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Dexamethasone and Citicoline Mitigate Cisplatin-Induced Peripheral Neuropathy: A Novel Experimental Study in Mice. 地塞米松和胞胆碱减轻顺铂诱导的周围神经病变:一项新的小鼠实验研究。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.51882
Farid Masoud, Bohloul Habib-Asl, Mohammad Charkhpour, Yashar Asadpour, Javad Mahmudi

Objectives: Given the rising prevalence of cisplatin-induced peripheral neuropathy (CisIPN), investigations to alleviate its adverse effects are required. Oxidative stress and free radical development are essential pathways of CisIPN. Specifically, dexamethasone and citicoline are characterized by anti-inflammatory and antioxidant activities that might reduce CisIPN incidence and severity. The current study assessed the possible impacts of novel interventions, dexamethasone, and, citicoline on CisIPN.

Materials and methods: Seventy-two male mice were randomly allocated into nine groups (n: 8/each group). Different doses of dexamethasone (7.5, 15, 30 mg/kg, i.p.), citicoline (10, 20, 40 mg/kg, i.p.), and the combination (dexamethasone 7.5 mg/kg + citicoline 10 mg/kg, i.p.) were injected in the first three days and one day before receiving cisplatin (2 mg/kg, i.p.). The tail-flick method was used for assessing nociception. Besides, malondialdehyde (MDA), interleukin-1 beta (IL-1β), tumor necrosis factor-α (TNF-α), total antioxidant capacity (TAC), and mice weight differences (ΔW) were measured.

Results: Different doses of dexamethasone and citicoline enhanced latency time (p<0.05). Moreover, dexamethasone 15 mg/kg diminished the level of MDA and increased TAC (p<0.05) and in 30 mg/kg, MDA was reduced (p<0.05). Besides, 20 and 40 mg/kg of citicoline reduced MDA and elevated TAC (p<0.05), and 10 mg/kg merely reduced MDA (p<0.05). Dexamethasone in all doses declined IL-1β and TNF-α levels, and citicoline only at 40 mg/kg lessened their levels (p<0.05). Interestingly, ΔW declined more in the dexamethasone and citicoline groups than the cisplatin group (p<0.05).

Conclusion: Dexamethasone and citicoline attenuate CisIPN through anti-inflammatory activity, improving the antioxidant capacity, and inhibiting lipid peroxidation.

目的:鉴于顺铂诱导的周围神经病变(CisIPN)的患病率不断上升,研究减轻其不良反应是必要的。氧化应激和自由基的发展是CisIPN的重要途径。具体来说,地塞米松和胞胆碱具有抗炎和抗氧化活性,可能降低CisIPN的发生率和严重程度。目前的研究评估了新型干预措施地塞米松和胞胆碱对CisIPN的可能影响。材料与方法:雄性小鼠72只,随机分为9组,每组8只。在接受顺铂治疗(2 mg/kg, 1 p)前3天和前1天分别注射不同剂量的地塞米松(7.5、15、30 mg/kg, i.p)、胞替胆碱(10、20、40 mg/kg, i.p)及联合(地塞米松7.5 mg/kg +胞替胆碱10 mg/kg, i.p)。用甩尾法评估伤害感觉。测定丙二醛(MDA)、白细胞介素-1β (IL-1β)、肿瘤坏死因子-α (TNF-α)、总抗氧化能力(TAC)和小鼠体重差异(ΔW)。结果:不同剂量地塞米松和胞胆碱均可延长CisIPN潜伏期(ppppppp)。结论:地塞米松和胞胆碱可通过抗炎活性、提高抗氧化能力、抑制脂质过氧化作用减轻CisIPN。
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引用次数: 1
Nasotransmucosal Delivery of Curcumin-Loaded Mucoadhesive Microemulsions for Treating Inflammation-Related CNS Disorders. 含姜黄素的黏附微乳经鼻粘膜递送治疗炎症相关中枢神经系统疾病。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.45945
Mukeshkumar Shamalbhai Patel, Snigdha Das Mandal, Surjyanarayan Mandal, Shital Faldu, Jayvadan Patel

Objectives: This investigation was aimed at designing an effective mucoadhesive microemulsion system to accomplish higher brain uptake of curcumin through intranasal route.

Materials and methods: Mucoadhesive microemulsion of curcumin (MMEC) was developed using screened oil, surfactant, and co-surfactant by Box-Behnken design and was evaluated for mucoadhesion, stability, and naso-ciliotoxicity study. Comparative brain uptake of curcumin after nasal administration of MMEC and polycarbophil curcumin gel and intravenous administration of plain curcumin solution was studied by performing bio-distribution study in Swiss albino rats.

Results: The results showed that all formulation variables i.e., the amount of capmul MCM (X1), Smix (accenon CC: transcutol P) (X2) and percentage of aqueous. Polycarbophil (X3) had a significant effect (p<0.05) on the responses. The developed MMEC was stable and non-ciliotoxic with 66.74 ± 3.46 nm and 98.58% ± 1.21 as average globule size and drug content, respectively. Polydispersibility index (0.133 ± 0.17) data and transmission electron microscopy study depicted the narrow size distribution of MMEC. Furthermore, following a comparative investigation of the brain uptake of curcumin among MMEC, plain drug gel and intravenous administration at 2.86 mg/kg, more brain uptake of curcumin was demonstrated for MMEC over intravenous application. Moreover, curcumin uptake in olfactory bulb after nasal administration of MMEC (31.11 ± 1.6) was than 9.44 times higher than intravenous injection of curcumin solution (3.25 ± 1.01). Area under curve represents the ratio of 2.86 mg/kg in brain tissue to plasma acquired afterward(s) the intranasal injection of MMEC (and it) was essentially greater than after the intravenous administration of curcumin solution.

Conclusion: Findings of the investigation revealed that optimal MMEC and intranasal route may be considered to be promising and an alternative approach for brain targeting of curcumin.

目的:设计一种有效的黏附微乳系统,通过鼻内途径实现姜黄素的高脑吸收。材料与方法:采用Box-Behnken设计,采用筛选过的油、表面活性剂和助表面活性剂制备姜黄素粘接微乳液,并对其粘接性、稳定性和鼻-纤毛毒性进行了研究。采用生物分布研究的方法,对瑞士白化大鼠经鼻给药多酚型姜黄素凝胶和静脉给药普通姜黄素溶液后姜黄素的脑摄取进行了比较。结果:各处方变量MCM (X1)、Smix (accenon CC: transcutol P) (X2)和水相百分率均能影响制剂的质量。结论:研究结果表明,最佳MMEC和鼻内途径可能被认为是姜黄素脑靶向治疗的一种有前途的替代途径。
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引用次数: 3
Fabrication and Evaluation of Matrix Type Novel Transdermal Patch Loaded with Tramadol Hydrochloride. 新型基质型盐酸曲马多透皮贴剂的制备与评价。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.43678
Shankhadip Nandi, Saptarshi Mondal

Objectives: Transdermal drug delivery as a novel drug delivery system has become a major research interest to the scientists for its controlled drug release and improved patient compliance. This study was conducted to develop an optimized transdermal patch of tramadol hydrochloride using an appropriate amount of suitable polymers. It was also planned to control the drug permeation rate from the device to achieve a sustained release pattern.

Materials and methods: Several numbers of formulations were prepared by altering the amount of excipients. Physicochemical and biopharmaceutical parameters were checked to get the optimized formulation with desired characteristics.

Results: Fourier transform infrared spectroscopy results displayed no abnormal peaks and hence concluded that the drug and polymers were compatible with each other. The minimum standard deviation values of different physicochemical parameters assured that the method of preparation was skilled to develop patches with least intra-batch variability. A higher percentage of hydroxypropyl methylcellulose (HPMC) resulted in the greater tensile strength, moisture content and water vapor transmission rate of the patches. A high folding endurance value (>200) indicated the flexibility of the prepared patches and their integrity to the skin. The transdermal patches coded as F26 containing only HPMC polymer demonstrated the desired drug permeation rate (65.51%) within 12 hours through ex vivo permeation studies.

Conclusion: The formulation coded as F26 was found to be the most optimized patch as it exhibited sustained drug permeation rate followed by higuchi diffusion kinetics, that also confirmed the capability of the formulation to exhibit matrix type drug delivery.

目的:经皮给药作为一种新型的给药系统,因其药物释放控制和提高患者依从性而成为科学家研究的热点。本研究采用适量合适的聚合物制备盐酸曲马多透皮贴剂。还计划控制药物从装置的渗透速率,以实现持续释放模式。材料与方法:通过改变辅料的用量,制备了若干剂型。通过理化参数和生物制药参数的校核,得到了符合要求的最佳配方。结果:傅里叶变换红外光谱结果未见异常峰,认为药物与聚合物具有相容性。不同理化参数的最小标准偏差值保证了制备方法能够熟练地开发出批次内变异性最小的贴剂。羟丙基甲基纤维素(HPMC)含量越高,贴片的拉伸强度、含水率和水蒸气透过率越高。高折叠耐力值(>200)表明制备的贴片具有柔韧性和与皮肤的完整性。编码为F26的仅含HPMC聚合物的透皮贴剂,通过体外透皮研究,在12小时内达到了理想的药物透皮率(65.51%)。结论:编码为F26的制剂具有持续的药物渗透速率和通口扩散动力学,是最优的贴剂,这也证实了该制剂具有基质型给药的能力。
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引用次数: 1
Analgesic and Sedative-Hypnotic Potentiality of Crude Methanolic Extract of Gomphandra tetrandra (Wall.) Sleumer Leaves. 红方草粗甲醇提取物的镇痛和镇静催眠作用Sleumer树叶。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.09216
N M Mahmudul Alam Bhuiya, Forman Hossen, Monirul Islam, Moynul Hasan

Objectives: Gomphandra tetrandra (Wall.) Sleumer (leaves) belonging to the family Stemonuraceae was investigated for preliminary phytochemical screening and evaluating their pharmacological activities in various pharmacological models.

Materials and methods: The crude methanolic extract was screened with different chemical reagents for the qualitative detection of different phytochemical groups. The peripheral analgesic function was determined using the acetic acid-induced writhing procedure and sedative-hypnotic behaviors were assessed using hole-board, open field, and hole-cross tests using different doses of the extract (200 mg/kg and 400 mg/kg body weight).

Results: Phytochemical screening revealed that methanolic extract of G. tetranda leaves contains steroids, gums, mucilages, phytosterols, carbohydrates, and flavonoids. The crude methanolic extract at 200 mg/kg and 400 mg/kg doses showed statistically significant activity in acetic acid-induced writhing inhibition test with 60% (p<0.01) and 76.47% (p<0.01) inhibition, respectively, compared to control. The extract also had dose-dependent substantial (p<0.01) sedative-hypnotic activities compared with diazepam in the hole-board, open field, and hole-cross tests.

Conclusion: It may be assumed that the methanolic leaf extract of G. tetrandra possesses a strong possibility of having analgesic and sedative-hypnotic activity due to the presence of bioactive compounds in its leaves. Moreover, observed results have opened a new era of in-depth research to discover the possible mechanism of analgesic and sedative-hypnotic activity.

目的:芡实(墙)研究了菊科植物茎叶,对其进行了初步的植物化学筛选,并在各种药理模型中对其药理活性进行了评价。材料与方法:用不同的化学试剂筛选粗甲醇提取物,定性检测不同的植物化学基团。采用醋酸诱导扭体法测定小鼠的外周镇痛功能,采用孔板法、开场法和孔交叉法测定不同剂量的提取物(200 mg/kg和400 mg/kg体重)对小鼠的镇静催眠行为进行评估。结果:植物化学筛选表明,红叶甲醇提取物含有甾体、树胶、粘液、植物甾醇、碳水化合物和黄酮类化合物。200 mg/kg和400 mg/kg粗甲醇提取物在醋酸诱导扭体抑制试验中的活性均有统计学意义,抑制率为60% (ppp)。结论:由于其叶中存在生物活性物质,可以推测七叶草甲醇提取物具有很强的镇痛和镇静催眠活性的可能性。此外,观察结果开启了深入研究镇痛和镇静催眠活性可能机制的新时代。
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引用次数: 0
Determination of Metoclopramide Hydrochloride in Pharmaceutical Formulations using N-Oxidation Caroate. n -氧化法测定制剂中盐酸甲氧氯普胺的含量。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.33733
Mykola Blazheyevskiy, Deghinmotei Alfred-Ugbenbo, Olena Oleksandrivna Mozgova, Valery Petrovich Moroz

Objectives: To develop two (titrimetric and spectrophotometric) simple, rapid, sensitive and cost-effective methods for the determination of metoclopramide (MCP) in pharmaceutical dosage forms.

Materials and methods: The titrimetric method (A) was based on the N-oxidation reaction involving the use of potassium hydrogen peroxymonosulfate and subsequent iodometric back titration of a known residual reagent. The spectrophotometric method (B) was based on derivatization of MCP with potassium hydrogen peroxymonosulfate in the presence of iodide to produce a chromogen (triiodide) with a wavelength of maximum absorption at 350 nm.

Results: Method "A" was applicable over the concentration range of 0.25-3.5 mg to end volume 10 mL. In method "B", Beer's law was obeyed over the concentration range of 0.3-3.5 μg/mL with molar absorptivity of 24600 L/mol cm. The limits of quantification were calculated to be 0.25 mg/10 mL (A) and 0.2 μg/mL (B), respectively.

Conclusion: The proposed methods were suitable for determination of MCP as a pure substance in tablets and injection.

目的:建立两种简便、快速、灵敏、经济的测定药品剂型中甲氧氯普胺(MCP)的方法(滴定法和分光光度法)。材料和方法:滴定法(A)基于n -氧化反应,涉及使用过氧单硫酸氢钾和随后已知残留试剂的碘量反滴定。分光光度法(B)是在碘化物存在的情况下,用过氧单硫酸氢钾衍生MCP生成最大吸收波长为350 nm的显色剂(三碘化物)。结果:方法A在0.25 ~ 3.5 mg ~ 10ml浓度范围内适用,方法B在0.3 ~ 3.5 μg/mL浓度范围内符合比尔定律,摩尔吸光度为24600 L/mol cm。定量限分别为0.25 mg/10 mL (A)和0.2 μg/mL (B)。结论:所建立的方法适用于片剂和注射剂中MCP的纯度测定。
{"title":"Determination of Metoclopramide Hydrochloride in Pharmaceutical Formulations using <i>N</i>-Oxidation Caroate.","authors":"Mykola Blazheyevskiy,&nbsp;Deghinmotei Alfred-Ugbenbo,&nbsp;Olena Oleksandrivna Mozgova,&nbsp;Valery Petrovich Moroz","doi":"10.4274/tjps.galenos.2021.33733","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.33733","url":null,"abstract":"<p><strong>Objectives: </strong>To develop two (titrimetric and spectrophotometric) simple, rapid, sensitive and cost-effective methods for the determination of metoclopramide (MCP) in pharmaceutical dosage forms.</p><p><strong>Materials and methods: </strong>The titrimetric method (A) was based on the <i>N</i>-oxidation reaction involving the use of potassium hydrogen peroxymonosulfate and subsequent iodometric back titration of a known residual reagent. The spectrophotometric method (B) was based on derivatization of MCP with potassium hydrogen peroxymonosulfate in the presence of iodide to produce a chromogen (triiodide) with a wavelength of maximum absorption at 350 nm.</p><p><strong>Results: </strong>Method \"A\" was applicable over the concentration range of 0.25-3.5 mg to end volume 10 mL. In method \"B\", Beer's law was obeyed over the concentration range of 0.3-3.5 μg/mL with molar absorptivity of 24600 L/mol cm. The limits of quantification were calculated to be 0.25 mg/10 mL (A) and 0.2 μg/mL (B), respectively.</p><p><strong>Conclusion: </strong>The proposed methods were suitable for determination of MCP as a pure substance in tablets and injection.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"19 5","pages":"589-594"},"PeriodicalIF":1.7,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9634443/pdf/TJPS-19-589.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40437628","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: 0
Investigation of Selected Medicinal Plants for Their Anti-Obesity Properties. 部分药用植物抗肥胖作用的研究。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.97572
Sıla Özlem Şener, Eylül Cılız, Berre Nur Öztekin, Merve Badem, Ufuk Özgen

Objectives: Obesity, which is a risk factor for diabetes, hypertension, cardiovascular diseases, and cancer, is caused serious health problems and economic costs on a global scale. Nowadays, pancreatic lipase inhibitors that cause inhibition of lipid digestion and lipid absorption are one of the limited treatment approaches for obesity. Plant-derived secondary metabolites can be used for treating obesity. The aim of this study was to research the antiobesity potential of Amaranthus albus L. (Amaranthaceae), Helichrysum compactum Boiss. (Asteraceae), Chenopodium album L. (Chenopodiaceae), and Agrimonia eupatoria L. (Rosaceae).

Materials and methods: To detect the antiobesity potentials of the plants, in vitro lipase inhibitory activity studies by spectroscopic method and quantitative analysis studies of some anti-obesity effective secondary metabolites by reversed-phase high performance liquid chromatography (RP-HPLC) technique were carried out.

Results: In vitro lipase inhibitory studies showed that all plant extracts possess lipase inhibitory effect, and the highest lipase inhibitory potential was observed for H. compactum (IC50: 45.70 μg/mL ± 2.3618). According to HPLC analyses, p-coumaric acid (0.27 mg/g) in A. albus; benzoic acid (0.33 mg/g) in C. album; vanillic acid (7.32 mg/g), syringaldehyde (14.97 mg/g), quercetin (4.66 mg/g), p-coumaric acid (0.71 mg/g), and benzoic acid (3.43 mg/g) in H. compactum; p-coumaric acid (0.71 mg/g) and benzoic acid (3.43 mg/g) in A. eupatoria were detected.

Conclusion: In conclusion, H. compactum is the most remarkable natural source for the study. The fact remains that all plants may be promising candidates for treating obesity.

肥胖是糖尿病、高血压、心血管疾病和癌症的一个危险因素,在全球范围内造成了严重的健康问题和经济成本。目前,抑制脂质消化和脂质吸收的胰脂肪酶抑制剂是肥胖的有限治疗方法之一。植物源次生代谢物可用于治疗肥胖。本研究旨在研究苋菜科(Amaranthus albus L.)蜡菊(Helichrysum compactum Boiss)的抗肥胖潜力。(Asteraceae)、Chenopodium album L. (Chenopodiaceae)和Agrimonia eupatoria L.(蔷薇科)。材料与方法:为检测植物的抗肥胖潜能,采用光谱学方法对其体外脂肪酶抑制活性进行了研究,并采用反相高效液相色谱(RP-HPLC)技术对部分抗肥胖有效次级代谢产物进行了定量分析。结果:体外脂酶抑制实验表明,所有植物提取物均具有抑制脂酶的作用,其中以密实草脂酶抑制电位最高(IC50: 45.70 μg/mL±2.3618)。高效液相色谱法分析,白菖蒲中对香豆酸含量为0.27 mg/g;C. album中苯甲酸含量为0.33 mg/g;香草酸(7.32 mg/g)、丁香醛(14.97 mg/g)、槲皮素(4.66 mg/g)、对香豆酸(0.71 mg/g)、苯甲酸(3.43 mg/g);对香豆酸含量为0.71 mg/g,苯甲酸含量为3.43 mg/g。结论:总之,压实草是本研究最显著的天然来源。事实上,所有的植物都可能是治疗肥胖的有希望的候选者。
{"title":"Investigation of Selected Medicinal Plants for Their Anti-Obesity Properties.","authors":"Sıla Özlem Şener,&nbsp;Eylül Cılız,&nbsp;Berre Nur Öztekin,&nbsp;Merve Badem,&nbsp;Ufuk Özgen","doi":"10.4274/tjps.galenos.2021.97572","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.97572","url":null,"abstract":"<p><strong>Objectives: </strong>Obesity, which is a risk factor for diabetes, hypertension, cardiovascular diseases, and cancer, is caused serious health problems and economic costs on a global scale. Nowadays, pancreatic lipase inhibitors that cause inhibition of lipid digestion and lipid absorption are one of the limited treatment approaches for obesity. Plant-derived secondary metabolites can be used for treating obesity. The aim of this study was to research the antiobesity potential of <i>Amaranthus albus</i> L. (Amaranthaceae), <i>Helichrysum compactum</i> Boiss. (Asteraceae), <i>Chenopodium album</i> L. (Chenopodiaceae), and <i>Agrimonia eupatoria</i> L. (Rosaceae).</p><p><strong>Materials and methods: </strong>To detect the antiobesity potentials of the plants, <i>in vitro</i> lipase inhibitory activity studies by spectroscopic method and quantitative analysis studies of some anti-obesity effective secondary metabolites by reversed-phase high performance liquid chromatography (RP-HPLC) technique were carried out.</p><p><strong>Results: </strong><i>In vitro</i> lipase inhibitory studies showed that all plant extracts possess lipase inhibitory effect, and the highest lipase inhibitory potential was observed for <i>H. compactum</i> (IC<sub>50</sub>: 45.70 μg/mL ± 2.3618). According to HPLC analyses, <i>p</i>-coumaric acid (0.27 mg/g) in <i>A. albus</i>; benzoic acid (0.33 mg/g) in <i>C. album</i>; vanillic acid (7.32 mg/g), syringaldehyde (14.97 mg/g), quercetin (4.66 mg/g), <i>p</i>-coumaric acid (0.71 mg/g), and benzoic acid (3.43 mg/g) in <i>H. compactum</i>; <i>p</i>-coumaric acid (0.71 mg/g) and benzoic acid (3.43 mg/g) in <i>A. eupatoria</i> were detected.</p><p><strong>Conclusion: </strong>In conclusion, <i>H. compactum</i> is the most remarkable natural source for the study. The fact remains that all plants may be promising candidates for treating obesity.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"19 5","pages":"498-504"},"PeriodicalIF":1.7,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9634444/pdf/TJPS-19-498.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40659553","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: 0
Development and Evaluation of Floating Microspheres of Anticonvulsant Drug by 32 Full Factorial Design. 32全因子设计抗惊厥药物漂浮微球的研制与评价。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.53050
Manish Bhise, Karunakar Shukla, Sourabh Jain, Nitin Bhajipale, Suresh Sudke, Pramod Burakle

Objectives: Present study was to develop and evaluate gastroretentive microspheres by the solvent evaporation technique.

Materials and methods: Gabapentin and HPMC K100 were used to develop the formulations. Gastroretentive microspheres were developed by the solvent evaporation technique from the preliminary batches of gabapentin microspheres batch FMG3 were selected for factorial study.

Results: Factorial batches showed the mean particle size of the floating microsphere formulations for gabapentin (FFMG1-FFMG9) was in the range of 185.63 ± 0.13 to 510.04 ± 0.09 μm. The percentage yields of formulations FFMG1 to FFMG9 for gabapentin ranged from 53.5 ± 0.95 to 96.64 ± 0.42. The buoyancy percentage was calculated for the formulations and found that all formulations could float on dissolution medium for 12 h. The drug loading in gabapentin microspheres was found 65.29 ± 0.46 to 84.3 ± 0.44. The swelling study was found to be 756.34 ± 1.48 to 890.46 ± 0.78 for gabapentin. Batch FFMG6 and FFMC2 showed better drug release 99.1% and 99.25% respectively. The optimized formulation FFMG6 for gabapentin showed an n value 0.8474 and R2 value 0.9965.

Conclusion: Optimized formulation obeys Korsmeyer-Peppas release. Scanning electron microscopy images of microspheres were spherical, discrete, and freely flowing. ANOVA for the given formulations showed p value less than 0.0500. The stability study indicated no significant changes in the microspheres. In radiographic images, floating microspheres were retained in the stomach of rabbits for twelve hours.

目的:利用溶剂蒸发技术制备胃保留微球并对其进行评价。材料与方法:以加巴喷丁、HPMC K100配制。以加巴喷丁微球为原料,采用溶剂蒸发法制备胃保留微球,选择FMG3批次进行析因研究。结果:阶乘批析结果表明,加巴喷丁漂浮微球制剂(ffmg1 ~ ffmg9)的平均粒径范围为185.63±0.13 ~ 510.04±0.09 μm;复方FFMG1 ~ FFMG9对加巴喷丁的收率范围为53.5±0.95 ~ 96.64±0.42。计算了各制剂的浮力百分比,发现各制剂均可在溶出介质上漂浮12 h。加巴喷丁微球的载药量为65.29±0.46 ~ 84.3±0.44。加巴喷丁的肿胀研究结果为756.34±1.48 ~ 890.46±0.78。批次FFMG6和FFMC2的释药效果较好,分别为99.1%和99.25%。加巴喷丁最佳处方FFMG6的n值为0.8474,R2为0.9965。结论:优化后的配方符合Korsmeyer-Peppas释放规律。微球扫描电镜图像呈球形,离散,自由流动。对给定配方的方差分析显示p值小于0.0500。稳定性研究表明微球无明显变化。在x线摄影图像中,漂浮的微球在兔子的胃中保留了12小时。
{"title":"Development and Evaluation of Floating Microspheres of Anticonvulsant Drug by 3<sup>2</sup> Full Factorial Design.","authors":"Manish Bhise,&nbsp;Karunakar Shukla,&nbsp;Sourabh Jain,&nbsp;Nitin Bhajipale,&nbsp;Suresh Sudke,&nbsp;Pramod Burakle","doi":"10.4274/tjps.galenos.2021.53050","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.53050","url":null,"abstract":"<p><strong>Objectives: </strong>Present study was to develop and evaluate gastroretentive microspheres by the solvent evaporation technique.</p><p><strong>Materials and methods: </strong>Gabapentin and HPMC K100 were used to develop the formulations. Gastroretentive microspheres were developed by the solvent evaporation technique from the preliminary batches of gabapentin microspheres batch FMG3 were selected for factorial study.</p><p><strong>Results: </strong>Factorial batches showed the mean particle size of the floating microsphere formulations for gabapentin (FFMG1-FFMG9) was in the range of 185.63 ± 0.13 to 510.04 ± 0.09 μm. The percentage yields of formulations FFMG1 to FFMG9 for gabapentin ranged from 53.5 ± 0.95 to 96.64 ± 0.42. The buoyancy percentage was calculated for the formulations and found that all formulations could float on dissolution medium for 12 h. The drug loading in gabapentin microspheres was found 65.29 ± 0.46 to 84.3 ± 0.44. The swelling study was found to be 756.34 ± 1.48 to 890.46 ± 0.78 for gabapentin. Batch FFMG6 and FFMC2 showed better drug release 99.1% and 99.25% respectively. The optimized formulation FFMG6 for gabapentin showed an n value 0.8474 and R<sup>2</sup> value 0.9965.</p><p><strong>Conclusion: </strong>Optimized formulation obeys Korsmeyer-Peppas release. Scanning electron microscopy images of microspheres were spherical, discrete, and freely flowing. ANOVA for the given formulations showed <i>p</i> value less than 0.0500. The stability study indicated no significant changes in the microspheres. In radiographic images, floating microspheres were retained in the stomach of rabbits for twelve hours.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"19 5","pages":"595-602"},"PeriodicalIF":1.7,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9634442/pdf/TJPS-19-595.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40437629","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: 2
Safety in Cosmetics and Cosmetovigilance, Current Regulations in Türkiye. 化妆品的安全与警惕,现行法规在日本。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.40697
İmran Altıokka, Melike Üner

Although it is considered that cosmetics do not have side effects, studies have revealed that a significant number of consumers experience side effects. Undesirable effects arising from the use of cosmetic products have created the need for a reporting and evaluation system, which is responsible for some restrictions on the use of cosmetics ingredients and putting into cosmetic regulation effect, called cosmetovigilance. However, the new cosmetovigilance concept needs some updates to become more effective for public health. For instance, side effects related to cosmetic use have been reported more frequently recently, but this rate is still quite low. Additionally, since the current cosmetic directive does not recognize cosmeceuticals as a distinct category from cosmetics, some products named cosmetic under the laws may affect the bottom layers of dermis and cause systemic side effects. Although the manufacturers must show safety assessments to the Turkish Pharmaceutical and Medical Device Agency to get a license, after launching they do not have post-vigilance reporting to the institution, which is another problem of the system. In this review, the current cosmetovigilance system in Türkiye was discussed and some hardships encountered were criticized regarding the implementation of the system. Additionally, scientific studies are conducted on cosmetic ingredients that can have side effects and contribute to the developing cosmetovigilance concept. Because of the study, the importance of the feedback of healthcare professionals in the cosmetovigilance system, the consultancy service to be given to the consumer and patient about the contents that should be considered. Besides, there is a need for new studies to indicate the adverse reaction incidence related to cosmetics in the Turkish market. Another outcome of this review article is to understand the importance of the new regulations regarding the increase in the new active ingredients in the cosmetic market.

虽然人们认为化妆品没有副作用,但研究表明,相当多的消费者会出现副作用。由于使用化妆品产生的不良影响,需要建立一个报告和评估系统,该系统负责对化妆品成分的使用进行一些限制并发挥化妆品监管作用,称为化妆品警惕。然而,新的化妆品警惕概念需要一些更新才能对公众健康更有效。例如,与化妆品使用有关的副作用最近被报道得越来越频繁,但这个比率仍然很低。此外,由于目前的化妆品指令没有将药妆品与化妆品区分开来,一些在法律下被命名为化妆品的产品可能会影响真皮层的底层,并导致全身副作用。尽管制造商必须向土耳其制药和医疗器械管理局(Turkish Pharmaceutical and Medical Device Agency)出示安全评估报告才能获得许可证,但在上市后,他们没有向该机构提交警戒后报告,这是该系统的另一个问题。本文对我国现行化妆品警戒制度进行了讨论,并对该制度实施过程中遇到的困难进行了批评。此外,对可能有副作用的化妆品成分进行了科学研究,并有助于发展化妆品警惕概念。由于该研究,医疗保健专业人员的反馈在化妆品警戒系统的重要性,咨询服务应给予消费者和患者有关的内容应考虑。此外,有必要进行新的研究,以表明土耳其市场上与化妆品有关的不良反应发生率。这篇综述文章的另一个结果是了解关于化妆品市场中新活性成分增加的新法规的重要性。
{"title":"Safety in Cosmetics and Cosmetovigilance, Current Regulations in Türkiye.","authors":"İmran Altıokka,&nbsp;Melike Üner","doi":"10.4274/tjps.galenos.2021.40697","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.40697","url":null,"abstract":"<p><p>Although it is considered that cosmetics do not have side effects, studies have revealed that a significant number of consumers experience side effects. Undesirable effects arising from the use of cosmetic products have created the need for a reporting and evaluation system, which is responsible for some restrictions on the use of cosmetics ingredients and putting into cosmetic regulation effect, called cosmetovigilance. However, the new cosmetovigilance concept needs some updates to become more effective for public health. For instance, side effects related to cosmetic use have been reported more frequently recently, but this rate is still quite low. Additionally, since the current cosmetic directive does not recognize cosmeceuticals as a distinct category from cosmetics, some products named cosmetic under the laws may affect the bottom layers of dermis and cause systemic side effects. Although the manufacturers must show safety assessments to the Turkish Pharmaceutical and Medical Device Agency to get a license, after launching they do not have post-vigilance reporting to the institution, which is another problem of the system. In this review, the current cosmetovigilance system in Türkiye was discussed and some hardships encountered were criticized regarding the implementation of the system. Additionally, scientific studies are conducted on cosmetic ingredients that can have side effects and contribute to the developing cosmetovigilance concept. Because of the study, the importance of the feedback of healthcare professionals in the cosmetovigilance system, the consultancy service to be given to the consumer and patient about the contents that should be considered. Besides, there is a need for new studies to indicate the adverse reaction incidence related to cosmetics in the Turkish market. Another outcome of this review article is to understand the importance of the new regulations regarding the increase in the new active ingredients in the cosmetic market.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"19 5","pages":"610-617"},"PeriodicalIF":1.7,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9634450/pdf/TJPS-19-610.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40440133","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: 1
Stability Indicating RP-HPLC and Spectrophotometric Methods for Simultaneous Estimation of Sodium Benzoate and Cefdinir in the Presence of its Degradation Products-Application to Blank Subtraction Method. 稳定性指示RP-HPLC和分光光度法同时测定苯甲酸钠和头孢地尼降解产物的方法——空白减法的应用。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.35020
Mahmoud Abdelfettah Mohamed, Mohamed El-Kassem Mohamed Hassouna

Objectives: Empower 3 software is important in modeling, optimization, and reducing the time of manual calculation of related substance by subtracting the baseline of a blank chromatogram from the unknown sample automatically; so, the major objective of the developed method is to introduce a new, selective, and economical high performance liquid chromatography (HPLC) and spectrophotometric method for simultaneous estimation of sodium benzoate (SDB) and cefdinir (CFR) in the presence of its degradation products.

Materials and methods: Chromatographic separation is optimized and adjusted using two methods; method (I) is characterized for separation of active pharmaceutical ingredient (CFR) in pure and dosage forms using Atlantis dC18 column [4.6 mm x 250 mm (5 μm particle size or equivalent)] with a mobile phase consisting of methanol: 0.02 M phosphate buffer solution pH 3.0 (40:60 v/v) at a flow rate of 1.0 mL/minute, injection volume 10 μL and wavelength 254 nm. Method (II) is identified for related substances in a Hichrom C18 column (15 x 0.46 cm), 5 μm particle size or equivalent, using a binary gradient consisting of solution A [0.1% tetramethylammonium hydroxide solution (pH: 5.5) with 0.1 M EDTA (1000:0.4 v/v)] and solution B (0.1% tetramethylammonium hydroxide solution (pH 5.5): acetonitrile: methanol : 0.1 M EDTA (500:300:200:0.4 v/v) using injection volume 10 μL for reversed-phase HPLC with a wavelength equals to 254 nm and flow rate 1.0 mL/min. Two ecofriendly spectrophotometric methods were successfully used to resolve the spectral overlap of drugs.

Results: Method A, the first derivative of ratio spectra spectrophotometric method (1stDD) where CFR was determined at two wavelengths 283.5 nm, 313.4 nm and SDB was determined at 216.7 nm, 235.5 nm. Method B, ratio subtraction method is performed to overcome the interference between CFR and the preservative SDB. The ultraviolet spectrum of the laboratory mixture is divided by that of CFR (20 μg/mL) as a divisor then subtracting the amplitudes in the plateau region at 250-315 nm (the constant) from that of the ratio spectrum. The zero-order spectra of SDB were obtained at 225 nm by multiplying the resulting ratio spectra by the divisor (CFR), zero order of CFR was been estimated at a wavelength value of 283 nm after multiplication of the divisor by the obtained constant.

Conclusion: The optimized method was adjusted and validated as per International Conference on Harmonization guidelines and could be easily utilized by quality control laboratories and for laboratory-prepared mixtures.

Empower 3软件通过自动从未知样品中减去空白色谱的基线,在建模、优化和减少人工计算相关物质的时间方面发挥了重要作用;因此,本研究的主要目的是建立一种新的、选择性的、经济的高效液相色谱和分光光度法同时测定苯甲酸钠(SDB)和头孢地尼(CFR)降解产物的方法。材料和方法:采用两种方法对色谱分离进行优化和调整;方法(1)采用Atlantis dC18色谱柱[4.6 mm × 250 mm (5 μm粒径或相当物)],流动相为甲醇:0.02 M磷酸盐缓冲液pH 3.0 (40:60 v/v),流速为1.0 mL/min,进样量为10 μL,波长为254 nm,分离纯剂型和剂型中的活性药物成分(CFR)。方法(II)在Hichrom C18色谱柱(15 x 0.46 cm)中鉴定相关物质,5 μm粒度或同等大小,使用二元梯度组成的溶液a[0.1%四甲基氢氧化铵溶液(pH: 5.5)与0.1 M EDTA (1000:0.4 v/v)]和溶液B(0.1%四甲基氢氧化铵溶液(pH: 5.5):乙腈:甲醇:0.1 M EDTA (500:300:200:0.4 v/v),进样量为10 μL,反相HPLC,波长为254 nm,流速为1.0 mL/min。两种生态友好的分光光度法成功地解决了药物的光谱重叠。结果:方法A为比值光谱一阶导数分光光度法(1stDD), CFR分别在283.5 nm、313.4 nm测定,SDB分别在216.7 nm、235.5 nm测定。方法B采用比例减法克服CFR与防腐剂SDB之间的干扰。将实验室混合物的紫外光谱除以CFR (20 μg/mL)的紫外光谱作为除数,然后在比值光谱中减去高原地区250 ~ 315 nm(常数)的振幅。将得到的比值光谱乘以所得到的因数(CFR)得到SDB在225 nm处的零阶光谱,将所得到的因数乘以所得到的常数得到283 nm处的零阶CFR。结论:优化后的方法符合国际协调会议的指导方针,可方便地用于质控实验室和实验室配制的制剂。
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引用次数: 0
Potential Drug Interactions in Adults Living in Manaus: A Real-World Comparison of Two Databases, 2019. 居住在马瑙斯的成年人的潜在药物相互作用:两个数据库的真实世界比较,2019。
IF 1.7 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2022-10-31 DOI: 10.4274/tjps.galenos.2021.96603
Tayanny Margarida Menezes Almeida Biase, Giulia Sartori Bruniéri, Marcus Tolentino Silva, Taís Freire Galvão

Objectives: Drug information systems are commonly used by professionals to assist in the identification of drug interactions and to ensure the safe use of medications. Real-world evidence about the comparison of different drug interaction sources is scarce. We aimed to compare two drug interaction databases to identify interactions in a population-based survey.

Materials and methods: This is a cross-sectional study based on a previous survey performed in the city of Manaus, Brazil, in 2019. We included adults aged 18 years and over, who used two or more medicines 15 days before the interview. To assess potential drug interactions, we searched Micromedex and UpToDate databases. The primary outcome was the prevalence of potential drug interactions in each database. Weighted Kappa statistics were calculated to assess agreement on the presence of drug interaction, documentation and severity.

Results: A total of 752 participants were included in the study. The prevalence of drug interactions was 43.8% [95% confidence interval (CI): 40.2, 47.3%] in UpToDate and 30.2% (95% CI: 26.9, 33.5%), in Micromedex. The agreement related to drug interactions between the two databases was fair (Kappa: 0.631). For severity (Kappa: 0.398) and documentation (Kappa: 0.311), the agreement was poor.

Conclusion: Agreement among compared databases was sub-optimal. Better quality and transparency of evidence available in drug interaction sources are needed to support informed healthcare professionals' decision.

目的:药物信息系统通常被专业人员用于协助识别药物相互作用并确保药物的安全使用。关于不同药物相互作用来源的比较的真实证据很少。我们的目的是比较两种药物相互作用数据库,以确定基于人群的调查中的相互作用。材料和方法:这是一项基于2019年在巴西马瑙斯市进行的一项调查的横断面研究。我们纳入了18岁及以上的成年人,他们在访谈前15天使用了两种或更多的药物。为了评估潜在的药物相互作用,我们检索了Micromedex和UpToDate数据库。主要结果是每个数据库中潜在药物相互作用的发生率。计算加权Kappa统计来评估药物相互作用、文献记录和严重程度的一致性。结果:共有752名参与者被纳入研究。在UpToDate中药物相互作用的发生率为43.8%[95%可信区间(CI): 40.2, 47.3%],在Micromedex中为30.2% (95% CI: 26.9, 33.5%)。两个数据库在药物相互作用方面的一致性是公平的(Kappa: 0.631)。对于严重性(Kappa: 0.398)和文档(Kappa: 0.311),一致性很差。结论:所比较数据库之间的一致性不是最优的。需要提高药物相互作用来源证据的质量和透明度,以支持知情的医疗保健专业人员的决策。
{"title":"Potential Drug Interactions in Adults Living in Manaus: A Real-World Comparison of Two Databases, 2019.","authors":"Tayanny Margarida Menezes Almeida Biase,&nbsp;Giulia Sartori Bruniéri,&nbsp;Marcus Tolentino Silva,&nbsp;Taís Freire Galvão","doi":"10.4274/tjps.galenos.2021.96603","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.96603","url":null,"abstract":"<p><strong>Objectives: </strong>Drug information systems are commonly used by professionals to assist in the identification of drug interactions and to ensure the safe use of medications. Real-world evidence about the comparison of different drug interaction sources is scarce. We aimed to compare two drug interaction databases to identify interactions in a population-based survey.</p><p><strong>Materials and methods: </strong>This is a cross-sectional study based on a previous survey performed in the city of Manaus, Brazil, in 2019. We included adults aged 18 years and over, who used two or more medicines 15 days before the interview. To assess potential drug interactions, we searched Micromedex and UpToDate databases. The primary outcome was the prevalence of potential drug interactions in each database. Weighted Kappa statistics were calculated to assess agreement on the presence of drug interaction, documentation and severity.</p><p><strong>Results: </strong>A total of 752 participants were included in the study. The prevalence of drug interactions was 43.8% [95% confidence interval (CI): 40.2, 47.3%] in UpToDate and 30.2% (95% CI: 26.9, 33.5%), in Micromedex. The agreement related to drug interactions between the two databases was fair (Kappa: 0.631). For severity (Kappa: 0.398) and documentation (Kappa: 0.311), the agreement was poor.</p><p><strong>Conclusion: </strong>Agreement among compared databases was sub-optimal. Better quality and transparency of evidence available in drug interaction sources are needed to support informed healthcare professionals' decision.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"19 5","pages":"543-551"},"PeriodicalIF":1.7,"publicationDate":"2022-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9634440/pdf/TJPS-19-543.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40447747","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: 0
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Turkish Journal of Pharmaceutical Sciences
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