Bioequivalence of a New Generic Formulation of Erlotinib Hydrochloride 150 mg Tablets versus Tarceva in Healthy Volunteers under Fasting Conditions

Jawhari, Dalia

doi:10.4172/jbb.1000190

Cited by 11 publications

(7 citation statements)

References 8 publications

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“…On the other hand, at low pHs, the hydrogen bonds can occur between the protons of the CH 2 groups in the aromatic ring of drugs and the nitrogen atoms of the PUF, which can increase the extraction efficiency [20,33,34].…”

Section: Effect Of Phmentioning

confidence: 99%

Carbon nanotube/polyurethane modified hollow fiber‐pencil graphite electrode for in situ concentration and electrochemical quantification of anticancer drugs Capecitabine and Erlotinib

Es’haghi

Moeinpour

2019

Engineering in Life Sciences

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A sensitive electrochemical sensor has been designed for in situ preconcentration and determination of anticancer drugs Capecitabine (CPT) and Erlotinib hydrochloride (ETHC) based on a pencil graphite electrode modified with multivalued carbon nanotube—polyurethane (MWCNT‐PUFIX) nanocomposite that was supported with a piece of polypropylene hollow fiber (HF‐PGE). The electrochemical behavior of CPT and ETHC on the MWCNT‐PUFIX/HF‐PGE modified electrode was investigated by differential pulse voltammetry (DPV) techniques and the obtained results confirmed its efficiency for sensing of CPT and ETHC. The synthesized nanocomposite was characterized by infrared spectroscopy and scanning electron microscope. After optimization of some effective parameters on the method efficiency including pH, nanocomposite amount, the type of organic solvent, scan rate and the effect of some additives, the mentioned sensor presented suitable results for determination of CPT and ETHC with the linear ranges from 7.70 to 142.00 μM and 0.11 to 23.50 μM and detection limits of 0.11 and 0.02 μM, respectively. Also, the fabricated sensor has shown good performance in analysis of CPT and ETHC in biological samples.

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Section: Effect Of Phmentioning

confidence: 99%

Carbon nanotube/polyurethane modified hollow fiber‐pencil graphite electrode for in situ concentration and electrochemical quantification of anticancer drugs Capecitabine and Erlotinib

Es’haghi

Moeinpour

2019

Engineering in Life Sciences

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“…These anticancer drugs have warnings in their inserts to avoid PPIs because drugs require an acidic environment to be fully absorbed. Several studies have been conducted comprising erlotinib and dasatinib (Jawhari et al 2014;Yang et al 2017;Steinberg 2007;Keam 2008).…”

Section: Further Readingmentioning

confidence: 99%

Drug Transporters

Talevi¹,

Bellera²,

Pesce³

2018

ADME Processes in Pharmaceutical Sciences

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“…Erlotinib is extensively metabolized by CYP3A4 and, to a lesser extent, by CYP1A2 and the extrahepatic isoform CYP1A1 with metabolites excreted by the biliary system [8]. In numerous investigations [9,10,11], high inter-patient variability of pharmacokinetics in erlotinib exposure has been noted.…”

Section: Introductionmentioning

confidence: 99%

Analytical Method Validation and Bioequivalence Study of Erlotinib 150 Mg Tablets in Iranian Healthy Volunteers Under Fasting Condition

ELHAM

Sadrai

Shokri

et al. 2023

Int J Pharm Pharm Sci

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Objective: This study aims to compare a generic formulation of the drug erlotinib 150 mg tablet to the brand-name version to validate the analytical method and bioequivalence studies. Methods: Erlotinib hydrochloride tablets (test versus reference formulation) were compared in a randomized, two-period crossover study to determine their pharmacokinetic properties and bioequivalence in healthy Iranian volunteers. 14 d passed between each treatment during the washout period. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) was used to analyze erlotinib, and the method validation is presented. Results: Over the range of 6.25-3200 ng/ml, the analytical method was verified as linear (R2= 0.998). The technique was also accurate and precise at various concentrations. The results showed that the pharmacokinetics of the two products were comparable. Following administration of the test and reference products, the geometric averages for (Area under the curve) AUC0-72, AUCinf, and maximum plasma concentration (Cmax) were 104.71 (90% CI, 93.39-117.40), 104.68 (90% CI, 93.47-117.23), and 104.85 (90% CI, 94.61-116.21), respectively. The outcomes fell within the permitted tolerance of 0.8 to 1.25. Conclusion: For the determination of erlotinib in plasma, the used analytical approach is accurate, precise, repeatable, and selective. Additionally, the bioequivalence research revealed no appreciable differences in pharmacokinetic characteristics between the reference and test products. Therefore, it is possible to assert that the generic erlotinib product and the reference product are bioequivalent.

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Bioequivalence of a New Generic Formulation of Erlotinib Hydrochloride 150 mg Tablets versus Tarceva in Healthy Volunteers under Fasting Conditions

Cited by 11 publications

References 8 publications

Carbon nanotube/polyurethane modified hollow fiber‐pencil graphite electrode for in situ concentration and electrochemical quantification of anticancer drugs Capecitabine and Erlotinib

Carbon nanotube/polyurethane modified hollow fiber‐pencil graphite electrode for in situ concentration and electrochemical quantification of anticancer drugs Capecitabine and Erlotinib

Drug Transporters

Analytical Method Validation and Bioequivalence Study of Erlotinib 150 Mg Tablets in Iranian Healthy Volunteers Under Fasting Condition

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