Application of quality by design in optimization of nanoformulations: Principle, perspectives and practices

Birla D 1 , Khandale N 1 , Bashir B 1 , ShahbazAlam M 1 , Vishwas S 1 , Gupta G 2 Show all authors , Dureja H 3 , Kumbhar PS 4 , Disouza J 4 , Patravale V 5 , Veiga F 6 , Paiva-Santos AC 6 , Pillappan R 7 , Paudel KR 8 , Goh BH 9 , Singh M 10 , Dua K 10 , Singh SK 11

Affiliations 

  • 1 School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India
  • 2 Centre for Research Impact & Outcome-Chitkara College of Pharmacy, Chitkara University, Rajpura, 140401, India
  • 3 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, 124001, Haryana, India
  • 4 Department of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar, Tal. Panhala, Dist., Kolhapur, Maharashtra, India, 416 113
  • 5 Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Matunga, Mumbai, Maharashtra, India, 400019
  • 6 Department of Pharmaceutical Technology, Faculty of Pharmacy of the University of Coimbra, University of Coimbra, Coimbra, Portugal
  • 7 NITTE (Deemed to Be University), NGSM Institute of Pharmaceutical Sciences [NGSMIPS], Mangaluru, Karnataka, India
  • 8 Centre of Inflammation, Faculty of Science, School of Life Sciences, Centenary Institute and University of Technology Sydney, Sydney, NSW, 2007, Australia
  • 9 ARCCIM, School of Public Health, Faculty of Health, University of Technology Sydney, Sydney, Australia
  • 10 Faculty of Health, Graduate School of Health, University of Technology Sydney, Sydney, Australia
  • 11 School of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India. singhsachin23@gmail.com
Drug Deliv Transl Res, 2025 Mar;15(3):798-830.
PMID: 39126576 DOI: 10.1007/s13346-024-01681-z

Abstract

Nanoparticulate drug delivery systems (NDDS) based nanoformulations have emerged as promising drug delivery systems. Various NDDS-based formulations have been reported such as polymeric nanoparticles (NPs), nanoliposomes, solid lipid NPs, nanocapsules, liposomes, self-nano emulsifying drug delivery systems, pro liposomes, nanospheres, microemulsion, nanoemulsion, gold NPs, silver NPs and nanostructured lipid carrier. They have shown numerous advantages such as enhanced bioavailability, aqueous solubility, permeability, controlled release profile, and blood-brain barrier (BBB) permeability. This advantage of NDDS can help to deliver pure drugs to the target site. However, the formulation of nanoparticles is a complex process that requires optimization to ensure product quality and efficacy. Quality by Design (QbD) is a systemic approach that has been implemented in the pharmaceutical industry to improve the quality and reliability of drug products. QbD involves the optimization of different parameters like zeta potential (ZP), particle size (PS), entrapment efficiency (EE), polydispersity index (PDI), and drug release using statistical experimental design. The present article discussed the detailed role of QbD in optimizing nanoformulations and their advantages, advancement, and applications from the industrial perspective. Various case studies of QbD in the optimization of nanoformulations are also discussed.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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