ArticleMolecular pharmaceutics2024
iBCS: 3. A Biopharmaceutics Classification System for Orally Inhaled Drug Products.
Article in Molecular pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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Who cites it
12 citing papers in PubMed, 18 citations in OpenAlex.
- Amikacin pharmacokinetics after nebulization among intubated patients.Critical care (London, England) · 2026Trial
- Advances in Formulation and Technological Strategies for Montelukast Pulmonary Delivery.ACS omega · 2026Review
- Informing Sampling Design for Lung Distribution Studies Using a Pulmonary Population Minimal PBPK Model.Clinical pharmacokinetics · 2026Article
- Solvent-free aqueous spray drying of poorly soluble drugs enabled by hot-feed micellar solubilization and high-Tg polymer matrices.International journal of pharmaceutics: X · 2026Article
- A single oral administration of resveratrol cocrystals enables potent antisepsis therapy via interfering neutrophil extracellular traps formation.International journal of pharmaceutics: X · 2025Article
- An In Vitro-In Vivo Comparison of Two Levodopa Dry Powder Products for Inhalation: A Randomized Trial Comparing Inbrija and Levodopa Cyclops.Pharmaceutics · 2025Article
- iBCS: 4. Application of the Inhalation Biopharmaceutics Classification System to the Development of Orally Inhaled Drug Products.Molecular pharmaceutics · 2025Review
- An In Vitro Dissolution Method for Inhaled Drugs Depositing in the Tracheobronchial Lung Region.Pharmaceutical research · 2025Article
- Navigating the Development of Dry Powder for Inhalation: A CDMO Perspective.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Development of Novel Fluticasone/Salmeterol/Tiotropium-Loaded Dry Powder Inhaler and Bioequivalence Assessment to Commercial Products in Rats.Pharmaceutics · 2025Article
- Assessment of drug permeability using a small airway microphysiological system.Frontiers in pharmacology · 2025Article
- Development of a biorelevant dissolution method for inhalation products: Proof of concept using drugs with diverse solubilities.ADMET & DMPK · 2025Article
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Authors and funding
16 authors at 13 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this article, we specify for the first time a quantitative biopharmaceutics classification system for orally inhaled drugs. To date, orally inhaled drug product developers have lacked a biopharmaceutics classification system like the one developed to navigate the development of immediate release of oral medicines. Guideposts for respiratory drug discovery chemists and inhalation product formulators have been elusive and difficult to identify due to the complexity of pulmonary physiology, the intricacies of drug deposition and disposition in the lungs, and the influence of the inhalation delivery device used to deliver the drug as a respirable aerosol. The development of an inhalation biopharmaceutics classification system (iBCS) was an initiative supported by the Product Quality Research Institute (PQRI). The goal of the PQRI iBCS working group was to generate a qualitative biopharmaceutics classification system that can be utilized by inhalation scientists as a "rule of thumb" to identify desirable molecular properties and recognize and manage CMC product development risks based on physicochemical properties of the drug and the deposited lung dose. Herein, we define the iBCS classes quantitatively according to the dose number and permeability. The proposed iBCS was evaluated for its ability to categorize marketed inhaled drugs using data from the literature. The appropriateness of the classification of each drug was assessed based on published development, clinical and nonclinical data, and mechanistic physiologically based biopharmaceutics modeling. The inhaled drug product development challenges for each iBCS classification are discussed and illustrated for different classes of marketed inhaled drugs. Finally, it is recognized that discriminatory laboratory methods to characterize regional lung deposition, dissolution, and permeability will be key to fully realizing the benefits of an iBCS to streamline and derisk inhaled drug development.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.