Abstract

Based on their solubility and permeability, drugs are typically divided into four classes (Classes I–IV) according to the biopharmaceutics classification system (BCS). Of these classes, BCS class II drugs have high permeability and low solubility; not only do these characteristics constitute the rate-limiting step in the formulation of these drugs but the low solubility in water results in low bioavailability. Thus, methods for improving their solubility have been developed using lipid carriers such as liposomes, niosomes, and aquasomes; other approaches include self-micro-emulsifying drug delivery systems (SMEDDS) and self-nano-emulsifying drug delivery systems (SNEDDS). Currently, niosome-based drug delivery systems that utilize nonionic surfactants, drugs, and cholesterol in varying ratios are being widely used to deliver both hydrophilic and lipophilic drugs in addition to several other applications of niosomes.

Highlights

  • The biopharmaceutics classification system (BCS) is a useful mechanism used by researchers for obtaining biowaivers during in vivo bioequivalence studies and for decision making when determining the required solubility and permeability during drug discovery

  • Niosomes are uncharged surfactant vesicles comprising microscopic lamellar structures built upon an amalgamation of uncharged surfactants such as the alkyl or dialkyl polyglycerol ether class and cholesterol formed via subsequent hydration in an aqueous buffer [2]

  • Antigen entrapment within the niosomes enhanced the size of vesicles from sub microns to micrometers (1–2.7 μm), which can be attributed to the high molecular weight of antigens and their stronger hydrophobic nature that causes protein aggregation in the hydrophobic zones of the vesicle bilayers while feasibly establishing a level of vesicle fusion or manipulating the packing positioning of the surfactants

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Summary

INTRODUCTION

The biopharmaceutics classification system (BCS) is a useful mechanism used by researchers for obtaining biowaivers during in vivo bioequivalence studies and for decision making when determining the required solubility and permeability during drug discovery This is because BCS is established upon a scientific blueprint highlighting the three rate-limiting steps critical in oral absorption: the liberation of the drug from its dosage form [1], prolongation of the dissolved state along with the whole gastrointestinal (GI) tract [2], and penetration of the drug molecules via the GI membrane into the blood [3]. The MDCK cells present more issues than Caco-2 cells including less expression of various efflux pumps and failure to meet the criteria for screening of chemical series with identified efflux problems Both the in vitro Caco-2/MDCK cell lines method and the in situ rat perfusion methods are trusted by the FDA in terms of BCS classification. Both vesicles comprise a bilayer, which is composed of uncharged surfactants in the case of niosomes and of phospholipids in the case of liposomes

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