QbD-Steered Systematic Development

of Drug Delivery Nanoconstructs: Vital

Precepts, Retrospect and Prospects

18

Bhupinder Singh, Teenu Sharma, Ranjot Kaur, Sumant Saini,

Ripandeep Kaur, and Sarwar Beg

Abstract

Nanostructured systems provide immense advantages not only in regard to

delivery and release of drugs but also in their targeting potential. Such drug

nanoconstructs either can be modified for receptor-mediated and site-specific

targeting or can be used to regulate release of drugs, widely ranging from

insoluble to highly soluble molecules, proteins and peptides to monoclonal

antibodies, genes and small RNA. Nanoscale drug delivery systems can not

only be fine-tuned for desired drug release kinetics and biodistribution but can

also minimize the toxic effects, thereby enhancing the therapeutic index of a

given drug. The domain of developing nanostructured drug delivery formulations

has lately witnessed an enormous paradigm shift towards their methodical devel-

opment. Promulgation of Quality-by-Design (QbD) guidance documents by the

WHO, the US-FDA and other regulatory bodies has evidently influenced the

manufacturing approach of such drug products, furnishing comprehensive under-

standing of the consequent drug products and pharmaceutical processes. Lately, a

scientific approach, christened by the authors as “Formulation by Design (FbD)”,

has been in vogue, devoted wholly to QbD-steered development of drug products.

FbD strategy targets to harvest novel and cutting-edge systems utilizing thrifty

resources of developmental time, manpower, materials and finances. A diversity

of drug nanoconstructs has since been developed efficaciously as per FbD

principles and testified in literature. The present manuscript tends to furnish

coherent perspectives on the FbD terminology, methodology and applicability

in developing several wide-ranging nanoconstructs, providing their contemporary

updates from their academic, industrial and regulatory perspectives.

B. Singh (*) · T. Sharma · R. Kaur · S. Saini · R. Kaur · S. Beg

Centre of Excellence in Nano Biomedical Applications, Panjab University, Chandigarh, India

e-mail: bsbhoop@yahoo.com; bsbhoop@pu.ac.in

# The Author(s), under exclusive license to Springer Nature Singapore Pte

Ltd. 2022

R. C. Sobti, N. S. Dhalla (eds.), Biomedical Translational Research,

https://doi.org/10.1007/978-981-16-9232-1_18

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