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Review
. 2022 Jul 4;19(7):2032-2039.
doi: 10.1021/acs.molpharmaceut.2c00113. Epub 2022 May 16.

iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System

Jayne E Hastedt  1 , Per Bäckman  2 , Antonio Cabal  3 , Andy Clark  4 , Carsten Ehrhardt  5 , Ben Forbes  6 , Anthony J Hickey  7 , Guenther Hochhaus  8 , Wenlei Jiang  9 , Stavros Kassinos  10 , Philip J Kuehl  11 , David Prime  12 , Yoen-Ju Son  13 , Simon Teague  14 , Ulrika Tehler  15 , Jennifer Wylie  16
Affiliations
Review

iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System

Jayne E Hastedt et al. Mol Pharm. .

Abstract

For oral drugs, the formulator and discovery chemist have a tool available to them that can be used to navigate the risks associated with the selection and development of immediate release oral drugs and drug products. This tool is the biopharmaceutics classification system (giBCS). Unfortunately, no such classification system exists for inhaled drugs. The perspective outlined in this manuscript provides the foundational principles and framework for a classification system for inhaled drugs. The proposed classification system, an inhalation-based biopharmaceutics classification system (iBCS), is based on fundamental biopharmaceutics principles adapted to an inhalation route of administration framework. It is envisioned that a classification system for orally inhaled drugs will facilitate an understanding of the technical challenges associated with the development of new chemical entities and their associated new drug products (device and drug formulation combinations). Similar to the giBCS, the iBCS will be based on key attributes describing the drug substance (solubility and permeability) and the drug product (dose and dissolution). This manuscript provides the foundational aspects of an iBCS, including the proposed scientific principles and framework upon which such a system can be developed.

Keywords: PBPK; biopharmaceutics classification system; critical product attributes; iBCS; inhaled drugs; mechanistic modeling; pulmonary drug delivery.

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Conflict of interest statement

The authors declare no competing financial interest.

Figures

Figure 1
Figure 1
Schematic of clearance mechanisms from the lung as a function of deposition based on iBCS principles.
See this image and copyright information in PMC

References

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