Abstract Background The production of hospital-compounded medicines with a longer shelf life raises questions about drug-packaging interactions, especially desorption events involving extractables and leachables (E/L). A meta-synthesis of the literature was performed to describe which mass spectrometer is suitable for identifying and quantifying E/L. Methods A meta-synthesis of studies focused on the identification or quantification of E/L published between January 1997 and December 2017 was performed. Inclusion criteria were E/L studies dealing with pharmaceutical products, in which mass spectrometry (MS) coupled to liquid chromatography (LC) or gas chromatography (GC) was used. The full-text articles had to be available and written in English. Articles about food packaging, environmental contamination, counterfeit compounds, pharmacokinetics, or process-related impurity studies were excluded. Two researchers independently assessed the papers according to a score based on a seven-item questionnaire. Results In total, 32 papers matched our criteria and were included in the meta-synthesis. For qualitative analysis with LC, quadrupole time-of-flight (QTOF; n=4) and ion trap (n=4) mass detectors were used the most; and with GC, single quadrupole (n=8). For quantification studies with LC, QTOF (n=3) and triple quadrupole (n=2) were used the most; and with GC, single quadrupole (n=7). Conclusions For simultaneous qualitative and quantitative analysis of E/L with LC, QTOF or Orbitrap is a suitable detector. For quantitative analysis with LC only, triple quadrupole is suitable. For qualitative and quantitative analysis with GC, single quadrupole can be used.
{"title":"Investigation of Drug-Packaging Interactions with Mass Spectroscopy Detectors: A Meta-Synthesis of the Literature","authors":"C. Fauchere, M. Berger-Gryllaki, F. Sadeghipour","doi":"10.1515/PTHP-2018-0027","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0027","url":null,"abstract":"Abstract Background The production of hospital-compounded medicines with a longer shelf life raises questions about drug-packaging interactions, especially desorption events involving extractables and leachables (E/L). A meta-synthesis of the literature was performed to describe which mass spectrometer is suitable for identifying and quantifying E/L. Methods A meta-synthesis of studies focused on the identification or quantification of E/L published between January 1997 and December 2017 was performed. Inclusion criteria were E/L studies dealing with pharmaceutical products, in which mass spectrometry (MS) coupled to liquid chromatography (LC) or gas chromatography (GC) was used. The full-text articles had to be available and written in English. Articles about food packaging, environmental contamination, counterfeit compounds, pharmacokinetics, or process-related impurity studies were excluded. Two researchers independently assessed the papers according to a score based on a seven-item questionnaire. Results In total, 32 papers matched our criteria and were included in the meta-synthesis. For qualitative analysis with LC, quadrupole time-of-flight (QTOF; n=4) and ion trap (n=4) mass detectors were used the most; and with GC, single quadrupole (n=8). For quantification studies with LC, QTOF (n=3) and triple quadrupole (n=2) were used the most; and with GC, single quadrupole (n=7). Conclusions For simultaneous qualitative and quantitative analysis of E/L with LC, QTOF or Orbitrap is a suitable detector. For quantitative analysis with LC only, triple quadrupole is suitable. For qualitative and quantitative analysis with GC, single quadrupole can be used.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"65 1","pages":"3 - 14"},"PeriodicalIF":0.0,"publicationDate":"2019-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79960158","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}
E. Gautier, J. Saillard, C. Deshayes, S. Vrignaud, F. Lagarce, T. Briot
Abstract Background Microbial keratitis are severe infectionsgenerally linked to risk factors. High-doses antibiotic eye-drops could be required to avoid severe complications. In such cases, hospital pharmacists are in charge of their production given the lack of such formulations on the market. The stability of these antibiotic eye-drops is generally limited to a couple of days and publications generally do not describe addition of microbial preservatives even though it is a European Pharmacopeia requirement. The aim of this study was to describe a new ceftazidime eye-drops formulation at 50 mg/mL with a antimicrobial additive, benzalkonium chloride at 0.04 mg/mL. Methods Physico-chemical studies of this new formulation were performed by a stability indicating HPLC-UV method validated according to ICH standards, osmolality measurements, pH monitoring and visual examinations. Antimicrobial preservative efficacy was evaluated according to the method from the European Pharmacopeia. Results After 75 days at −20 °C followed by 7 days at 4 °C, or after 7 days at 4 °C, the eye-drops were stable. A degradation trend was finally observed at day 14 at 4 °C. Conclusions A new ceftazidime eye-drops formulation is proposed with a stability of 7 days. Outpatients do not need to return to the hospital pharmacy for repeat dispensing, thus possibly improving treatment compliance.
{"title":"Stability of a 50 mg/mL Ceftazidime Eye-Drops Formulation","authors":"E. Gautier, J. Saillard, C. Deshayes, S. Vrignaud, F. Lagarce, T. Briot","doi":"10.1515/PTHP-2018-0025","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0025","url":null,"abstract":"Abstract Background Microbial keratitis are severe infectionsgenerally linked to risk factors. High-doses antibiotic eye-drops could be required to avoid severe complications. In such cases, hospital pharmacists are in charge of their production given the lack of such formulations on the market. The stability of these antibiotic eye-drops is generally limited to a couple of days and publications generally do not describe addition of microbial preservatives even though it is a European Pharmacopeia requirement. The aim of this study was to describe a new ceftazidime eye-drops formulation at 50 mg/mL with a antimicrobial additive, benzalkonium chloride at 0.04 mg/mL. Methods Physico-chemical studies of this new formulation were performed by a stability indicating HPLC-UV method validated according to ICH standards, osmolality measurements, pH monitoring and visual examinations. Antimicrobial preservative efficacy was evaluated according to the method from the European Pharmacopeia. Results After 75 days at −20 °C followed by 7 days at 4 °C, or after 7 days at 4 °C, the eye-drops were stable. A degradation trend was finally observed at day 14 at 4 °C. Conclusions A new ceftazidime eye-drops formulation is proposed with a stability of 7 days. Outpatients do not need to return to the hospital pharmacy for repeat dispensing, thus possibly improving treatment compliance.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"52 1","pages":"219 - 226"},"PeriodicalIF":0.0,"publicationDate":"2018-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84673790","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}
Mouloud Yessaad, L. Bernard, D. Bourdeaux, P. Chennell, V. Sautou
Abstract Background Water-soluble vitamins are often included simultaneously in pharmaceutical formulations as food complements or in parenteral nutrition mixtures. Given their sensitivity to heat, light or pH variations, it is important to study their stability using validated stability indicating methods. We thus aimed to validate a liquid chromatography (LC) stability-indicating method for the simultaneous quantification of 5 water-soluble vitamins. Methods We analyzed four water-soluble B vitamins (nicotinamide, pyridoxine, folic acid, cyanocobalamin) and ascorbic acid using a LC method with diode array detector. They were separated on a C18 stationary phase under gradient elution of solvent A [0.2 % of metaphosphoric acid in water and acetonitrile 98:2] and solvent B (100 % acetonitrile). All vitamins were subjected to forced degradation conditions and we showed that the obtained degradation products didn’t interfere with the vitamins. Results The method allows the separation of the 5 water-soluble vitamins in a 30 minute run without any interference from the breakdown products obtained with acid/alkaline solutions, hydrogen peroxide, temperature and light. It meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity. Conclusions This stability-indicating method can be used for carrying out stability studies of water-soluble vitamins in pharmaceutical preparations.
{"title":"Development of a Stability Indicating Method for Simultaneous Analysis of Five Water-Soluble Vitamins by Liquid Chromatography","authors":"Mouloud Yessaad, L. Bernard, D. Bourdeaux, P. Chennell, V. Sautou","doi":"10.1515/PTHP-2018-0026","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0026","url":null,"abstract":"Abstract Background Water-soluble vitamins are often included simultaneously in pharmaceutical formulations as food complements or in parenteral nutrition mixtures. Given their sensitivity to heat, light or pH variations, it is important to study their stability using validated stability indicating methods. We thus aimed to validate a liquid chromatography (LC) stability-indicating method for the simultaneous quantification of 5 water-soluble vitamins. Methods We analyzed four water-soluble B vitamins (nicotinamide, pyridoxine, folic acid, cyanocobalamin) and ascorbic acid using a LC method with diode array detector. They were separated on a C18 stationary phase under gradient elution of solvent A [0.2 % of metaphosphoric acid in water and acetonitrile 98:2] and solvent B (100 % acetonitrile). All vitamins were subjected to forced degradation conditions and we showed that the obtained degradation products didn’t interfere with the vitamins. Results The method allows the separation of the 5 water-soluble vitamins in a 30 minute run without any interference from the breakdown products obtained with acid/alkaline solutions, hydrogen peroxide, temperature and light. It meets all the qualitative and quantitative criteria for validation with an acceptable accuracy and good linearity. Conclusions This stability-indicating method can be used for carrying out stability studies of water-soluble vitamins in pharmaceutical preparations.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"17 1","pages":"207 - 218"},"PeriodicalIF":0.0,"publicationDate":"2018-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80885944","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}
Nelly Lonca, F. Maillard, G. Leguelinel, T. Sharkawi, I. Soulairol
Abstract Background The intolerance to Acetylsalicylic Acid (ASA) can be detected by conducting oral provocation testing (OPT), which is to gradually introduce low doses of ASA. To perform this test, hospital pharmacies compound small batches of different low-dosage ASA capsules. This work aims to validate a method for fast HPLC-UV assay that allows routine quality control and physicochemical stability studies of capsules. Methods The chromatographic separation is performed using a C18 column Kinetex (100 A, 50×4.6 mm, 2.6 µm) equipped with a precolumn C18. Separation is achieved using a mobile phase composed of water-acetonitrile-orthophosphoric acid (68:32:0.2 v/v/v) at a flow rate of 0.8 mL/min and UV detection at 237 nm. Results Validation shows that the method was suitable for routine analysis and could be used to perform stability studies. Conclusions The 5, 25, 100 and 250 mg dosed capsules show acceptable stability over 12 months, while the 1 mg dosed capsule show an unacceptable degradation of more than 15 % after 3 months. Therefore, hospital pharmacy can plan the manufacture of capsules and anticipate the requests of doctors.
背景对乙酰水杨酸(ASA)不耐受可通过口服激发试验(OPT)检测，即逐渐引入低剂量的ASA。为了进行这项试验，医院药房配制了小批量不同低剂量的ASA胶囊。本工作旨在验证一种快速HPLC-UV测定方法，该方法可用于胶囊的常规质量控制和理化稳定性研究。方法采用C18柱Kinetex (100 a, 50×4.6 mm, 2.6µm)，柱前为C18。采用水-乙腈-正磷酸(68:32:2 .2 v/v/v)为流动相，流速为0.8 mL/min，紫外检测波长为237 nm。结果验证表明，该方法适用于常规分析，可用于稳定性研究。结论5、25、100和250 mg剂量胶囊在12个月内的稳定性可接受，而1 mg剂量胶囊在3个月后的降解率超过15%，这是不可接受的。因此，医院药房可以计划胶囊的生产，预测医生的需求。
{"title":"Validation of an HPLC Assay Method for Routine QC Testing and Stability Study of Compounded Low-Dose Capsules of Acetylsalicylic Acid","authors":"Nelly Lonca, F. Maillard, G. Leguelinel, T. Sharkawi, I. Soulairol","doi":"10.1515/PTHP-2018-0022","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0022","url":null,"abstract":"Abstract Background The intolerance to Acetylsalicylic Acid (ASA) can be detected by conducting oral provocation testing (OPT), which is to gradually introduce low doses of ASA. To perform this test, hospital pharmacies compound small batches of different low-dosage ASA capsules. This work aims to validate a method for fast HPLC-UV assay that allows routine quality control and physicochemical stability studies of capsules. Methods The chromatographic separation is performed using a C18 column Kinetex (100 A, 50×4.6 mm, 2.6 µm) equipped with a precolumn C18. Separation is achieved using a mobile phase composed of water-acetonitrile-orthophosphoric acid (68:32:0.2 v/v/v) at a flow rate of 0.8 mL/min and UV detection at 237 nm. Results Validation shows that the method was suitable for routine analysis and could be used to perform stability studies. Conclusions The 5, 25, 100 and 250 mg dosed capsules show acceptable stability over 12 months, while the 1 mg dosed capsule show an unacceptable degradation of more than 15 % after 3 months. Therefore, hospital pharmacy can plan the manufacture of capsules and anticipate the requests of doctors.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"4 1","pages":"199 - 206"},"PeriodicalIF":0.0,"publicationDate":"2018-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73060813","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}
Abstract Our department of pharmacy takes over all the medical skin tests prescribed by the allergy department. The production takes place in specific premises, with qualified and calibrated equipment, by a qualified and regularly assessed staff—in compliance with the French preparation guidelines. The whole activity is under the responsibility of a pharmacist—handlings are performed by hospital pharmacy technicians. Each new intradermal skin test demand leads to a feasibility analysis—irritating nature, dilution solvent, concentration—this information is gathered in a thesaurus. The manufacturing steps are the following: prescription validation, production sheet and label printing, preparation of the needed equipment, batch numbers and expiration date checking, handling under a vertical laminar flow hood and control after production. The preparation activity increases continuously and the thesaurus currently contents 302 rows with following information: drug, dilution and reconstitution solvent, pure solution concentration and maximum concentration to test with intradermal tests. Work would prospect in costs reduction and resources optimization. Thanks to the allergists’ confidence, the partnership between the two departments can go on. This guarantees the quality of the preparations tested on patients but also the skin tests reproducibility.
{"title":"Pharmaceutical Preparations for Intradermal Drug Tests","authors":"S. Ménétré, S. Robert, B. Demoré","doi":"10.1515/PTHP-2018-0023","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0023","url":null,"abstract":"Abstract Our department of pharmacy takes over all the medical skin tests prescribed by the allergy department. The production takes place in specific premises, with qualified and calibrated equipment, by a qualified and regularly assessed staff—in compliance with the French preparation guidelines. The whole activity is under the responsibility of a pharmacist—handlings are performed by hospital pharmacy technicians. Each new intradermal skin test demand leads to a feasibility analysis—irritating nature, dilution solvent, concentration—this information is gathered in a thesaurus. The manufacturing steps are the following: prescription validation, production sheet and label printing, preparation of the needed equipment, batch numbers and expiration date checking, handling under a vertical laminar flow hood and control after production. The preparation activity increases continuously and the thesaurus currently contents 302 rows with following information: drug, dilution and reconstitution solvent, pure solution concentration and maximum concentration to test with intradermal tests. Work would prospect in costs reduction and resources optimization. Thanks to the allergists’ confidence, the partnership between the two departments can go on. This guarantees the quality of the preparations tested on patients but also the skin tests reproducibility.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"114 1","pages":"227 - 234"},"PeriodicalIF":0.0,"publicationDate":"2018-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73221788","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}
Anne J.A. Drost-Wijnne, R. V. van Wezel, M. Deenen, J. P. C. M. van Doornmalen Gomez Hoyos, R. Grouls
Abstract Background A new development in drug compounding is the production of ready-to-administer sterilized prefilled syringes. A challenge with these syringes is the method of terminal sterilization. There is no information available whether water cascade sterilization is a suitable method. We investigated the effect of this sterilization method on cyclic olefin (co)polymer (CCP/COC) syringes. Methods For two brands ten prefilled syringes were sterilized using water cascade sterilization. The closure integrity, stopper movement, weight, diameter and physical appearance were determined before and after sterilization. As sterility test, additional syringes were filled with tryptic soy broth (TSB) and sterilized. After fourteen days microbiological growth was determined. Results Closure integrity testing showed no dye penetration inside the syringe. Together with the results for weight this showed that closure integrity is guaranteed. No significant stopper movement, deviation in diameter or visual anomalies were observed. No microbiological growth in TSB was visible. Conclusions The results of this proof of principle study show that the physical and microbiological stability of the cyclic olefin (co)polymer syringes is guaranteed during sterilization using a water cascade sterilizer. These results do not rule out the necessity for further stability experiments (e. g. interaction with drug product) to further proof the concept.
{"title":"A Proof of Principle Study of the Terminal Sterilization of Prefilled Syringes Using A Water Cascade Process","authors":"Anne J.A. Drost-Wijnne, R. V. van Wezel, M. Deenen, J. P. C. M. van Doornmalen Gomez Hoyos, R. Grouls","doi":"10.1515/PTHP-2018-0020","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0020","url":null,"abstract":"Abstract Background A new development in drug compounding is the production of ready-to-administer sterilized prefilled syringes. A challenge with these syringes is the method of terminal sterilization. There is no information available whether water cascade sterilization is a suitable method. We investigated the effect of this sterilization method on cyclic olefin (co)polymer (CCP/COC) syringes. Methods For two brands ten prefilled syringes were sterilized using water cascade sterilization. The closure integrity, stopper movement, weight, diameter and physical appearance were determined before and after sterilization. As sterility test, additional syringes were filled with tryptic soy broth (TSB) and sterilized. After fourteen days microbiological growth was determined. Results Closure integrity testing showed no dye penetration inside the syringe. Together with the results for weight this showed that closure integrity is guaranteed. No significant stopper movement, deviation in diameter or visual anomalies were observed. No microbiological growth in TSB was visible. Conclusions The results of this proof of principle study show that the physical and microbiological stability of the cyclic olefin (co)polymer syringes is guaranteed during sterilization using a water cascade sterilizer. These results do not rule out the necessity for further stability experiments (e. g. interaction with drug product) to further proof the concept.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"13 1","pages":"191 - 198"},"PeriodicalIF":0.0,"publicationDate":"2018-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80016914","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}
J. Sorrieul, J. Robert, H. Kieffer, C. Folliard, C. Devys
Abstract Intrathecal analgesia has increased over the last 30 years. In oncology, it is a real alternative for the treatment of refractory pain. The diversity of the molecules alone or in combination that can be used, the risk related to the route of administration, and the cost of certain molecules are all arguments in favor of centralized preparation within the pharmacy. The purposes of this work are first of all to explain the reasons for centralization of these preparations, and in a second time to describe the circuit developed within our establishment.
{"title":"Feedback on the Centralization of Intrathecal Analgesic Preparations in Hospital Pharmacy","authors":"J. Sorrieul, J. Robert, H. Kieffer, C. Folliard, C. Devys","doi":"10.1515/PTHP-2018-0017","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0017","url":null,"abstract":"Abstract Intrathecal analgesia has increased over the last 30 years. In oncology, it is a real alternative for the treatment of refractory pain. The diversity of the molecules alone or in combination that can be used, the risk related to the route of administration, and the cost of certain molecules are all arguments in favor of centralized preparation within the pharmacy. The purposes of this work are first of all to explain the reasons for centralization of these preparations, and in a second time to describe the circuit developed within our establishment.","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"3 1","pages":"177 - 182"},"PeriodicalIF":0.0,"publicationDate":"2018-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84130400","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}
S. Huvelle, M. Godet, L. Galanti, M. Closset, B. Bihin, J. Jamart, J. Hecq
Abstract Background Piperacillin-Tazobactam is frequently infused in hospitals. The use of a generic version was considered after the out of stock of the brand name Tazocin®. The stability of 4 g of Tazocin® in 120 mL of dextrose 5 % (D5) was demonstrated during 35 days at 5 °C ± 3 °C after freezing (−20 °C) and microwave thawing (FMT). The aim of the study was to investigate and compare the long-term stability of Tazocin® and a generic product in the same conditions. Methods Five polyolefin bags of 4 g of Piperacillin/Tazobactam® Sandoz and 5 bags of 4 g of Tazocin® were prepared under aseptic conditions in 120 mL of D5 and stored 3 months at 20 °C then thawed and stored 58 days at 5 ± 3 °C. Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed. The concentrations were measured by HPLC, at 211 nm for tazobactam and 230 nm for piperacilline. Results No significant change in pH values or optic densities, no crystals were detected. The lower confidence limit at 95 % of the concentration for the solutions remains superior to 90 % of the initial concentration until 58 days of storage at 5 ± 3 °C. Conclusion Under these conditions, 4 g/120 mL of Piperacillin/Tazobactam® Sandoz or Tazocin® in D5 infusion in polyolefin bags remains stable at least for 58 days at 5 ± 3 °C after FMT
背景哌拉西林-他唑巴坦是医院输注的常用药物。在品牌名称Tazocin®缺货后，考虑使用通用版本。在冷冻(- 20°C)和微波解冻(FMT)后，在5°C±3°C条件下，4 g Tazocin®在120 mL 5%葡萄糖(D5)中的稳定性被证明为35天。该研究的目的是调查和比较他唑嗪®和仿制药在相同条件下的长期稳定性。方法在120 mL D5中，无菌条件下制备5袋4 g哌拉西林/他唑巴坦®山德士和5袋4 g他唑巴坦®聚烯烃，20℃保存3个月，5±3℃解冻保存58 d。并进行了不同波长的分光光度法吸光度、pH值测定、目测和显微观察。高效液相色谱法测定其浓度，他唑巴坦在211 nm，哌拉西林在230 nm。结果pH值、光密度无明显变化，未检出晶体。在5±3°C条件下保存58天，95%浓度下的下限仍然优于初始浓度的90%。结论在此条件下，4 g/120 mL哌拉西林/他唑巴坦®山德士或他唑巴坦®聚烯烃袋D5输注在FMT后5±3℃下至少保持58天的稳定性
{"title":"Long-Term Stability Comparison between an Original and a Generic Version of Piperacillin/Tazobactam in Dextrose 5 % Infusion Polyolefin Bags at 5 ± 3 °C after Microwave Freeze-Thaw Treatment","authors":"S. Huvelle, M. Godet, L. Galanti, M. Closset, B. Bihin, J. Jamart, J. Hecq","doi":"10.1515/PTHP-2018-0014","DOIUrl":"https://doi.org/10.1515/PTHP-2018-0014","url":null,"abstract":"Abstract Background Piperacillin-Tazobactam is frequently infused in hospitals. The use of a generic version was considered after the out of stock of the brand name Tazocin®. The stability of 4 g of Tazocin® in 120 mL of dextrose 5 % (D5) was demonstrated during 35 days at 5 °C ± 3 °C after freezing (−20 °C) and microwave thawing (FMT). The aim of the study was to investigate and compare the long-term stability of Tazocin® and a generic product in the same conditions. Methods Five polyolefin bags of 4 g of Piperacillin/Tazobactam® Sandoz and 5 bags of 4 g of Tazocin® were prepared under aseptic conditions in 120 mL of D5 and stored 3 months at 20 °C then thawed and stored 58 days at 5 ± 3 °C. Spectrophotometric absorbance at different wavelengths, pH measurement, visual and microscopic observations were also performed. The concentrations were measured by HPLC, at 211 nm for tazobactam and 230 nm for piperacilline. Results No significant change in pH values or optic densities, no crystals were detected. The lower confidence limit at 95 % of the concentration for the solutions remains superior to 90 % of the initial concentration until 58 days of storage at 5 ± 3 °C. Conclusion Under these conditions, 4 g/120 mL of Piperacillin/Tazobactam® Sandoz or Tazocin® in D5 infusion in polyolefin bags remains stable at least for 58 days at 5 ± 3 °C after FMT","PeriodicalId":19802,"journal":{"name":"Pharmaceutical Technology in Hospital Pharmacy","volume":"48 1","pages":"143 - 151"},"PeriodicalIF":0.0,"publicationDate":"2018-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75096349","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}
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