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Delayed-release oral mesalamine tablet mimicking a small jejunal gastrointestinal stromal tumor:A case report

World Journal of Clinical Cases 2022年第19期10卷 6710-6715页

作者： Fabio Frosio Emanuele Rausa Paolo Marra Marie-Christine Boutron-Ruault Alessandro Lucianetti Department of General Surgery ASST Papa Giovanni XXIII HospitalBergamo 24127Italy Department of Radiology ASST Papa Giovanni XXIII HospitalBergamo 24127Italy Paris-Saclay University UVSQInsermGustave RoussyExposome and Heredity TeamCentre for Epidemiology and Population Health(CESP U1018)Villejuif 94800France

BACKGROUND enteric-coated medications are supposed to pass intact through the gastric environment and to release the drug content into the small intestine or the colon.Before dissolution of the enteric coating,they may appear hyperdense on computed tomography(CT).Unfortunately,few reports have been published on this topic so far.In this case report,the hyperdense appearance on contrastenhanced CT of an enteric-coated mesalamine tablet was initially misinterpreted as a jejunal gastrointestinal stromal tumor(GIST).CASE SUMMARY An asymptomatic 81-year-old male patient,who had undergone laparoscopic right nephrectomy four years earlier for stage 1 renal carcinoma,was diagnosed with a jejunal GIST at the 4-year follow-up thoraco-abdominal CT scan.He was referred to our hub hospital for gastroenterological evaluation,and subsequently underwent 18-fluorodeoxyglucose positron emission tomography,abdominal magnetic resonance imaging,and video capsule endoscopy.None of these examinations detected any lesion of the small intestine.After reviewing all the CT images in a multidisciplinary setting,the panel estimated that the hyperdense jejunal image was consistent with a tablet rather than a GIST.The tablet was an 800 mg delayed-release enteric-coated oral mesalamine tablet(Asacol®),which had been prescribed for non-specific colitis,while not informing the hospital physicians.CONCLUSION Delayed-release oral mesalamine(Asacol®),like other enteric-coated medications,can appear as a hyperdense image on a CT scan,mimicking a small intestinal GIST.Therefore,adetailed knowledge of the patients’medications and a multidisciplinary review of the images areessential.

关键词： Mesalamine enteric-coating Asacol Tablet Gastrointestinal stromal tumor Case report

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Pharmacokinetic Evaluation of Chitosan-Succinyl-Prednisolone Conjugate Microparticles as a Colonic Delivery System: Comparison with enteric-Coated Conjugate Microparticles

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Health 2014年第11期6卷 1286-1295页

作者： Hiraku Onishi Department of Drug Delivery Research Hoshi University Tokyo Japan

In the previous study, chitosan-succinyl-prednisolone conjugate microparticles (MP) were found to exhibit good efficacy and reduced toxicity nearly as well as their Eudragit L-coated microparticles (MP/EuL). This proposes a question whether enteric-coating of MP is necessary or not. Although MP/EuL were already examined for their pharmacokinetic and gastrointestinal behaviors, MP have not been done yet. Therefore, in this study, MP were evaluated by investigating pharmacokinetic features in detail. MP with the in vitro features equivalent to those of the previous conjugate microparticles could be produced more readily in the modified preparative method. Pharmacokinetic and gastrointestinal behaviors of MP were investigated by intragastric dosing (5 mg PD eq./kg) to rats with 2,4,6-trinitrobenzenesulfonic acid-induced ulcerative colitis. The plasma concentration was suppressed extensively in MP as well as MP/EuL, supporting the reduction of PD systemic toxic side effects. However, the plasma level increased gradually up to 7 h in MP, but not in MP/EuL. At 8 h after dosing, MP were detected in the stomach to a fair extent, and free PD was found there, indicating that MP were subjected to trapping in the stomach probably due to positive charge of chitosan molecules. For MP, such prolonged localization and slow release of PD in the stomach were probably associated with the gradual increase in plasma concentration. Therefore, MP/EuL were evaluated to be superior to MP for effective targeting to ulcerative colitis. It is concluded that enteric-coating is very important for the targeting system using MP.

关键词： Chitosan-Succinyl-Prednisolone Conjugate Microparticle enteric-coating Pharmacokinetic Feature Gastrointestinal Behavior 2 4 6-Trinitrobenzenesulfonic Acid-Induced Ulcerative Colitis

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Formulation Optimization Utilizing D-Optimal Experimental Design of Oral Capsules Containing enteric-Coated Pellets of Lansoprazole and<i>in vivo </i>Bioequivalence

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Pharmacology & Pharmacy 2017年第5期8卷 153-171页

作者： Anh Quang Luong Thang Ngoc Vu Dang Hoa Nguyen Sultan M. Alshahrani John Mark Christensen Chien Ngoc Nguyen Department of Pharmacy National Institute of Burns Hanoi Vietnam Research and Training Center for Pharmacy Military Medical University Hanoi Vietnam Military Institute of Pharmaceutical Analysis and Research Hanoi Vietnam Department of Pharmaceutics Hanoi University of Pharmacy Hanoi Vietnam Department of Pharmaceutical Sciences College of Pharmacy Oregon State University Corvallis Oregon USA National Institute of Pharmaceutical Technology Hanoi University of Pharmacy Hanoi Vietnam

An optimized formulation of capsules containing Lansoprazole enteric-coated pellets using D-Optimal design with a polynomial statistical model were prepared by using Eudragit?L100 as an enteric coated polymer to provide resistance to simulated gastric acid dissolution in buffer media. D-Optimal experimental design was used to determine the optimal level for three coating layers that were applied to formulate the enteric-coated pellets including a drug loading layer, a sub-coating, and an outer enteric coating. Dissolution studies were performed on the prepared Lansoprazole capsules. Less than 5 percent of Lansoprazole was released in 60 minutes in an acidic dissolution medium (pH 1.2) and greater than 90 percent of active ingredient was released in the next 60 minutes in a buffer dissolution medium (pH 6.8). The Lansoprazole capsules were stable with no observable change in physico-chemical properties in accelerated and normal storage conditions for 6 and 18 months, respectively. The pharmacokinetic parameters Cmax, Tmax, AUC0-t, and AUC0-∞ were determined after administration of the D-Optimal design optimized capsules of LPZ to healthy beagle dogs and were statistically compared to Gastevin? capsules as a reference (KRKA, Slovenia) using the non-compartmental method with the aid of WinNonlin 5.2 software. The analysis of variance showed that the two formulations did not demonstrate bioequivalence using a 90% confidence interval range (80% - 120%) of Cmax, AUC0-t, and AUC0-∞. No significant difference in Tmax was found at the 0.95 significance level using the Wilcoxon signed-rank test. D-Optimal Experimental Design provided definitive direction for an optimal formulation of capsules containing enteric-coated pellets of lansoprazole loaded within the coating of pellets that provided similar bioequivalence to Gastevin.

关键词： Lansoprazole D-Optimal Pellets enteric-coating Pharmacokinetic Parameters

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