Abstract
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.
Highlights
Polymer nanotechnology is one of the most potential drug delivery technologies for overcoming problems in drug distribution, such as low solubility and permeability [1]
On comparing pure Ezetamibe and Ezetamibe Polymeric nanoparticles (PNs) data collected from FTIR spectra, as shown in fig. 1 and table 2
From the data it was determined that the appropriate frequencies of fingerprint regions of Ezetamibe drug were replicable in Ezetamibe PNs i.e., there is no any vibrational changes when the Ezetamibe mixed with the formulation excipients and there was no any change in amorphous nature of the drug
Summary
Polymer nanotechnology is one of the most potential drug delivery technologies for overcoming problems in drug distribution, such as low solubility and permeability [1]. The creation of innovative polymeric nanoparticle formulations that can change the pharmacological, biopharmaceutical, and pharmacokinetic characteristics of pharmaceuticals has been aided by advances in nanotechnology [2]. Polymeric nanoparticles (PNs) are particulate materials with a onedimensional size of at least 10–100 nm. Polymeric nanoparticles (NPs) are one of the most commonly employed nanomaterials in nanomedicine because they can deliver a drug to a specific region of an organ with a lower dose, increasing drug bioavailability at the desired target [3]. Polymeric NPs are used in drug delivery, such as medicine conjugation and entanglement, prodrugs, stimuli sensitive systems, imaging modalities, and theranostics [4]. Biodegradable polymeric nanostructures have shown exceptional promise in a variety of therapeutic applications, including analysis, imaging, sedative delivery, cosmetic agents, organ embeds, and tissue design [5]
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