18.10 Conclusion and Future Prospects

Having proved their enormous worth in improving the product quality, therapeutic

efficacy, patient compliance and safety, a diversity of nanostructured drug delivery

systems have progressively been sought-after today. To facilitate their smooth

approvals and launches, accordingly, rational formulation development of such

drug nanoconstructs is judiciously called for. FbD, being a science-, risk- and

design-steered paradigm, extends unique benefits to a drug delivery scientist in the

rational development of robust, efficacious, safe and stable nanopharmaceuticals in

an effectual, time-effectual and cost-effectual fashion. Of late, the drug control

agencies accentuate for demonstration of “patient-centric” quality as “built-into”

the system, instead of testing the same in the final end products. Concerted initiatives

embarked upon to ingather immense utility of such rational approaches would,

therefore, be crucial in realizing the “win-win” state for patients, pharma houses

and drug regulators.

For a drug delivery researcher, the principal benefits of switching over to these

systematic and rational FbD approaches are unearthing potential of the cause-effect

minutiae during the formulation development path, leading eventually to compre-

hensive product and process understanding. Its thriving implementation relies upon

Fig. 18.15 A pictorial collage of the company logos of varied pharma houses which have been

involved in industry-institute liaison and consultancies, including updated training to their scientists

on QbD precepts

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

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