Pharmacokinetic profile of a new controlled-release isosorbide-5-mononitrate 60 mg scored tablet (Monoket Multitab®)

Stockis, Armel; Bruyn, Steven De; Deroubaix, X.; Jeanbaptiste, B; Lebacq, E.; Nollevaux, Fabrice; Poli, Gianluigi; Acerbi, Daniela

doi:10.1016/s0939-6411(01)00210-7

Cited by 17 publications

(9 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In the current study, we investigated the angiogenic effects of different cardiovascular drugs, including aspirin, pravastatin, metoprolol and ISMN. ISMN, one of the most frequently used compounds for CHD treatment, is an organic nitrate vasodilator that can reduce myocardial oxygen demand and increase oxygen supply by vasodilating capacitance veins and coronary arteries ( Stockis et al , 2002 ). Here, we found that only ISMN could increase the number and the length of ISVs in zebrafish embryos, indicating the potential angiogenic ability of ISMN.…”

Section: Discussionmentioning

confidence: 99%

Isosorbide mononitrate promotes angiogenesis in embryonic development of zebrafish

Liu

Qin

2020

Genet. Mol. Biol.

View full text Add to dashboard Cite

Coronary heart disease (CHD) is a leading cause of death worldwide, and angiogenesis plays important roles in CHD. Thus, in the present study, the angiogenic efficacy of four common cardiovascular medicines (aspirin, pravastatin, metoprolol and isosorbide mononitrate (ISMN)) was determined by the number and length of zebrafish intersegmental vessels (ISVs) after immersing zebrafish embryos in different medicines. Results showed that ISMN significantly increased the length and number of ISVs. ISMN is a long-acting nitrate ester drug. It has been used as a vasodilator to dilate arteries and veins to reduce the cardiac preload and postload. However, the effect of ISMN on angiogenesis remains unclear. Thus, by in vitro experiments, the angiogenic mechanism of ISMN was evaluated through detecting the viability and proliferation of human umbilical vein endothelial cells (HUVECs) and the expression of angiogenesis-related genes and miRNAs. Results indicated that ISMN could increase the viability and proliferation of HUVECs by decreasing apoptosis, and elevated the expressions of vedf , kdrl , pdgfr in zebrafish embryos. Furthermore, the expressions of miR-126, miR-130a and miR-210 were also regulated in ISMN-treated HUVECs. In conclusion, ISMN could promote angiogenesis in zebrafish embryos and HUVECs, implying ISMN may be a potential therapeutic in treating angiogenesis-related diseases.

show abstract

Section: Discussionmentioning

confidence: 99%

Isosorbide mononitrate promotes angiogenesis in embryonic development of zebrafish

Liu

Qin

2020

Genet. Mol. Biol.

View full text Add to dashboard Cite

show abstract

“…The method is linear over the concentration range of 1.0–1,000 ng/mL, with imprecision and inaccuracy below 15%. Both chromatographic methods have been previously developed and validated30–33 according to the United States Food and Drug Administration’s guidelines for bioanalytical method validation 34…”

Section: Methodsmentioning

confidence: 99%

Combined isosorbide dinitrate and ibuprofen as a novel therapy for muscular dystrophies: evidence from Phase I studies in healthy volunteers

Cossu

Cattaneo

Fucile

et al. 2014

DDDT

View full text Add to dashboard Cite

We designed two Phase I studies that assessed healthy volunteers in order to evaluate the safety and to optimize the dosing of the combination of the drugs isosorbide dinitrate, a nitric oxide donor, and ibuprofen, a nonsteroidal antiinflammatory drug. We designed these studies with the aim of designing a Phase II trial to evaluate the drugs’ efficacy in patients affected by Duchenne muscular dystrophy. For the first trial, ISOFEN1, a single-dose, randomized-sequence, open-label, active control, three-treatment cross-over study, was aimed at comparing the pharmacokinetics of ibuprofen 200 mg and isosorbide dinitrate 20 mg when given alone and concomitantly. The pharmacokinetics of ibuprofen given alone versus ibuprofen given concomitantly with isosorbide dinitrate were similar, as documented by the lack of statistically significant differences in the main drug’s pharmacokinetic parameters (time to maximal concentration [Tmax], maximal concentration [Cmax], area under the curve [AUC]0–t, and AUC0–∞). Similarly, we found that the coadministration of ibuprofen did not significantly affect the pharmacokinetics of isosorbide dinitrate. No issues of safety were detected. The second trial, ISOFEN2, was a single-site, dose titration study that was designed to select the maximum tolerated dose for isosorbide dinitrate when coadministered with ibuprofen. Eighteen out of the 19 enrolled subjects tolerated the treatment well, and they completed the study at the highest dose of isosorbide dinitrate applied (80 mg/day). One subject voluntarily decided to reduce the dose of isosorbide dinitrate from 80 mg to 60 mg. The treatment-related adverse events recorded during the study were, for the large majority, episodes of headache that remitted spontaneously in 0.5–1 hour – a known side effect of isosorbide dinitrate. These studies demonstrate that the combination of isosorbide dinitrate and ibuprofen does not lead to pharmacokinetic interactions between the two drugs; they also demonstrate that the combination of isosorbide dinitrate and ibuprofen has optimal tolerability and safety profiles that are similar to those previously reported for isosorbide dinitrate and ibuprofen given alone.

show abstract

“…2B. Compared with the previous methods [4][5][6][7][8][9][10][11][12][13][14][15][16] regarding the determination of 5-ISMN in human plasma, our method demonstrated a higher sensitivity with an LLOQ of 1.04 ng/mL. The high sensitivity obtained was attributed to the efficient chromatographic separation afforded by the fast LC system with use of 1.7 m particles packed column, which leads to a reduction in the number of co-eluting species and it seems to be particularly advantageous when coupled to ESI-MS, providing a higher spectral purity of peaks and an apparent reduction in ion suppression hence lower limits of detection.…”

Section: Linearity and Lloqmentioning

confidence: 99%

“…The analytical techniques employed in recent years for the quantification of 5-ISMN in human plasma included gas chromatography with electron-capture detection (GC-ECD) [4][5][6][7][8][9][10], GC-MS [11], HPLC [12], HPLC-MS [9,13,14] and HPLC-MS/MS [15,16]. The lower limit of quantification (LLOQ) of all those methods was over 2.3 ng/mL [6].…”

Section: Introductionmentioning

confidence: 99%

High performance liquid chromatography–electrospray ionization mass spectrometric determination of isosorbide 5-mononitrate in human plasma

Sun

Cai

et al. 2007

Journal of Chromatography B

View full text Add to dashboard Cite

Pharmacokinetic profile of a new controlled-release isosorbide-5-mononitrate 60 mg scored tablet (Monoket Multitab®)

Cited by 17 publications

References 23 publications

Isosorbide mononitrate promotes angiogenesis in embryonic development of zebrafish

Isosorbide mononitrate promotes angiogenesis in embryonic development of zebrafish

Combined isosorbide dinitrate and ibuprofen as a novel therapy for muscular dystrophies: evidence from Phase I studies in healthy volunteers

High performance liquid chromatography–electrospray ionization mass spectrometric determination of isosorbide 5-mononitrate in human plasma

Contact Info

Product

Resources

About