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AuthorPintu, Prajapati
AuthorPatel, Anjali
AuthorDesai, Aneri
AuthorShah, Pranav
AuthorPulusu, Veera Shakar
AuthorHaque, Anzarul
AuthorKalam, Mohd Abul
AuthorShah, Shailesh
Available date2024-09-11T05:09:43Z
Publication Date2024-11-15
Publication NameSpectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy
Identifierhttp://dx.doi.org/10.1016/j.saa.2024.124731
ISSN13861425
URIhttps://www.sciencedirect.com/science/article/pii/S1386142524008977
URIhttp://hdl.handle.net/10576/58778
AbstractIbrutinib, an antineoplastic agent tackling chronic lymphocytic leukemia, mantle cell lymphoma, and Waldenstrom’s Macroglobulinemia, falls under the category of BCS class II drugs, characterized by a puzzling combination of low solubility and high permeability. Its oral bioavailability remains a perplexing challenge, merely reaching 2.9 % due to formidable first-pass metabolism hurdles. In a bid to surmount this obstacle, researchers embarked on a journey to develop ibrutinib-loaded NLCs (Nanostructured Lipid Carriers) using a methodology steeped in complexity: a Design of Experiments (DoE)-based hot melted ultrasonication approach. Despite a plethora of methods for analyzing ibrutinib in various matrices, the absence of a spectrofluorimetric method for assessing it in rat plasma added to the enigma. Thus emerged a spectrofluorimetric method, embodying principles of white analytical chemistry and analytical quality by design, employing a Placket-Burman design for initial method exploration and a central composite design for subsequent refinement. This method underwent rigorous validation in accordance with ICH guidelines, paving the way for its application in scrutinizing the in-vivo pharmacokinetics of ibrutinib-loaded NLCs, juxtaposed against commercially available formulations. Surprisingly, the optimized NLCs exhibited a striking 1.82-fold boost in oral bioavailability, shedding light on their potential efficacy. The environmental impact of this method was scrutinized using analytical greenness tools, affirming its eco-friendly attributes. In essence, the culmination of these efforts has not only propelled advancements in drug bioavailability but also heralded the dawn of a streamlined and environmentally conscious analytical paradigm.
SponsorThe authors of the manuscript are thankful to the principal of Maliba Pharmacy College for providing necessary instrumentation facility and infrastructures to carry out the present research work. The authors extend their appreciation to the Researchers Supporting Project number (RSPD2024R726), King Saudi University, Riyadh, Saudi Arabia.
Languageen
PublisherElsevier
SubjectIbrutinib-loaded nanostructured lipid carriers
Quality by design approach
Placket-Burman design
Central composite design
Spectrofluorimetric method
TitleIn-vivo pharmacokinetic study of ibrutinib-loaded nanostructured lipid carriers in rat plasma by sensitive spectrofluorimetric method using harmonized approach of quality by design and white analytical chemistry
TypeArticle
Volume Number321
ESSN1386-1425
dc.accessType Full Text


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