The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects.

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Although a large number of new drug molecules with varied therapeutic potentials have been discovered in the recent decade, yet most of them are still in developmental process. This can be attributed to the limited aqueous solubility which governs the bioavailability of such drug molecules. Hence, there is a requisite for a technology-based product (formulation) in order to overcome such issues without compromising on the therapeutic response. The purpose of this review is to provide an insight to the formulation of drug nanoparticles for enhancing solubility and dissolution velocity with concomitant enhancement in bioavailability. In the recent decade, nanonization has evolved from a concept to reality owing to its versatile applications, especially in the development of drugs having poor solubility. In this review, a relatively simple and scalable approach for the manufacture of drug nanoparticles and latest characterization techniques utilized to evaluate the drug nanoparticles are discussed. The drug nanoparticulate approach described herein provides a general applicability of the platform technology in designing a formulation for drugs associated with poor aqueous solubility.

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