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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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Targeted bile acids and gut microbiome profiles reveal the hepatoprotective effect of WZ tablet(Schisandra sphenanthera extract) against LCA-induced cholestasis

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Chinese Journal of Natural Medicines 2020年第3期18卷 211-218页

作者： LI Dong-Shun HUANG Quan-Fei GUAN Li-Huan ZHANG Hui-Zhen LI Xi FU Kai-Li CHEN Yi-Xin WAN Jian-Bo HUANG Min BI Hui-Chang Guangdong Provincial Key Laboratory of New Drug Design and Evaluation School of Pharmaceutical SciencesSun Yat-Sen UniversityGuangzhou 510000China State Key Laboratory of Quality Research in Chinese Medicine Institute of Chinese Medical SciencesUniversity of MacaoMacao 999078China

Cholestasis is caused by the obstacle of bile formation or secretion and can develop into severe liver diseases. We previously reported the ethanol extract of Schisandra sphenanthera(Wuzhi tablet, WZ) can significantly protect against lithocholic acid(LCA)-induced intrahepatic cholestasis in mice, partially due to the activation of PXR pathway and promotion of liver regeneration.However, the effect of WZ on the bile acids profile and gut microbiome in cholestastic mice remain unknown. In this study, the effect of WZ against LCA-induced liver injury was evaluated and its effect on the bile acids metabolome and gut microbiome profiles in cholestastic mice was further investigated. Targeted metabolomics analysis was performed to examine the change of bile acids in the serum, liver, intestine and feces. The change of intestinal flora were detected by the genomics method. Targeted metabolomics analysis revealed that WZ enhanced the excretion of bile acids from serum and liver to intestine and feces. Genomics analysis of gut microbiome showed that WZ can reverse LCA-induced gut microbiome disorder to the normal level. In conclusion, WZ protects against LCAinduced cholestastic liver injury by reversing abnormal bile acids profiles and alteration of gut microbiome.

关键词： Cholestasis Wuzhi tablet Schisandra sphenanthera Metabolome Gut microbiome Bile acids

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Discovery of synergistic anti-inflammatory compound combination from herbal formula GuGe FengTong tablet

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Chinese Journal of Natural Medicines 2018年第9期16卷 683-692页

作者： LIU Le-Le LIU Qun LI Ping LIU E-Hu State Key Laboratory of Natural Medicines School of Traditional Chinese PharmacyChina Pharmaceutical University

Multi-components in herbal formulae exert holistic effects in synergistic or additive manners. However, appropriate strategies and supportive evidences are still lacking to uncover the synergistic or additive combinations. The present investigation aimed at seeking a screening strategy to identify the targeted combinations in GuG e FengT ong tablet(GGFTT), an herbal formula. Two compounds, belonging to different chemical classes, were combined with different concentration ratios and their anti-inflammation effects were investigated. The most significant anti-inflammatory combinations were evaluated by combination index(CI) method(additive effect, CI = 1; synergism, CI 1). The modulating effects of candidate combinations on pro-inflammatory cytokines and MAPKs signaling pathway were also detected. Two combinations, "biochanin A + 6-gingerol"(Bio-6 G) and "genistein + 6-gingerol"(Gen-6 G), showed synergistic effects(CI < 1), and Bio-6 G was selected for further study. Compared with single compound, Bio-6 G could synergistically inhibit the production of pro-inflammatory cytokines(TNF-α, IL-1β, and IL-6) and the activation of MAPKs signaling pathway in LPS-stimulated RAW264.7 cells. The combined results showed that Bio-6 G was a synergistic anti-inflammatory combination in GGFTT. Our results could provide a useful strategy to screen the synergistic combinations in herbal formulae.

关键词： GuGe FengTong tablet Synergistic combinations Anti-inflammation Cytokines MAPKs

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Metabolic profile of Guge Fengtong tablet in rat urine and bile after oral administration,using high-performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight mass spectrometry

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Chinese Journal of Natural Medicines 2015年第12期13卷 954-960页

作者： ZENG Su-Ling LI Ping LIU E-Hu State Key Laboratory of Natural Medicines China Pharmaceutical University

In the present study, we developed and validated a rapid analytical method using high performance liquid chromatography coupled with quadrupole time of flight mass spectrometry(HPLC-Q-TOF/MS) to investigate the metabolic profile of Guge Fengtong tablet(GGFTT), a traditional Chinese medicine. The urine and bile samples were collected with 24 h after oral administration of GGFTT. A total of 34 compounds, including 11 parent compounds and 23 metabolites were unambiguously or tentatively identified. Our results indicated that glucuronidation, oxidation and methylation were the major metabolic pathways of the constituents in GGFTT. In addition, the results of this work also demonstrated the feasibility of HPLC-ESI-Q-TOF/MS for reliable characterization of the in vivo metabolites from herbal preparations.

关键词： Guge Fengtong tablet HPLC-Q-TOF/MS Urine Bile Metabolite

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Identification and determination of major constituents in a traditional Chinese medicine compound recipe Xiongdankaiming tablet using HPLC-PDA/ESI-MS^n and HPLC-UV/ELSD

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Journal of Zhejiang University-Science B(Biomedicine & Biotechnology) 2013年第7期14卷 604-614页

作者： Shu-fang WANG Jing LENG Yi-min XU Mei-ling FENG Institute of Pharmaceutical Informatics Zhejiang University School of Pharmaceutical Sciences Zhejiang University of Technology

Xiongdankaiming tablet (XDKMT), a well-known compound in traditional Chinese medicine, is widely used for the treatment of acute iridocyclitis and primary open-angle glaucoma. In this paper, accurate and reliable methods were developed for the identification of 20 constituents using high-performance liquid chromatography with photodiode array and electron spray ionization-mass spectrometry (HPLC-PDA/ESI-MSn ), and determination of nine of the constituents (chlorogenic acid, gentiopicroside, isochlorogenic acid B, diosmetin-7-O-β-D-glucopyranoside, apigenin, diosmetin, tauroursodeoxycholic acid, acacetin, and taurochenodeoxycholic acid) was developed using HPLC with ultraviolet absorption detector and evaporative light scattering detector (HPLC-UV/ELSD) for the first time. The best results were obtained on a Zorbax SB-C18 column with gradient elution using water (0.1% formic acid) (A) and methanol (0.1% formic acid) (B) at a flow rate of 0.7 ml/min. Tauroursodeoxycholic acid and taurochenodeoxycholic acid, owing to their low UV absorption, were detected by ELSD. The other seven compounds were analyzed by HPLC-UV with variable wavelengths. The calibration curves of all nine constituents showed good linear regression (R2 >0.9996) within the linearity ranges. The limits of detection and quantification were in the ranges of 0.0460-9.90 μg/ml and 0.115-24.8 μg/ml, respectively. The accuracy, in terms of recovery, varied from 95.3% to 104.9% with relative standard deviations (RSDs) less than 4.4%. Precision (with the intra- and inter-day variations less than 4.4%) was also suitable for its intended use. The developed method was successfully applied for the analysis of major components in XDKMT, which provides an appropriate method for the quality control of XDKMT.

关键词： Traditional Chinese medicine (TCM) compound recipe Xiongdankaiming tablet HPLC-UV/ELSD HPLC-MS Quality control

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Formulation of a film-coated dutasteride tablet bioequivalent to a soft gelatin capsule(Avodart~?): Effect of γ-cyclodextrin and solubilizers

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Asian Journal of Pharmaceutical Sciences 2019年第3期14卷 313-320页

作者： Mi-Hong Min Jin-Hyong Park Mi-Ran Choi Jong-Hyun Hur Byung-Nak Ahn Dae-Duk Kim College of Pharmacy and Research Institute of Pharmaceutical Sciences Seoul National UniversitySeoul08826Republic of Korea Central Research Institute Whanin Pharmaceutical Company4FGBSA107Gwanggyo-roYeongtong-guSuwon16229Republic of Korea

The aim of this study was to optimize a tablet formulation of dutasteride that is bioequivalent to a commercially available soft gelatin capsule(Avodart~?). The effect of cyclodextrin on enhancing the aqueous solubility of dutasteride was investigated, after which the formulation was further optimized with solubilizing polymer and surfactant. Among the cyclodextrins tested, the highest solubility was observed when dutasteride was complexed with γ-cyclodextrin. Moreover, the addition of polyvinylpyrrolidone and Gelucire/TPGS further enhanced the solubility of dutasteride. Differential scanning calorimetry(DSC) and powder X-ray diffraction(pX RD) studies demonstrated that dutasteride existed in the amorphous form in the complex. Optimized dutasteride complexes were selected after a pharmacokinetic study in rats, and film-coated tablets were prepared by the direct compression method. In vitro dissolution profiles for the tablets of dutasteride complexes were similar to those of the reference. Moreover, pharmacokinetic parameters including the C max and AUC values after oral administration in beagle dogs were not significantly different from those of the reference with a relative bioavailability of 92.4%. These results suggest the feasibility of developing a tablet formulation of dutasteride using cyclodextrin complex in addition to a solubilizing polymer and surfactant.

关键词： Dutasteride tablet Cyclodextrin Complex Formulation

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Prediction of effects of punch shapes on tableting failure by using a multi-functional single-punch tablet press

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Asian Journal of Pharmaceutical Sciences 2017年第5期12卷 412-417页

作者： Takashi Osamura Yoshiko Takeuchi Risako Onodera Masahiro Kitamura Yoshiteru Takahashi Kohei Tahara Hirofumi Takeuchi Laboratory of Pharmaceutical Engineering Gifu Pharmaceutical University1-25-4Daigaku-NishiGifu501-1196Japan Pharmaceutical Technology Department Sawai Pharmaceutical Co.Ltd12-34HiroshibachoSuita-ShiOsaka564-0052Japan

We previously determined 'tableting properties' by using a multi-functional single-punch tablet press(GTP-1). We proposed plotting 'Compactability' on the x-axis against'Manufacturability' on the y-axis to allow visual evaluation of 'tableting properties'. Various types of tableting failure occur in commercial drug production and are influenced by the amount of lubricant used and the shape of the punch. We used the GTP-1 to measure'tableting properties' with different amounts of lubricant and compared the results with those of tableting on a commercial rotary tableting machine. tablets compressed with a small amount of lubricant showed bad 'Manufacturability', leading to sticking of powder on punches.We also tested various punch shapes. The GTP-1 correctly predicted the actual tableting results for all punch shapes. With punches that were more likely to cause tableting failure, our system predicted the effects of lubricant quantity in the tablet formulation and the occurrence of sticking in the rotary tableting machine.

关键词： tableting Formulation design Lubricant Punch shape Single-punch tablet press Losartan potassium

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Formulation design of granules prepared by wet granulation method using a multi-functional single-punch tablet press to avoid tableting failures

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Asian Journal of Pharmaceutical Sciences 2018年第2期13卷 113-119页

作者： Takashi Osamura Yoshiko Takeuchi Risako Onodera Masahiro Kitamura Yoshiteru Takahashi Kohei Tahara Hirofumi Takeuchi Laboratory of Pharmaceutical Engineering Gifu Pharmaceutical University Pharmaceutical Technology Department Sawai Pharmaceutical Co.Ltd

We previously determined "tableting properties" by using a multi-functional single-punch tablet press(GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability"on the y-axis to allow visual evaluation of "tableting properties". Here, we examined whether this evaluation method can be used in the formulation design of tablets prepared by wet granulation. We used the GTP-1 to measure "tableting properties" with different amounts of binder, disintegrant, and lubricant, and compared the results with those of tableting on a commercial rotary tableting machine. tableting failures(capping and binding in particular) occurred when samples that had been evaluated as having poor "Compactability" or"Manufacturability" on the GTP-1 were compressed on the rotary tableting machine. Thus,our evaluation method predicted tableting failure at the commercial scale. The method will prove useful for scaling up production.

关键词： tableting formulation design wet granulation capping binding single-punch tablet press

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Continuous melt granulation to develop high drug loaded sustained release tablet of Metformin HCl

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Asian Journal of Pharmaceutical Sciences 2017年第1期12卷 37-50页

作者： Pradnya Vaingankar Purnima Amin Department of Pharmaceutical Sciences and Technology Institute of Chemical Technology University under Section 3 of UGC Act–1956 Elite Status and Centre of Excellence–Government of Maharashtra

The present work explores the application of melt granulation technology to develop a high drug loaded sustained release matrix tablet of Metformin HCl using hydroxypropylcellulose(HPC) as a hydrophilic binder and stearic acid as an extrusion aid for producing cohesive granules. This novel approach allowed the use of a minimum number of excipients to reduce the tablet size, and to enhance compressibility of the drug. This also offered a cost effective method owing to the elimination of a ‘drying step’ prevalent in wet granulation method.Moreover, this research also focuses on resolving the processability issues associated with the use of HPC Nisso-H at high drug loading. The thermal lubricants were screened for this purpose and evaluated for their impact on extrudability, granule and tablet characteristics. Stearic acid was selected as the thermal lubricant, which not only contributed to the inhibition of burst release, but also improved the flow property of the granules.The developed matrix tablet(75% drug loading) resulted in 670 mg of weight for 500 mg dose strength and showed sustained drug release over 10 h. When compared, with conventional granulation techniques, it was observed that, under identical compression force, the tablet prepared by MG exhibited superior compactibility along with tablet hardness and optimal drug release profile. FTIR suggested nonexistence of chemical interaction between the drug and the other excipients while XRD and DSC analysis revealed the crystalline state of the drug.Furthermore, the results obtained from Raman spectroscopy proved the uniform distribution of the Metformin HCl and polymer in the final dosage form. This technology leads to the manufacture of sustained release matrix formulation with reduced tablet size of a high dose,highly water soluble drug otherwise difficult to process using standard batch-granulation.

关键词： Metformin hydrochloride Hydroxypropylcellulose High drug loaded tablet Melt granulation

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Design and evaluation of an extended-release matrix tablet formulation; the combination of hypromellose acetate succinate and hydroxypropylcellulose

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Asian Journal of Pharmaceutical Sciences 2017年第2期12卷 149-156页

作者： Sachiko Fukui Hideki Yano Shuichi Yada Tsuyoshi Mikkaichi Hidemi Minami Formulation Technology Research Laboratories Daiichi Sankyo Co.Ltd.1-2-58HiromachiShinagawa-kuTokyo 140-8710Japan Drug Metabolism&Pharmacokinetics Research Laboratories Daiichi Sankyo Co.Ltd.1-2-58HiromachiShinagawa-kuTokyo 140-8710Japan

The purpose of this study was to develop an extended-release(ER) matrix tablet that shows robust dissolution properties able to account for the variability of pH and mechanical stress in the GI tract using a combination of enteric polymer and hydrophilic polymer. Hypromellose acetate succinate(HPMCAS) and hydroxypropylcellulose(HPC) were selected as ER polymers for the ER matrix tablet(HPMCAS/HPC ER matrix tablet). Oxycodone hydrochloride was employed as a model drug. Dissolution properties of the HPMCAS/HPC ER matrix tablets were evaluated and were not affected by the pH of the test medium or paddle rotating speed.In a USP apparatus 3(bio-relevant dissolution method), dissolution profiles of the HPMCAS/HPC ER matrix tablets containing oxycodone hydrochloride were similar to that of the reference product(OxyC ontin). Moreover, in vivo performance after oral administration of the HPMCAS/HPC ER matrix tablets to humans was simulated by GastroP lus based on dissolution profiles from the USP apparatus 3. The plasma concentration-time profile simulated was similar to that of the reference product. These results suggest that the combination of HPMCAS and HPC shows a robust dissolution profile against pH and paddle rotating speed and indicates the appropriate extended-release profile in humans.

关键词： Extended-release matrix tablet Hypromellose acetate succinate Hydroxypropylcellulose Robust dissolution USP apparatus 3

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