Pharmaceutical Technology in Hospital Pharmacy最新文献

{"title":"After Ten Issues Our Journal Has Found Its Audience and Main Topics","authors":"F. Lagarce","doi":"10.1515/PTHP-2018-0024","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0024","url":null,"abstract":"","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"1 1","pages":"121 - 122"},"PeriodicalIF":0.0,"publicationDate":"2018-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89754031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Qualification and Performance Evaluation of an Automated System for Compounding Injectable Cytotoxic Drugs","authors":"L. Carrez, V. Martin, A. Verrey, P. Furrer, L. Bouchoud, L. Falaschi, P. Bonnabry","doi":"10.1515/PTHP-2018-0012","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0012","url":null,"abstract":"Abstract Background Use of automated systems for the production of chemotherapy will increase in answer to hospitals’ needs to rationalise production. The aim of the study was to evaluate the performance of a PharmaHelp® automated system for compounding chemotherapy. Methods Viable and non viable particles in air and liquid were measured by particle counter. Surface chemical contamination was simulated with a quinine solution. Microbiological contamination and aseptic processes were studied using media-fill tests. Dose accuracy was evaluated using a gravimetric method, in simulation studies and with real products in daily practice. Productivity was calculated by batch of ten IV-bags. Results No particles or microbiological contamination were detected. Filling was accurate for all the volumes of non-viscous solution studied (97–103 %). Minimum volumes which could be prepared accurately were 2 mL and 5 mL for the non-viscous and viscous solutions, respectively. For 2–5 mL volumes, the robot was less accurate than average, and 0–2 % of bags were rejected (deviation>10 %). Average fill deviations were from 0–3 % for 2–5 mL volumes and<1 % for volumes above 5 mL. Average production time for ten bags was 61±11 min. Conclusions The automated system was able to produce chemotherapy effectively, delivering appropriate quality with productivity comparable to manual preparations. These results confirmed that such automated systems have the potential to guarantee optimal safety for patients and technicians.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"6 1","pages":"165 - 175"},"PeriodicalIF":0.0,"publicationDate":"2018-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80087332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Environmental and Product Contamination during the Preparation of Antineoplastic Drugs with Robotic Systems","authors":"I. Krämer, M. Federici, R. Schierl","doi":"10.1515/PTHP-2018-0018","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0018","url":null,"abstract":"Abstract Background Robotic systems are designed to minimize the exposure to antineoplastic drugs during automated preparation. However, contamination cannot be completely excluded. The aim of the study was to evaluate the contamination with antineoplastic drugs on the working surfaces and on the outer surface of the ready-to-use products (infusion bags and syringes) during automated preparation with different versions of a robot and manual preparation. Methods Surface contamination with platinum (Pt) and 5-fluorouracil (5-FU) was measured by wipe sampling and quantified by voltammetry for Pt and GC-MS for 5-FU. Sampling was performed on pre-defined locations in the working areas before and after preparation of standardized test products. The outer surfaces of Pt- or 5-FU-containing infusion bags and 5-FU-containing syringes were sampled without and after manual capping. Results Overall, the surface contamination in the working areas of the robotic system ranged from 0.4 to 114 pg/cm2 for Pt and from 1.3 to 1,250,000 pg/cm2 for 5-FU. The highest contamination levels were detected after preparation on the gripper of the robotic arm and on the surface beneath the dosing device. In most cases, measured concentrations were higher after preparation. Outer surfaces of infusion bags prepared with the robotic system were less contaminated than manually prepared bags. Contamination on the outer surface of syringes varied depending on the procedure adopted. Conclusions The risk of contamination is localised inside the working area of the robot. The outer surfaces of products were only marginally contaminated. Cleaning procedures of the working area are to be further investigated. An effective decontamination procedure for the working area of the robot and automated capping of filled syringes should be developed to further minimize the occupational risk.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"2 1","pages":"153 - 164"},"PeriodicalIF":0.0,"publicationDate":"2018-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81820238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physico-Chemical Stability of Sodium Thiosulfate Infusion Solutions in Polyolefin Bags at Room Temperature over a Period of 24 Hours","authors":"E. D’huart, J. Vigneron, F. Ranchon, N. Vantard, C. Rioufol, B. Demoré","doi":"10.1515/PTHP-2018-0015","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0015","url":null,"abstract":"Abstract Background Many publications described sodium thiosulfate used to prevent the renal toxicity induced by cisplatin hyperthermic intraperitoneal chemotherapy. After around 60 or 90 minutes of hyperthermic chemotherapy, cisplatin was drained and then, sodium thiosulfate was infused by intravenous route. Sodium thiosulfate is used in two steps: a first step, at 9 g/m2 in 250 mL of 0.9 % sodium chloride over 10 minutes followed by a second step, at 12 g/m2 in 1000 mL of 0.9 % sodium chloride over 6 hours. The purpose of this work was to study the stability of sodium thiosulfate at 16 mg/mL in 0.9 % sodium chloride polyolefin bags 1000 mL and at 72 mg/mL in 0.9 % sodium chloride polyolefin bags 250 mL, at 25 °C, protected or unprotected from light. Methods Chemical stability was analysed by high performance liquid chromatography (HPLC) coupled to a photodiode array detector after preparation and after 6-hour or 24-hour storage. The method was validated according to the International Conference on Harmonisation (ICH). Physical stability was evaluated by visual and subvisual inspection (turbidimetry by UV spectrophotometry at 550 nm). Three bags for each condition were prepared. On each time of the analysis, three samples were prepared for each bag and analysed by HPLC. pH values were evaluated on each moment of the analysis. Results Sodium thiosulfate solutions diluted in 0.9 % sodium chloride at 16 and 72 mg/mL retained more than 95 % of the initial concentration during 24 hours. Concerning pH measurements, the maximum variation was 0.24 pH unit. No visual modification such as colour change, precipitation or gas formation was observed. The absorbance at 550 nm obtained for each sample was less than 0.010 AU. Conclusions Sodium thiosulfate solutions at 16 mg/mL in 1000 mL 0.9 % sodium chloride and at 72 mg/mL in 250 mL 0.9 % sodium chloride are stable physically and chemically over a period of 24 hours at 25 °C, with or without protection from light. This stability study allows the use of sodium thiosulfate in renal protection protocols during cisplatin hyperthermic intraperitoneal chemotherapy.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"83 1","pages":"135 - 142"},"PeriodicalIF":0.0,"publicationDate":"2018-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85407138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Frontmatter","authors":"","doi":"10.1515/pthp-2018-frontmatter2","DOIUrl":"https://doi.org/10.1515/pthp-2018-frontmatter2","url":null,"abstract":"","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"1995 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2018-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75682573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"HPLC – Quality by Design Approach for Simultaneous Detection of Torsemide, Spironolactone and Their Degradant Impurities","authors":"Unnati Bihola, P. Prajapati, Y. K. Agrawal","doi":"10.1515/PTHP-2018-0011","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0011","url":null,"abstract":"Abstract A simple, highly robust (quality by design (QbD) approach), precise and accurate method using high performance liquid chromatography coupled to mass spectrometry has been established for the simultaneous separation, identification and quantitation of a Torsemide (TOR), spironolactone (SPI) and their degradant impurities. The chromatographic separations of drugs and impurities were achieved on a inertsil ODS-3 µm C18, 150 mm × 4.6 mm, while the isocratic elution using a ternary mobile phase mixture of methanol, acetonitrile and water (5:3:2 v/v/v) at a flow rate of 0.2 mL/min was adopted for achieving optimum separations. The quantitation of torsemide and spironolactone was accomplished by UV detection at 254 nm and identification of the degradants were done by comparing identical mass in mass spectrometer. The recoveries of the torsemide and spironolactone were obtained higher than 98 % with good validation parameters; linearity (r2>0.994), LOD and LOQ was 10 and 33 ng for TOR and 75 and 248 ng for SPI respectively. The quality by design (QbD) approach has been successfully utilized to prove the method is robust even deliberate changes in critical parameters.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"9 1","pages":"123 - 134"},"PeriodicalIF":0.0,"publicationDate":"2018-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87946612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paediatric Needs: Challenge and Opportunities for Hospital Pharmacists","authors":"F. Marçon","doi":"10.1515/PTHP-2018-0016","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0016","url":null,"abstract":"","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"24 4","pages":"47 - 48"},"PeriodicalIF":0.0,"publicationDate":"2018-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1515/PTHP-2018-0016","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72467903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Physicochemical and Microbiological Stability of a New Oral Clonidine Solution for Paediatric Use","authors":"C. Verlhac, D. Lannoy, F. Bourdon, M. Titécat, E. Fréalle, C. Nassar, C. Berneron, P. Odou","doi":"10.1515/PTHP-2018-0006","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0006","url":null,"abstract":"Abstract Background As many drugs are unavailable for paediatric use, hospital pharmacies are often required to develop suitable formulations themselves. Clonidine is commonly used in paediatrics (in severe hypertension, in opiate withdrawal syndrome, in tics and Gilles de la Tourette syndrome or in anaesthetic premedication) but no appropriate formulation has been drawn up. The aims of this work were to develop an oral solution of clonidine dedicated to children and to assess its physicochemical and microbiological stability. Methods Formulation of an oral solution of clonidine hydrochloride suitable for neonates and paediatrics was developed using the active pharmaceutical ingredient (API), with as few excipients as possible and without any complex excipient vehicle. A stability study was made according to GERPAC-SFPC guidelines. At each point in time (D0, D1, D7, D15, D29, D60 and D90), visual aspect (limpidity), pH and osmolality were established. Clonidine concentration was quantified using a stability-indicating HPLC-UV-DAD method previously developed from a forced degradation study and validated according to SFSTP Pharma. Microbiological stability was also tested according to the European Pharmacopeia monograph with the best adapted method (by comparing membrane filtration and inclusion). Solutions were stored in amber glass bottles with an oral adapter for up to 3 months in two different conditions: 5 °C +/– 3 °C and at 25 °C +/– 2 °C with 60 % residual humidity (climatic chamber). Results The formulated oral solution is composed of API at a concentration of 10 µg/mL and of potassium sorbate (0.3 %), citric acid, potassium citrate (pH 5 buffer) and sodium saccharine (0.025 %). Forced degradation highlighted six degradation products and the method was validated in the acceptance limits of ± 5 %. On D29, the mean percentages of the initial clonidine concentrations (+/–standard deviation) were 92.95+/–1.28 % in the solution stored at 25 °C +/– 2 °C and 97.44+/–1.21 % when stored at 5 °C +/– 3 °C. On D90, means were respectively 81.82+/–0.41 % and 93.66+/–0.71 %. The visual aspect did not change. Physical parameters remained stable during the study: pH varied from 4.94 to 5.09 and osmolality from 82 to 92 mOsm/kg in the two conditions tested here. Membrane filtration appeared to be the more sensitive method. Whatever the storage conditions,<1 micro-organism/mL was identified (only environmental) with no detected E.coli. Conclusions This formulation is stable for at least 3 months at 5 °C +/– 3 °C in amber glass bottles and for one month when stored at room temperature. Microbiological stability was proven in accordance with the European Pharmacopeia.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"77 1","pages":"79 - 90"},"PeriodicalIF":0.0,"publicationDate":"2018-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74198769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Preparation of Oral Suspensions for Paediatric Patients – a Challenge for Pharmacists","authors":"C. Bruns, M. Ober","doi":"10.1515/PTHP-2018-0008","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0008","url":null,"abstract":"Abstract The preparation of liquid oral dosage forms for paediatric patients may pose a challenge on pharmacies. Marketed ready-to-use suspension vehicles do have advantages and disadvantages. In order to overcome the disadvantages a dedicated suspension vehicle, which can be prepared by every pharmacy, was cooperatively developed by pharmacist specialists on a national level in Germany. Marketed as well as pharmacy prepared suspension vehicles provide added value for pharmacy preparations for the special need of paediatric patients of different age groups.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"6 1","pages":"113 - 119"},"PeriodicalIF":0.0,"publicationDate":"2018-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89823365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmaceutical Technology in Practice: A Personal View","authors":"A. Florence","doi":"10.1515/PTHP-2018-0013","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0013","url":null,"abstract":"Abstract This opinion piece argues that the collective knowledge of drugs and medicines, their nature, formulation and manufacture, their delivery and evaluation is unique to pharmacy and it reasserts the fact that science underpins the clinical use of medicines. It argues this from a personal standpoint of an academic pharmaceutical technologist and recounts examples from the author’s own experience.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"106 1","pages":"183 - 187"},"PeriodicalIF":0.0,"publicationDate":"2018-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77890049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}