Integration of Quality by Design (QbD) Principles in the Engineering of an Oral Delivery Nanosystem Loaded with Fenofibrate
DOI:
https://doi.org/10.37285/ijpsn.2024.17.4.6Abstract
Background: Fenofibrate (FEN) is the FDA-approved drug used in the treatment of hyperlipidemia. FEN possesses limited bioavailability orally due to its low solubility. As a result, more frequent and larger doses are needed, which increases the likelihood of adverse effects.
Objectives: This study aimed to develop and optimize polymeric nanoparticles loaded with Fenofibrate (FEN) using the solvent evaporation method.
Method: A Quality by Design (QbD) approach was used to ensure the quality of the finished product by evaluating the impact of critical material attributes (CMAs) and critical process parameters (CPPs) on the critical quality attributes (CQAs) of nanoparticles. The impact of CMAs (quantity of polycaprolactone, % polyvinyl alcohol, and % sodium lauryl sulphate) on particle size and Drug Entrapment Efficiency (DEE) was studied using Box-Behnken Design.
Results: The optimized nanoparticles have 246.5 ± 4.38 nm particle size and 77.53 ± 0.9% DEE. SEM and TEM were used to analyze the surface morphology of nanoparticles. Furthermore, In-Vitro drug release study of optimized formulation was performed to confirm the efficacy of the polymeric nanoparticles.
Conclusion: The solvent evaporation method was utilized to effectively formulate FEN-loaded polymeric nanoparticles and optimized through QbD principles to achieve minimum particle size and maximum % DEE
Downloads
Metrics
Keywords:
Fenofibrate, polymeric nanoparticles, Quality by Design (QbD), Box-Behnken DesignPublished
How to Cite
Issue
Section
References
Jing L, Li SB, Xie L, Lei Y, Lai YR, Zhang LL. Type 2 Diabetes and Hyperlipidemia Caused by AKT2 Gene Combined with PLIN1 Gene Mutation: A Case Report. Biomedical and Environmental Sciences. 2023;36(4):371-5.
Shenoy A, Buttar HS, Dicholkar P, Kaur G, Chintamaneni M. Role of nutraceuticals, functional foods, and spices in the management of metabolic syndrome and related disorders. Functional Foods and Nutraceuticals in Metabolic and Non-Communicable Diseases: Elsevier; 2022. p. 583-601.
O’Neill WQ, Xie X, Gui S, Yu H, Davenport J, Cartwright T, et al. Repositioning fenofibrate to reactivate p53 and reprogram the tumor-immune microenvironment in HPV+ head and neck squamous cell carcinoma. Cancers. 2022;14(2):282.
Warzecha KW, Pudełek M, Catapano J, Madeja Z, Czyż J. Long-Term Fenofibrate Treatment Stimulates the Phenotypic Microevolution of Prostate Cancer Cells In Vitro. Pharmaceuticals. 2022;15(11):1320.
Mohammed BS, Al-Gawhari FJ. Preparation of Posaconazole Nanosponges for Improved Topical Delivery System.
Domingues C, Santos A, Alvarez-Lorenzo C, Concheiro A, Jarak I, Veiga F, et al. Where is nano today and where is it headed? A review of nanomedicine and the dilemma of nanotoxicology. ACS nano. 2022;16(7):9994-10041.
Zamansky M, Zehavi Na, Sintov AC, Ben-Shabat S. The Fundamental Role of Lipids in Polymeric Nanoparticles: Dermal Delivery and Anti-Inflammatory Activity of Cannabidiol. Molecules. 2023;28(4):1774.
Mohammadian S, Khazaei M, Maghami P, Avan A, Rezaei M. Polycaprolactone-based nanocarriers containing 5-fluorouracil as a therapeutic guided drug delivery approach for enhancing anticancer activity. Current cancer drug targets. 2023;23(7):524-33.
Patil D, Nangare S, Patil G, Nerkar K, Patil G. Development of thiolated polyethylene glycol-poly (lactic-co-glycolic acid) co-polymeric nanoparticles for intranasal delivery of quetiapine: in vitro–ex vivo characterization. International Journal of Polymeric Materials and Polymeric Biomaterials. 2023;72(9):714-24.
Mehrotra N, Anees M, Tiwari S, Kharbanda S, Singh H. Polylactic acid based polymeric nanoparticle mediated co-delivery of navitoclax and decitabine for cancer therapy. Nanomedicine: Nanotechnology, Biology and Medicine. 2023;47:102627.
Pires PC, Mascarenhas-Melo F, Pedrosa K, Lopes D, Lopes J, Macário-Soares A, et al. Polymer-based biomaterials for pharmaceutical and biomedical applications: A focus on topical drug administration. European Polymer Journal. 2023:111868.
Abid M, Mahmood M, Batool M, Sumrra SH, Nazar MF. Biodegradable polymeric nanoparticle drug for oral delivery applications. Novel Platforms for Drug Delivery Applications: Elsevier; 2023. p. 333-48.
Wang X, Fan Y, Yan J, Yang M. Engineering polyphenol-based polymeric nanoparticles for drug delivery and bioimaging. Chemical Engineering Journal. 2022;439:135661.
Wen M, Yu N, Wu S, Huang M, Qiu P, Ren Q, et al. On-demand assembly of polymeric nanoparticles for longer-blood-circulation and disassembly in tumor for boosting sonodynamic therapy. Bioactive Materials. 2022;18:242-53.
Begines B, Ortiz T, Pérez-Aranda M, Martínez G, Merinero M, Argüelles-Arias F, et al. Polymeric nanoparticles for drug delivery: Recent developments and future prospects. Nanomaterials. 2020;10(7):1403.
Simão J, Chaudhary S, Ribeiro A. Implementation of Quality by Design (QbD) for Development of Bilayer Tablets. European Journal of Pharmaceutical Sciences. 2023:106412.
Dawoud MH, Abdel-Daim A, Nour MS, Sweed NM. A Quality by Design Paradigm for Albumin-Based Nanoparticles: Formulation Optimization and Enhancement of the Antitumor Activity. Journal of Pharmaceutical Innovation. 2023:1-20.
Leonardi D, Lamas MC, Salomon CJ. A Quality by Design Update on Nano-drug Delivery Systems. Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development. 2023:117-38.
Taleuzzaman M, Sartaj A, Kumar Gupta D, Gilani SJ, Mirza MA. Phytosomal gel of Manjistha extract (MJE) formulated and optimized with central composite design of Quality by Design (QbD). Journal of Dispersion Science and Technology. 2023;44(2):236-44.
Gokemeijer J, Wen Y, Jawa V, Mitra-Kaushik S, Chung S, Goggins A, et al. Survey Outcome on Immunogenicity Risk Assessment Tools for Biotherapeutics: an Insight into Consensus on Methods, Application, and Utility in Drug Development. The AAPS Journal. 2023;25(4):55.
Kesharwani D, Paul SD, Paliwal R, Satapathy T. Exploring potential of diacerin nanogel for topical application in arthritis: Formulation development, QbD based optimization and pre-clinical evaluation. Colloids and Surfaces B: Biointerfaces. 2023;223:113160.
Rathod V, Gajera B, Pinninti A, Mohammed IA, Dave RH. Strategizing Spray Drying Process Optimization for the Manufacture of Redispersible Indomethacin Nanoparticles Using Quality-by-Design Principles. AAPS PharmSciTech. 2023;24(5):133.
Rahman SNR, Katari O, Pawde DM, Boddeda GSB, Goswami A, Mutheneni SR, et al. Application of design of experiments® approach-driven artificial intelligence and machine learning for systematic optimization of reverse phase high performance liquid chromatography method to analyze simultaneously two drugs (cyclosporin A and etodolac) in solution, human plasma, nanocapsules, and emulsions. AAPS PharmSciTech. 2021;22(4):155.
Putta CL, Rahman SNR, Chakraborthy P, Shunmugaperumal T. Development, systematic optimization and biofilm disruption activity of eugenol-based nanosized emulsions stabilized with Tween 80. Journal of Microencapsulation. 2023(just-accepted):1-17.
Koilpillai J, Narayanasamy D. Development and characterization of novel surface engineered Depofoam: a QbD coupled failure modes and effects analysis risk assessment-based optimization studies. Journal of Liposome Research. 2023:1-17.
Sharma S, Naman S, Goyal K, Baldi A. Simultaneous Estimation of Atovaquone and Mefloquine Hydrochloride: QbD based Method Development and Validation. INDIAN Journal of Pharmaceutical Education and Research. 2023;57(1):250-63.
Donthi MR, Saha RN, Singhvi G, Dubey SK. Dasatinib-Loaded Topical Nano-Emulgel for Rheumatoid Arthritis: Formulation Design and Optimization by QbD, In Vitro, Ex Vivo, and In Vivo Evaluation. Pharmaceutics. 2023;15(3):736.
Boyuklieva R, Hristozova A, Pilicheva B. Synthesis and Characterization of PCL-Idebenone Nanoparticles for Potential Nose-to-Brain Delivery. Biomedicines. 2023;11(5):1491.
Dong Y, Feng S-S. Poly (D, L-lactide-co-glycolide)(PLGA) nanoparticles prepared by high pressure homogenization for paclitaxel chemotherapy. International journal of pharmaceutics. 2007;342(1-2):208-14.
Shahat A, Kubra KT, El-marghany A. Equilibrium, Thermodynamic and kinetic modeling of triclosan adsorption on Mesoporous carbon nanosphere: Optimization using Box-Behnken design. Journal of Molecular Liquids. 2023:122166.
Ramzan N, Abbas G, Mahmood K, Aziz M, Rasul S, Ahmed N, et al. Concomitant effect of quercetin and its copper complex in the development of sustained-release nanoparticles of polycaprolactone, used for the treatment of skin infection. Molecular Pharmaceutics. 2022;20(2):1382-93.
Obeidat WM, Gharaibeh SF, Jaradat A. The Influence of Drugs Solubilities and Chitosan-TPP Formulation Parameters on the Mean Hydrodynamic Diameters and Drugs Entrapment Efficiencies into Chitosan-TPP Nanoparticles. AAPS PharmSciTech. 2022;23(7):262.
Ahmady AR, Solouk A, Saber-Samandari S, Akbari S, Ghanbari H, Brycki BE. Capsaicin-loaded alginate nanoparticles embedded polycaprolactone-chitosan nanofibers as a controlled drug delivery nanoplatform for anticancer activity. Journal of Colloid and Interface Science. 2023;638:616-28.
Mehata AK, Suseela MNL, Behera C, Kumari P, Mahto SK, Muthu MS. Chitosan-alginate nanoparticles of cabazitaxel: Design, dual-receptor targeting and efficacy in lung cancer model. International Journal of Biological Macromolecules. 2022;221:874-90.
Nayak AK, Ahmed SA, Beg S, Tabish M, Hasnain MS. Application of quality by design for the development of biopharmaceuticals. Pharmaceutical quality by design: Elsevier; 2019. p. 399-411.
Rapalli VK, Khosa A, Singhvi G, Girdhar V, Jain R, Dubey SK. Application of QbD principles in nanocarrier-based drug delivery systems. Pharmaceutical quality by design: Elsevier; 2019. p. 255-96.
Mahmoud BS, McConville C. Development and optimization of irinotecan-loaded pcl nanoparticles and their cytotoxicity against primary high-grade glioma cells. Pharmaceutics. 2021;13(4):541.
Devrim B, Bozkir A. Design and evaluation of hydrophobic ion-pairing complexation of lysozyme with sodium dodecyl sulfate for improved encapsulation of hydrophilic peptides/proteins by lipid-polymer hybrid nanoparticles. Journal of Nanomedicine & Nanotechnology. 2015;6(1):1.
Kolipaka T, Sen S, Mane SS, Bajad GD, Dengale SJ, Ranjan OP. Development of posaconazole nanosuspension for bioavailability enhancement: Formulation optimization, in vitro characterization, and pharmacokinetic study. Journal of Drug Delivery Science and Technology. 2023;83:104434.
