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A simple, sensitive, and straightforward LC-MS approach for rapid analysis of three potential genotoxic impurities in rabeprazole formulations

Yenugu VMR, Ambavaram VBR, Moniruzzaman M, Madhavi G

J Sep Sci, 2018 Nov;41(21):3966-3973.
PMID: 30138541 DOI: 10.1002/jssc.201800626

In the present study, a sensitive and fully validated liquid chromatography with mass spectrometry method was developed for the quantification of three potential genotoxic impurities in rabeprazole drug substance. The separation was achieved on Symmetry C18 column (100 × 4.6 mm, 3.5 μm) using 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B in gradient elution mode at 0.5 mL/min flow rate. Triple quadrupole mass detection with electrospray ionization was operated in selected ion recording mode for the quantification of impurities. The calibration curves were demonstrated good linearity over the concentration range of 1.0-4.5 ppm for O-phenylenediamine, 1.8-4.5 ppm for 4-nitrolutidine-N-oxide and 1.0-4.5 ppm for benzyltriethylammonium chloride with respect to 10 mg/mL of rabeprazole. The correlation coefficient obtained in each case was >0.998. The recoveries were found satisfactory over the range between 94.22 and 106.84% for all selected impurities. The method validation was carried out following International Conference on Harmonization guidelines, from which the developed method was able to quantitate the impurities at 1.0 ppm for O-phenylenediamine, 1.8 ppm for 4-nitrolutidine-N-oxide and 1.0 ppm for benzyltriethylammonium chloride. Furthermore, the proposed method was successfully evaluated for the determination of selected impurities from bulk drug and formulation samples of rabeprazole within the acceptable limits.

Matched MeSH terms: Rabeprazole/toxicity; Rabeprazole/chemistry*
Fulltext Commentary: rabeprazole improves symptoms in patients with functional dyspepsia in Japan

Yap PR, Mahadeva S, Goh KL

Aliment Pharmacol Ther, 2013 Nov;38(10):1321-2.
PMID: 24134501 DOI: 10.1111/apt.12497
Matched MeSH terms: Rabeprazole/therapeutic use*
Stomach specific polymeric low density microballoons as a vector for extended delivery of rabeprazole and amoxicillin for treatment of peptic ulcer

Choudhary S, Jain A, Amin MCIM, Mishra V, Agrawal GP, Kesharwani P

Colloids Surf B Biointerfaces, 2016 May 01;141:268-277.
PMID: 26859118 DOI: 10.1016/j.colsurfb.2016.01.048

The study was intended to develop a new intra-gastric floating in situ microballoons system for controlled delivery of rabeprazole sodium and amoxicillin trihydrate for the treatment of peptic ulcer disease. Eudragit S-100 and hydroxypropyl methyl cellulose based low density microballoons systems were fabricated by employing varying concentrations of Eudragit S-100 and hydroxypropyl methyl cellulose, to which varying concentrations of drug was added, and formulated by stirring at various speed and time to optimize the process and formulation variable. The formulation variables like concentration and ratio of polymers significantly affected the in vitro drug release from the prepared floating device. The validation of the gastro-retentive potential of the prepared microballoons was carried out in rabbits by orally administration of microballoons formulation containing radio opaque material. The developed formulations showed improved buoyancy and lower ulcer index as compared to that seen with plain drugs. Ulcer protective efficacies were confirmed in ulcer-bearing mouse model. In conclusion, greater compatibility, higher gastro-retention and higher anti-ulcer activity of the presently fabricated formulations to improve potential of formulation for redefining ulcer treatment are presented here. These learning exposed a targeted and sustained drug delivery potential of prepared microballoons in gastric region for ulcer therapeutic intervention as corroborated by in vitro and in vivo findings and, thus, deserves further attention for improved ulcer treatment.

Matched MeSH terms: Rabeprazole/administration & dosage; Rabeprazole/pharmacokinetics*; Rabeprazole/chemistry
Fulltext High-dose rabeprazole-amoxicillin dual therapy and rabeprazole triple therapy with amoxicillin and levofloxacin for 2 weeks as first and second line rescue therapies for Helicobacter pylori treatment failures

Goh KL, Manikam J, Qua CS

Aliment Pharmacol Ther, 2012 May;35(9):1097-102.
PMID: 22404486 DOI: 10.1111/j.1365-2036.2012.05054.x

BACKGROUND:
H. pylori eradication failures are difficult to treat and rescue therapies often consist of complex treatment regimens.

AIM:
To determine an effective and practical rescue therapeutic strategy for H. pylori treatment failures using two consecutive regimens: first rescue therapy - rabeprazole 20 mg t.d.s. and amoxicillin 1 g t.d.s. for 2 weeks and for failures a further second rescue therapy - rabeprazole 20 mg b.d., levofloxacin 500 mg b.d., amoxicillin 1 g b.d. for a further 2 weeks.

METHODS:
Consecutive patients who failed the proton pump inhibitor (PPI) 1-week triple therapy were recruited for the study. H. pylori status was determined by a C(13) urea breath test.

RESULTS:
One hundred and forty-nine patients received the first rescue therapy. Seven were not compliant to medication/defaulted follow-up. Eradication success- first rescue therapy: per protocol (PP) analysis-107/142 (75.4%) (95% CI (68.3-82.4%) and intention to treat (ITT) analysis-107/149 (71.8%) 95% CI (64.6-79.0%). Thirty-one of 35 patients who failed the first rescue therapy received the second rescue therapy. All were compliant with medications. Eradication success- PP and ITT was 28/31 (90.3%) 95% CI (74.2-98.0%). The cumulative eradication rate using both rescue therapies: PP analysis- 135/138 (97.8%) 95% CI: (93.8-99.6%), ITT analysis- 135/149 (90.6%) 95% CI: (84.7-94.8%).

CONCLUSIONS:
A 2-week high dose PPI-amoxicillin dual therapy followed by a PPI-amoxicillin-levofloxacin triple therapy were highly successful in achieving eradication in H. pylori treatment failures.

Matched MeSH terms: Rabeprazole/administration & dosage; Rabeprazole/therapeutic use
Searching for an optimal therapy for H pylori eradication: High-dose proton-pump inhibitor dual therapy with amoxicillin vs. standard triple therapy for 14 days

Hwong-Ruey Leow A, Chang JV, Goh KL

Helicobacter, 2020 Oct;25(5):e12723.
PMID: 32713104 DOI: 10.1111/hel.12723

BACKGROUND & AIMS: We compared a high-dose dual therapy (HDDT) with rabeprazole and amoxicillin and compared it with a standard triple therapy (STT) with rabeprazole, amoxicillin, and clarithromycin for 2 weeks for H pylori eradication in treatment naïve patients.
METHODS: H pylori-positive patients were randomly assigned to either a rabeparzole (Pariet) 20 mg b.i.d., amoxicillin (Ospamox) 1 g b.i.d. and clarithromycin (Klacid) 500 mg b.i.d. for 14 days or rabeprazole (Pariet) 20 mg q.i.d., amoxicillin (Ospamox) 1 g q.i.d. also for 14 days. Eradication was tested for by the C13 -UBT at least 4 weeks after the completion of therapy.
RESULTS: H pylori was eradicated in 86.2% of patients (81/94) (95% CI: 77.8-91.7) in the STT group compared with 92.8% (90/97) (95% CI: 85.9-96.5) in the HDDT group on ITT analysis. On PP analysis, H pylori was eradicated in 91.0% of patients (81/89) (95% CI: 83.3-95.4) in the STT group compared with 93.8% (90/96) (95% CI: 87.0-97.1) in the HDDT group. Side effects were few although many patients in the STT arm complained of bitter taste. The HDDT arm was well tolerated by patients.
CONCLUSIONS: The HDDT gave a high eradication rate comparable to the STT for 2 weeks and was a well-tolerated regimen for H pylori eradication.

Matched MeSH terms: Rabeprazole/administration & dosage*
Non-erosive reflux disease (NERD), symptomatic and asymptomatic erosive reflux disease (ERD): from hypersensitive to hyposensitive esophagus

Hartono JL, Qua CS, Goh KL

Dig Dis Sci, 2011 Jan;56(1):90-6.
PMID: 20467897 DOI: 10.1007/s10620-010-1275-5

AIMS: To compare the esophageal sensitivity to acid and saline in patients with symptomatic and asymptomatic erosive reflux disease (ERD), non-erosive reflux disease (NERD) and controls, and to assess the response to proton-pump inhibitors in patients with symptomatic ERD and NERD.
METHODOLOGY: Patients with GERD and a control group of healthy asymptomatic volunteers were recruited. All subjects underwent esophagogastroduodenoscopy and the acid-saline perfusion test. Symptomatic ERD and NERD patients were given rabeprazole 20 mg twice daily for 2 weeks and their response to treatment assessed.
RESULTS: A total of 105 subjects were recruited: ERD=37 (symptomatic=24, asymptomatic=13), NERD=34 and controls=34. During saline perfusion, only the NERD group recorded a significantly higher sensitivity score compared to controls (2.74±7.28 vs. 0) (p=0.035). During acid perfusion, symptomatic ERD (15.42±13.42) and NERD (16.71±15.04) had significantly higher scores versus controls and asymptomatic ERD patients (both p<0.001). The mean %∆ reflux symptom score following treatment was significantly higher in symptomatic ERD patients compared to NERD patients (89.08±21.67 vs. 58.53±32.54; p<0.001).
CONCLUSIONS: Patients with NERD were a generally hypersensitive group while asymptomatic ERD patients represent a hyposensitive group of patients which merits further study.

Matched MeSH terms: Rabeprazole
Non-cardiac chest pain: prevalence of reflux disease and response to acid suppression in an Asian population

Mohd H, Qua CS, Wong CH, Azman W, Goh KL

J Gastroenterol Hepatol, 2009 Feb;24(2):288-93.
PMID: 19054255 DOI: 10.1111/j.1440-1746.2008.05702.x

Gastroesophageal reflux disease is thought to be the commonest cause of 'non-cardiac chest pain'. The use of proton-pump inhibitors resulting in improvement in the chest pain symptom would support this causal association.

Matched MeSH terms: Rabeprazole
East Asian perspective on the interaction between proton pump inhibitors and clopidogrel

Zou D, Goh KL

J Gastroenterol Hepatol, 2017 Jun;32(6):1152-1159.
PMID: 28024166 DOI: 10.1111/jgh.13712

Both proton pump inhibitors (PPIs) and clopidogrel are widely prescribed in the Asia-Pacific population. PPIs are the mainstay therapeutic agents for prophylaxis against aspirin gastropathy and for acid-related disorders including gastroesophageal reflux disease. They are also co-prescribed with oral anticoagulant agents and with dual-antiplatelet therapy for the treatment and prevention of gastrointestinal bleeding. Clopidogrel belongs to the drug class of thienopyridines and is currently the most widely prescribed oral anticoagulant agent either alone or in combination with aspirin. Platelet inhibition by clopidogrel is prone to significant inter-individual variability and is believed to be affected by several factors such as genetics and drug-drug interactions. Since it was first reported in 2009, the potential for drug-drug interactions between PPIs and clopidogrel has remained headline news, and its significance in clinical practice is the subject of an ongoing debate. For East Asian patients in particular, the clinical relevance of the interaction between PPIs and clopidogrel remains unclear because of conflicting data, as well as underrepresentation of East Asian subjects in landmark trials. Increased CYP2C19 genetic polymorphisms in individuals from Asia-Pacific countries only fuel the confusion. Recent studies in East Asian cohorts suggests that the potential of PPIs to attenuate the efficacy of clopidogrel could be minimized by the use of newer PPIs with weaker affinity for the CYP2C19 isoenzyme, namely, pantoprazole, dexlansoprazole, and rabeprazole. This review aims to help clinicians choose the most appropriate PPI for co-prescription with clopidogrel in patients from Asia-Pacific countries.

Matched MeSH terms: Rabeprazole