Pub Date : 2010-08-19DOI: 10.3109/10601333.2010.485317
A. Di Donato, C. Fontana, D. Alemanno, A. Di Giacomo
The aim of this prospective study was to evaluate the efficacy of endoscopic epidurolysis in the treatment of degenerative chronic low back pain. Three-hundred and fifty patients with Visual analog scale (VAS) and Oswestry Low Back Pain Disability Index (ODI) from 0–60% (0–20%, group A; 20–40%, group B; 40–60%, group C) were enrolled and treated prospectively with endoscopic epidurolysis by means of a Myelotec endoscope and by the intermittent instillation of saline solution added with hyaluronidase. Targeted application of ozone and ciprofloxacin close to the abnormal areas was also performed. Short- and long-term efficacy was prospectively evaluated. A VAS score < 5 and ODI < 40% were considered as a positive outcome. The treatment significantly reduces the VAS in all three groups of patients, starting from the first week and throughout the entire follow-up period (p < 0.001), also the Disability Index (ODI) showed a statistically significant decrease of the score (p < 0.001), that was particularly evident at 3 months and maintained up to long-term follow-up intervals. In conclusion, epiduroscopy by mechanical adhesiolysis and administration on targeted areas of ciprofloxacina and ozone seems to be, in this prospective study, an effective technique to provide sensible and persisting pain relief and act of improving ODI in chronic low back pain.
{"title":"Epiduroscopy in treatment of degenerative chronic low back pain: A prospective analysis and follow-up at 60 months","authors":"A. Di Donato, C. Fontana, D. Alemanno, A. Di Giacomo","doi":"10.3109/10601333.2010.485317","DOIUrl":"https://doi.org/10.3109/10601333.2010.485317","url":null,"abstract":"The aim of this prospective study was to evaluate the efficacy of endoscopic epidurolysis in the treatment of degenerative chronic low back pain. Three-hundred and fifty patients with Visual analog scale (VAS) and Oswestry Low Back Pain Disability Index (ODI) from 0–60% (0–20%, group A; 20–40%, group B; 40–60%, group C) were enrolled and treated prospectively with endoscopic epidurolysis by means of a Myelotec endoscope and by the intermittent instillation of saline solution added with hyaluronidase. Targeted application of ozone and ciprofloxacin close to the abnormal areas was also performed. Short- and long-term efficacy was prospectively evaluated. A VAS score < 5 and ODI < 40% were considered as a positive outcome. The treatment significantly reduces the VAS in all three groups of patients, starting from the first week and throughout the entire follow-up period (p < 0.001), also the Disability Index (ODI) showed a statistically significant decrease of the score (p < 0.001), that was particularly evident at 3 months and maintained up to long-term follow-up intervals. In conclusion, epiduroscopy by mechanical adhesiolysis and administration on targeted areas of ciprofloxacina and ozone seems to be, in this prospective study, an effective technique to provide sensible and persisting pain relief and act of improving ODI in chronic low back pain.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"17 1","pages":"69 - 74"},"PeriodicalIF":0.0,"publicationDate":"2010-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88208118","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}
Pub Date : 2010-08-19DOI: 10.3109/10601333.2010.491077
S. Naimer
While many issues regarding emergency care of polytrauma are still under debate, it is agreed that immediate control of acute external traumatic hemorrhage is the most critical instance where intervention by the rescue team plays a decisive role in determining the fate of the wounded. The aim of this report is to describe the evolution of a novel procedure for treating the bleeding wound that offers clear and obvious advantages. The method uses an elastic, adhesive dressing (ELAD) that eventually resulted in a single unit, utilizing a transparent material. This product is also termed Rapid Wrap™ (currently developed by Rapid Healing Technologies). The elastic adhesive dressing application is performed by placing the contact pad over the area of injured tissue and rapidly wrapping the roll component over the wound with growing tension. This paper follows the development of a new life saving device and demonstrates rewarding research for the treatment of profusely bleeding injuries.
{"title":"New era of transparent compression to control bleeding from traumatic wounds: Removing the blindfold","authors":"S. Naimer","doi":"10.3109/10601333.2010.491077","DOIUrl":"https://doi.org/10.3109/10601333.2010.491077","url":null,"abstract":"While many issues regarding emergency care of polytrauma are still under debate, it is agreed that immediate control of acute external traumatic hemorrhage is the most critical instance where intervention by the rescue team plays a decisive role in determining the fate of the wounded. The aim of this report is to describe the evolution of a novel procedure for treating the bleeding wound that offers clear and obvious advantages. The method uses an elastic, adhesive dressing (ELAD) that eventually resulted in a single unit, utilizing a transparent material. This product is also termed Rapid Wrap™ (currently developed by Rapid Healing Technologies). The elastic adhesive dressing application is performed by placing the contact pad over the area of injured tissue and rapidly wrapping the roll component over the wound with growing tension. This paper follows the development of a new life saving device and demonstrates rewarding research for the treatment of profusely bleeding injuries.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"24 1","pages":"82 - 86"},"PeriodicalIF":0.0,"publicationDate":"2010-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89587347","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}
Pub Date : 2010-08-19DOI: 10.3109/10601333.2010.486404
V. Sripuram, Harish K. Kaushik, S. Bedada, Narasimha Y. Reddy, K. Vangara, S. Praneeth Kumar, G. Indirapriyadarshini, K. Devarakonda
An isocratic reversed-phase high-performance liquid chromatographic method with ultraviolet detection at 254 nm has been developed for the determination of doxorubicin in human plasma. Plasma samples were extracted by a selective one-step liquid–liquid extraction using dichloromethane. Doxorubicin and the internal standard epirubicin were separated using a column packed with C18 material, using a mobile phase consisting of water:acetonitrile (75:25v/v). The calibration graph for doxorubicin was linear in the range 0.2–10 μg/mL, with a correlation coefficient, R2 = 0.9986. Lower limit of quantitation was 0.2 μg/mL, using 1 mL plasma samples. The extraction recovery ranged from 98.5–101.1%, and the recovery rate was consistent for drug and internal standard examined at each level. The interday and intraday precision values ranged between 0.5–2%. Validation data showed that the assay for doxorubicin is sensitive, selective, accurate, and reproducible. The assay has been used in population pharmacokinetics study.
{"title":"Development and validation of rapid and sensitive HPLC method for the quantitative determination of doxorubicin in human plasma","authors":"V. Sripuram, Harish K. Kaushik, S. Bedada, Narasimha Y. Reddy, K. Vangara, S. Praneeth Kumar, G. Indirapriyadarshini, K. Devarakonda","doi":"10.3109/10601333.2010.486404","DOIUrl":"https://doi.org/10.3109/10601333.2010.486404","url":null,"abstract":"An isocratic reversed-phase high-performance liquid chromatographic method with ultraviolet detection at 254 nm has been developed for the determination of doxorubicin in human plasma. Plasma samples were extracted by a selective one-step liquid–liquid extraction using dichloromethane. Doxorubicin and the internal standard epirubicin were separated using a column packed with C18 material, using a mobile phase consisting of water:acetonitrile (75:25v/v). The calibration graph for doxorubicin was linear in the range 0.2–10 μg/mL, with a correlation coefficient, R2 = 0.9986. Lower limit of quantitation was 0.2 μg/mL, using 1 mL plasma samples. The extraction recovery ranged from 98.5–101.1%, and the recovery rate was consistent for drug and internal standard examined at each level. The interday and intraday precision values ranged between 0.5–2%. Validation data showed that the assay for doxorubicin is sensitive, selective, accurate, and reproducible. The assay has been used in population pharmacokinetics study.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"20 1","pages":"75 - 81"},"PeriodicalIF":0.0,"publicationDate":"2010-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91305934","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}
Pub Date : 2010-06-01DOI: 10.3109/10601331003680812
{"title":"A message from the Publisher","authors":"","doi":"10.3109/10601331003680812","DOIUrl":"https://doi.org/10.3109/10601331003680812","url":null,"abstract":"","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"42 1","pages":"31 - 31"},"PeriodicalIF":0.0,"publicationDate":"2010-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79656216","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}
Pub Date : 2010-05-18DOI: 10.3109/10601333.2010.480974
K. P. Virk
There are several factors that play a key role in the growth of clinical research specific to Brazil. These include a large, diverse, rapidly growing population much of which is treatment-naïve, shortened approval times, improved GCP compliance, and an emergence of diseases predominant in developed countries. Successful patient enrolment and retention rates, and proximity to Western biopharmaceutical companies are additional factors. Due to the fact that the Brazilian population exhibits great racial and ethnic diversity, as well as differences in economic and educational backgrounds, there are significant hurdles that foreign sponsors must consider. These include linguistic and cultural barriers, as well as other socio-economic factors such as poverty and illiteracy. Successful outsourcing of clinical trials to Brazil therefore involves an understanding of these factors, and how they affect clinical research.
{"title":"Addressing issues affecting clinical trials in Brazil","authors":"K. P. Virk","doi":"10.3109/10601333.2010.480974","DOIUrl":"https://doi.org/10.3109/10601333.2010.480974","url":null,"abstract":"There are several factors that play a key role in the growth of clinical research specific to Brazil. These include a large, diverse, rapidly growing population much of which is treatment-naïve, shortened approval times, improved GCP compliance, and an emergence of diseases predominant in developed countries. Successful patient enrolment and retention rates, and proximity to Western biopharmaceutical companies are additional factors. Due to the fact that the Brazilian population exhibits great racial and ethnic diversity, as well as differences in economic and educational backgrounds, there are significant hurdles that foreign sponsors must consider. These include linguistic and cultural barriers, as well as other socio-economic factors such as poverty and illiteracy. Successful outsourcing of clinical trials to Brazil therefore involves an understanding of these factors, and how they affect clinical research.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"98 1","pages":"52 - 59"},"PeriodicalIF":0.0,"publicationDate":"2010-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83582149","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}
Pub Date : 2010-05-18DOI: 10.3109/10601331003698517
M. Faiyazuddin, Sarfaraz Ahmad, G. Mustafa, F. Ahmad, F. Shakeel
Evidence of differences in bioavailability from different oral formulations of the same therapeutic agents had become obvious by the early 1960s. The consequent 40 years have produced the body of scientific belief, debate, and policy on the subject of bioequivalence. The motivating force behind many of these events has been the continued interest of the food and drug administration (FDA) to improve the manner in which these studies are conducted, the quality of the data generated from such studies, and the methods by which they are evaluated. Bioanalytical data used to support regulatory submission needs to be accurate and reproducible. In order to have confidence in the reliability of the data, it is important that the analytical method used to generate it is well characterized and fully validated. However, bioavailability assessment (BA) and bioequivalence (BE) studies are necessary in filing of the data towards the drug approval. This review article describes the methods for assessing bioavailability and bioequivalence; and bioanalytical approaches of pharmaceuticals in vivo and in vitro and also a waiver of BA/BE studies based on the biopharmaceutical classification (BCS) system.
{"title":"Bioanalytical approaches, bioavailability assessment, and bioequivalence study for waiver drugs: In vivo and in vitro perspective","authors":"M. Faiyazuddin, Sarfaraz Ahmad, G. Mustafa, F. Ahmad, F. Shakeel","doi":"10.3109/10601331003698517","DOIUrl":"https://doi.org/10.3109/10601331003698517","url":null,"abstract":"Evidence of differences in bioavailability from different oral formulations of the same therapeutic agents had become obvious by the early 1960s. The consequent 40 years have produced the body of scientific belief, debate, and policy on the subject of bioequivalence. The motivating force behind many of these events has been the continued interest of the food and drug administration (FDA) to improve the manner in which these studies are conducted, the quality of the data generated from such studies, and the methods by which they are evaluated. Bioanalytical data used to support regulatory submission needs to be accurate and reproducible. In order to have confidence in the reliability of the data, it is important that the analytical method used to generate it is well characterized and fully validated. However, bioavailability assessment (BA) and bioequivalence (BE) studies are necessary in filing of the data towards the drug approval. This review article describes the methods for assessing bioavailability and bioequivalence; and bioanalytical approaches of pharmaceuticals in vivo and in vitro and also a waiver of BA/BE studies based on the biopharmaceutical classification (BCS) system.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"28 1","pages":"32 - 41"},"PeriodicalIF":0.0,"publicationDate":"2010-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88346334","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}
Pub Date : 2010-05-18DOI: 10.3109/10601331003796634
Shiva N. V. Prasad Bathula, Seshagiri Rao JVLN
A simple and sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed for the routine determination of Clarithromycin in human plasma, with Alprazolam as the internal standard. The separation was carried out on an Phenomenex (C18 100 × 4.6 mm, i.d 5 µm) column, with Acetonitrile and 10 mM Ammonium acetate Buffer solution (95:5) as the mobile phase under isocratic conditions at a flow rate of 0.2 mL/min. Detection of the analytes was achieved using positive ion electrospray tandem mass spectrometry in selected reaction monitoring (SRM) mode. The standard curves were linear (r2 > 0.99) over the concentration range of 300–5000 ng/mL. The intra- and inter-day precision (RSD) values were below 15%. The method is validated for the estimation of Clarithromycin in human plasma over a concentration range of 300–5000 ng/mL. Expected recoveries were observed. Limit of detection of the methods is 3.0 ng/ mL and limit of quantitation is 10.0 ng/mL that shows that the developed method has adequate sensitivity. The method was successfully applied to the pharmacokinetic study of Clarithromycin tablets in healthy male volunteers after oral administration.
{"title":"A simple and sensitive liquid chromatography–mass spectrometry routine method for determination of clarithromycin in human plasma: Application to a clinical pharmacokinetic study","authors":"Shiva N. V. Prasad Bathula, Seshagiri Rao JVLN","doi":"10.3109/10601331003796634","DOIUrl":"https://doi.org/10.3109/10601331003796634","url":null,"abstract":"A simple and sensitive liquid chromatography-mass spectrometry (LC-MS) method was developed for the routine determination of Clarithromycin in human plasma, with Alprazolam as the internal standard. The separation was carried out on an Phenomenex (C18 100 × 4.6 mm, i.d 5 µm) column, with Acetonitrile and 10 mM Ammonium acetate Buffer solution (95:5) as the mobile phase under isocratic conditions at a flow rate of 0.2 mL/min. Detection of the analytes was achieved using positive ion electrospray tandem mass spectrometry in selected reaction monitoring (SRM) mode. The standard curves were linear (r2 > 0.99) over the concentration range of 300–5000 ng/mL. The intra- and inter-day precision (RSD) values were below 15%. The method is validated for the estimation of Clarithromycin in human plasma over a concentration range of 300–5000 ng/mL. Expected recoveries were observed. Limit of detection of the methods is 3.0 ng/ mL and limit of quantitation is 10.0 ng/mL that shows that the developed method has adequate sensitivity. The method was successfully applied to the pharmacokinetic study of Clarithromycin tablets in healthy male volunteers after oral administration.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"65 1","pages":"60 - 66"},"PeriodicalIF":0.0,"publicationDate":"2010-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86055527","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}
Pub Date : 2010-05-18DOI: 10.3109/10601331003777444
H. Bang, Stephen P Flaherty, Jafar Kolahi, J. Park
There is strong consensus in the clinical trial community that blinding is an important issue in randomized controlled trials. At present grossly incomplete reporting of procedures and the use of any assessment for blinding still prevails. The term ‘double-blind’ has almost become a convention without any checks or balances. Also there is a lack of consensus on quantitative procedures for evaluating the success of blinding in the literature. This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data. Finally, it proposes a sample blinding assessment protocol to address some of these issues.
{"title":"Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol","authors":"H. Bang, Stephen P Flaherty, Jafar Kolahi, J. Park","doi":"10.3109/10601331003777444","DOIUrl":"https://doi.org/10.3109/10601331003777444","url":null,"abstract":"There is strong consensus in the clinical trial community that blinding is an important issue in randomized controlled trials. At present grossly incomplete reporting of procedures and the use of any assessment for blinding still prevails. The term ‘double-blind’ has almost become a convention without any checks or balances. Also there is a lack of consensus on quantitative procedures for evaluating the success of blinding in the literature. This article reviews statistical methods of blinding assessment along with software options, and discusses some of the most pressing issues surrounding the acquisition, interpretation, and reporting of blinding data. Finally, it proposes a sample blinding assessment protocol to address some of these issues.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"52 1","pages":"42 - 51"},"PeriodicalIF":0.0,"publicationDate":"2010-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84461899","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}
Pub Date : 2010-02-26DOI: 10.3109/10601331003623309
M. Tawakkul, P. Faustino, V. Sayeed, M. Khan, Saeed R. Khan
A rapid, sensitive, and specific ultra-performance liquid chromatographic (UPLC) method was developed for the simultaneous determination of dantrolene and its potential degradation impurities. Chromatographic separation was achieved on a Waters Acquity UPLC system using a Waters BEH C18 (2.1 × 100 mm, 1.7 µM) analytical column and Waters BEH C18 (2.1 × 5 mm, 1.7 µM) guard column. The compounds were eluted with a linear acetonitrile gradient (25–75%) over 3 min with a buffer composition of sodium acetate for method development, quantitation, and forced degradation studies. The flow rate was maintained at 0.5 mL/min. Column temperature was maintained at 35°C. Injection volume was 4 µL, and analysis was detected by a photodiode array detector at 375 nm. The method was validated according to USP Category I requirements for dantrolene. Forced degradation of dantrolene was conducted under the conditions of hydrolysis, oxidation, photolysis, and stability-indicating UPLC method was developed and validated. Two degradation products (related compound B and C) were formed in 0.1 N NaOH and 0.1 N HCl, respectively. The dantrolene was stable to oxidative decomposition. The degradation behavior under UV light was similar to 0.1 N HCl conditions. The method was used successfully for the quality assessment of dantrolene and its three impurities.
建立了一种快速、灵敏、特异的超高效液相色谱(UPLC)同时测定丹trolene及其潜在降解杂质的方法。色谱分离在Waters Acquity UPLC系统上实现，使用Waters BEH C18 (2.1 × 100 mm, 1.7µM)分析柱和Waters BEH C18 (2.1 × 5 mm, 1.7µM)保护柱。用乙腈线性梯度(25-75%)在3分钟内用醋酸钠缓冲成分洗脱化合物，用于方法开发、定量和强制降解研究。流速维持在0.5 mL/min。柱温保持在35℃。进样量为4µL，在375 nm处用光电二极管阵列检测器检测。该方法按照美国药典(USP)第I类对丹曲林的要求进行了验证。在水解、氧化、光解条件下对丹trolene进行了强制降解，建立了稳定性指示UPLC方法并进行了验证。在0.1 N NaOH和0.1 N HCl中分别形成两种降解产物(相关化合物B和C)。丹trolene对氧化分解稳定。紫外光下的降解行为与0.1 N HCl条件相似。该方法可用于丹曲林及其三种杂质的质量评价。
{"title":"Development and application of a validated stability-indicating Ultra-Performance Liquid Chromatography (UPLC) method for the determination of dantrolene and its related impurities","authors":"M. Tawakkul, P. Faustino, V. Sayeed, M. Khan, Saeed R. Khan","doi":"10.3109/10601331003623309","DOIUrl":"https://doi.org/10.3109/10601331003623309","url":null,"abstract":"A rapid, sensitive, and specific ultra-performance liquid chromatographic (UPLC) method was developed for the simultaneous determination of dantrolene and its potential degradation impurities. Chromatographic separation was achieved on a Waters Acquity UPLC system using a Waters BEH C18 (2.1 × 100 mm, 1.7 µM) analytical column and Waters BEH C18 (2.1 × 5 mm, 1.7 µM) guard column. The compounds were eluted with a linear acetonitrile gradient (25–75%) over 3 min with a buffer composition of sodium acetate for method development, quantitation, and forced degradation studies. The flow rate was maintained at 0.5 mL/min. Column temperature was maintained at 35°C. Injection volume was 4 µL, and analysis was detected by a photodiode array detector at 375 nm. The method was validated according to USP Category I requirements for dantrolene. Forced degradation of dantrolene was conducted under the conditions of hydrolysis, oxidation, photolysis, and stability-indicating UPLC method was developed and validated. Two degradation products (related compound B and C) were formed in 0.1 N NaOH and 0.1 N HCl, respectively. The dantrolene was stable to oxidative decomposition. The degradation behavior under UV light was similar to 0.1 N HCl conditions. The method was used successfully for the quality assessment of dantrolene and its three impurities.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"81 1","pages":"21 - 29"},"PeriodicalIF":0.0,"publicationDate":"2010-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89407111","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}
Pub Date : 2010-02-26DOI: 10.3109/10601330903571691
S. Shafiq, F. Shakeel
The aim of the present investigations was to evaluate the capacity of a combination of Labrasol and Plurol oleique as surfactant and cosurfactant on self-nanoemulsification efficiency of ramipril nanoemulsion. Sefsol-218, Labrasol, Plurol oleique, and standard buffer solution (pH 5.0) were selected as oil phase, surfactant, cosurfactant, and aqueous phase, respectively. Nanoemulsion formulations of ramipril were developed by a spontaneous emulsification method. Pseudoternary phase diagrams were constructed to identify nanoemulsion zones of ramipril. Selected formulations were evaluated in terms of thermodynamic stability tests using centrifugation, heating–cooling cycles, and freeze–thaw stress test. Some formulations were found stable and other formulations were unstable upon thermodynamic stability tests. Thermodynamically stable formulations were taken for self-nanoemulsification efficiency test. All the selected formulations passed self-nanoemulsification test in grade E only but not in grades A and B. Because none of the formulations passed the self-nanoemulsification efficiency test in grades A and B, it was concluded that a combination of Labrasol and Plurol is not suitable as surfactant and cosurfactant, respectively, for oral or self-nanoemulsifying drug delivery system of ramipril.
{"title":"Stability and self-nanoemulsification efficiency of ramipril nanoemulsion containing labrasol and plurol oleique","authors":"S. Shafiq, F. Shakeel","doi":"10.3109/10601330903571691","DOIUrl":"https://doi.org/10.3109/10601330903571691","url":null,"abstract":"The aim of the present investigations was to evaluate the capacity of a combination of Labrasol and Plurol oleique as surfactant and cosurfactant on self-nanoemulsification efficiency of ramipril nanoemulsion. Sefsol-218, Labrasol, Plurol oleique, and standard buffer solution (pH 5.0) were selected as oil phase, surfactant, cosurfactant, and aqueous phase, respectively. Nanoemulsion formulations of ramipril were developed by a spontaneous emulsification method. Pseudoternary phase diagrams were constructed to identify nanoemulsion zones of ramipril. Selected formulations were evaluated in terms of thermodynamic stability tests using centrifugation, heating–cooling cycles, and freeze–thaw stress test. Some formulations were found stable and other formulations were unstable upon thermodynamic stability tests. Thermodynamically stable formulations were taken for self-nanoemulsification efficiency test. All the selected formulations passed self-nanoemulsification test in grade E only but not in grades A and B. Because none of the formulations passed the self-nanoemulsification efficiency test in grades A and B, it was concluded that a combination of Labrasol and Plurol is not suitable as surfactant and cosurfactant, respectively, for oral or self-nanoemulsifying drug delivery system of ramipril.","PeriodicalId":10446,"journal":{"name":"Clinical Research and Regulatory Affairs","volume":"13 1","pages":"12 - 7"},"PeriodicalIF":0.0,"publicationDate":"2010-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75274894","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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