1 Vol.:(0123456789) Scientific RepoRtS | (2020) 10:14765 | https://doi.org/10.1038/s41598-020-71751-y www.nature.com/scientificreports QbD based eudragit coated Meclizine Hcl immediate and extended release multiparticulates: formulation, characterization and pharmacokinetic evaluation using HpLc‑fluorescence detection method faaiza Qazi 1 , Muhammad Harris Shoaib 1* , Rabia ismail Yousuf 1 , fahad Siddiqui 1 , Muhammad iqbal nasiri 2,3 , Kamran Ahmed 1 , iyad naeem Muhammad 2 & Farrukh Rafq Ahmed 2 this study is based on the QbD development of extended‑release (eR) extruded‑spheronized pellets of Meclizine Hcl and its comparative pharmacokinetic evaluation with immediate‑release (iR) pellets. HPLC-fuorescence method was developed and validated for plasma drug analysis. IR drug cores were prepared from lactose, MCC, and PVP using water as granulating fuid. Three-level, three-factor CCRD was applied for modeling and optimization to study the infuence of Eudragit (RL100-RS100), TEC, and talc on drug release and sphericity of coated pellets. HPLC-fuorescence method was sensitive with LLOQ 1 ng/ml and linearity between 10 and 200 ng/ml with R 2 > 0.999. Pharmacokinetic parameters were obtained by non‑compartmental analysis and results were statistically compared using logarithmically transformed data, where p > 0.05 was considered as non-signifcant with a 90% CI limit of 0.8–1.25. The AUC 0–t and AUC 0–∞ of ER pellets were not signifcantly diferent with geometric mean ratio 1.0096 and 1.0093, respectively. The C max of IR pellets (98.051 ng/ml) was higher than the ER pellets (84.052 ng/ml) and the T max of ER pellets (5.116 h) was higher than the IR pellets (3.029 h). No signifcant food efect was observed on key pharmacokinetic parameters of ER pellets. Eudragit RL100 (6%) coated Meclizine HCl pellets have a potential therapeutic efect for an extended time period. Meclizine HCl, prescribed for both prophylactic and therapeutic management of nausea, dizziness, and vomiting owing to motion sickness, acts as an antagonist on histamine (H1) receptors. It is also used for the treatment of pruritus, Type 1 hypersensitivity reactions as well as vertigo related to disease conditions afecting the ves- tibular system. Meclizine HCl belongs to the biopharmaceutics classifcation system (BCS) class II, attributed to low solubility and high permeability 1 . It is currently not available as an extended-release (ER) dosage form. open 1 Department of Pharmaceutics and Bioavailability and Bioequivalence Research Facility, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi 75270, Pakistan. 2 Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, University of Karachi, Karachi 75270, Pakistan. 3 Department of Pharmaceutics, Faculty of Pharmacy, Hamdard University, Karachi, Pakistan. * email: harrisshoaib2000@ yahoo.com