For other compounds, effective dosage forms present greater challenges. The FIH dosage form should be a logical step towards commercialization and not simply a stop gap to facilitate data acquisition.įor BCS Class I molecules, FIH formulations are straightforward and may consist of essentially the neat API. One school of thought is that first in human (FIH) drug dosage forms should be designed to maximize bioavailability. The BCS can, however, when integrated with other information, serve as an effective tool for efficient drug development. Still, most approaches remain fragmented in their methodology, ignoring commercially and biologically important factors. Various schemes exist that attempt to funnel a given active pharmaceutical ingredient (API) towards a particular drug delivery technique based on the BCS category. For example, a BCS Class II compound (permeable but relatively insoluble) would likely not be a good clinical candidate without the use of enhanced formulation techniques aimed at increasing solubility or rate of dissolution. This system can be used to flag drugs that should not be tested clinically unless appropriate formulation strategies are employed (see Figure 1). More and more however, the industry is using the BCS as a tool in drug product development. permission to skip in vivo bioequivalence studies) are reserved for drug products that meet certain requirements around solubility and permeability and also rapidly dissolve in the human body. Importantly, since the majority of drugs are orally dosed, the system was designed around oral drug delivery. 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. The Biopharmaceutical Classification System (BCS) is an experimental model that measures permeability and solubility under prescribed conditions. Implantable Drug Delivery Systems and Combination Products.Stability Indicating Method Development.

Analytical Method Development and Validation.Solubility & Bioavailability Enhancement.

Examples of bcs class 2 drugs list