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The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension.
J Pharm Pharmacol. 2005 Mar; 57(3):273-85.JP

Abstract

Bioavailability (BA) and bioequivalence (BE) play a central role in pharmaceutical product development and BE studies are presently being conducted for New Drug Applications (NDAs) of new compounds, in supplementary NDAs for new medical indications and product line extensions, in Abbreviated New Drug Applications (ANDAs) of generic products and in applications for scale-up and post-approval changes. The Biopharmaceutics Classification System (BCS) has been developed to provide a scientific approach for classifying drug compounds based on solubility as related to dose and intestinal permeability in combination with the dissolution properties of the oral immediaterelease (IR) dosage form. The aim of the BCS is to provide a regulatory tool for replacing certain BE studies by accurate in-vitro dissolution tests. The aim of this review is to present the status of the BCS and discuss its future application in pharmaceutical product development. The future application of the BCS is most likely increasingly important when the present framework gains increased recognition, which will probably be the case if the BCS borders for certain class II and III drugs are extended. The future revision of the BCS guidelines by the regulatory agencies in communication with academic and industrial scientists is exciting and will hopefully result in an increased applicability in drug development. Finally, we emphasize the great use of the BCS as a simple tool in early drug development to determine the rate-limiting step in the oral absorption process, which has facilitated the information between different experts involved in the overall drug development process. This increased awareness of a proper biopharmaceutical characterization of new drugs may in the future result in drug molecules with a sufficiently high permeability, solubility and dissolution rate, and that will automatically increase the importance of the BCS as a regulatory tool over time.

Authors+Show Affiliations

Department of Pharmaceutics, Uppsala University, Box 580, S-75123 Uppsala, Sweden.No affiliation info available

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

15807982

Citation

Lennernäs, Hans, and Bertil Abrahamsson. "The Use of Biopharmaceutic Classification of Drugs in Drug Discovery and Development: Current Status and Future Extension." The Journal of Pharmacy and Pharmacology, vol. 57, no. 3, 2005, pp. 273-85.
Lennernäs H, Abrahamsson B. The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. J Pharm Pharmacol. 2005;57(3):273-85.
Lennernäs, H., & Abrahamsson, B. (2005). The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. The Journal of Pharmacy and Pharmacology, 57(3), 273-85.
Lennernäs H, Abrahamsson B. The Use of Biopharmaceutic Classification of Drugs in Drug Discovery and Development: Current Status and Future Extension. J Pharm Pharmacol. 2005;57(3):273-85. PubMed PMID: 15807982.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension. AU - Lennernäs,Hans, AU - Abrahamsson,Bertil, PY - 2005/4/6/pubmed PY - 2005/8/2/medline PY - 2005/4/6/entrez SP - 273 EP - 85 JF - The Journal of pharmacy and pharmacology JO - J Pharm Pharmacol VL - 57 IS - 3 N2 - Bioavailability (BA) and bioequivalence (BE) play a central role in pharmaceutical product development and BE studies are presently being conducted for New Drug Applications (NDAs) of new compounds, in supplementary NDAs for new medical indications and product line extensions, in Abbreviated New Drug Applications (ANDAs) of generic products and in applications for scale-up and post-approval changes. The Biopharmaceutics Classification System (BCS) has been developed to provide a scientific approach for classifying drug compounds based on solubility as related to dose and intestinal permeability in combination with the dissolution properties of the oral immediaterelease (IR) dosage form. The aim of the BCS is to provide a regulatory tool for replacing certain BE studies by accurate in-vitro dissolution tests. The aim of this review is to present the status of the BCS and discuss its future application in pharmaceutical product development. The future application of the BCS is most likely increasingly important when the present framework gains increased recognition, which will probably be the case if the BCS borders for certain class II and III drugs are extended. The future revision of the BCS guidelines by the regulatory agencies in communication with academic and industrial scientists is exciting and will hopefully result in an increased applicability in drug development. Finally, we emphasize the great use of the BCS as a simple tool in early drug development to determine the rate-limiting step in the oral absorption process, which has facilitated the information between different experts involved in the overall drug development process. This increased awareness of a proper biopharmaceutical characterization of new drugs may in the future result in drug molecules with a sufficiently high permeability, solubility and dissolution rate, and that will automatically increase the importance of the BCS as a regulatory tool over time. SN - 0022-3573 UR - https://www.unboundmedicine.com/medline/citation/15807982/The_use_of_biopharmaceutic_classification_of_drugs_in_drug_discovery_and_development:_current_status_and_future_extension_ L2 - https://academic.oup.com/jpp/article-lookup/doi/10.1211/0022357055263 DB - PRIME DP - Unbound Medicine ER -