Pharmaceutical Usefulness of Biopharmaceutics Classification System: Overview and New Trend

Abstract

Since the introduction of the biopharmaceutics classification system (BCS) in 1995, it has viewed as an effective tool to categorize drugs in terms of prediction for bioavailability (BA) and bioequivalence (BE). The BCS consist of four drug categories: class I (highly soluble and highly permeable), class II (low soluble and highly permeable), class III (highly soluble and low permeable) and class IV (low soluble and low permeable), and almost all drugs belong to one of these categories. Likewise, classifying drugs into four categories according to their solubility and permeability is simple and relatively not controversial, and thus the FDA adopted the BCS as a science-based approach in establishing a series of regulatory guidance for the industry. Actually, many pharmaceutical companies have gained a lot of benefits, which directly connect to cost loss and failure decrease in the early stage of drug development. Recently, instead of solubility, using dissolution characteristics (e.g. intrinsic dissolution rate) have provided an improvement in the classification in correlating more closely with in vivo drug dissolution rather than solubility by itself. Furthermore, a newly modified-version of BCS, biopharmaceutics drug disposition classification system (BDDCS), which classify drugs into four categories according to solubility and metabolism, has been introduced and gained much attention as a new insight in respect with the drug classification. This report gives a brief overview of the BCS and its implication, and also introduces the recent new trend of drug classification.

Impact of drying on dissolution behavior of carvedilol-loaded sustained release solid dispersion: development and characterization

“…Disulfiram, Nilvadipine, Ibuprofen, Indomethacin, Diclofenac Sodium, Nifedipine, Ketoprofen, Flurbiprofen etc. can also be considered to do further research by using the SRSD approach [ 46 , 47 ]. Beside this, in preparing the SRSD with combination use of amphiphilic and sustained release polymers in this study, we used Eudragit® RSPO and Kolliphor® P188; and there might be still a great opportunity for researchers to identify any possible substitute of excipients that can bring similar results with a lower cost.…”

Inclusion Complexes of Non-Steroidal Anti-Inflammatory Drugs with Cyclodextrins: A Systematic Review

“…For instance, the Log P (octanol-water partition coefficient) values for sodium diclofenac, ibuprofen, piroxicam, and paracetamol are 4.51, 3.97, 1.8, and 0.31, respectively [115]. Sodium diclofenac, ibuprofen, and piroxicam are classified as class II drugs and paracetamol as class III according to the Biopharmaceutics Classification System [116,117]. Considering that most NSAID preparations aim for systemic distribution, the development of pharmaceutical formulations based on CD inclusion complexes may be a promising strategy to reverse their low solubility [117,118].…”

Meloxicam gyógyszerhatóanyag részecskeméret csökkentése impulzuslézeres ablációval

“…[20] A BCS II. osztályba tartoznak például a carbamazepine, dapsone, flurbiprofen, ibuprofen, naproxen, piroxicam és a meloxicam hatóanyagok [21], [22].…”