Rabeprazole

This study reports the reliability and validity of the distress subscale of the GERD Symptom Assessment Scale (GSAS) and the acute SF-36 Health Survey in a clinical trial setting. Patients with moderately severe GERD completed the GSAS and SF-36 at baseline and four weeks following treatment. The age (mean +/- SD) of the 187 patients was 45.5 +/- 11.1 years and most were female (63%) and Caucasian (78%). All scales met the 0.70 reliability criterion except for the SF-36 bodily pain scale. Mean baseline GSAS scores were significantly (P < 0.001) poorer by 10-17% among patients reporting more severe levels of all symptoms. Mean baseline SF-36 physical component summary scores were significantly (P < 0.02) poorer among patients reporting more severe levels of regurgitation, early satiety, bloating, and nausea. Patients reporting complete and satisfactory heartburn relief reported improvements in GSAS scores that were 13% and 10% greater, respectively, than patients who did not ex...

Chemometric stability indicating methods are presented for the determination of rabeprazole sodium in presence of its acid induced degradation products using spectrophotometry, differential pulse polarography and differential pulse anodic voltammetry at a glassy carbon electrode. The applied chemometric techniques are multivariate ones including classical least squares (CLS), principal component regression (PCR) and partial least squares (PLS). A difference spectrophotometric (DeltaA) method has also been applied. To develop the multivariate calibrations, a training set was used, consisting of 20 mixture solutions of rabeprazole sodium and its degradation products. These mixtures show percentage degradation ranging from 0.5-65%, 0.5-95% and 0.6-75% for the spectrophotometric, polarographic and anodic voltammetric calibrations, respectively. The UV absorbances were recorded in 0.1 M NaOH within the wavelength range 220-340 nm at 2 nm intervals. The polarograms and anodic voltammogram...

A stability-indicating thin layer chromatographic (TLC) method for determination of dexrabeprazole (DEX) and domperidone (DOM) in combined dosage form has been developed and validated. The mobile phase selected was acetone:toluene:methanol (4.5:4.5:0.5, v/v/v) with ultraviolet (UV) detection at 285 nm. The retention factors for DEX and DOM were found to be 0.49 ± 0.02 and 0.24 ± 0.03, respectively. The method was validated with respect to linearity, accuracy, precision, and robustness. The linearity range for DEX was 50–350 ng/band (r 2 = .9960) and for DOM was 100–700–n /band (r 2 = .9982), respectively. The method was successfully applied for the analysis of drugs in pharmaceutical formulation.

This study reports the reliability and validity of the distress subscale of the GERD Symptom Assessment Scale (GSAS) and the acute SF-36 Health Survey in a clinical trial setting. Patients with moderately severe GERD completed the GSAS and SF-36 at baseline and four weeks following treatment. The age (mean ± sd) of the 187 patients was 45.5 ± 11.1 years and most were female (63%) and Caucasian (78%). All scales met the 0.70 reliability criterion except for the SF-36 bodily pain scale. Mean baseline GSAS scores were significantly (P poorer by 10–17% among patients reporting more severe levels of all symptoms. Mean baseline SF-36 physical component summary scores were significantly (P poorer among patients reporting more severe levels of regurgitation, early satiety, bloating, and nausea. Patients reporting complete and satisfactory heartburn relief reported improvements in GSAS scores that were 13% and 10% greater, respectively, than patients who did not experience these levels of relief (P . In conclusion, the GSAS and SF-36 scales were reliable and valid measures in this clinical trial. Differences of 10% in GSAS distress scores correspond to differences in symptom severity at a point in time and to changes in symptom severity over time. The SF-36 was not as useful in detecting differences in symptom severity over time.

There is controversy about the efficacy of treating patients with laryngopharyngeal reflux (LPR) using proton pump inhibitors (PPIs). We assessed the effects of high doses of the PPI rabeprazole in patients with LPR.Patients with LPR symptoms were assigned randomly to receive rabeprazole (20 mg, twice daily, n = 42) or placebo (n = 40) for 12 weeks. All patients completed symptom questionnaires; these provided demographic information and the reflux symptom index before, during, and 6 weeks after cessation of treatment. Videolaryngostroboscopy was used to document the laryngeal findings and determine the reflux finding score.Twenty-four patients (57.1%) in the rabeprazole group and 27 patients (67.5%) in the placebo group had pH-documented LPR. The total reflux symptom index score decreased significantly in the group given rabeprazole, compared with patients given placebo, at weeks 6 and 12, but not at week 18. However, there were no significant differences in reflux finding scores between the rabeprazole and placebo groups at any of the time points.Twelve weeks of treatment with rabeprazole (20 mg, twice daily) significantly improved reflux symptoms, compared with placebo, in patients with LPR. Relapse of symptoms was observed 6 weeks after stopping PPI therapy, indicating the requirement for longer treatment duration in patients with LPR.

The purpose of this study was to assess the effect of rabeprazole 20 mg once a day on patient-reported health-related quality of life in routine clinical practice. Patients with erosive gastroesophageal reflux disease participating in an open-label, 8-week study completed the SF-36 Health Survey before and after treatment with rabeprazole. For all SF-36 scales, there was a statistically significant (p < or = 0.007) improvement in mean scores from baseline to week 8. Improvements in each of the subscales, except for physical functioning, general health, and mental health, were at least 5% in magnitude, a level considered clinically meaningful. Furthermore, while baseline scores were significantly poorer than general United States population scores, follow-up scores for four of the subscales (role limitations due to physical problems, social functioning, role limitations due to emotional problems, and mental health) were comparable to general population scores. In conclusion, rabep...

A highly selective, sensitive and accurate HPLC method has been developed and validated for the estimation of four proton-pump inhibitors (PPI), lansoprazole (LPZ), omeprazole (OPZ), pantoprazole (PPZ) and rabeprazole (RPZ), with 500 µL human plasma using zonisamide as an internal standard (IS). The sample preparation involved simple liquid–liquid extraction of LPZ, OPZ, PPZ and RPZ and IS from human plasma with ethyl acetate. The baseline separation of all the peaks was achieved with 0.1% triethylamine (pH 6.0):acetonitrile (72:28, v/v) at a flow rate of 1 mL/min on a Zorbax C8 column. The total chromatographic run time was 11.0 min and the simultaneous elution of IS, OPZ, RPZ, PPZ and LPZ occurred at approximately 2.42, 4.45, 5.02 and 9.37 min, respectively. The method was proved to be accurate and precise at linearity range of 20.61–1999.79 ng/mL with a correlation coefficient (r) of ≥0.999. The limit of quantitation for each of the PPI studied was 20.61 ng/mL. The intra- and inter-day precision and accuracy values were found to be within the assay variability limits as per the FDA guidelines. The developed assay method was applied to a pharmacokinetic study in human volunteers. Copyright © 2009 John Wiley & Sons, Ltd.

Aim:  To developing, stability indicating validating bioanalytical method for the estimation of Levosulpiride and Rabeprazole Sodium by RP-HPLC method which is expected to be accurate, precise, linear, stable and selective Methods of measuring drugs in biologic media are increasingly important problems related to bioavailability and bioequivalence, new drug development, drug abuse, clinical pharmacokinetics, and drug research are highly dependent on accurately measured drugs in biological fluids.
Method: to development of New Bioanalytical method for estimation in combined oral solid formulation of Levosulpiride and Rabeprazole Sodium. Stationary phase Hibra C18(250×4.6 mm i.d.,5µ) column at wavelength of 240nm. Using 10mM ammonium acetate is mobile phase in an isocratic elution mode at a flow ratio 0.8ml/min.
Result: the retention time of Levosulpiride and Rabeprazole Sodium were 9.92 and 4.27min respectively and internal standard RT was 12.04min, therefore no interference between internal standard and drug peaks. Quantitation was achieved with UV detect in at 240nm based on peak areas with linearity concentration ranges 0.024-2.4 µg/ml for levosulpiride, 0.024-1.24 µg/ml for rabeprazole sodium (R2 value 0.9985 and 0.9993). The LOD’s were 0.003µg/ml, LOQ’s found to be 0.009µg/ml and 0.01µg/ml respectively.
Conclusion: the developed method for the estimation of Levosulpiride and Rabeprazole in plasma is rugged, rapid, sensitive, precise, selective and linear and is therefore, can be employed for a bioequivalence study to evaluate its applicability further.

                  Key words: levosulpiride, rabeprazole, amisulpiride, RP-HPLC.

Background  A trial of empirical PPI therapy is usual practice for most patients with symptoms of gastro-oesophageal reflux disease (GERD) in primary care.Aim  To determine if the 4-week efficacy of rabeprazole 20 mg for resolving heartburn and regurgitation symptoms is non-inferior to esomeprazole 40 mg or 20 mg.Methods  In all, 1392 patients were randomized to rabeprazole 20 mg, esomeprazole 20 mg or 40 mg once daily. Patients, doctors and assessors were blinded. Symptom resolution data were collected on days 0–7 and day-28 using the Patient Assessment of Upper Gastrointestinal Disorders Symptom Severity Index with a shortened version used on days 8–27.Results  Rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete resolution of regurgitation and satisfactory resolution of heartburn and regurgitation. For complete heartburn resolution, the efficacy of rabeprazole 20 mg and esomeprazole 40 mg was statistically indistinguishable, although the non-inferiority test was inconclusive. Rabeprazole 20 mg was non-inferior to esomeprazole 20 mg for all outcomes.Conclusions  In uninvestigated GERD patients, rabeprazole 20 mg was non-inferior to esomeprazole 40 mg for complete and satisfactory relief of regurgitation and satisfactory relief of heartburn, and not different for complete resolution of heartburn.

OBJECTIVE This study was conducted to assess the effect of combination treatment of quinine and rabeprazole in the treatment of uncomplicated Plasmodium falciparum malaria. METHODS The study included 50 patients of uncomplicated P. falciparum malaria. Group 1 (25 patients) received quinine and placebo (Q+P) while Group 2 (25 patients) received quinine and rabeprazole (Q+R). Diagnosis was confirmed by peripheral blood film (PBF) and rapid diagnostic test (RDT). Temperature was recorded every 6 h. All patients were followed-up on Days 7, 14, 21, 28 for detailed clinical and parasitological examination. RESULTS A total of 20 patients in each group completed the treatment and followed-up for 28 days. While two patients in Group 1 (Q+P) and one patient in Group 2 (Q+R) were lost in follow-up; and seven (Q+P = 4, Q+R =3) patients were withdrawn from the study. Fever clearance time (FCT) of the two groups was also almost similar (Group 1 : 2 = 52.8 : 51.3 h). No statistically significant d...

To compare efficacy and tolerability of four proton pump inhibitors (PPIs) commonly used in the short-term therapy of esophagitis in elderly patients. A total of 320 patients over 65 years with endoscopically diagnosed esophagitis were randomly assigned to one of the following treatments for 8 wk: (1) omeprazole 20 mg/d; (2) lansoprazole 30 mg/d; (3) pantoprazole 40 mg/d, or (4) rabeprazole 20 mg/d. Major symptoms, compliance, and adverse events were recorded. After 8 wk, endoscopy and clinical evaluation were repeated. Per protocol and intention to treat healing rates of esophagitis were: omeprazole = 81.0% and 75.0%, lansoprazole = 90.7% (P = 0.143 vs omeprazole) and 85.0%, pantoprazole = 93.5% (P = 0.04 vs omeprazole) and 90.0% (P = 0.02 vs omeprazole), rabeprazole = 94.6% (P = 0.02 vs omeprazole) and 88.8% (P = 0.04 vs omeprazole). Dividing patients according to the grades of esophagitis, omeprazole was significantly less effective than the three other PPIs in healing grade 1 es...

Gastroesophageal reflux disease (GERD) is characterized by heartburn and related symptoms that are distressing to patients and interfere with everyday functioning and well-being. A measure of symptom distress, the GERD Symptom Assessment Scale (GSAS), was included in two randomized, placebo-controlled trials of rabeprazole among patients with nonerosive GERD. The age (mean ± SD) of the 223 patients was 43.5 ± 11.9 years, and most were female (67%) and Caucasian (78%). Significantly greater reductions in symptom distress were observed among patients receiving rabeprazole 20 mg daily for 4 weeks relative to those receiving placebo (−0.62 vs −0.36, P P GERD. Rabeprazole significantly reduced the distress associated with a broad range of GERD symptoms, and the magnitude of this effect was meaningful to patients.