Drug nanocargos establish an intimate contact with biological membranes

resulting eventually into an improved membrane penetration and permeability and

assigning them the ability to improve pharmacokinetic fate and biodistribution of a

vast majority of drug molecules (Zahin et al. 2019). At the same time, nanoparticles,

by virtue of their much greater surface area-to-volume ratios, increase drug dissolu-

tion rate too, enabling them to overcome solubility-limited bioavailability of a vast

number of drug candidates (Bhatia 2017; Zahin et al. 2019).

The escalating number of approvals of nanoscale drug products by the drug

regulatory agencies, with several more in various clinical trial phases, is an authori-

tative testament to the growing prominence of effective and safe nanopharmaceutical

products (Danhier et al. 2017; Transparency Market Research 2018). Albeit such

nanoformulations are estimated to fulfil the conventional compendial requirements,

their strikingly different nanoscale characteristics make them amenable to high

product quality inconsistencies. Design of robust nanocarriers possessing the desired

quality traits, as well as their manufacturing processes, is invariably a Herculean task

in this age (Prud’homme and Svenson 2012; De Crozals et al. 2016).

18.2

Drug Delivery Product Development

Drug delivery formulations have been developed since centuries by the straightfor-

ward intuitive approach of hit-and-trials. Typically, it involves investigating the

effect of the respective product and process variables by choosing one-factor-at-a-

Fig. 18.1 A diversity of crucial biological barriers that a drug delivery system has to cross in the

human body

18

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

317