Bcs Pharmaceuticals
Introduction The Biopharmaceutics Classification System (BCS) is a framework for classifying drug substances based upon their aqueous solubility and permeability across biological membranes (). The FDA BCS guidance () provides recommendations for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications (SNDA) who wish to request a waiver of in vivo bioequivalence (BE) studies for immediate-release (IR) solid oral dosage forms. Drug substances are classified based on their intestinal permeability (or the fraction of oral dose absorbed) and aqueous solubility at multiple pH values covering the range found in the gastrointestinal (GI) tract.
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The solubility class boundary is based according to Papadopoulou et al. () the highest dose strength of the drug substance in a pharmaceutical product that is dissolved in 250 ml (8 oz.) of aqueous buffer. Class I drugs have high permeability, and high solubility at all pH values between 1.0 and 7.5 (original FDA guidance from 2000), between 1.0 and 6.8 (new FDA draft guidance, May 2015) () or between 1.2 and 6.8 (European Medicines Agency (EMA) and World Health Organization (WHO) (,); such compounds are well absorbed but may have poor bioavailability (BA) due to extensive first-pass metabolism. Class II compounds have high permeability, but their solubility is below the class boundary at one or more pH values (e.g., at low pH for acids or at neutral pH for bases). The fraction absorbed may be limited by their solubility; therefore, it is not uncommon to see a wide range of extent of absorption for this class of compounds. Class III drugs have low permeability and high solubility, and their fraction absorbed is sometimes limited by their permeability. Class IV drugs have both low permeability and low solubility.
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The Biopharmaceutics Classification System is a system to differentiate the drugs on the basis of their solubility and permeability. This system restricts the prediction using the parameters solubility and intestinal permeability. The solubility classification is based on a United States Pharmacopoeia (USP) aperture. BCS thus enables manufacturers to reduce the cost of approving Biopharmaceutics Classification System Chavda HV, Patel CN1, Anand IS2 Departments of Pharmaceutics and Pharmaceutical Technology, 1Pharmaceutical Chemistry, 2Pharmacology, Shri Sarvajanik Pharmacy College, Hemchandracharya North Gujarat University, Nr.
Bcs Class 2 Drug
Class I drugs can be granted waivers from in vivo BE testing (“biowaivers”) due to their consistently high fraction absorbed, regardless of formulation (). Several authors have suggested that Class III compounds should also be eligible for biowaivers if a new formulation does not change the permeability or the GI transit time of the drug (–). WHO recommends, and the new FDA draft guidance () makes provision for, biowaivers for BCS Class III drug products, but only in cases where the generic and comparator drug products are very rapidly dissolving and the excipients meet certain criteria (e.g., qualitatively the same, quantitatively very similar, well-established for use in products containing that drug substance, do not affect GI motility or interactions with transport processes, and do not affect the pharmacokinetics (PK) of the drug substance) (,).
This suggestion has also been proposed based upon a theoretical assessment of drug BA (,). Certain excipients have been shown either to enhance the in vitro permeability of drugs (e.g., by changing membrane integrity or affecting transporters) or to modify GI transit time (,).
Bcs Classification Of Drugs
Limited human data also suggest that some excipients may alter the BA of BCS Class III drugs (,). Several of these excipients have been demonstrated to alter membrane permeability directly, but others may work by inhibiting secretory transport mechanisms (). In order to determine if a new formulation of a BCS III drug is suitable for a biowaiver, the potential effect(s) of the excipient(s) on permeability need to be evaluated. If no effect can be discerned in a well-validated in vitro model, it is reasonable to expect no change in permeability in vivo as well (–).
Bcs Pharmaceuticals
First described for this purpose in 1989 (), the utility of the Caco-2 cell monolayer model for qualitative (e.g., rank-order or high vs. Low) prediction of the oral absorption of drugs has been validated repeatedly since then (–). This series of experiments had three objectives: 1) to determine whether a series of commonly used excipients would alter the permeability of model drug compounds in both a Caco-2 cell monolayer system ( in vitro model) and an in situ rat intestinal perfusion model (surrogate for human in vivo data); 2) to determine whether there was a correlation between the Caco-2 and in situ rat intestinal perfusion models; and 3) to evaluate the relative suitability of the two models for testing the effects of excipients. The excipients were selected on the basis of their aqueous solubility and prevalence in IR formulations. Five excipients were selected for testing: hydroxypropyl methylcellulose (HPMC), povidone, polyethylene glycol (PEG)-400, sodium lauryl sulfate (SLS), and lactose. All of these are commonly used in oral formulations, and some have been shown to act as penetration enhancers ().