Quantitative Determination of Amlodipine From Caco-2 Cell Monolayers by High-Performance Liquid Chromatography–mass Spectrometry/Mass Spectrometry

Logoyda, Liliya

doi:10.22159/ajpcr.2018.v11i6.24971

Cited by 8 publications

(3 citation statements)

References 10 publications

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“…24-well insert plate was removed from its feeder plate and placed in a new sterile 24-well transport analysis plate. The medium was aspirated and inserts washed with PBS twice (Arena and Phillips 2003;Sevin et al 2013;Srinivasan et al 2015;Logoyda 2018).…”

Section: Cultivation Of Caco-2 Cellsmentioning

confidence: 99%

Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

Shulyak¹,

Liushuk²,

Semeniuk³

et al. 2022

PHAR

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Atorvastatin and lisinopril are a successful combination for the treatment of patients with chronic heart failure and hypertension. Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro were described. In medium with hydrochloric acid pH 1.2, in the medium of acetate buffer solution with a pH of 4.5 and in the medium phosphate buffer solution with a pH of 6.8 for 15 min more than 85% of the active substance passes into solution, hence the dissolution profiles these drugs in these environments are similar, and the drugs in them are “very quickly soluble”. Among the in vitro models that make it possible to assess the degree of absorption of API, the most widely used culture of adenocarcinoma cells of the colon – Caco-2. The development of the analytical methodology and its validation is the final stage of both the dissolution study and the Caco-2 test, as well as the biowaver procedure. It plays the most important role in the reliability of the results for all the above procedures and tests. To study permeability, method LC-MS/MS was developed. According to the obtained results, atorvastatin and lisinopril showed low permeability. The values of recovery of transport of test and control substances through the monolayer of cells of the Caco-2 line indicate that the results of the experiment can be considered reliable. The equivalence of the drugs “Lisinopril”, tablets of 10 mg and “Atorvastatin”, tablets of 10 mg, belongs to class III BCS proven by in vitro studies.

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Section: Cultivation Of Caco-2 Cellsmentioning

confidence: 99%

Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

Shulyak¹,

Liushuk²,

Semeniuk³

et al. 2022

PHAR

Self Cite

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“…For a successful study of this substance by these methods, usually, derivatization of active groups with one or more reagents is carried out. [3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21] However, as practice shows, in case of using tianeptine for the purpose of obtaining a narcotic effect, urine contains products of its metabolism or disintegration.…”

Section: Original Articlementioning

confidence: 99%

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Logoyda¹

2019

IJGP

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Introduction: Coaxil (tianeptine) is a new generation antidepressant with selective serotoninergic action. Recently, a significant increase in non-medical use of the atypical tricyclic antidepressant drug, tianeptine, has been observed in Ukraine. According to domestic narcologists and psychiatrists, there is information on tianeptine abuse by drug addicts. In literature, there is information that this medicine combines characteristics of opium, heroin, and cocaine in it. Receiving of tianeptine in high dosages (400-600 mg intravenously) leads to a state of euphoria and gives a narcotic effect that is several times stronger than heroin and cocaine. The aim of the Study: The aim of the research was to study of tianeptine metabolism products in the human body in urine by gas chromatography-mass spectrometry. Methods: The analysis has been carried out on a gas chromatograph Agilent 6890N with a massselective detector Agilent 5973 and an injector Agilent 7683 (USA) equipped with a chromatographic quartz capillary geyser of FactorFour Varian (USA). Gas carrier was helium. Results and Discussion: The analysis of extracts received as with acidic and with alkaline pH values has shown metabolites of tianeptine MC5 in them. Besides the main metabolite (MC5), there have also been desalkyldesaminotianeptine and desalkyldesaminonortianeptine in the extracts obtained at pH 3-4 and in the extracts obtained at pH 9-10-desalkyltianeptine and a metabolite, the structure of which has not been established at the moment. Based on the fact that the main metabolite of tianeptine MC5 is isolated from the urine both at acidic pH values (pH = 3-4) and alkaline (pH = 9-10), it is possible to use as acidic as alkaline extracts for the chromatography-mass spectrometry analysis. Conclusions: The possibility of using gas chromatography and mass spectrometry methods for metabolites has been shown. The main metabolite of tianeptine can be isolated from the urine at acidic and also at alkaline pH values of the medium.

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“…Caco-2 permeability values for bisoprolol are in agreement with BCS Class I and high bioavailability in humans. [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] In Ukraine, bisoprolol tablets are produced by different manufacturers. The aim of our research was to study dissolution kinetics of bisoprolol tablets to assess their equivalence under conditions in vitro according to the biowaiver.…”

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confidence: 99%

Untitled

Logoyda¹

2019

AJP

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Introduction: Biowaiver procedure, nowadays, is a trend of Modern Biopharmaceuticals. The biowaiver approach based on Biopharmaceutical Classification System BCS is intended to replace bioequivalence in vivo studies. Bisoprolol is a medicine most commonly used for heart diseases, the beta blocker family of medications, and is of the β 1-selective type. The Aim of the Study: The aim was to study the dissolution kinetics of bisoprolol tablets to assess their equivalence under conditions in vitro according to the biowaiver. Methods: The study of dissolution kinetics of drugs in the form of bisoprolol tablets has been carried out in accordance with the requirements of the "biowaiver" procedure, the recommendations of the SPhU, and the WHO requirements to assess the possibility of replacing the pharmacokinetic studies in vivo by tests in vitro. Results and Discussion: The possibility to use the recommendations of the "biowaiver" procedure for the registration of generics bisoprolol tablets has been found. The studies conducted have shown that bisoprolol can be referred to Class І of the BCS, i.e., substances with a high biopharmaceutical solubility and a high penetration rate. It will allow conducting comparative studies in vitro to confirm the equivalence of drugs. Conclusions: The evaluated bisoprolol drugs fulfill biowaiver criteria for drugs containing BCS Class I active pharmaceutical ingredients. Both drugs are "rapidly dissolving," both meet the criteria of dissolution profile similarity, f 2 (i.e., the dissolution profile of the test product is similar to that of the reference product in pH 1.2, 4.5, and 6.8 buffers using the paddle method at 75 rpm), and both are considered to be in vitro equivalent without in vivo evaluation.

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Quantitative Determination of Amlodipine From Caco-2 Cell Monolayers by High-Performance Liquid Chromatography–mass Spectrometry/Mass Spectrometry

Cited by 8 publications

References 10 publications

Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

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Quantitative Determination of Amlodipine From Caco-2 Cell Monolayers by High-Performance Liquid Chromatography–mass Spectrometry/Mass Spectrometry

Cited by 8 publications

References 10 publications

﻿Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

﻿Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

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Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro

Study of the dissolution kinetics of drugs in solid dosage form with lisinopril and atorvastatin and intestinal permeability to assess their equivalence in vitro