scholarly journals Sa1238 MUCOSAL INTEGRITY TESTING CAN RULE OUT REFLUX IN REFRACTORY GERD

2020 ◽  
Vol 91 (6) ◽  
pp. AB125
Author(s):  
Matthew H. Meyers ◽  
Dhyanesh A. Patel ◽  
Tina Higginbotham ◽  
Chris Slaughter ◽  
Stuart Wildhorn ◽  
...  
2018 ◽  
Vol 3 (4) ◽  
pp. 191-198
Author(s):  
Anne J.A. Drost-Wijnne ◽  
Ralph A.C. Van Wezel ◽  
Maarten J. Deenen ◽  
Joost P.C.M. Van Doornmalen Gomez Hoyos ◽  
René J.E. Grouls

Abstract Background A new development in drug compounding is the production of ready-to-administer sterilized prefilled syringes. A challenge with these syringes is the method of terminal sterilization. There is no information available whether water cascade sterilization is a suitable method. We investigated the effect of this sterilization method on cyclic olefin (co)polymer (CCP/COC) syringes. Methods For two brands ten prefilled syringes were sterilized using water cascade sterilization. The closure integrity, stopper movement, weight, diameter and physical appearance were determined before and after sterilization. As sterility test, additional syringes were filled with tryptic soy broth (TSB) and sterilized. After fourteen days microbiological growth was determined. Results Closure integrity testing showed no dye penetration inside the syringe. Together with the results for weight this showed that closure integrity is guaranteed. No significant stopper movement, deviation in diameter or visual anomalies were observed. No microbiological growth in TSB was visible. Conclusions The results of this proof of principle study show that the physical and microbiological stability of the cyclic olefin (co)polymer syringes is guaranteed during sterilization using a water cascade sterilizer. These results do not rule out the necessity for further stability experiments (e. g. interaction with drug product) to further proof the concept.


2019 ◽  
Vol 156 (6) ◽  
pp. S-70
Author(s):  
Teminioluwa Ajayi ◽  
Michael Blanco ◽  
Dhyanesh A. Patel ◽  
Caroline Barrett ◽  
Sarah Ferguson ◽  
...  

2020 ◽  
Vol 91 (6) ◽  
pp. AB254-AB255
Author(s):  
Dhyanesh A. Patel ◽  
Tina Higginbotham ◽  
James C. Slaughter ◽  
Stuart Wildhorn ◽  
Micheal F. Vaezi

2021 ◽  
Author(s):  
Yu Cheng ◽  
Dong Yang ◽  
Xiaoyu Sun ◽  
Lixia Wang ◽  
Zhifeng Zhang ◽  
...  

Abstract Backgrounds. Research on esophageal mucosal integrity in gastro-oesophageal reflux disease (GERD) has been taken seriously in recent years, especially in refractory GERD. Mean nocturnal baseline impedance (MNBI) is proposed as an indicator of impaired mucosal integrity. We aimed to compare the MNBI value and investigate the impact of esophageal motility on MNBI in different subtypes of refractory GERD. Methods. Endoscopy, high-resolution manometry, and 24h impedance-pH monitoring were performed in 412 refractory GERD patients. From these patients, 94 erosive esophagitis (EE), 52 non-erosive reflux disease (NERD), and 31 Barrett's esophagus (BE) patients were enrolled in the study. EE group 54 included Los Angeles (LA) Grade-A/B and 40 LA Grade-C/D patients. 52 functional heartburn (FH) patients were used as the control. MNBI was acquired at 3 and 5 cm above lower esophageal sphincter (LES) and was compared between groups. Parameters of esophagogastric junction (EGJ) and LES, along with esophageal peristaltic sequences were recorded. Univariate and multivariate regression analysis were performed to determine the impact of these motility factors on MNBI in different subtypes of refractory GERD. Results. MNBI values were signifiantly lower in all subgroups of refractory GERD patients than in FH patients. MNBI in NERD patients was similar with LA-A/B and LA-C/D patients. MNBI in NERD and LA-C/D patients was signifiantly lower than in BE patients. No difference in MNBI was found between LA-A/B and BE patients. Ineffective esophageal motility and absent contractility were the risk factor for decreased MNBI in LA-A/B and LA-C/D patients, respectively. Type III EGJ (hiatus hernias) and decreased LES length were the risk factor for decreased MNBI in NERD and BE patients, respectively. Conclusions. Impaired mucosal integrity of NERD patients was as severe as that of EE patients and hiatus hernias were the risk factor, therefore, mucosal protections and explorations of hiatus hernias should be emphasized in refractory NERD patients. Weakened esophageal body peristalsis and decreased LES length were the risk factor for the impaired mucosal integrity of refractory EE patients and BE patients, respectively, and thus the therapy on peristaltic disorders and LES function was recommended for them. These results provided new ideas for optimizing the treatment of refractory GERD.


2019 ◽  
Vol 156 (6) ◽  
pp. S-223-S-224
Author(s):  
Rishi D. Naik ◽  
Caroline Barrett ◽  
Sarah Ferguson ◽  
Chris Slaughter ◽  
Tina Higginbotham ◽  
...  

2020 ◽  
Vol 158 (6) ◽  
pp. S-1066
Author(s):  
Dhyanesh A. Patel ◽  
Tina Higginbotham ◽  
James C. Slaughter ◽  
Stuart Wildhorn ◽  
Micheal F. Vaezi

2019 ◽  
Vol 156 (6) ◽  
pp. S-699
Author(s):  
Miles Basil ◽  
David A. Schwartz ◽  
Chris Slaughter ◽  
Tina Higginbotham ◽  
Sara N. Horst ◽  
...  

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