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Sanjay Garg - One of the best experts on this subject based on the ideXlab platform.
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compatibility studies between Isosorbide Mononitrate and selected excipients used in the development of extended release formulations
Journal of Pharmaceutical and Biomedical Analysis, 2004Co-Authors: Rajan K Verma, Sanjay GargAbstract:Abstract Techniques of thermal and isothermal stress testing (IST) were used to evaluate the compatibility of Isosorbide Mononitrate (IMN) with selected excipients used in the development of extended release formulations. In the first phase of the study, differential scanning calorimeter (DSC) was used as a tool to detect any interaction. In the next phase, excipients defined in the prototype formula were tested for their compatibility with IMN using IST. Based on the results, cellulose acetate and MCC were found to show interaction with IMN. Results of IST demonstrated incompatibility between IMN and cellulose acetate. All the excipients defined in the prototype formula were found to be compatible with IMN. Using the excipients that were found to be compatible with IMN, formulations were optimized. The optimized formulation was found to be stable after 3 months of storage at accelerated stability conditions (40 °C and 75% RH). In conclusion, tools of DSC, and IST were successfully employed to evaluate the compatibility of IMN with selected excipients.
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development and evaluation of extended release formulations of Isosorbide Mononitrate based on osmotic technology
International Journal of Pharmaceutics, 2003Co-Authors: Rajan K Verma, Aditya Mohan Kaushal, Sanjay GargAbstract:Abstract Extended release formulations of Isosorbide Mononitrate (IMN), based on osmotic technology, were developed. Target release profile was selected and different variables were optimized to achieve the same. Formulation variables like type (PVP, PEG-4000, and HPMC) and level of pore former (0–55%, w/w of polymer), percent weight gain were found to affect the drug release from the developed formulations. Drug release was inversely proportional to the membrane weight but directly related to the initial level of pore former in the membrane. Burst strength of the exhausted shells was inversely proportional to the level of pore former, but directly affected by the membrane weight. Satisfactory burst strength (more than 320 g) was obtained when PVP was used as pore former (up to 55%, w/w of polymer) at the membrane weight of 7.5% and more. The release from the developed formulations was independent of pH and agitational intensity, but dependent on the osmotic pressure of the release media. Results of SEM studies showed the formation of pores in the membrane from where the drug release occurred. The formulations were found to be stable after 3 months of accelerated stability studies. Prediction of steady-state levels showed the plasma concentrations of IMN to be within the desired range.
Martina Felder - One of the best experts on this subject based on the ideXlab platform.
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long term results of a clinical trial of nadolol with or without Isosorbide Mononitrate for primary prophylaxis of variceal bleeding in cirrhosis
Hepatology, 2000Co-Authors: Carlo Merkel, R Marin, C Donada, Giorgio Cavallarin, Pierluigi Torboli, Piero Amodio, Giuliana Sebastianelli, David Sacerdoti, Massimo Bolognesi, Martina FelderAbstract:It is clearly established that β-blockers decrease the risk of a first variceal bleeding in cirrhosis. We have recently shown that the addition of Isosorbide Mononitrate to nadolol decreases the rate of variceal bleeding in patients with cirrhosis and varices, compared with nadolol alone, after a median follow-up of 30 months. It is not established if the long-term treatment with the combination continues to be beneficial. Therefore, we assessed the long-term effect of this combination on first variceal bleeding, complications, and death. One hundred forty-six cirrhotic patients with esophageal varices included in a previously published multicenter, randomized study comparing nadolol (40-160 mg/d) with the combination nadolol plus Isosorbide Mononitrate (10-20 mg 3 times per day) were followed up for up to 7 years (median follow-up, 55 months). The primary end-point was variceal bleeding of any severity. Twenty-four patients (16 in the nadolol group, and 8 in the combination group) experienced variceal bleeding (log rank test, P = .02). Cumulative risk of bleeding was 29% and 12%, respectively (95% CI for the difference, 1%-23%). Two and 4 patients, respectively, had bleeding from portal hypertensive gastropathy (log rank test, P = .20). Thirty and 25 patients, respectively, died during follow-up (log rank test, P = .13). Twelve and 10 patients, respectively, had de novo occurrence of ascites during follow-up (log rank test, P = .29). In conclusion, nadolol plus Isosorbide Mononitrate is significantly more effective than nadolol alone in the long-term use. Side effects are few, and no deleterious effects on ascites occurrence or on survival occur after long-term use of this combination.
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randomised trial of nadolol alone or with Isosorbide Mononitrate for primary prophylaxis of variceal bleeding in cirrhosis
The Lancet, 1996Co-Authors: Carlo Merkel, R Marin, E Enzo, C Donada, Giorgio Cavallarin, Pierluigi Torboli, Piero Amodio, Giuliana Sebastianelli, David Sacerdoti, Martina FelderAbstract:Summary Background The risk of having a first cirrhosis-associated variceal bleed is lowered by about 50% by β-blockers. Use of β-blockers is currently recommended for patients with cirrhosis and oesophageal varices that are at risk of bleeding. We aimed to test the effectiveness of Isosorbide Mononitrate as an adjunct to the β-blocker nadolol in the prophylaxis of first variceal bleeding in these patients. Methods We did a randomised multicentre study to compare the non-selective β -blocker, nadolol, with nadolol plus Isosorbide Mononitrate in 146 relatively well (Child-Pugh score ≤11) patients who had oesophageal varices at risk of bleeding. Patients on nadolol alone received a single oral 40 mg daily dose. Every second day the dose was titrated to achieve 20–25% decrease in resting heart rate (maximum dose 160 mg daily). Patients receiving both drugs received nadolol as above then Isosorbide Mononitrate was added starting with 10 mg orally twice daily, which was increased to 20 mg unless hypotension or severe headache occurred. The main endpoint was the occurrence of variceal bleeding of any severity. Patients were followed up for up to 40 months. Findings During the study period 11 of 74 patients from the nadolol alone group and four of 72 from the nadalol plus Isosorbide Mononitrate group had variceal bleeding (logrank test p=0·03). Cumulative risk of variceal bleeding was 18% in the nadolol group and 7·5% in the combined treatment group (95% CI for difference 1–25%). Two patients in each group had a non-variceal bleed related to portal hypertension. 14 patients from the nadolol only group and eight from the combined treatment group died during the study period (log-rank test p=0·09). Four and eight patients, respectively, had to discontinue one of the drugs because of side-effects. Interpretation Nadolol plus Isosorbide Mononitrate is signifcantly more effective than nadolol alone in the primary prophylaxis of variceal bleeding in relatively well patients with cirrhosis, and has few side-effects.
Erling Ekerhovd - One of the best experts on this subject based on the ideXlab platform.
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Outpatient vaginal administration of the nitric oxide donor Isosorbide Mononitrate for cervical ripening and labor induction postterm: a randomized controlled study.
American journal of obstetrics and gynecology, 2020Co-Authors: Maria Bullarbo, Bjorn Andersch, Monica Eriksson Orrskog, Lena Granstrom, Anders Norström, Erling EkerhovdAbstract:Our aim was to examine the efficacy, safety, and acceptability of Isosorbide Mononitrate for cervical ripening and labor induction in women in an outpatient setting. Two hundred pregnant women of at least 42 weeks' gestation with an unripe cervix were randomly selected to receive vaginally either 40 mg Isosorbide Mononitrate or placebo tablets. Twenty-two women treated with Isosorbide Mononitrate went into labor within 24 hours compared to 8 women in the placebo group (P < .05). In women who did not go into labor, cervical status was similar in the 2 groups the next day. Headache was a common side effect. No maternal or fetal side effects of clinical importance were registered. Outpatient cervical ripening and labor induction with Isosorbide Mononitrate seems to be an effective, safe, and well tolerated procedure. The definitive clinical efficacy and safety needs to be evaluated in larger series of patients.
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cervical priming in the first trimester morphological and biochemical effects of misoprostol and Isosorbide Mononitrate
Acta Obstetricia et Gynecologica Scandinavica, 2009Co-Authors: Nina Vukas Radulovic, Erling Ekerhovd, Gun Abrahamsson, A NorstromAbstract:Objective. To evaluate morphological changes and inflammatory events in the uterine cervix following presurgical treatment with the prostaglandin analogue misoprostol or the nitric oxide donor Isosorbide Mononitrate (IMN). Design. Experimental study. Settings. Sahlgrenska University Hospital, Gothenburg, Sweden. Population of sample. Primigravid women (n=32) scheduled for surgical termination of first trimester pregnancy, treated vaginally overnight with either misoprostol (200 µg), IMN (40 mg) or no treatment (controls). Methods. Before evacuation, cervical biopsies were obtained with the use of a Tru-Cut® biopsy needle. Morphology was studied by electron microscopy. For assessment of inflammatory events the expression of the matrix metalloproteinases MMP-1 and MMP-9 was estimated by immunohistochemistry and interleukin IL-8 was quantified by ELISA. Results. Misoprostol induced splitting and disorganization of the collagen fibres. Compared to specimens from women who had received no treatment, the granul...
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Outpatient cervical ripening before first-trimester surgical abortion: a comparison between misoprostol and Isosorbide Mononitrate.
Acta Obstetricia et Gynecologica Scandinavica, 2007Co-Authors: Nina Vukas Radulovic, Anders Norström, Erling EkerhovdAbstract:Background. Vaginal administration of prostaglandin analogues as well as nitric oxide donors before first-trimester surgical abortion has been shown to induce effective cervical ripening. In addition, nitric oxide donors, such as Isosorbide Mononitrate and nitroglycerin, have been associated with a patient-friendly side-effect profile when administered 3 h before the surgical procedure. We wanted to compare the cervical ripening effect and possible side effects of Isosorbide Mononitrate and the prostaglandin analogue misoprostol when self-administered at bedtime the evening before surgical abortion. Methods. One hundred and twenty nulliparous women scheduled for suction termination of pregnancy in the first trimester were randomly assigned to receive per vaginam either 40 mg of Isosorbide Mononitrate or 200 µg of misoprostol. Sixty of the women were included for assessment of cervical ripening as well as evaluation of side effects. The other 60 women were recruited for assessment of side effects only. Cer...
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outpatient vaginal administration of the nitric oxide donor Isosorbide Mononitrate for cervical ripening and labor induction postterm a randomized controlled study
American Journal of Obstetrics and Gynecology, 2007Co-Authors: Maria Bullarbo, Bjorn Andersch, A Norstrom, Monica Eriksson Orrskog, Lena Granstrom, Erling EkerhovdAbstract:Objective Our aim was to examine the efficacy, safety, and acceptability of Isosorbide Mononitrate for cervical ripening and labor induction in women in an outpatient setting. Study design Two hundred pregnant women of at least 42 weeks' gestation with an unripe cervix were randomly selected to receive vaginally either 40 mg Isosorbide Mononitrate or placebo tablets. Results Twenty-two women treated with Isosorbide Mononitrate went into labor within 24 hours compared to 8 women in the placebo group ( P Conclusion Outpatient cervical ripening and labor induction with Isosorbide Mononitrate seems to be an effective, safe, and well tolerated procedure. The definitive clinical efficacy and safety needs to be evaluated in larger series of patients.
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vaginal administration of the nitric oxide donor Isosorbide Mononitrate for cervical ripening at term a randomized controlled study
American Journal of Obstetrics and Gynecology, 2003Co-Authors: Erling Ekerhovd, Maria Bullarbo, Bjorn Andersch, A NorstromAbstract:OBJECTIVE: Our aim was to examine the effect of the nitric oxide donor Isosorbide Mononitrate on the uterine cervix at term and to evaluate possible adverse effects of this treatment. STUDY DESIGN: Term pregnant women were randomly selected to receive either 40 mg vaginally administered Isosorbide Mononitrate or placebo 4 hours before elective cesarean section. Cervical status, maternal blood pressure, maternal pulse rate, fetal heart rate, umbilical arterial Doppler indices, and various side effects were examined. RESULTS: Isosorbide Mononitrate induced a significant increase in cervical distensibility. It also caused a significant change in maternal blood pressure and maternal pulse rate. In addition, the frequency of maternal headache and palpitations was significantly higher in the Isosorbide Mononitrate group versus the placebo group. However, the intensity of these symptoms was moderate. CONCLUSION: Vaginal administration of 40 mg of Isosorbide Mononitrate induces cervical ripening at term. Although the majority of women experienced side effects, no serious clinical maternal or fetal adverse effects, resulting in specific medication or emergency cesarean section, were diagnosed.
A Norstrom - One of the best experts on this subject based on the ideXlab platform.
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cervical priming in the first trimester morphological and biochemical effects of misoprostol and Isosorbide Mononitrate
Acta Obstetricia et Gynecologica Scandinavica, 2009Co-Authors: Nina Vukas Radulovic, Erling Ekerhovd, Gun Abrahamsson, A NorstromAbstract:Objective. To evaluate morphological changes and inflammatory events in the uterine cervix following presurgical treatment with the prostaglandin analogue misoprostol or the nitric oxide donor Isosorbide Mononitrate (IMN). Design. Experimental study. Settings. Sahlgrenska University Hospital, Gothenburg, Sweden. Population of sample. Primigravid women (n=32) scheduled for surgical termination of first trimester pregnancy, treated vaginally overnight with either misoprostol (200 µg), IMN (40 mg) or no treatment (controls). Methods. Before evacuation, cervical biopsies were obtained with the use of a Tru-Cut® biopsy needle. Morphology was studied by electron microscopy. For assessment of inflammatory events the expression of the matrix metalloproteinases MMP-1 and MMP-9 was estimated by immunohistochemistry and interleukin IL-8 was quantified by ELISA. Results. Misoprostol induced splitting and disorganization of the collagen fibres. Compared to specimens from women who had received no treatment, the granul...
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outpatient vaginal administration of the nitric oxide donor Isosorbide Mononitrate for cervical ripening and labor induction postterm a randomized controlled study
American Journal of Obstetrics and Gynecology, 2007Co-Authors: Maria Bullarbo, Bjorn Andersch, A Norstrom, Monica Eriksson Orrskog, Lena Granstrom, Erling EkerhovdAbstract:Objective Our aim was to examine the efficacy, safety, and acceptability of Isosorbide Mononitrate for cervical ripening and labor induction in women in an outpatient setting. Study design Two hundred pregnant women of at least 42 weeks' gestation with an unripe cervix were randomly selected to receive vaginally either 40 mg Isosorbide Mononitrate or placebo tablets. Results Twenty-two women treated with Isosorbide Mononitrate went into labor within 24 hours compared to 8 women in the placebo group ( P Conclusion Outpatient cervical ripening and labor induction with Isosorbide Mononitrate seems to be an effective, safe, and well tolerated procedure. The definitive clinical efficacy and safety needs to be evaluated in larger series of patients.
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vaginal administration of the nitric oxide donor Isosorbide Mononitrate for cervical ripening at term a randomized controlled study
American Journal of Obstetrics and Gynecology, 2003Co-Authors: Erling Ekerhovd, Maria Bullarbo, Bjorn Andersch, A NorstromAbstract:OBJECTIVE: Our aim was to examine the effect of the nitric oxide donor Isosorbide Mononitrate on the uterine cervix at term and to evaluate possible adverse effects of this treatment. STUDY DESIGN: Term pregnant women were randomly selected to receive either 40 mg vaginally administered Isosorbide Mononitrate or placebo 4 hours before elective cesarean section. Cervical status, maternal blood pressure, maternal pulse rate, fetal heart rate, umbilical arterial Doppler indices, and various side effects were examined. RESULTS: Isosorbide Mononitrate induced a significant increase in cervical distensibility. It also caused a significant change in maternal blood pressure and maternal pulse rate. In addition, the frequency of maternal headache and palpitations was significantly higher in the Isosorbide Mononitrate group versus the placebo group. However, the intensity of these symptoms was moderate. CONCLUSION: Vaginal administration of 40 mg of Isosorbide Mononitrate induces cervical ripening at term. Although the majority of women experienced side effects, no serious clinical maternal or fetal adverse effects, resulting in specific medication or emergency cesarean section, were diagnosed.
Carlos Guarner - One of the best experts on this subject based on the ideXlab platform.
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endoscopic ligation compared with combined treatment with nadolol and Isosorbide Mononitrate to prevent recurrent variceal bleeding
The New England Journal of Medicine, 2001Co-Authors: Candid Villanueva, German Soriano, S Sainz, Xavier Torras, X Cusso, Josep Minana, Jordi Ortiz, Adolfo Gallego, Jaume Boadas, Carlos GuarnerAbstract:Background After an episode of acute bleeding from esophageal varices, patients are at high risk for recurrent bleeding and death. We compared two treatments to prevent recurrent bleeding — endoscopic ligation and combined medical therapy with nadolol and Isosorbide Mononitrate. Methods We randomly assigned 144 patients with cirrhosis who were hospitalized with esophageal variceal bleeding to receive treatment with endoscopic ligation (72 patients) or the combined medical therapy (72 patients). Sessions of ligation were repeated every two to three weeks until the varices were eradicated. The mean (±SD) dose of nadolol was 96±56 mg per day, and the mean dose of Isosorbide was 66±22 mg per day. The primary end points were recurrent bleeding, complications, and death. Results The median follow-up period was 21 months. A total of 35 patients in the ligation group and 24 in the medication group had recurrent bleeding. The probability of recurrence was lower in the medication group, both for all episodes relate...
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nadolol plus Isosorbide Mononitrate compared with sclerotherapy for the prevention of variceal rebleeding
The New England Journal of Medicine, 1996Co-Authors: Candid Villanueva, Joaquim Balanzo, Maria Teresa Novella, German Soriano, S Sainz, Xavier Torras, X Cusso, Carlos Guarner, F VilardellAbstract:Background Patients who have bleeding from esophageal varices are at high risk for rebleeding and death. We compared the efficacy and safety of endoscopic sclerotherapy with the efficacy and safety of nadolol plus Isosorbide Mononitrate for the prevention of variceal rebleeding. Methods Eighty-six hospitalized patients with cirrhosis and bleeding from esophageal varices diagnosed by endoscopy were randomly assigned to treatment with repeated sclerotherapy (43 patients) or nadolol plus Isosorbide-5-Mononitrate (43 patients). The primary outcomes were rebleeding, death, and complications. The hepatic venous pressure gradient was measured at base line and after three months. Results Base-line data were similar in the two groups, and the median follow-up was 18 months in both. Eleven patients in the medication group and 23 in the sclerotherapy group had rebleeding. The actuarial probability of remaining free of rebleeding was higher in the medication group for all episodes related to portal hypertension (P = ...