Central composite design augmented quality-by-design-based systematic formulation of erlotinib hydrochloride-loaded chitosan-poly (lactic-co-glycolic acid) nanoparticles

Harsh P Nijhawan; Bala Prabhakar; Khushwant S Yadav

doi:10.1080/20415990.2024.2342771

Central composite design augmented quality-by-design-based systematic formulation of erlotinib hydrochloride-loaded chitosan-poly (lactic-co-glycolic acid) nanoparticles

Ther Deliv. 2024 May 9. doi: 10.1080/20415990.2024.2342771. Online ahead of print.

Authors

Harsh P Nijhawan¹, Bala Prabhakar¹, Khushwant S Yadav¹

Affiliation

¹ Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Mumbai, India.

PMID: 38722230
DOI: 10.1080/20415990.2024.2342771

Abstract

Aim: This study aimed to formulate erlotinib hydrochloride (ERT-HCL)-loaded chitosan (CS) and poly (lactic-co-glycolic acid) (PLGA) nanoparticles (NPs) using Quality-by-Design (QbD) to optimize critical quality attributes (CQAs). Materials & methods: Quality target product profile (QTPP) and CQAs were initially established. Based on L8-Taguchi screening and risk assessments, central composite design (CCD) design was used to optimize NPs. Results: ERT-HCL-loaded CS-PLGA NPs had a mean particle diameter, zeta potential and entrapment efficiency of 226.50 ± 1.62 d.nm, 27.66 ± 0.64 mV and 78.93 ± 1.94 %w/w, respectively. The NPs exhibited homogenous spherical morphology and sustained release for 72 h. Conclusion: Using systematic QbD approach, ERT-HCL was encapsulated in CS-PLGA NPs, optimizing CQAs. These findings propel future research for improved NSCLC treatment.

Keywords: PLGA; Quality-by-Design (QbD); Taguchi design; central composite design (CCD); chitosan; erlotinib hydrochloride; nanoparticles; non-small cell lung cancer; safety.