scholarly journals Quality by Design Applied Development of Immediate-Release Rabeprazole Sodium Dry-Coated Tablet

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 259
Author(s):  
Sang-Ho Lee ◽  
Joo-Eun Kim
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Proton Pump ◽  
Reflux Disease ◽  
Quality By Design ◽  
Inner Core ◽  
Immediate Release ◽  
Pharmaceutical Dosage Form ◽  
Coated Tablet ◽  
Rabeprazole Sodium

The aim of this study was to develop immediate-release oral rabeprazole sodium tablets with rapid efficacy and gastric stability for the treatment of gastroesophageal reflux disease. Rabeprazole sodium is a commonly prescribed proton pump inhibitor; however, it is extremely unstable and degrades in acidic environments. Hence, it has been manufactured and supplied only in enteric-coated tablet form, while immediate-release (IR) formulations for this drug are very limited. In this study, we applied the quality by design (QbD) approach to formulate and optimize an IR dry-coated tablet containing rabeprazole sodium as an inner core with an outer sodium bicarbonate layer to stabilize the active pharmaceutical ingredient at gastric pH. We also investigated the stability of the pharmaceutical dosage form and its pharmacokinetic profile. The results show that the developed tablets are stable for approximately 12 months and have a high dissolution rate, greater than or equal to 90% at 30 min. Further, in vivo beagle pharmacokinetics confirmed that the newly developed IR tablet had an AUCt which is bioequivalent to the existing delayed-release rabeprazole tablet; however, its Tmax was 0.5 h, which is up to seven times faster than that of the existing tablet. Moreover, the IR tablet was found to immediately absorb in the stomach. Hence, the development of IR tablets can be used as a platform to overcome the technical and commercial limitations currently associated with various proton pump inhibitors used to treat patients with gastroesophageal reflux disease that require immediate therapeutic relief.

Potential reasons for proton pump inhibitor failure in the treatment of gastroesophageal reflux disease

2008 ◽  
Vol 149 (40) ◽  
pp. 1881-1888 ◽  
Author(s):  
Márk Juhász ◽  
Zsolt Tulassay
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Proton Pump Inhibitor ◽  
Gastroesophageal Reflux ◽  
Proton Pump ◽  
Reflux Disease

A protonpumpagátlók (protonpumpa-inhibitorok, PPI) bevezetése új fejezetet nyitott a gastrooesophagealis refluxbetegség (gastroesophageal reflux disease, GERD) kezelésében. A betegek kisebb, de nem jelentéktelen hányadában azonban a PPI sem hatékony. Ilyen esetekben az első kérdés mindig az, hogy a tünetek valóban GERD-nek tulajdoníthatók-e, vagy egyéb betegség után kell kutatnunk. Ha a GERD a legvalószínűbb lehetőség, akkor a további vizsgálatok és a több támadáspontú kezelés előtt fel kell térképeznünk a beteg együttműködését (compliance). Ha az eredménytelen PPI-kezelés hátterében nem helytelenül kezelt GERD áll, akkor számos egyéb kórkép lehetőségét is fel kell vetnünk. Összefoglaló közleményünkben az elkülönítő diagnosztikai kérdésekről adunk áttekintést.

scholarly journals Profile of the Change in Depression during Proton-Pump Inhibitor Therapy in Patients with Gastroesophageal Reflux Disease: Influence of the Mucosal Break

2021 ◽  
Vol 18 (11) ◽  
pp. 5964
Author(s):  
Chia-Liang Wu ◽  
Chien-Lin Chen ◽  
Shu-Hui Wen
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Proton Pump ◽  
Reflux Disease ◽  
Proton Pump Inhibitor Therapy ◽  
Linear Regression Models ◽  
Independent Variable ◽  
The Difference ◽  
Mucosal Break ◽  
The Impact

Given the frequent concomitance between depression and gastroesophageal reflux disease (GERD), it is important to evaluate the change of depression in patients with GERD, especially considering the presence of esophageal mucosal breaks (MB). This study aimed to examine the change in the levels of depression in patients with GERD during proton-pump inhibitors (PPI) therapy. We designed a prospective cohort study to explore the profile of the alteration in depression with respect to the impact of esophageal MB. This study recruited 172 eligible patients with GERD between February 2016 and May 2018. The change in depression was defined as the difference between the respective Taiwanese Depression Questionnaire (TDQ) scores obtained at baseline and after PPI therapy. Multivariate linear regression models were used to estimate the factors associated with the change in depression. The results revealed statistically significant improvements in the TDQ score (mean score: baseline = 13.2, after PPI therapy = 10.9, p < 0.01, Cohen’s d = 0.30) during PPI therapy for GERD. Moreover, the MB was an independent variable associated with changes in the TDQ score [B = 3.31, 95% confidence interval (CI): (1.12, 5.51), p < 0.01] and the improvement in depression [odds ratio = 0.38, 95% CI: (0.17, 0.86), p = 0.02]. Our findings revealed that depressive symptoms improved slightly following PPI therapy. Moreover, MB was an unfavorable prognostic factor for the improvement in depression.

675 FUNDOPLICATION VERSUS ORAL PROTON PUMP INHIBITORS FOR GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Luca Schiliró Tristão ◽  
Francisco Tustumi ◽  
Guilherme Tavares ◽  
Letícia Nogueira Datrino ◽  
Maria Carolina Andrade Serafim ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Adverse Events ◽  
Proton Pump ◽  
Reflux Disease ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Oral Intake

Abstract   Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few is reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Methods This systematic review was guided by PRISMA statement. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. The inclusion criteria were (I) patients with GERD; (II) Randomized clinical trials, comparing oral intake PPI with FPT; (III) relevant outcomes for this review. The exclusion criteria were (I) reviews, case reports, editorials and letters (II) transoral or endoscopic FPT (III) studies with no full text. No restrictions were set for language or period. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Results Ten RCT were included. Meta-analysis showed that heartburn (RD = −0.19; 95% CI = −0.29, −0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). There was no significant difference between groups in the percentage of time with pH less than 4 in 24 hours, sustained remission and Gastrointestinal Symptom Rating Scale. Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. Conclusion FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT, such as those with severe erosive esophagitis, severe respiratory symptoms, low adherence to continuous drug treatment and patients with non-acid reflux, to ensure better results.

scholarly journals Vonoprazan versus proton pump inhibitors for the management of gastroesophageal reflux disease

Medicine ◽  
2018 ◽  
Vol 97 (39) ◽  
pp. e12574 ◽  
Author(s):  
Hyun Kang ◽  
Beom Jin Kim ◽  
Geunjoo Choi ◽  
Jae Gyu Kim
Keyword(s):  
Gastroesophageal Reflux Disease ◽  
Gastroesophageal Reflux ◽  
Proton Pump Inhibitors ◽  
Proton Pump ◽  
Reflux Disease
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