Tamoxifen-Loaded Eudragit Nanoparticles: Quality by Design Approach for Optimization of Nanoparticles as Delivery System

Muzna Ali Khattak; Zafar Iqbal; Fazli Nasir; Steven H Neau; Sumaira Irum Khan; Talaya Hidayatullah; Sadia Pervez; Mirina Sakhi; Syeda Rabqa Zainab; Shazma Gohar; Fawaz Alasmari; Altafur Rahman; Gul E Maryam; Arbab Tahir

doi:10.3390/pharmaceutics15102373

Tamoxifen-Loaded Eudragit Nanoparticles: Quality by Design Approach for Optimization of Nanoparticles as Delivery System

Pharmaceutics. 2023 Sep 22;15(10):2373. doi: 10.3390/pharmaceutics15102373.

Authors

Affiliations

¹ Department of Pharmacy, University of Peshawar, Peshawar 25120, Pakistan.
² Department of Pharmacy, Cecos University of IT and Emerging Sciences, Peshawar 25000, Pakistan.
³ Department of Pharmacy, Sarhad University of Science and Information Technology, Peshawar 25000, Pakistan.
⁴ Philadelphia College of Pharmacy, University of Sciences, Philadelphia, PA 19104, USA.
⁵ Pharmacy Department, Faculty of Health and Medical Sciences, Mirpur University of Science and Technology, New Mirpur City 10250, Pakistan.
⁶ Department of Pharmacy, University of Swabi, Swabi 23430, Pakistan.
⁷ Department of Pharmacology and Toxicology, College of Pharmacy, King Saud University, Riyadh 11362, Saudi Arabia.

Abstract

Nanoparticles have numerous applications as drug carriers in drug delivery. The aim of the study was to produce tamoxifen nanoparticles with a defined size and higher encapsulation for efficient tissue uptake with controlled drug release. The quality by design approach was utilized to produce tamoxifen-loaded Eudragit nanoparticles by identifying the significant process variables using the nanoprecipitation method. The process variables (amount of drug, polymer, and surfactant) were altered to analyze the influence on particle size (PS), % encapsulation efficiency (EE). The results showed that the drug and polymer individually as well as collectively have an impact on PS, while the surfactant has no impact on the PS. The %EE was influenced by the surfactant individually and in interaction with the drug. The linear regression model was endorsed to fit the data showing high R² values (PS, 0.9146, %EE, 0.9070) and low p values (PS, 0.0004, EE, 0.0005). The PS and EE were confirmed to be 178 nm and 90%, respectively. The nanoparticles were of spherical shape, as confirmed by SEM and TEM. The FTIR confirmed the absence of any incompatibility among the ingredients. The TGA confirmed that the NPs were thermally stable. The in vitro release predicted that the drug release followed Higuchi model.

Keywords: Eudragit RS 100; design of experiment; drug delivery; nanoparticles; response surface methodology; statistical analysis; tamoxifen.

Grants and funding

The research work (grant number 6685) was funded by the Higher Education of Pakistan (HEC). The research was also supported by the Researchers supporting project number (RSP2022R235), King Saud University, Riyadh, Saudi Arabia.