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iBCS: 1. Principles and Framework of an Inhalation-Based Biopharmaceutics Classification System
Jayne E Hastedt1, Per Bäckman2, Antonio Cabal3
1JDP Pharma Consulting, San Carlos, California 94070, United States.
Molecular Pharmaceutics
|May 16, 2022
Summary
A new inhalation-based biopharmaceutics classification system (iBCS) is proposed to aid in developing inhaled drugs. This system adapts oral drug principles to inhalation, addressing challenges in drug formulation and delivery.
Area of Science:
- Pharmacology
- Drug Delivery
- Biopharmaceutics
Background:
- The biopharmaceutics classification system (BCS) aids oral drug development.
- No equivalent system currently exists for inhaled drugs.
- Inhaled drug development faces unique challenges.
Purpose of the Study:
- To propose a foundational framework for an inhalation-based biopharmaceutics classification system (iBCS).
- To adapt established biopharmaceutics principles for the inhalation route.
- To facilitate the development of new chemical entities and drug products for inhalation.
Main Methods:
- Adapting fundamental biopharmaceutics principles to an inhalation route framework.
- Defining key attributes for drug substance (solubility, permeability) and drug product (dose, dissolution).
Main Results:
- A proposed scientific framework for the iBCS has been established.
- The iBCS will be based on drug substance and drug product characteristics.
- The system aims to mirror the utility of the oral BCS.
Conclusions:
- The iBCS provides a necessary tool for inhaled drug development.
- This classification system will help navigate technical challenges in formulation and device design.
- The iBCS is crucial for advancing the field of inhaled therapeutics.
Keywords:
PBPKbiopharmaceutics classification systemcritical product attributesiBCSinhaled drugsmechanistic modelingpulmonary drug deliveryMore Related Videos
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