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The Risk of Drug-Drug Interactions with Paracetamol in a Population of Hospitalized Geriatric Patients. 住院老年患者中扑热息痛与药物相互作用的风险
Pub Date : 2020-01-19 eCollection Date: 2020-01-01 DOI: 10.1155/2020/1354209
Lykke Ida Kaas Oldenburg, Kim Peder Dalhoff, Luana Østerdal Sandoval, Charlotte Vermehren

Aims: This study investigates the consumption of paracetamol and the risk of potential drug-drug interactions and assesses the clinical impact hereof in patients admitted to a department of geriatric medicine.

Methods: A retrospective and longitudinal study was conducted in patients who had been receiving paracetamol upon or during hospitalization. The hospital files of the included patients were reviewed, including documentation of concomitant medications, diagnoses, biochemical values, and adverse incidents during admission. These parameters were used as a clinical follow-up when assessing a clinical probability impact of the identified drug-drug interactions.

Results: In total, 104 patients were admitted during the study period. 91 (87.5%) of these (mean age 86 years) received a prescription or were treated with paracetamol. Of these, 10% were evaluated as being at risk of potential drug-drug interactions with paracetamol. Seven of the potential drug-drug interactions were related to treatments with warfarin, one with valsartan and one with phenytoin. Of the nine patients at risk, six did experience either abnormal biochemical values or potential related clinical incidents. Four patients experienced increased INR (range 3.2-4.6), of which one patient suffered from anaemia and one with hematemesis. Two patients experienced increased ALAT/ASAT (55/42 U/I and 87/51 U/I, both females). One experienced hypertension.

Conclusion: A large majority of the patients in this study received treatment with paracetamol. Six patients were evaluated as having abnormal biochemical values or were experiencing clinical incidents during their hospitalization potentially related to the identified potential drug-drug interactions.

目的:本研究调查某老年医学科住院患者扑热息痛的使用情况和潜在的药物相互作用风险,并评估其临床影响。方法:对住院时或住院期间服用扑热息痛的患者进行回顾性和纵向研究。我们回顾了纳入患者的医院档案,包括伴随用药、诊断、生化值和入院期间不良事件的记录。这些参数被用作评估确定的药物-药物相互作用的临床概率影响的临床随访。结果:研究期间共收治104例患者。其中91人(87.5%)(平均年龄86岁)接受处方或使用扑热息痛治疗。其中,10%被评估为有可能与扑热息痛发生药物相互作用的风险。7例潜在的药物-药物相互作用与华法林治疗有关,1例与缬沙坦治疗有关,1例与苯妥英治疗有关。在有风险的9名患者中,6名患者确实经历了异常的生化值或潜在的相关临床事件。4例患者INR升高(范围3.2-4.6),其中1例出现贫血,1例出现呕血。2例患者ALAT/ASAT升高(55/42 U/I和87/51 U/I,均为女性)。其中一人患有高血压。结论:本研究中绝大多数患者接受了扑热息痛治疗。6名患者被评估为有异常生化值或在住院期间经历可能与确定的潜在药物-药物相互作用相关的临床事件。
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引用次数: 2
Over the Counter Sale of Antibiotics at Drug Stores Found in Mizan-Aman Town, Southwest Ethiopia: A Cross-Sectional Simulated Client Visit Study. 埃塞俄比亚西南部Mizan-Aman镇药店发现的抗生素非处方销售:一项横断面模拟客户访问研究。
Pub Date : 2019-04-07 eCollection Date: 2019-01-01 DOI: 10.1155/2019/3510659
Getahun Damisie, Solomon Hambisa, Mohammed Yimam

Background: Antibiotics are crucial drugs, particularly in the developing world, where infectious diseases are a common cause of death. Misuse and overuse of antibiotics have driven the emergency of antibiotic-resistant bacteria, which in turn leads to a loss of efficacy of these drugs. This study aimed to assess the professional practice on OTC sale of antibiotics at community drug retail outlets found in Mizan-Aman town.

Methods: A cross-sectional simulated client visit study was conducted among community drug retail outlets found in Mizan-Aman town, Southwest Ethiopia, from 14 to 28 March, 2018. Currently, there are 18 commercially licensed community drug retail outlets in Mizan-Aman town and the study was undertaken on all drug retail outlets. Each drug retail outlet was visited once by investigators who simulated inflicting clinical scenario according to simulated client method pharmacy surveys. Three different clinical scenarios were chosen and, in each of the three cases, three levels of demand were used to obtain the antibiotic. The findings of the study were entered, cleared, coded, and stored into Epi Info version 3.5.1 and exported to Statistical Package for Social Sciences (Windows version 21) and the collected data were compiled and presented as descriptive statistics using tables and figures.

Results: Most, 17 (94.4%), of drug stores out of the total 18 in which all three clinical scenarios were allotted were issued antibiotics without a need of medical prescription with three different levels of demands. Antibiotics were sold without a prescription in most (94.4%) of drug stores in which a urinary tract infection clinical scenario was presented. Similarly, antibiotics were obtained without a prescription for acute diarrhea from 16 (88.9%) drug stores. With respect to sore throat simulation, antimicrobial drugs were obtained without a prescription from 14 (77.8%) drug stores. Commonly dispensed antibiotics were Metronidazole (50.0%), Ciprofloxacin (38.9%), and Amoxicillin (71.4%) for acute diarrhea, urinary tract infection, and sore throat case scenarios, respectively. Only 1 drug store (5.5%) refused to dispense any kind of antibiotics.

Conclusion: The results of this study demonstrate that nonprescription sales of antibiotics were highly pronounced in contrary to national guidelines regarding this practice. Most of antibiotics were dispensed without a prescription when the simulator asked any medication to alleviate his/her symptoms.

背景:抗生素是至关重要的药物,特别是在发展中国家,传染病是造成死亡的常见原因。抗生素的滥用和过度使用导致了抗生素耐药细菌的紧急情况,这反过来又导致这些药物的疗效丧失。本研究旨在评估米赞安曼镇社区药品零售网点抗生素非处方销售的专业做法。方法:对2018年3月14日至28日在埃塞俄比亚西南部米赞-阿曼镇发现的社区药品零售网点进行横断面模拟客户访问研究。目前,Mizan-Aman镇有18个商业许可的社区药品零售网点,该研究是在所有药品零售网点进行的。每个药品零售网点由调查者访问一次,调查者根据模拟客户法药房调查模拟施加临床情景。选择了三种不同的临床情况,在每种情况下,使用三种需求水平来获得抗生素。将研究结果输入、清除、编码并存储在Epi Info 3.5.1版本中,并导出到Statistical Package for Social Sciences (Windows version 21)中,收集到的数据进行汇编,并使用表格和数字作为描述性统计。结果:在全部3种临床情景分配的18家药店中,绝大多数(17家,占94.4%)的药店均有3种不同需求水平的免处方抗菌药物。在大多数(94.4%)出现尿路感染临床情况的药店,无处方销售抗生素。同样,16家(88.9%)药店无处方获得治疗急性腹泻的抗生素。在咽喉痛模拟方面,14家(77.8%)药店无处方获得抗菌药物。在急性腹泻、尿路感染和咽喉炎病例中,常用的抗生素分别为甲硝唑(50.0%)、环丙沙星(38.9%)和阿莫西林(71.4%)。只有1家药店(5.5%)拒绝配发任何种类的抗生素。结论:本研究的结果表明,抗生素的非处方销售是非常明显的违反国家指导方针关于这种做法。当模拟器要求任何药物来缓解他/她的症状时,大多数抗生素是在没有处方的情况下分发的。
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引用次数: 13
The Challenges and Knowledge Gaps in Malaria Therapy: A Stakeholder Approach to Improving Oral Quinine Use in the Treatment of Childhood Malaria in Ghana. 疟疾治疗的挑战和知识差距:利益相关者改善口服奎宁治疗加纳儿童疟疾的方法。
Pub Date : 2018-11-14 eCollection Date: 2018-01-01 DOI: 10.1155/2018/1784645
Bartholomew Yir-Erong, Marcel Tunkumgnen Bayor, Isaac Ayensu, Stephen Yao Gbedema, Joshua Boateng

Background: The study was undertaken to elicit the knowledge, views, and perceptions of key stakeholders on malaria, its bioburden, and treatment options, in order to ascertain the knowledge gabs and challenges, especially in the use of oral quinine in childhood malaria.

Methods: A cross-sectional survey was conducted using a well-structured Likert Scale and self-administered questionnaire. The principal site of the study was a government-run children's hospital located in the Ashiedu Keteke Sub-Metro of Accra. The study population included health workers, parents, and guardians or care givers. The participants were 300, purposively selected, and consisted of both men (41%) and women (59%) who were twenty years and above, whether employed (42%), self-employed (37%), or unemployed (21%).

Results: Majority of the participants (78%) demonstrated above average knowledge of malaria. However, their awareness of the causes, modes of transmission, signs, and symptoms as well as preventive mechanisms of malaria did not result in low incidence of malaria. About 77% of the respondents agreed they would seek treatment within 24 hours once signs and symptoms are detected. Though close to 50% undertook home treatment of malaria, majority eventually sought treatment at hospital or clinic. Above 92% of respondents knew that quinine is used to treat malaria and agreed its bitter taste greatly affects compliance, especially in children. Consequently, 95% of the respondents would be glad if its bitter taste is masked.

Conclusion: The study demonstrated the availability of substantial knowledge of the devastating effects of malaria, especially in children. Therefore, there is the need to ensure the availability and utilization of effective paediatric formulations in the fight against malaria. From this study, fast dissolving oral thin film with a good mouth feel, would be the formulation of choice for quinine.

背景:本研究旨在了解主要利益攸关方对疟疾及其生物负担和治疗方案的认识、观点和看法,以确定知识差距和挑战,特别是在儿童疟疾口服奎宁的使用方面。方法:采用结构完善的李克特量表和自填问卷进行横断面调查。该研究的主要地点是位于阿克拉Ashiedu Keteke地铁站的一家政府经营的儿童医院。研究人群包括卫生工作者、父母、监护人或照顾者。参与者有300人,是有目的选择的,包括男性(41%)和女性(59%),年龄在20岁及以上,有工作(42%)、自雇(37%)或失业(21%)。结果:大多数参与者(78%)表现出高于平均水平的疟疾知识。然而,他们对疟疾的病因、传播方式、体征和症状以及预防机制的认识并没有导致疟疾的低发病率。约77%的受访者同意,一旦发现体征和症状,他们将在24小时内寻求治疗。虽然近50%的疟疾患者接受了家庭治疗,但大多数人最终在医院或诊所寻求治疗。92%以上的答复者知道奎宁用于治疗疟疾,并同意奎宁的苦味极大地影响了依从性,尤其是儿童。因此,95%的回答者会很高兴,如果它的苦味被掩盖。结论:这项研究表明,人们对疟疾的破坏性影响,特别是对儿童的破坏性影响有了大量了解。因此,有必要确保在防治疟疾的斗争中提供和利用有效的儿科配方。从这项研究中,具有良好口感的快速溶解口服薄膜将成为奎宁的首选配方。
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引用次数: 1
Antimicrobial Resistance Profile of Different Clinical Isolates against Third-Generation Cephalosporins. 不同临床分离株对第三代头孢菌素的耐药性谱。
Pub Date : 2018-09-09 DOI: 10.1155/2018/5070742
Fanta Gashe, Eshetu Mulisa, Mekidim Mekonnen, Gemechu Zeleke

Background: Drug resistant microorganisms lead to an increase in morbidity and mortality as they boost the risk of inappropriate therapy. Hence, data on antimicrobial resistance help define the best possible treatment for individual patients. Therefore, this study aimed to screen the antimicrobial resistant profile of 3rd generation cephalosporin drugs in Jimma University Specialized Teaching Hospital.

Methods: A hospital based prospective cross-sectional study was conducted in Jimma University Specialized Hospital (JUSH) from April to August 2016. The clinical samples such as wound swab, urine, sputum, and stool were collected from hospitalized patients. Then, bacterial species were isolated and identified as per the standard microbiological methods. Antimicrobial susceptibility tests were carried out using various antimicrobial discs by Kirby-Bauer disc diffusion method.

Results: Totally, 248 bacterial isolates were obtained from 154 (62.1%) male and 94 (37.9%) female patients. Escherichia coli (25.4%) and Staphylococcus aureus (19.0 %) were the predominant organisms isolated from specimens. About 140 (56.5%) and 149 (60.1%) of the total bacterial isolates were found to be resistant to ceftriaxone and ceftazidime, respectively. The majority of Escherichia coli isolates 46 (73%) were resistant to ceftriaxone and 41 (65%) of them were resistant to ceftazidime. Staphylococcus aureus, which accounted 19% of the total bacterial isolates, showed 23.4% and 34% resistance to ceftriaxone and ceftazidime, respectively. Among the bacterial strains revealing resistant to ceftriazone and ceftazidime, about 109 (44%) and 108 (43.5%) of them were resistant to two, three, or four other drugs, respectively.

Conclusion: Bacterial resistance towards third-generation cephalosporin (ceftriaxone and ceftazidime) is escalating as more than half of the isolated strains demonstrated resistance to these drugs. Moreover, these strains also revealed multidrug resistance mainly against clinically used drugs which could render therapy unsuccessful. Therefore, in clinical use appropriate medications should be selected based on the data obtained from antimicrobial susceptibility tests.

背景:耐药微生物增加了不适当治疗的风险,导致发病率和死亡率增加。因此,抗微生物耐药性数据有助于确定个体患者的最佳治疗方法。因此,本研究旨在筛选金马大学专科教学医院第三代头孢菌素类药物的耐药性。方法:于2016年4月至8月在金马大学专业医院(JUSH)进行了一项基于医院的前瞻性横断面研究。从住院患者身上采集伤口拭子、尿液、痰液和粪便等临床样本。然后,根据标准微生物学方法分离和鉴定细菌种类。采用Kirby-Bauer纸片扩散法对不同类型的抗菌盘进行了药敏试验。结果:154例(62.1%)男性和94例(37.9%)女性患者共分离出248株细菌。大肠杆菌(25.4%)和金黄色葡萄球菌(19.0%)是从标本中分离的主要生物体。约140株(56.5%)和149株(60.1%)细菌分离株对头孢曲松和头孢他啶分别具有耐药性。大多数大肠杆菌分离株对头孢曲松耐药46株(73%),对头孢他啶耐药41株(65%)。金黄色葡萄球菌占细菌总数的19%,对头孢曲松和头孢他啶的耐药性分别为23.4%和34%。在显示对头孢曲松和头孢他啶有耐药性的菌株中,分别约有109株(44%)和108株(43.5%)对两种、三种或四种其他药物有耐药性。结论:细菌对第三代头孢菌素(头孢曲松和头孢他啶)的耐药性正在上升,因为超过一半的分离菌株对这些药物表现出耐药性。此外,这些菌株还显示出主要针对临床使用药物的多药耐药性,这可能导致治疗失败。因此,在临床使用中,应根据抗菌药物敏感性测试获得的数据选择合适的药物。
{"title":"Antimicrobial Resistance Profile of Different Clinical Isolates against Third-Generation Cephalosporins.","authors":"Fanta Gashe,&nbsp;Eshetu Mulisa,&nbsp;Mekidim Mekonnen,&nbsp;Gemechu Zeleke","doi":"10.1155/2018/5070742","DOIUrl":"10.1155/2018/5070742","url":null,"abstract":"<p><strong>Background: </strong>Drug resistant microorganisms lead to an increase in morbidity and mortality as they boost the risk of inappropriate therapy. Hence, data on antimicrobial resistance help define the best possible treatment for individual patients. Therefore, this study aimed to screen the antimicrobial resistant profile of 3rd generation cephalosporin drugs in Jimma University Specialized Teaching Hospital.</p><p><strong>Methods: </strong>A hospital based prospective cross-sectional study was conducted in Jimma University Specialized Hospital (JUSH) from April to August 2016. The clinical samples such as wound swab, urine, sputum, and stool were collected from hospitalized patients. Then, bacterial species were isolated and identified as per the standard microbiological methods. Antimicrobial susceptibility tests were carried out using various antimicrobial discs by Kirby-Bauer disc diffusion method.</p><p><strong>Results: </strong>Totally, 248 bacterial isolates were obtained from 154 (62.1%) male and 94 (37.9%) female patients. <i>Escherichia coli</i> (25.4%) and <i>Staphylococcus aureus</i> (19.0 %) were the predominant organisms isolated from specimens. About 140 (56.5%) and 149 (60.1%) of the total bacterial isolates were found to be resistant to ceftriaxone and ceftazidime, respectively. The majority of <i>Escherichia coli</i> isolates 46 (73%) were resistant to ceftriaxone and 41 (65%) of them were resistant to ceftazidime. <i>Staphylococcus aureus,</i> which accounted 19% of the total bacterial isolates, showed 23.4% and 34% resistance to ceftriaxone and ceftazidime, respectively. Among the bacterial strains revealing resistant to ceftriazone and ceftazidime, about 109 (44%) and 108 (43.5%) of them were resistant to two, three, or four other drugs, respectively.</p><p><strong>Conclusion: </strong>Bacterial resistance towards third-generation cephalosporin (ceftriaxone and ceftazidime) is escalating as more than half of the isolated strains demonstrated resistance to these drugs. Moreover, these strains also revealed multidrug resistance mainly against clinically used drugs which could render therapy unsuccessful. Therefore, in clinical use appropriate medications should be selected based on the data obtained from antimicrobial susceptibility tests.</p>","PeriodicalId":16744,"journal":{"name":"Journal of Pharmaceutics","volume":"2018 ","pages":"5070742"},"PeriodicalIF":0.0,"publicationDate":"2018-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1155/2018/5070742","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36534673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 39
Evaluation between the Usability and Physicochemical Property of Acyclovir Ointments. 阿昔洛韦软膏的可用性及理化性质评价。
Pub Date : 2018-08-01 eCollection Date: 2018-01-01 DOI: 10.1155/2018/8761394
Yutaka Inoue, Akiho Mitsumori, Itsuka Shinohara, Sachie Narumi, Isamu Murata, Ikuo Kanamoto

A lot of prescription medicines have become switch over-the-counter (OTC) medicines. However, additives in brand-name drugs, generic drugs, and switch OTC drugs differ; therefore, the feelings associated with the use of these medicines vary for patients. The aim of this study was to compare the physicochemical properties and the feeling of use (assuming skin as an index of usability) of acyclovir (ACV) ointments. Five ACV ointments were used: ACV-A, a brand-name drug, ACV-B and ACV-C, generic drugs, and ACV-D and ACV-E, switch OTC drugs. The physicochemical properties were evaluated by determining the content uniformity, water content, flattening, viscosity and viscoelasticity, and near-infrared (NIR) absorption spectroscopy. Skin friction was measured to evaluate the feeling associated with use. Results of the content uniformity test indicated that the ACV content was uniform, and equivalence was observed. Measurement of moisture content indicated that this parameter differed in each ointment preparation. The yield value, which was calculated by measuring flattening, was 4416.7 dyne/cm2 for ACV-A, 1175.7 dyne/cm2 for ACV-B, 2114.9 dyne/cm2 for ACV-C, 4234.5 dyne/cm2 for ACV-D, and 3620.7 dyne/cm2 for ACV-E. Measurement of viscosity and viscoelasticity revealed that viscosity increased with time and the viscoelasticity of each ointment. The second derivative of the NIR spectrum revealed that ACV-B and ACV-C had a wider spectrum of absorption than the other ointments. ACV-B had lesser friction than other ointments. These findings suggest that differences in the type and content of additives (macrogol) result in differences in the physicochemical properties of individual ointments.

许多处方药已经变成了非处方药。然而,品牌药、仿制药和非处方药中的添加剂有所不同;因此,与使用这些药物相关的感受因患者而异。本研究的目的是比较阿昔洛韦(ACV)软膏的物理化学性质和使用感觉(假设皮肤作为可用性指标)。使用了5种ACV软膏:ACV- a(品牌药),ACV- b和ACV- c(仿制药),ACV- d和ACV- e(非处方药)。通过测定其含量均匀性、含水量、扁化度、粘度和粘弹性以及近红外吸收光谱来评价其理化性质。测量皮肤摩擦来评估与使用相关的感觉。含量均匀性试验结果表明,ACV含量均匀,具有等效性。水分含量的测量表明,这一参数在每种软膏制剂中有所不同。ACV-A的屈服值为4416.7达因/cm2, ACV-B的屈服值为1175.7达因/cm2, ACV-C的屈服值为2114.9达因/cm2, ACV-D的屈服值为4234.5达因/cm2, ACV-E的屈服值为3620.7达因/cm2。粘度和粘弹性的测定表明,黏度随时间的增加而增加,每种软膏的粘弹性也随时间的增加而增加。近红外光谱二阶导数分析表明,ACV-B和ACV-C具有较宽的吸收光谱。与其他软膏相比,ACV-B的摩擦较小。这些发现表明,添加剂(巨醇)的种类和含量的差异导致了单个软膏的物理化学性质的差异。
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引用次数: 1
Self-Medication Practices among Community of Harar City and Its Surroundings, Eastern Ethiopia. 埃塞俄比亚东部哈拉尔市及其周边社区的自我药疗实践。
Pub Date : 2018-07-25 eCollection Date: 2018-01-01 DOI: 10.1155/2018/2757108
Sara Mamo, Yohanes Ayele, Mesay Dechasa

Purpose: Self-medication practice is often associated with irrational medication use. The aim of this study was to assess self-medication practices among community of Harar City and its surroundings, Eastern Ethiopia.

Methods: A cross-sectional study was conducted through exit interview in selected drug outlets of Harar City among 370 clients from March to April, 2017. The data was coded and entered into epi-data and processed and analyzed using SPSS version 20.

Results: Many participants practiced self-medication to alleviate their headache (30.30%), to treat their respiratory disorders (29.50%), and to treat their gastrointestinal disorders (27%). More than half (57.8%) of study participants declared that they were practicing self-medication due to prior experience and seeking less expensive service (20.50%). Two-fifths of them (40.3%) reported pharmacy professionals as source of information while 18.9% of respondents were advised by neighbors, friends, or relatives. About one-third (31.9%) of them did not have any source of information for self-medication practice. The most common type of drug used for self-medication by the participants was analgesic (42.2%). Approximately one-third (31.1%) of the subjects were expecting to be counseled by the pharmacy professionals about the drug side effects and to be helped in selecting their self-medication drug (30.3%).

Conclusion: Varieties of medications were used among study participants ranging from antipain to that of antibiotics for different complaints including headache, respiratory complaints, and gastrointestinal problems. Experience with drugs and diseases as well as affordability were frequently reported reasons for self-medication practice. Participants had different views toward the role of pharmacy professionals. Hence, it is very important to educate patients on responsible use of medications and create awareness on the role of pharmacist in self-selected medication use in community.

目的:自我用药往往与不合理用药有关。本研究的目的是评估埃塞俄比亚东部哈拉尔市及其周边社区的自我药疗做法。方法:采用横断面研究方法,于2017年3 - 4月在哈拉尔市选定的药品网点对370名客户进行退出访谈。对数据进行编码并录入epi-data,使用SPSS version 20进行处理和分析。结果:许多参与者通过自我药疗来缓解头痛(30.30%)、治疗呼吸系统疾病(29.50%)和治疗胃肠道疾病(27%)。超过一半(57.8%)的研究参与者表示,由于之前的经验,他们正在进行自我药疗,并寻求更便宜的服务(20.50%)。五分之二(40.3%)的受访者表示药房专业人员是信息来源,而18.9%的受访者是由邻居、朋友或亲戚建议的。约三分之一(31.9%)的人没有任何自我药疗实践的信息来源。参与者最常用的自我药疗药物是镇痛药(42.2%)。约三分之一(31.1%)的受试者希望得到药学专业人员关于药物副作用的咨询,并希望在选择自我药疗药物方面得到帮助(30.3%)。结论:研究参与者使用了多种药物,从止痛药到抗生素,用于治疗不同的疾病,包括头痛、呼吸系统疾病和胃肠道疾病。药物和疾病的经验以及负担能力是经常报告的自我药疗做法的原因。参加者对药剂专业人员的角色有不同的看法。因此,教育患者负责任地使用药物并提高对药剂师在社区自我选择药物使用中的作用的认识是非常重要的。
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引用次数: 20
In Vitro and In Vivo Quality Evaluation of Glibenclamide Tablets Marketed in Addis Ababa, Ethiopia. 在埃塞俄比亚亚的斯亚贝巴上市的格列本脲片的体内外质量评价。
Pub Date : 2018-07-18 eCollection Date: 2018-01-01 DOI: 10.1155/2018/7916368
Haile Kassahun, Kaleab Asres, Ayenew Ashenef

Good quality drugs fulfilling the regulatory parameters and produced per the current good manufacturing (CGMP) standards are very critical for best therapeutic outcome in patient therapy. Hence, this study assesses quality as well as physicochemical bioequivalence of five brands of glibenclamide tablets marketed in Addis Ababa using in vitro and in vivo methods. Friability, disintegration, dissolution, and assay for the content of active ingredients were evaluated using the methods described in the British Pharmacopeia (2009) and United States Pharmacopeia (2007). All the brands of glibenclamide tablets complied with the official specification for hardness, friability, disintegration, and assay. Difference factor (f1) values were less than 15 and similarity factor (f2) values were greater than 50 for all products of glibenclamide. The hypoglycemic effect of different products of glibenclamide tablets was evaluated on normoglycemic mice. The in vivo studies indicated that there is no significant difference in percent reduction of blood glucose level between the brands of glibenclamide and the innovator product (p > 0.05). Hence, based on the in vivo results and in vitro dissolution studies, the brands might be substituted with the innovator product in clinical practice.

满足监管参数并按照现行良好生产(CGMP)标准生产的高质量药物对于患者治疗的最佳治疗效果至关重要。因此,本研究采用体外和体内方法评估亚的斯亚贝巴市售的五种品牌格列本脲片的质量和理化生物等效性。使用英国药典(2009)和美国药典(2007)中描述的方法对有效成分的易碎性、崩解性、溶出度和含量测定进行了评估。各牌号格列本脲片硬度、脆碎度、崩解度和含量测定均符合官方标准。所有格列本脲产品的差异因子(f1)值均小于15,相似因子(f2)值均大于50。观察格列苯脲片不同产品对正常血糖小鼠的降糖作用。体内研究表明,格列本脲与创新产品的血糖水平降低百分比无显著差异(p > 0.05)。因此,基于体内结果和体外溶出度研究,这些品牌可能会在临床实践中被创新产品所取代。
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引用次数: 8
Association of PLGA Microspheres to Carrier Pellets by Fluid Bed Coating: A Novel Approach towards Improving the Flowability of Microparticles. 流化床包覆聚乳酸微球与载体微球的结合:一种改善微球流动性的新方法。
Pub Date : 2018-07-02 eCollection Date: 2018-01-01 DOI: 10.1155/2018/3874348
André O'Reilly Beringhs, Aline Benedita Dos Santos Fonseca, Angela Machado De Campos, Diva Sonaglio

Micro- and nanoparticles have been vastly studied due to their biopharmaceutical advantages. However, these particles generally display very weak packing and poor mechanical properties. Hereby, a new methodology is proposed to associate poorly flowing particles to macrostructures targeting the improvement of flowability and redispersibility of the particles. Cecropia glaziovii-loaded PLGA microspheres (4.59 ± 0.04 μm) were associated with carrier pellets by film coating in a top-spray fluid bed equipment. Optimal conditions were determined employing a IV-Optimal factorial design and RGB image analysis as 1% (w/v) Kollicoat® Protect as coating polymer (2:1 weight ratio of coating suspension to carrier pellets), containing 5 mg/mL microspheres (loading of 28.07 ± 1.01 mg/g). The method led to an improvement of the overall flowability. No relevant molecular interactions between PLGA microspheres and polymers were found. Microspheres detached rapidly from the surface of the pellets, without agglomeration, when exposed to hydrodynamic forces. In vitro release profiles, prior to and after fluid bed coating, showed no relevant changes in drug release rate and extent. The methodology developed is suitable for further applications when an improvement on the flow properties and redispersibility of the product is desired. We showed an easy-to-implement methodology that can be executed without significant increase in costs.

由于其在生物制药方面的优势,微粒子和纳米粒子得到了广泛的研究。然而,这些颗粒通常表现出非常弱的堆积和较差的机械性能。因此,提出了一种新的方法,将流动性差的颗粒与宏观结构联系起来,以改善颗粒的流动性和再分散性。在顶喷流化床装置中,采用膜包法制备了玻璃天眼微球(4.59±0.04 μm)与载体微球。采用IV-Optimal析因设计和RGB图像分析确定最佳条件为:1% (w/v) Kollicoat®Protect为包被聚合物(包被悬浊液与载体颗粒的重量比为2:1),含5 mg/mL微球(载药量为28.07±1.01 mg/g)。该方法提高了整体流动性。未发现聚乳酸微球与聚合物之间存在相关的分子相互作用。当受到水动力作用时,微球迅速从颗粒表面分离而不团聚。体外释放曲线,在流化床包衣之前和之后,药物的释放速度和程度没有相关的变化。当需要改善产品的流动特性和再分散性时,所开发的方法适用于进一步的应用。我们展示了一种易于实现的方法,可以在不显著增加成本的情况下执行。
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引用次数: 3
Effect of Skin Model on In Vitro Performance of an Adhesive Dermally Applied Microarray Coated with Zolmitriptan. 皮肤模型对涂覆佐米曲坦的皮肤贴敷微阵列体外性能的影响。
Pub Date : 2018-06-03 eCollection Date: 2018-01-01 DOI: 10.1155/2018/7459124
Mahmoud Ameri, Hayley Lewis, Paul Lehman

Franz cell studies, utilizing different human skin and an artificial membrane, evaluating the influence of skin model on permeation of zolmitriptan coated on an array of titanium microprojections, were evaluated. Full thickness and dermatomed ex vivo human skin, as well as a synthetic hydrophobic membrane (Strat-M®), were assessed. It was found that the choice of model demonstrated different absorption kinetics for the permeation of zolmitriptan. For the synthetic membrane only 11% of the zolmitriptan coated dose permeated into the receptor media, whilst for the dermatomed skin 85% permeated into the receptor. The permeation of zolmitriptan through full thickness skin had a significantly different absorption profile and time to maximum flux in comparison to the dermatomed skin and synthetic model. On the basis of these results dermatomed skin may be a better estimate of in vivo performance of drug-coated metallic microprojections.

利用不同的人体皮肤和人造膜进行Franz细胞研究,评估皮肤模型对涂覆在钛微投影阵列上的唑米曲坦渗透的影响。评估全层和离体皮肤,以及合成疏水膜(Strat-M®)。结果表明,模型的选择对唑米曲坦的渗透具有不同的吸收动力学。对于合成膜,只有11%的唑米曲坦包被剂量渗透到受体介质中,而对于皮肤化的皮肤,85%渗透到受体中。佐米曲坦通过全层皮肤的吸收曲线和达到最大通量的时间与人造皮肤和皮肤模型有显著不同。在这些结果的基础上,皮肤可以更好地估计药物包覆金属微投影的体内性能。
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引用次数: 9
Cocoa Pod Husk Pectin Intended as a Pharmaceutical Excipient Has No Adverse Effects on Haematological Parameters in Sprague Dawley Rats. 可可豆荚皮果胶作为药用辅料对大鼠血液学参数无不良影响。
Pub Date : 2018-05-31 eCollection Date: 2018-01-01 DOI: 10.1155/2018/1459849
Ofosua Adi-Dako, Kwabena Ofori-Kwakye, Kennedy Kwami Edem Kukuia, Jerry Asiedu-Larbi, Alexander Kwadwo Nyarko, Doris Kumadoh, Grace Frimpong

Natural polymer research has recently become the focus of intensive research in the quest for new enabling excipients for novel drugs in pharmaceutical formulation for optimal treatment outcomes. Evaluations of some excipients have shown deleterious haematological effects of varying extents on the safety profile of these excipients. A 90-day subchronic toxicity study was conducted to evaluate the influence of cocoa pod husk (CPH) pectin on indicators for haematotoxicity. Male and female Sprague Dawley rats (SDRs) were fed with CPH pectin in doses up to 71.4 mg/kg. The effects of CPH pectin on the haematological indices, direct and total bilirubin, and the spleen were determined. The results indicated that CPH pectin did not induce any untoward toxic effects on the haematological indices, bilirubin levels, and the spleen. There were, however, elevations in MCV at day 30, which was not sustained after the 90 days. The data obtained from this study did not reveal any remarkable findings of toxicological relevance to the haematopoietic system.

天然聚合物的研究最近已成为深入研究的焦点,以寻求新的赋形剂在药物配方中的新药,以获得最佳的治疗效果。一些赋形剂的评估显示,这些赋形剂对血液有不同程度的有害影响。为评价可可豆荚果胶对血液毒性指标的影响,进行了为期90天的亚慢性毒性研究。雄性和雌性Sprague Dawley大鼠(drs)分别饲喂CPH果胶,剂量高达71.4 mg/kg。测定CPH果胶对血液学指标、直接胆红素和总胆红素及脾脏的影响。结果表明,CPH果胶对血液学指标、胆红素水平和脾脏均无不良毒性作用。然而,MCV在第30天升高,90天后没有持续。从这项研究中获得的数据没有显示任何显著的毒理学发现与造血系统相关。
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引用次数: 6
期刊
Journal of Pharmaceutics
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