Open AccessIMPLEMENTATION OF FACTORIAL DESIGN TO OPTIMIZE THE FORMULATION METHOD OF EZETIMIBE POLYMERIC NANOPARTICLE BY HOMOGENIZATION CUM ULTRA-SONICATION METHOD
Author(s) -
BALA NAGAMANI D.,
BHASKAR REDDY K.,
SESHA MAHESWARAMMA K.,
BRITO RAJ S.
Publication year - 2022
Publication title -
international journal of applied pharmaceutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.238
H-Index - 15
ISSN - 0975-7058
DOI - 10.22159/ijap.2022v14i2.43783
Subject(s) - dispersity , zeta potential , factorial experiment , sonication , particle size , nanoparticle , materials science , dissolution , chemical engineering , homogenization (climate) , chromatography , polymer , chemistry , nanotechnology , mathematics , composite material , organic chemistry , polymer chemistry , biodiversity , ecology , statistics , engineering , biology
Objective: The objective of this study is to use a 23 factorial design to optimize the formulation factors of Ezetimibe polymeric nanoparticle.Methods: By varying formulation variables such as polymer concentration (hydroxyl propyl methyl cellulose composition) and process variables such as homogenization time (min) and ultra-sonication time, the formulation of polymeric nanoparticles was designed using a 23 factorial design and prepared using the homogenization cum ultra-sonication method (min). Particle size (nm), zeta potential (mV), polydispersity index, entrapment efficiency (%), drug content, in vitro drug release, in vitro release kinetic studies, and stability studies were used to analyse and optimize polymeric nanoparticles according to ICH criteria.Results: R7 formulation showed predicted and desired less particle size 87.0±3.64 nm; maximum zeta potential-33.4±2.32 mV; desired polydispersity index 0.488±0.20; maximum entrapment efficiency of 96.45±2.42 % and controlled dissolution release pattern of about 90.42±3.56% in 24h.Conclusion: The polymeric nanoparticle was formulated and optimized by the parameters like Particle Size (PS in nm), Polydispersity Index (PI), Zeta potential (Zp in mV), % Entrapment Efficiency and in vitro drug release for 24 h were evaluated. These parameters showed significant changes while formulating polymeric nanoparticles along with various formulation and process variables. From the release pattern data it was observed that PNs show a significant improvement of dissolution character of Ezetamibe. According to the findings, PNs have a controlled drug release pattern and can be used as a suitable drug delivery carrier for low solubility and poorly bioavailable drugs like Ezetamibe to improve its dissolution.