Pharmaceutical Technology in Hospital Pharmacy最新文献

{"title":"Physicochemical Stability of Extemporaneously Prepared Oral Suspension of Fluconazole 50 mg/mL in SuspendIt™","authors":"K. Ip, A. Shan, M. Carvalho, S. Baker, D. Banov","doi":"10.1515/PTHP-2018-0007","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0007","url":null,"abstract":"Abstract Background There is a lack of an age-appropriate formulation of fluconazole. The extemporaneous preparation of an oral suspension with an extended beyond-use-date may represent a good therapeutic alternative for the paediatric population. Methods A fluconazole 50 mg/mL oral suspension was prepared and evenly distributed into twenty amber plastic bottles: ten bottles were stored in controlled room temperature (25 °C) whereas the remainder ten bottles were stored in refrigerated temperature (5 °C). The physical characteristics (colour/appearance, odor, pH and density) and chemical characteristics [fluconazole concentration using Ultra High Performance Liquid Chromatography (UPLC)] of the oral suspension were tested at nine pre-determined time-points over a period of 182 days. Results The density, pH and mean concentration of the oral suspension did not change significantly. The recovery of fluconazole ranged from 92.67 % to 98.79 % (5 °C) and from 94.31 % to 100.02 % (25 °C), both within the specification limits. Conclusions A palatable, sugar-free formula was developed for fluconazole 50 mg/mL in the oral suspending vehicle SuspendIt™ to allow an easy and rapid extemporaneous preparation in the hospital setting. The beyond-use-date of the formula was determined using a valid, stability-indicating analytical method and it was concluded that the extemporaneously prepared oral suspension is stable for 6 months at refrigerated and controlled room temperature.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"60 1","pages":"101 - 112"},"PeriodicalIF":0.0,"publicationDate":"2018-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78900716","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":"Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method","authors":"M. Bonnet, M. Dermu, Clara Roessle, M. Bellaiche, T. Abarou, V. Vasseur, Samira Benakouche, T. Storme","doi":"10.1515/PTHP-2018-0005","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0005","url":null,"abstract":"Abstract Background Eosinophilic Esophagitis is an increasing pathology which can cause stomach symptom like dysphagia, vomiting, food blockage. The treatment consists in dietary therapy and topical corticosteroid therapy to avoid the important number of side effects of the oral corticosteroids. There is presently no available topical form adapted for treating esophageal pathology. Methods The aim of this work was to develop an oral viscous budesonide gel (OVBG). A focus on palatability was made in order to use OVBG in children. A stability indicating HLPC method able to quantify budesonide contained in our OVBG has been developed. Results Previous work of Hefner and Al. showed that xanthan gum had a longer esophageal mucosal contact time than sucralose. This encouraged the development of a xanthan gum-based formulation. This OVBG has also the advantage to facilitate compliance thanks to its taste and pleasant texture. The stability length of the preparation can be extended over a 3-months period, stored in a refrigerator at 2–8 °C. Conclusions An adapted pediatric formulation with a 3-months stability was developed. Furthermore, the formulation can be easily reproduced in community pharmacy. Regarding the increasing number of patients concerned OVBG is a good answer to a real clinical need.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"1 1","pages":"91 - 99"},"PeriodicalIF":0.0,"publicationDate":"2018-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79089051","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 formulation: budesonide 0.1 mg/mL viscous oral solution for eosinophilic esophagitis using cyclodextrins","authors":"C. Ey, Christel Hosselet, Benjamin Villon, F. Marçon","doi":"10.1515/PTHP-2018-0004","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0004","url":null,"abstract":"Abstract Background Viscous oral solutions of budesonide (dose range: 1 mg to 2 mg) have long been used to treat eosinophilic oesophagitis in children. The objective of the present study was to provide a convenient paediatric pharmaceutical formulation of a viscous budesonide solution at a dose level of 0.1 mg/mL, using cyclodextrin as a solubilizer. Methods Solubility studies were performed with γ-cyclodextrin and hydroxypropyl-β-cyclodextrin, and viscosity was tested with a Brookfield viscometer. The stability of the final formulation was tested in a climatic chamber. Levels of budesonide, budesonide impurities and degradation products were assayed using the HPLC–UV method described for the budesonide-related substance assay in the European Pharmacopoeia monograph. Results The solubility of budesonide increased linearly with both cyclodextrins. Gamma cyclodextrin (complexation efficiency: 0.147) was preferred to hydroxypropyl-β-cyclodextrin (complexation efficiency: 0.064) as a solubilizing agent. Hydroxypropylcellulose (1 % m/v) was added to increase viscosity, and sucralose was added to improve palatability. The sterilized, filtered, final formulation was stable for at least 3 months when packed aseptically in sterile 15 mL type 1 amber glass vials. Conclusions We have developed a convenient, stable, preservative-free, viscous formulation of a budesonide solution for the hospital- and home-based treatment of paediatric patients.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"153 1","pages":"71 - 77"},"PeriodicalIF":0.0,"publicationDate":"2018-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78204359","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":"Safe use of Dexamethasone in pediatrics: design and evaluation of a novel stable oral suspension","authors":"Ana Santoveña-Estévez, Diego Dorta-Vera, I. González-García, Javier Suárez-González, Nuria Teigell-Pérez, J. Fariña","doi":"10.1515/PTHP-2018-0003","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0003","url":null,"abstract":"Abstract Background Dexamethasone is used in pediatrics mainly for treatment of croup and bronchopulmonary dysplasia. Commercially available pediatric oral formulations include inadequate excipients for this population. When there are only commercially available oral dosage forms for adults, a formulation is prepared to reduce the dose by manipulation of authorized tablets or injectable dosage forms. This practice most of times is made without the quality and control that process requires. The aim of this study is to propose a formulation secure and suitable for pediatrics by the use of a Standard Operating Procedure that ensures its quality. Methods Design of two formulations was performed with lowest number and amount of excipients suitable for pediatrics, avoiding use of dexamethasone salts and preservatives. An accurate and precise analytical method and a methodology for analyzing uniformity of doses were developed. Physical, chemical and microbiological stability was tested. Results Stability of Dexamethasone was improved by acidification with citric/citrate buffer. Proposed suspension complies with quality criteria required for an oral non-sterile formulation using Dexamethasone as active pharmaceutical ingredient, and the minimum number and quantity of excipients suitable for pediatrics. Conclusions This formulation is physical, chemical and microbiologically stable during 15 days storage at 5 and 25 °C.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"3 1","pages":"59 - 70"},"PeriodicalIF":0.0,"publicationDate":"2018-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88053399","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 Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend® SF PH4","authors":"Anne-Claire Bonnaure, R. Bellay, P. Rault, M. Lester, P. Boivin","doi":"10.1515/PTHP-2018-0001","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0001","url":null,"abstract":"Abstract Background Prednisone is a corticosteroid used in several inflammatory diseases and cancers. In France, no available prednisone drinkable formulation exists. Instead, an oral syrup of prednisone with ethanol, sodium benzoate and simple syrup is produced. However, sodium benzoate can induce neonatal icterus and alcohol is not authorized for children below 3 years of age. The aim of this study was to determine the stability of 5 mg/mL prednisone oral suspension in a commercial compounding excipient: Syrspend® SF PH4. Methods Three batches of oral suspensions were prepared, using micronized prednisone and Syrspend® SF PH4. They were packaged in amber glass vials and stored at room temperature. On day 0, 1, 4, 10, 30, 60 and 90, we observed physical and chemical stability (pH measurement, osmolality measurement, residual concentrations of prednisone and degradation product identification). A stability indicating method was developed using high performance liquid chromatography with Ultraviolet detection at 254 nm. Results Prednisone concentrations remained stable within ± 5 % of nominal values for 60 days. No degradation product and change of physicochemical properties were detected. Conclusion This study showed that 5 mg/mL prednisone oral suspension in Syrspend® SF PH4 is stable for 60 days, at room temperature and protected from light.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"69 2 1","pages":"49 - 57"},"PeriodicalIF":0.0,"publicationDate":"2018-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87661857","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":"The Introduction of SteriDefiTM: a Serious Game for Continuous Training of Sterilization Staff in French Hospitals","authors":"A. Robelet, Catherine Guimier-Pingault, C. Lambert","doi":"10.1515/PTHP-2018-0009","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0009","url":null,"abstract":"Abstract Sterilization is a pharmaceutical discipline constantly evolving and requiring highly qualified staff. In response to the need highlighted by French sterilization heads, the French Society for Sterilization Science (SF2S) has developed a serious game called “SteriDefiTM”. To design the game, a literature review was carried out in order to determine the essential points to be included in its specifications. The second step was to launch the IT (Information Technology) development. In parallel, a database was drafted by a panel of 8 experts in the field of sterilization. At last, the version initially produced was tested over a two-month period. The accessibility, its settings and gameplay were evaluated and improved. Data have been collected to determine the number of user establishments and games played since it was on line. In addition, a multi-centre study is planned to measure the evolution of knowledge and the satisfaction of players with the game.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"95 1","pages":"39 - 43"},"PeriodicalIF":0.0,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85719272","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":"Stability of 5 mg/mL Nitrendipine Oral Suspension in Syrspend® SF PH4","authors":"R. Bellay, Anne-Claire Bonnaure, P. Rault, Sophie Pertuisel, M. Lester, P. Boivin","doi":"10.1515/PTHP-2017-0030","DOIUrl":"https://doi.org/10.1515/PTHP-2017-0030","url":null,"abstract":"Abstract Background Nitrendipine is prescribed to children for the treatment of primary hypertension (off-label use). Available specialties (Nidrel®, Baypress® and others generic drugs) are only marketed in tablet form, which is unsuitable for pediatric use. A hospital preparation of nitrendipine oral suspension at 5 mg/mL was developed. The aim of the study was to determine physicochemical and microbiological stability of the nitrendipine oral suspension in order to set a shelf life for the preparation. Methods A validated high-performance liquid chromatographic (HPLC) method was developed for the assay of nitrendipine. Nitrendipine oral suspensions were prepared using 20 mg Nidrel® tablets and suspending vehicle Syrspend® SF PH4. These preparations were packaged in amber glass bottles and stored at room temperature. The physicochemical (pH, osmolality, nitrendipine concentration, macroscopic changes) and microbiological stability of the preparation was tested over 90 days. Nitrendipine concentration at day 0 was considered as 100 % and nitrendipine concentration in subsequent samples greater than 95 % were considered stable. Results The developed HPLC method was validated in terms of linearity, accuracy, precision and specificity. After 90 days, no significant pH and osmolality variation was observed. No microbial growth was noted. Concentrations of nitrendipine were found to be always higher 95 % of the initial concentration. Conclusions Nitrendipine oral suspensions 5 mg/mL are stable for at least 90 days when stored at temperature room and in amber glass bottles. This suspension is more suitable for children than tablets and allows obtaining accurate doses based on patient’s body weight.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"1 1","pages":"31 - 37"},"PeriodicalIF":0.0,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74875761","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":"Evolution of the Stabilis® Database: Creation of a Level of Evidence for Stability Studies","authors":"E. D’huart, P. Lider, J. Vigneron, B. Demoré","doi":"10.1515/PTHP-2018-0002","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0002","url":null,"abstract":"Abstract Background Stabilis® is an international database on stability and compatibility of drugs. The stability data comes mainly from publications of pharmaceutical journals. As the quality of the published stability studies is not equivalent, the objective of this work was to propose a level of evidence for the physico-chemical stability studies selected for the database. Methods At first, we evaluated the main pharmacological class consulted by the users. This work was then divided into 5 steps: (1) updating of the criteria to validate a stability study, (2) creating a grid rating articles, (3) rating of the articles of stability studies for anticancer, antifungal and antiviral drugs by 2 evaluators, (4) creation of new screens in the database to enter rating, to visualize the pictograms and commentaries by the users, (5) creation of a guideline to explain the different levels of evidence. Results The main pharmacological class consulted by Stabilis® users is the anticancer drugs and then antiinfectives. We have selected anticancer, antifungal and antiviral drugs for our study. Two hundred and forty publications were evaluated. The highest level attributed was A for anticancer and antifungal drugs and C for antiviral drugs. This difference can be explained by the fact that the majority of publications about antiviral drugs were older. The most frequent anomalies in the rating of articles were an incomplete or imperfect validation of the analytical method (high value of the coefficient of variation) and a defect in the evaluation of the stability indicating capacity. It must be noted that the level of evidence is not the quality level of the analytical method but the mixture of the quality of the method validation and of the results. This aspect was a choice of the Stabilis® team and seems important because the security of the patient is impacted by both aspects. Conclusions This new function contributes to help the Stabilis® users to evaluate the stability data published and to take a decision for their use in daily practice. This function will be progressively extended to other pharmacological classes of injectable drugs and then for non-injectable preparations.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"9 1","pages":"3 - 12"},"PeriodicalIF":0.0,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88981760","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":"Quality in Stability Testing","authors":"F. Lagarce","doi":"10.1515/pthp-2018-0010","DOIUrl":"https://doi.org/10.1515/pthp-2018-0010","url":null,"abstract":"","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"9 1","pages":"1 - 2"},"PeriodicalIF":0.0,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88433269","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":"Stability of Concentrated Solution of Vancomycin Hydrochloride in Syringes for Intensive Care Units","authors":"M. Godet, J. Simar, M. Closset, J. Hecq, M. Braibant, L. Soumoy, P. Gillet, J. Jamart, B. Bihin, L. Galanti","doi":"10.1515/PTHP-2017-0031","DOIUrl":"https://doi.org/10.1515/PTHP-2017-0031","url":null,"abstract":"Abstract Background Vancomycin is increasingly administrated by continuous infusion. But the treatment of patient in intensive care need restricted volume to prevent fluid overload. The aim of the study was to evaluate the physical and chemical stability of solutions of a high concentration of vancomycin hydrochloride in 5 % glucose or 0.9 % NaCl. Methods Eight syringes of 50 mL, containing 41.66 mg/mL of vancomycin hydrochloride four syringes in 5 % glucose and four in 0.9 % NaCl were prepared and stored at ambient temperature during 48 h. Immediately after preparation and during 48 h, vancomycin hydrochloride concentrations were measured by a high-performance liquid chromatography (HPLC). Spectrophotometric absorbance at different wavelengths, pH measurement and microscopic observations were also performed. Results All solutions were physico-chemically stable during the whole period storage at ambient temperature: no color change, turbidity, precipitation or opacity, no significant pH variations or optic densities were observed in the solutions. Any crystals were seen by microscopic analysis. Solutions are considered chemically stable as the lower limit of the 95 % unilateral confidence interval on the mean remained above 90 % of the initial concentration for at least 48 h. Conclusions Solutions of vancomycin hydrochloride 41.66 mg/mL in syringe of 5 % glucose or 0.9 % NaCl are physically and chemically stable for at least 48 h when stored in syringes at ambient temperature.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"30 1","pages":"23 - 30"},"PeriodicalIF":0.0,"publicationDate":"2018-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78620058","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}