Factorial design optimization of micelle enhanced synchronous spectrofluorimetric assay of Omarigliptin: Applied to content uniformity testing and in vitro drug release

Ayoub, Bassam M.; Mowaka, Shereen; Arafa, Mona G.

doi:10.1002/bio.3479

Cited by 8 publications

(6 citation statements)

References 28 publications

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“…48 Another reason is the tendency of CS to hydrate, limitedly swell when it comes in contact with high-pH dissolution media of a high pH, then form a gelatinous mass that slows drug diffusion. 49,50 F3 also showed sustained release due to the formation of a three-dimensional physical network of rigid gel.…”

Section: Discussionmentioning

confidence: 99%

Chitosan-Coated PLGA Nanoparticles for Enhanced Ocular Anti-Inflammatory Efficacy of Atorvastatin Calcium

Arafa¹,

Girgis²,

El-Dahan³

2020

IJN

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Background: Atorvastatin calcium (AT) is an ocular anti-inflammatory with limited bioavailability when taken orally due to its low solubility in low pH and extensive first-pass effect. To overcome these problems, AT was entrapped in polymeric nanoparticles (NPs) to improve surface properties and sustained release, in addition to achieving site-specific action. Methods: AT was entrapped in chitosan (CS)-coated polylactic-co-glycolic acid (PLGA) NPs to form AT-PLGA-CS-NPs (F1). F1 and free AT were embedded in thermosensitive Pluronic ® 127-hydroxypropyl methylcellulose (HPMC) to form thermosensitive gels (F2) and (F3) while F4 is AT suspension in water. F1 was assessed for size, surface charge, polydispersity index (PDI), and morphology. F2 and F3 were examined for gelation temperature, gel strength, pH, and viscosity. In vitro release of the four formulations was also investigated. The ocular irritancy and anti-inflammatory efficacy of formulations against prostaglandin E 1-(PGE 1) induced ocular inflammation in rabbits were investigated by counting the polymorphonuclear leukocytes (PMNs) and protein migrated in tears. Results: Oval F1 of 80.0-190.0±21.6 nm exhibited a PDI of 0.331 and zeta potential of 17.4 ±5.62 mV with a positive surface charge. F2 and F3 gelation temperatures were 35.17±0.22°C and 36.93±0.31°C, viscosity 12,243±0.64 and 9759±0.22 cP, gel strength 15.56±0.6 and 12.45 ±0.1 s, and pHs of 7.4±0.02 and 7.4±0.1, respectively. In vitro release of F1, F2, F3, and F4 were 48.21±0.31, 26.48±0.5, 84.76±0.11, and 100% after 24 hrs, respectively. All formulations were non-irritant. F2 significantly inhibited lid closure up to 3 h, PMN counts and proteins in tear fluids up to 5 h compared to other formulations. Conclusion: AT-PLGA-CS-NP thermosensitive gels proved to be successful ocular antiinflammatory drug delivery systems.

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Section: Discussionmentioning

confidence: 99%

Chitosan-Coated PLGA Nanoparticles for Enhanced Ocular Anti-Inflammatory Efficacy of Atorvastatin Calcium

Arafa¹,

Girgis²,

El-Dahan³

2020

IJN

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“…The literature review showed that few reported methods were available for determination of OMG either alone or in combination with other drugs. These methods comprise HPLC [ 8 – 10 ], spectrofluorimetry [ 11 ], spectrophotometry [ 12 ], and LC-MS/MS [ 13 ]. Concerning MET, a number of reported methods was available including HPLC [ 14 – 20 ], spectrophotometry [ 21 – 24 ], spectrofluorimetry [ 25 , 26 ], LC-MS/MS [ 27 – 30 ], and TLC [ 31 , 32 ].…”

Section: Introductionmentioning

confidence: 99%

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

et al. 2023

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A simple, selective, and sensitive RP-HPLC method was proposed for the simultaneous determination of two co-administered antidiabetic drugs (omarigliptin and metformin) with an anti-hyperlipidemic drug (ezetimibe) in a medicinally-recommended ratio of 2.5:50:1, respectively. The proposed procedure was optimized by adopting a quality-by-design approach. The influence of different factors on chromatographic responses was optimized by applying the two-level full factorial design (25). The optimum chromatographic separation was achieved using Hypersil BDS C18 column at 45 °C, and the mobile phase pumped isocratically composed of methanol: potassium dihydrogen phosphate buffer (6.6 mM; pH 7, 67:33% v/v) at a flow rate of 0.814 mL/min using 235 nm as a detection wavelength. The developed method was capable of separating this novel mixture in less than 8 min. The calibration plots of omarigliptin, metformin, and ezetimibe showed acceptable linearity over the ranges of 0.2-2.0, 0.5–25.0, and 0.1-2.0 µg/mL with quantitation limits of 0.06, 0.50, and 0.06 µg/mL, respectively. The proposed method was successfully applied to determine the studied drugs in their commercial tablets with high % recoveries (96.8-102.92%) and low % RSD values (less than 2%). The applicability of the method was extended to the in-vitro assay of the drugs in spiked human plasma samples with high % recoveries (94.3-105.7%). The suggested method was validated in accordance with ICH guidelines.

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“…Omarigliptin (OMR) is chemically known as [17]. It is a recent antidiabetic drug used for treatment of type II diabetes mellitus [18].…”

Section: Introductionmentioning

confidence: 99%

“…Being recently developed drug, OMR has not yet been listed in any pharmacopeia [22][23][24]. Literature survey revealed that different analytical techniques have been developed for OMR determination such as spectrofluorometry [17] and chromatography [19,[25][26][27]. Moreover, our previously reported stability study revealed that the drug was susceptible to hydrolytic and oxidative degradations [27].…”

Section: Introductionmentioning

confidence: 99%

A New Comparative Potentiometric Method for Analysis of Omarigliptin Using Three Different Sensors

et al. 2022

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This work represents first attempt for potentiometric determination of the most recent antidiabetic; omarigliptin. Three sensors, employing potassium tetrakis (p-chlorophenyl) borate as a lipophilic cation exchanger, were developed and compared. One liquid contact ionselective electrode and two carbon paste-based solid contact ones, plain one and another one modified with polyaniline nanoparticles, were employed. Performances of fabricated sensors were assessed as per IUPAC recommendations. Incorporation of hydrophobic polyaniline nanoparticles as ion-to-electron transducer layer at solid contact/ion-sensitive membrane interface enhanced sensitivity and stability of the third sensor showing LOD of 2.5 × 10 À 7 mol L À 1 and slope of 58.57 mV decade À 1 . The three sensors were applied for omarigliptin determination in presence of its degradation products, in dosage form and spiked human plasma.

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Factorial design optimization of micelle enhanced synchronous spectrofluorimetric assay of Omarigliptin: Applied to content uniformity testing and in vitro drug release

Cited by 8 publications

References 28 publications

<p>Chitosan-Coated PLGA Nanoparticles for Enhanced Ocular Anti-Inflammatory Efficacy of Atorvastatin Calcium</p>

<p>Chitosan-Coated PLGA Nanoparticles for Enhanced Ocular Anti-Inflammatory Efficacy of Atorvastatin Calcium</p>

Analytical quality-by-design approach for development and validation of HPLC method for the simultaneous estimation of omarigliptin, metformin, and ezetimibe: application to human plasma and dosage forms

A New Comparative Potentiometric Method for Analysis of Omarigliptin Using Three Different Sensors

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