18.9

QbD-Steered Nanomedicinal Work From Our Laboratories

The sojourn of implementing systematic approaches started at the University Insti-

tute of Pharmaceutical Sciences (UIPS), Panjab University, way back since the early

1990s somewhat quite intuitively, when the entire pharmaceutical world was bank-

ing on the traditional OFAT approach of developing drug products. Since then,

adoption of such systematic approaches has been a regular phenomenon at the

Institute for developing novel and nanostructured DDS of diverse types employing

diverse experimental designs, multivariate techniques, QRM and chemometric tools.

A platitude focussed to systematic, modern and rational drug product development,

as christened by us in 2001, viz. Formulation by Design (FbD), has been in vogue all

across the pharma world today (Singh 2013, 2014). Over the period of time, more

than 250 publications, including 15 books and 45 book chapters, have been churned

out exclusively on QbD-enabled development as the globally sought-after repertoire

of information (Beg et al. 2017a; Khurana et al. 2017; Garg et al. 2018; Sharma et al.

2020), bringing out six patents and a couple of synergistic technology transfers of

nanostructured drug delivery technologies too to the pharma industry. Systematic

QbD-steered development of the “best plausible” nanoformulations has invariably

resulted in tangible amelioration in the pharmacokinetic and/or pharmacodynamic

attributes over the conventional drug bioactives or their conventional formulations,

construing markedly superior therapeutic and safety potential of the nanoconstructs

Fig. 18.13 Vital governmental bodies across the globe regulating the nanotechnology-oriented

drug products

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QbD-Steered Systematic Development of Drug Delivery Nanoconstructs:. . .

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