Abstract
With the increasing research and development (R&D) difficulty of new molecular entities (NMEs), novel drug delivery systems (DDSs) are attracting widespread attention. This review investigated the current distribution of Food and Drug Administration (FDA)-approved pharmaceutical products and evaluated the technical barrier for the entry of generic drugs and highlighted the success and failure of advanced drug delivery systems. According to the ratio of generic to new drugs and the four-quadrant classification scheme for evaluating the commercialization potential of DDSs, the results showed that the traditional dosage forms (e.g., conventional tablets, capsules and injections) with a lower technology barrier were easier to reproduce, while advanced drug delivery systems (e.g., inhalations and nanomedicines) with highly technical barriers had less competition and greater market potential. Our study provides a comprehensive insight into FDA-approved products and deep analysis of the technical barriers for advanced drug delivery systems. In the future, the R&D of new molecular entities may combine advanced delivery technologies to make drug candidates into more therapeutically effective formulations.
Highlights
During the pipeline of research and development (R&D) activities in the pharmaceutical industry, two key steps play an important role for revolutionary new drugs, including new molecular entities (NMEs) and novel dosage forms
In 2017, only 46 NMEs were approved by the U.S Food and Drug Administration (FDA) [4]
A ratio of 5% between global clinical trials and global publications represents a key point of translational efficiency from academic research to clinical trials, while a 10% clinical success rate is the average clinical success rate of NMEs in the past 20 years [2].These advanced drug delivery technologies can be classified into four quadrants in a coordinate system
Summary
During the pipeline of research and development (R&D) activities in the pharmaceutical industry, two key steps play an important role for revolutionary new drugs, including new molecular entities (NMEs) and novel dosage forms. The high R&D costs and low NMEs output have pushed many pharmaceutical companies to advanced drug delivery systems. The 1st-generation (1950–1980) drug delivery systems (e.g., oral sustained release preparations, inhalations and transdermal patches) were developed rapidly, achieving high product translational efficiency [7,8,9]. The FDA has approved 34,673 drug products [18], including 114 administration routes [19] and 169 dosage forms [20]. The overall macro map of administration routes and dosage forms were plotted Within this macro map, several advanced drug delivery systems were further analyzed, including oral controlled release formulations, inhalation delivery system, transdermal patch and complex injection formulations.
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