution media and drug products from all BCS classes
Typically, drug properties such as dissolution and absorption are investigated independently. Study designs like this fail to recognise the complex interaction between these properties, leading to errors in in vitro-in vivo correlation, and increasing the number of studies needed to extract the same biological insight.
IDASTM provides the ability to evaluate absorption, permeation, accumulation, biomarker regulation, and metabolism in a single system. Additionally, we can test a finished dosage form from a tablet, capsule to suspension.
FREQUENTLY ASKED QUESTIONS
Who benefits from IDAS™?
IDAS is a highly flexible system that has numerous benefits over traditional dissoluation and permeability assays. It may be of particular use in the following cases:
- Independently measured solubility, permeability, and dissolution that rarely has physiologic relevance
- Poor correlation between in vitro drug product release characteristics and in vivo performance
- Limited utility of in vitro data in formulation development and optimization
What sort of applications are there for IDAS™?
Where IDAS™ really excels is in increasing your understanding of in vivo drug performance in areas that are differcult to address with typical in vitro assays. IDAS can be used to:
- Assess Formulations – Bioequivalence, Post Approval Changes, 505(b)(2) Formulations
- Analyze Food Effects
- Evaluate Locally Acting GI Products
- Assess Supersaturation
- Evaluate Particle Size Effects
TECHNOLOGIES AND METHOLOGIES
IDAS2™, a step change in modelling physiological pharmocokinetics in vitro
IDAS™ is a unqiue, proprietary technology platform solely developed by Absorption Systems. We have developed this from an expert awareness of the limitations of traditional in vitro dissolution and permeability studies.
The system combines a specialised dissolution vessel with a permeability chamber containing a Caco-2 monolayer, whose apical surfaces face the dissolution chamber, to model intestinal absorption. Dissolution can be assayed at specific timepoints by HPLC whilst drug permeability is assessed by LC/MS-MS.
More information is available in our initial white paper introducing IDAS.
Key advantages of IDAS2™
- Understand the impact of dissolution rate on intestinal permeability
- Can accomodate multiple solid drug formulations (e.g. capsule, tablet)
- Rapid development of improved formulations
- Improved in vitro-in vivo correlation (IVIVC)
REGULATORY CONSIDERATIONS
How can IDAS2™ support your drug approval?
In vitro dissolution and permeability studies are a cornerstone of pharmacokinetic characterisation for solid-form orally dosed drug products. The IDAS system provides a powerful option to obtain robust, reliable data that can inform in vivo studies.
IDAS data can contribute to regulatory exemptions possible via the BSC-based biowaiver system. Biowaivers are accepted for BSC Class I and III drugs by both the FDA and EMA, alongside other regulatory bodies.
