Sample Preparation of Posaconazole Oral Suspensions for Identification of the Crystal Form of the Active Pharmaceutical Ingredient

Determination of the polymorphic form of an active pharmaceutical ingredient (API) in a suspension could be really challenging because of the water phase and the low concentration of the API in this formulation. Posaconazole is an antifungal drug available also as an oral suspension. The aim of this study was to develop a sample-preparation method for polymorphic identification of the dispersed API by increasing the concentration of the API but with no compromise of polymorph stability. For this purpose, filtration, drying and centrifugation were tested for separating the API from the suspending medium. Centrifugation was selected because it succeeded in separating Posaconazole API with no polymorph transformation during the process. During this study, it was found that Posaconazole in oral suspensions is Form-S. However, when slower scanning rates were used for acquiring an XRPD pattern with better signal/noise ratio, Posaconazole was converted to Form I due to water loss. In order to protect the sample from conversion, different approaches were tested to secure an airtight sample including a commercially available XRPD sample holder with a dome-like transparent cap, standard polymethylmethacrylate (PMMA) sample holders covered with Mylar film, transparent pressure-sensitive tape and a transparent food membrane. Only usage of the transparent food membrane was found to protect the API from conversion for a period of at least two weeks and resulted in a Posaconazole Form-S XRPD pattern with no artificial peaks.

Clinical Observation of the Treatment of Hemorrhoids with Polyvinyl Alcohol Foam Sclerotherapy under Transparent Cap Assisted Endoscope

Objective: To explore the clinical effect of domestic capsosol foam sclerotherapy in the treatment of hemorrhoids under transparent cap assisted endoscope. Methods: According to the experimental requirements, 120 cases of hemorrhoids hospitalized in gastroenterology department in our hospital from February to December in 2019 were selected as the treatment group. The foam sclerotherapy of polidocanol and the air in accordance with the 1:4 ratio was injected into varicose hemorrhoids and hemorrhoids through a transparent cap assisted endoscope. At the same time, 100 patients were selected as the control group and the patients were treated according to the routine protocol. The symptom score and clinical efficacy of the two groups were observed under different treatment schemes. Results: 120 patients were successfully injected with foam sclerotherapy under endoscope. There were significant differences in clinical symptom score and clinical efficacy between the injection sclerotherapy group and the control group. There were statistically significant differences in the bleeding, prolapse, painful defecation, anal foreign body sensation, impact on daily work, and hemorrhoids data between the treatment group and the control group (P<0.05). Conclusion: Transparent cap assisted endoscopic injection of polidocanol sclerotherapy in the treatment of hemorrhoids can effectively improve the clinical symptoms of patients, promote the improvement of the disease, and the curative effect is satisfactory. It is a new method of minimally invasive treatment of hemorrhoids, which is worthy of wide promotion in clinical practice.

Underwater cap-assisted Endoscopic Retrograde Cholangiopancreatography in patients with surgically altered anatomy: a pilot study

Introduction Endoscopic retrograde cholangiopancreatography (ERCP) in surgically altered anatomy (SAA) pa-tients is technically challenging and associated with a significant number of failures. We examined the feasibility and efficacy of a novel technique for management of jaundice orcholangitis second-ary to bile duct stones (BDS), called underwater cap-assisted ERCP (u-ERCP). Methods Between June 2019 and February 2020 all patients with jaundice or cholangitis secondary to bile duct stones (BDS) with SAA who underwent u-ERCP were enrolled. The u-ERCP tecnnique combines the underwater advancement of a pediatric colonoscope with a transparent cap fitted on the tip of the endoscope. We evaluated the technical success, clinical suc-cess and adverse events associated with u-ERCP. Results We describe the technique itself and our first experience in 6 patients. A complete and successful procedure was carried out in all patients with no adverse events occurrence. None of the patients needed additional treatments for recurrence of symptoms during the follow-up period. Conclusions The u-ERCP can be considered as a promising alternative for successful endoscopic management of biliary disease in patients with SAA.

A transparent cap assisted endoscopic injection sclerotherapy for the treatment of patients with esophageal varices

Aim: The aim of this study was to compare the efficacy and safety of cap assisted endoscopic injection sclerotherapy(EIS) versus direct endoscopic injection sclerotherapy(EIS) in the management of patients with cirrhosis after esophageal variceal bleeding . Methods: Patients with cirrhosis suffering from esophageal variceal bleeding who underwent EIS with or without the help of a transparent cap in Shandong Provincial Hospital between Novermber December 2014 and April 2017 were included in this retrospective study. All of the cases included in the study were divided into two groups: Group A (EIS with a transparent cap, n=50), Group B (direct EIS, n=45). Data collected included patients’ demographics, details of the procedure, variceal eradication, variceal rebleeding, variceal recurrence and survival during the follow-up period. All data were expressed as mean ± SD. Quantitative variables were compared by Student t test, and qualitative variables were compared by the Fisher exact test or the chi-square test. A P value less than 0.05 was considered significant. Results: The mean duration of follow-up was similar in both groups(16.3±10.2 mo and 15.5±9.5 mo, respectively). To achieve the eradication of varices, the volume of sclerosant (64.86±10.62 ml vs 104.73±21.25 ml, P =0.044), the mean number of sessions (2.37±1.15 times vs 5.70±1.57 times, p =0.042), the time required to perform endoscopic treatment(6.57±1.50 minutes vs 11.22±2.29 minutes, P =0.049) and the time for the initial esophageal varices eradication were significantly reduced in the cap assisted EIS group than in the direct EIS group(5.43±1.38 weeks vs 8.93±1.5 weeks, P =0.041). The probability of variceal recurrence and rebleeding was significantly higher in the direct EIS group than in cap assisted EIS group. Only 22 patients (44%) developed complications in the cap assisted EIS group as compared to 30 patients ( P =0.039) in the EIS group. The probability of survival was similar in both groups ( P =0.133). Conclusion: EIS with a transparent cap is an effective and safe treatment for esophageal varices.