What is a Biowaiver in Biopharmaceutics?

A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval).

Which drug class within the Biopharmaceutics Classification System BCS is most likely to be absorbed rapidly from the intestines?

It has been reported that some BCS Class II compounds, which have particular biopharmaceutical characteristics, such as weak acids, particularly the high permeability, low molecular weight non-steroidal anti-inflammatory drugs (NSAIDs), are rapidly and completely absorbed orally (Davies, 1995; Davies and Anderson, 1997 …

What is BCS Biowaiver?

BCS-based biowaivers are applicable to drug products where the drug substance or substances exhibit high solubility and, either high permeability (BCS Class I) or low permeability (BCS Class III). A biowaiver is applicable when the drug substance(s) in test and reference products are identical.

How are drugs classified according to the Biopharmaceutics Classification System?

Within the framework of human pharmaceuticals, drugs can be classified into one of the following four BCS categories: Class I: high solubility, high permeability: generally very well-absorbed compounds. Class II: low solubility, high permeability: exhibits dissolution rate-limited absorption.

What are the requirements for a BCS based Biowaiver study?

To qualify for a BCS-based biowaiver for BCS Class I drug substances both the test product and reference product should display either very rapid (≥85% for the mean percent dissolved in ≤ 15 minutes) in vitro dissolution characteristics, or rapid (≥85% for the mean percent dissolved in ≤ 30 minutes) and similar in …

What is BCS Class II drug?

Class II – high permeability, low solubility Example: glibenclamide, bicalutamide, ezetimibe, aceclofenac. The bioavailability of those products is limited by their solvation rate. A correlation between the in vivo bioavailability and the in vitro solvation can be found.

How is BCS classification determined?

The drugs are classified in BCS on the basis of solubility, permeability, and dissolution. Solubility class boundaries are based on the highest dose strength of an immediate release product.

What are the features of Class 3 Biopharmaceutics Classification System?

BCS Class III drug substances are considered to be more susceptible to the effects of excipients. These drugs are not considered highly permeable and may have site-specific absorption, so there are a greater number of mechanisms through which excipients can affect their absorption than for BCS Class I drugs.

How do you do a BCS solubility study?

For the thermodynamic solubility of a compound, determine λmax of UV-Vis spectrophotometry (180 to 750 nm) out of the cut-off range of the solvent. Based on Beer-Lambert absorbance law (A=εbc and A<1), adjust the concentration (mostly between 10-5 to 10-4 M) and draw the calibration curve (y = ax + b).

What do you mean by BCS classification?

The Biopharmaceutical Classification System (BCS) is an experimental model that measures permeability and solubility under prescribed conditions. The original purpose of the system was to aid in the regulation of post-approval changes and generics, providing approvals based solely on in vitro data when appropriate.

What are the features of Class IV Biopharmaceutics Classification System?

Purpose: Biopharmaceutics classification system (BCS) class IV compounds, exhibits least oral bioavailability, low solubility and intestinal permeability among all pharmaceutical classes of drugs. Thus, these drugs need more compatible and efficient delivery system.

When to use BCS-based biowaivers in drug development?

BCS-based biowaivers are applicable to drug products where the drug substance(s) exhibit high solubility and, either high permeability (BCS Class I) or low permeability (BCS Class III).

What is the purpose of the who biowaiver list?

The WHO solubility classification, also referred to as the “WHO Biowaiver List”, is a tool for national regulatory authorities (NRAs) and pharmaceutical manufacturing companies, suggesting medical products that are eligible for a waiver from in vivo bioequivalence studies, which are usually necessary to

How are drug substances classified in the BCS?

The BCS categorizes drug substances into one of four BCS classes as follows: Class I: high solubility, high permeability Class II: low solubility, high permeability Class III: high solubility, low permeability Class IV: low solubility, low permeability This guidance provides recommendations to support the biopharmaceutics classification of drug