Reference

Oral bioavailability of pantoprazole suspended in sodium bicarbonate solution

Oral bioavailability of pantoprazole suspended in sodium bicarbonate solution. Ferron, Geraldine M.; Ku, Sherry; Abell, Madelyn; Unruh, Mary; Getsy, John; Mayer, Philip R.; Paul, Jeffrey (Clinical Pharmacokinetics, Wyeth Research, Collegeville, PA, USA). American Journal of Health-System Pharmacy, 60(13), 1324-1329 (English) 2003 American Society of Health-System Pharmacists. CODEN: AHSPEK. ISSN: 1079-2082. DOCUMENT TYPE: Journal CA Section: 63 (Pharmaceuticals) The bioavailability of pantoprazole when administered as a suspension in sodium bicarbonate soln. and as the oral tablet was studied. In an open-label; randomized, 2-period crossover study, healthy fasting subjects received either one enteric-coated 40-mg pantoprazole tablet by mouth with 240 mL of water or 20 mL of a suspension prepd. from one crushed pantoprazole tablet and 840 mg of sodium bicarbonate soln. and administered via a nasogastric tube. Treatments were sepd. by a 48-h washout period. Blood samples were collected at intervals up to 24 h after drug administration for measurement of pantoprazole concn. by high-performance liq. chromatog.Several substances with their cas registry numbers 144-55-8 and 102625-70-7 may be metioned in this study. (HPLC) and estn. of pharmacokinetic values. A sep. study was conducted to det. pantoprazole's stability in the suspension for up to 3 mo at 25, 5, and -20 °C; concns. were measured by HPLC. Twelve subjects completed the study. The suspension yielded pantoprazole Cmax values similar to those of the tablet formulation, but the drug was 25% less bioavailable. There was no lag time for the suspension. The suspension was stable for up to 2 wk at 5 °C and up to 3 mo at -20 °C. A suspension of pantoprazole in sodium bicarbonate soln. yielded a Cmax similar to that of the tablet formulation, and the drug was quickly absorbed. However, bioavailability was slightly lower with the suspension than with the tablet. .

Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease

Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease. van Zyl, J.; van Rensburg, C.; Vieweg, W.; Fischer, R. (University Hospital, Bloemfontein, S. Afr.Chemicals with cas numbers 102625-70-7 and 66357-35-5 also play role.). Digestion, 70(1), 61-69 (English) 2004 S. Karger AG. CODEN: DIGEBW. ISSN: 0012-2823. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Background/Aim: Gastroesophageal reflux disease (GERD) is a prevalent disease assocd. with a high symptom burden and a reduced quality of life. This multicenter, randomized, double-blind study compared relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) and from other gastrointestinal symptoms (epigastric pain, vomiting, nausea, flatulence, retching, and retrosternal feeling of tightness) and safety profiles of the proton pump inhibitor pantoprazole and the H2 antagonist ranitidine in patients suffering from symptomatic GERD. Methods: The patients [338 intention-to-treat (ITT) population; 284 per-protocol (PP) population] received 20 mg pantoprazole (once daily in the morning) plus ranitidine placebo (once daily in the evening; ITT n = 167, PP n = 136) or pantoprazole placebo (once daily in the morning) plus 300 mg ranitidine (once daily in the evening; ITT n = 171, PP n = 148) for 28 days. The primary efficacy criterion (ITT and PP populations) was relief from key GERD symptoms (heartburn, acid eructation, and pain on swallowing) after 28 days of treatment. Secondary criteria (PP) included relief from key GERD symptoms on day 14, relief from all gastrointestinal symptoms on days 14 and 28, and relief from key GERD symptoms on days 14 and 28. Safety evaluations included adverse events and lab. assessments. Results: Significantly more pantoprazole-treated patients were free from key GERD symptoms at day 28 (68.3%, n = 114) as compared with ranitidine-treated patients (43.3%, n = 74; 95% confidence interval for odds ratio 1.84-4.51). Pantoprazole was also significantly more efficacious in controlling all gastrointestinal symptoms of GERD. By day 28, 51.5% (n = 70) of the pantoprazole-treated patients were completely symptom free vs. 31.1% (n = 46) of the ranitidine-treated patients (95% confidence interval for odds ratio1.45-3.83). Both treatments were well tolerated. Conclusion: Pantoprazole is significantly superior to ranitidine in the treatment of key and assocd. gastrointestinal symptoms of GERD and is well tolerated. .