Evidence map›Paper›PMID 39126576›Full record

ReviewDrug delivery and translational research2025

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

Devendra Birla, Nikhil Khandale, Bushra Bashir, Md ShahbazAlam, Sukriti Vishwas, Gaurav Gupta, Harish Dureja, Popat S Kumbhar, John Disouza, Vandana Patravale and 8 more

Abstract readReview
PubMed Publisher
In one paragraph

Review in Drug delivery and translational research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Devendra BirlaSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India.
Nikhil KhandaleSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India.
Bushra BashirSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India.
Md ShahbazAlamSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India.
Sukriti VishwasSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India.
Gaurav GuptaCentre for Research Impact & Outcome-Chitkara College of Pharmacy, Chitkara University, Rajpura, 140401, India.
Harish DurejaDepartment of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, 124001, Haryana, India.
Popat S KumbharDepartment of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar, Tal. Panhala, Dist., Kolhapur, Maharashtra, India, 416 113.
John DisouzaDepartment of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar, Tal. Panhala, Dist., Kolhapur, Maharashtra, India, 416 113.
Vandana PatravaleDepartment of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Matunga, Mumbai, Maharashtra, India, 400019.
Francisco VeigaDepartment of Pharmaceutical Technology, Faculty of Pharmacy of the University of Coimbra, University of Coimbra, Coimbra, Portugal.
Ana Cláudia Paiva-SantosDepartment of Pharmaceutical Technology, Faculty of Pharmacy of the University of Coimbra, University of Coimbra, Coimbra, Portugal.
Ramkumar PillappanNITTE (Deemed to Be University), NGSM Institute of Pharmaceutical Sciences [NGSMIPS], Mangaluru, Karnataka, India.
Keshav Raj PaudelCentre of Inflammation, Faculty of Science, School of Life Sciences, Centenary Institute and University of Technology Sydney, Sydney, NSW, 2007, Australia.
Bey Hing GohARCCIM, School of Public Health, Faculty of Health, University of Technology Sydney, Sydney, Australia.
Manisha SinghFaculty of Health, Graduate School of Health, University of Technology Sydney, Sydney, Australia.
Kamal DuaFaculty of Health, Graduate School of Health, University of Technology Sydney, Sydney, Australia.
Sachin Kumar SinghSchool of Pharmaceutical Sciences, Lovely Professional University, Phagwara, Punjab, 144411, India. singhsachin23@gmail.com.ORCID 0000-0003-3823-6572

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Drug Delivery SystemsNanoparticle Drug Delivery SystemNanoparticlesDrug CompoundingDrug LiberationHumansParticle SizeNanoparticle Drug Delivery SystemDesign of ExperimentNanoformulationsOptimizationQuality by DesignRegulatory aspects

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.