Pub Date : 2023-05-09DOI: 10.4274/tjps.galenos.2022.69922
Taha Nazir, Nida Taha, Azharul Islam, Ishtiaq Rabbi, Pervaiz Akhter Shah
The recently explained cytokine, which is produced after the stimulation of interferon (IFN)-c, interleukin (IL)-2, and IL-18 is IL-32, has pro-inflammatory IFN-c, IL-2 and IL-18 are IL-32 mediator's properties that are generally entailed in many diseases, including infections, cancer, and chronic inflammation. After the initial statement in 2005, it promoted the osteoclast precursor's differentiation into TRAcP plus VNR plus multinucleated cells that express explicit osteoclast indicators. Furthermore, the loss of bone resorption might be accredited because of the collapse of the multinucleated cells, which are produced of the reaction to IL-32 to direct factoring that is ultimately essential for attaching the cells for bone resorption. Thus, in conclusion, IL-32, the pro-inflammatory mediator, has an important and indirect role in regulating osteoclast differentiation. In bone disorder's pathophysiology, critical role of IL-32 needs more scientific evidence to develop a rational treatment protocol. IL-32 can become a potent mediator of active osteoclast generation in the presence of receptor activator of NF-κB ligand (RANKL). This novel cytokine can introduce more favorable conditions for osteoclastogenesis in the rheumatic arthritis by increasing the RANKL and osteoprotegerin ratio in fibroblast-like synoviocytes.
{"title":"The Role of Pro-Inflammatory Mediator Interleukin-32 in Osteoclast Differentiation.","authors":"Taha Nazir, Nida Taha, Azharul Islam, Ishtiaq Rabbi, Pervaiz Akhter Shah","doi":"10.4274/tjps.galenos.2022.69922","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.69922","url":null,"abstract":"<p><p>The recently explained cytokine, which is produced after the stimulation of interferon (IFN)-c, interleukin (IL)-2, and IL-18 is IL-32, has pro-inflammatory IFN-c, IL-2 and IL-18 are IL-32 mediator's properties that are generally entailed in many diseases, including infections, cancer, and chronic inflammation. After the initial statement in 2005, it promoted the osteoclast precursor's differentiation into TRAcP plus VNR plus multinucleated cells that express explicit osteoclast indicators. Furthermore, the loss of bone resorption might be accredited because of the collapse of the multinucleated cells, which are produced of the reaction to IL-32 to direct factoring that is ultimately essential for attaching the cells for bone resorption. Thus, in conclusion, IL-32, the pro-inflammatory mediator, has an important and indirect role in regulating osteoclast differentiation. In bone disorder's pathophysiology, critical role of IL-32 needs more scientific evidence to develop a rational treatment protocol. IL-32 can become a potent mediator of active osteoclast generation in the presence of receptor activator of NF-κB ligand (RANKL). This novel cytokine can introduce more favorable conditions for osteoclastogenesis in the rheumatic arthritis by increasing the RANKL and osteoprotegerin ratio in fibroblast-like synoviocytes.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10176622/pdf/TJPS-20-121.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9463077","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}
Objectives: Early detection of bone cancer is critical for treating symptoms, minimizing pain, and increasing overall quality of life. It is critical to develop novel radiopharmaceuticals with high labeling efficiency and stability for the diagnosis of bone cancer. This research aims to design a novel radiopharmaceutical that may be used to diagnose bone cancer.
Materials and methods: In this study, ibandronate sodium (IBD), a bisphosphonate analog, was radiolabeled with technetium-99m [99mTc] and quality control tests on the newly developed radiopharmaceutical ([99mTc]Tc-IBD) were performed using radioactive thin layer chromatography. After that, the incorporation of [99mTc]Tc-IBD into hydroxyapatite (HA) crystals and a human bone osteosarcoma cell line (U2OS) was tested.
Results: According to the results obtained, optimal radiolabeling procedure was obtained for [99mTc]Tc-IBD with 200 μg.mL-1 IBD, 20 μg stannous chloride, and 99mTc with 37 MBq radioactivity. The reaction mixture was adjusted to pH 5.5 and incubated at room temperature for 15 min. The radiochemical purity of [99mTc]Tc-IBD was found to be greater than 95% at room temperature for up to 6 h. Additionally, chromatography analysis showed >95% [99mTc]Tc-IBD complex formation with promising stability for up to 24 h in saline and up to 2 h in cell medium. The percentage binding of IBD to HA was 83.70 ± 3.67 and the logP of [99mTc]Tc-IBD was -1.1014. The radiolabeled complex exhibited a higher rate of cell incorporation to U2OS cells compared to Reduced/Hydrolyzed 99mTcO4 -.
Conclusion: The newly produced radiopharmaceutical is very promising according to the results of in vitro cell culture, HA binding, and quality studies, and will be a step forward for further studies in nuclear medicine for bone cancer diagnostics.
{"title":"Radiolabeling, Quality Control, and Cell Binding Studies of New <sup>99m</sup>Tc-Labeled Bisphosphonates: <sup>99m</sup>Tc-Ibandronate Sodium.","authors":"Meliha Ekinci, Derya İlem Özdemir, Emre Özgenç, Evren Gündoğdu, Makbule Aşıkoğlu","doi":"10.4274/tjps.galenos.2022.01346","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.01346","url":null,"abstract":"<p><strong>Objectives: </strong>Early detection of bone cancer is critical for treating symptoms, minimizing pain, and increasing overall quality of life. It is critical to develop novel radiopharmaceuticals with high labeling efficiency and stability for the diagnosis of bone cancer. This research aims to design a novel radiopharmaceutical that may be used to diagnose bone cancer.</p><p><strong>Materials and methods: </strong>In this study, ibandronate sodium (IBD), a bisphosphonate analog, was radiolabeled with technetium-99m [<sup>99m</sup>Tc] and quality control tests on the newly developed radiopharmaceutical ([<sup>99m</sup>Tc]Tc-IBD) were performed using radioactive thin layer chromatography. After that, the incorporation of [<sup>99m</sup>Tc]Tc-IBD into hydroxyapatite (HA) crystals and a human bone osteosarcoma cell line (U2OS) was tested.</p><p><strong>Results: </strong>According to the results obtained, optimal radiolabeling procedure was obtained for [<sup>99m</sup>Tc]Tc-IBD with 200 μg.mL<sup>-1</sup> IBD, 20 μg stannous chloride, and <sup>99m</sup>Tc with 37 MBq radioactivity. The reaction mixture was adjusted to pH 5.5 and incubated at room temperature for 15 min. The radiochemical purity of [<sup>99m</sup>Tc]Tc-IBD was found to be greater than 95% at room temperature for up to 6 h. Additionally, chromatography analysis showed >95% [<sup>99m</sup>Tc]Tc-IBD complex formation with promising stability for up to 24 h in saline and up to 2 h in cell medium. The percentage binding of IBD to HA was 83.70 ± 3.67 and the logP of [<sup>99m</sup>Tc]Tc-IBD was -1.1014. The radiolabeled complex exhibited a higher rate of cell incorporation to U2OS cells compared to Reduced/Hydrolyzed <sup>99m</sup>TcO<sub>4</sub> -.</p><p><strong>Conclusion: </strong>The newly produced radiopharmaceutical is very promising according to the results of <i>in vitro</i> cell culture, HA binding, and quality studies, and will be a step forward for further studies in nuclear medicine for bone cancer diagnostics.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10176626/pdf/TJPS-20-91.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9463073","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}
Objectives: Respiratory tract infections (RTIs) are common in children. To treat the symptoms of simple health problems, individuals look for natural healing methods that can be easily prepared at home. The aim of this study was to determine the plants and herbal products used by the parents of children suffering from viral upper respiratory tract symptoms by questionaire. In the study, applications and products, other than plants used by families for their children were also investigated.
Materials and methods: This study is a cross-sectional survey conducted at Faculty of Medicine, Gazi University (Ankara, Türkiye). A questionnaire form was used by scanning the existing literature and reviewed with the patients face to face by the researchers. The data obtained from the study were analyzed with the Statistical Package for the Social Sciences (SPSS) statistical program.
Results: About half of the participants reported that they used non-chemical drug practices for their children with upper RTIs. The most common practice was to prepare herbal tea (30.5%), followed by mandarin/orange and/or their juice (26.9%) for oral application. The most used herbal tea for upper RTIs is with linden (Tilia sp.). Patients who used linden usually prepared it as tea, in other words by infusion, and served their children 1-2 cups/1-3 times a week. Except for herbal tea, the participants mostly used honey (19.0%) for their children's symptoms.
Conclusion: Where available, appropriate doses and dosage forms of herbal supplement products with scientifically proven efficacy and safety should be determined for the pediatric population. Parents should use these products based on the recommendations of their pediatrician.
{"title":"Use of Herbal Tea/Herbal Preparations for Children with Symptoms of Viral Upper Respiratory Infections.","authors":"Methiye Mancak Karakuş, Anıl Tapısız, Nazmi Mutlu Karakaş, Melis Deniz, Ufuk Koca Çalışkan","doi":"10.4274/tjps.galenos.2022.65475","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.65475","url":null,"abstract":"<p><strong>Objectives: </strong>Respiratory tract infections (RTIs) are common in children. To treat the symptoms of simple health problems, individuals look for natural healing methods that can be easily prepared at home. The aim of this study was to determine the plants and herbal products used by the parents of children suffering from viral upper respiratory tract symptoms by questionaire. In the study, applications and products, other than plants used by families for their children were also investigated.</p><p><strong>Materials and methods: </strong>This study is a cross-sectional survey conducted at Faculty of Medicine, Gazi University (Ankara, Türkiye). A questionnaire form was used by scanning the existing literature and reviewed with the patients face to face by the researchers. The data obtained from the study were analyzed with the Statistical Package for the Social Sciences (SPSS) statistical program.</p><p><strong>Results: </strong>About half of the participants reported that they used non-chemical drug practices for their children with upper RTIs. The most common practice was to prepare herbal tea (30.5%), followed by mandarin/orange and/or their juice (26.9%) for oral application. The most used herbal tea for upper RTIs is with linden (<i>Tilia</i> sp.). Patients who used linden usually prepared it as tea, in other words by infusion, and served their children 1-2 cups/1-3 times a week. Except for herbal tea, the participants mostly used honey (19.0%) for their children's symptoms.</p><p><strong>Conclusion: </strong>Where available, appropriate doses and dosage forms of herbal supplement products with scientifically proven efficacy and safety should be determined for the pediatric population. Parents should use these products based on the recommendations of their pediatrician.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986947/pdf/TJPS-20-8.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9111960","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}
Objectives: The intracellular parasitic protozoan, Leishmania spp., causes several forms of diseases in humans. Cytotoxicity and emergence of new strains resistance to the current anti-leishmanial drugs have encouraged researchers to focus on new resources. Glucosinolates (GSL) are found mainly in the Brassicaceae family with potential cytotoxic and anti-parasitic properties. The present study reports in vitro antileishmanial activity of the GSL fraction from Alyssum linifolium seeds against Leishmania major.
Materials and methods: The GSL fraction was prepared by ion-exchange and reversed-phase chromatography. For the assessment of antileishmanial activity, the promastigotes and amastigotes of L. major were treated with different concentrations of the fraction (75-625 μg/mL).
Results: The IC50 was 245 µg/mL for anti-promastigote effect of the GSL fraction and 250 µg/mL for its anti-amastigote effect that had a significant difference (p<0.05) with both glucantime and amphotericin B. The selectivity index of the GSL fraction (15.8), to glucantime and amphotericin B, was greater than 10, indicating the selective effect of this fraction against L. major amastigotes. Glucoiberverin was the major constituent of the GSL fraction characterized using nuclear magnetic resonance and electron ionization-mass spectrometry spectra. Based on gas chromatography-mass spectrometry data, iberverin and iberverin nitrile, the hydrolysis constituents from glucoiberverin, included 76.91% of the total seed volatiles.
Conclusion: The results suggest that GSLs like glucoiberverin could be considered a new promising candidate for further studies on antileishmanial activity.
目的:细胞内寄生原生动物利什曼原虫引起人类多种疾病。细胞毒性和对当前抗利什曼药物产生耐药性的新菌株的出现促使研究人员将重点放在新的资源上。硫代葡萄糖苷(Glucosinolates, GSL)主要存在于十字花科植物中,具有潜在的细胞毒和抗寄生特性。本研究报道了Alyssum linifolium种子GSL部分对利什曼原虫的体外抗利什曼原虫活性。材料和方法:采用离子交换-反相色谱法制备GSL馏分。采用不同浓度的提取物(75 ~ 625 μg/mL)处理大黄乳杆菌原毛菌和无尾毛菌,考察其抗利什曼原虫活性。结果:GSL部位抗promastigote作用的IC50为245µg/mL,其抗amastigote作用的IC50为250µg/mL,两者具有显著性差异(pL. major amastigotes)。利用核磁共振和电子电离质谱分析对GSL部分的主要成分进行了表征。气相色谱-质谱分析结果表明,从葡萄籽中提取的水解成分——鸢尾素和鸢尾素腈占总挥发物的76.91%。结论:GSLs类糖维苷可作为抗利什曼原虫活性进一步研究的新候选物。
{"title":"<i>In Vitro</i> Anti-Leishmanial Activity of Glucosinolate Fraction from <i>Alyssum linifolium</i> Steph. ex Willd (Brassicaceae).","authors":"Fatemeh Mirzaee, Roghiyeh Faridnia, Mahdi Fakhar, Hamed Kalani, Somayeh Shahani","doi":"10.4274/tjps.galenos.2022.78027","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.78027","url":null,"abstract":"<p><strong>Objectives: </strong>The intracellular parasitic protozoan, <i>Leishmania</i> spp., causes several forms of diseases in humans. Cytotoxicity and emergence of new strains resistance to the current anti-leishmanial drugs have encouraged researchers to focus on new resources. Glucosinolates (GSL) are found mainly in the Brassicaceae family with potential cytotoxic and anti-parasitic properties. The present study reports <i>in vitro</i> antileishmanial activity of the GSL fraction from <i>Alyssum linifolium</i> seeds against <i>Leishmania major</i>.</p><p><strong>Materials and methods: </strong>The GSL fraction was prepared by ion-exchange and reversed-phase chromatography. For the assessment of antileishmanial activity, the promastigotes and amastigotes of <i>L. major</i> were treated with different concentrations of the fraction (75-625 μg/mL).</p><p><strong>Results: </strong>The IC<sub>50</sub> was 245 µg/mL for anti-promastigote effect of the GSL fraction and 250 µg/mL for its anti-amastigote effect that had a significant difference (<i>p</i><0.05) with both glucantime and amphotericin B. The selectivity index of the GSL fraction (15.8), to glucantime and amphotericin B, was greater than 10, indicating the selective effect of this fraction against <i>L. major</i> amastigotes. Glucoiberverin was the major constituent of the GSL fraction characterized using nuclear magnetic resonance and electron ionization-mass spectrometry spectra. Based on gas chromatography-mass spectrometry data, iberverin and iberverin nitrile, the hydrolysis constituents from glucoiberverin, included 76.91% of the total seed volatiles.</p><p><strong>Conclusion: </strong>The results suggest that GSLs like glucoiberverin could be considered a new promising candidate for further studies on antileishmanial activity.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986943/pdf/TJPS-20-16.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9111961","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}
Pub Date : 2023-03-02DOI: 10.4274/tjps.galenos.2022.57699
Ufuk İnce, M İhsan Han
Objectives: The development of antimicrobial molecules discussed with considerable achievement over the past decades provided many classes of semisynthetic or synthetic compounds. Resistance to many antimicrobial agents requires the discovery of novel molecules.
Materials and methods: In this study, ten ethylparaben hydrazide-hydrazone derivatives, the previously reported, were evaluated for their in vitro antibacterial and antifungal activities. The microbroth dilution method was used for the determination of the minimum inhibitory concentration (MIC) values of the novel molecules.
Results: The antimicrobial activities of the molecules were found in a wide range with MIC values of 2-256 μg/mL. The synthesized compounds showed good to moderate antimicrobial activity compared with the standards. Among the synthesized molecules, compound 3g showed the best antimicrobial activity at 2 μg/mL against Staphylococcus aureus strain (ATCC 29213).
Conclusion: Ethylparaben hydrazide-hydrazone compounds in our study were found to have antimicrobial activities. Ethylparaben is currently used as an antibacterial agent and preservative for preparations. These studies are necessary since they detect the relationship between the substitutions and activity.
{"title":"Investigation of Antimicrobial Activity of Some Ethylparaben Hydrazide-Hydrazone Derivatives.","authors":"Ufuk İnce, M İhsan Han","doi":"10.4274/tjps.galenos.2022.57699","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.57699","url":null,"abstract":"<p><strong>Objectives: </strong>The development of antimicrobial molecules discussed with considerable achievement over the past decades provided many classes of semisynthetic or synthetic compounds. Resistance to many antimicrobial agents requires the discovery of novel molecules.</p><p><strong>Materials and methods: </strong>In this study, ten ethylparaben hydrazide-hydrazone derivatives, the previously reported, were evaluated for their <i>in vitro</i> antibacterial and antifungal activities. The microbroth dilution method was used for the determination of the minimum inhibitory concentration (MIC) values of the novel molecules.</p><p><strong>Results: </strong>The antimicrobial activities of the molecules were found in a wide range with MIC values of 2-256 μg/mL. The synthesized compounds showed good to moderate antimicrobial activity compared with the standards. Among the synthesized molecules, compound 3g showed the best antimicrobial activity at 2 μg/mL against <i>Staphylococcus aureus</i> strain (ATCC 29213).</p><p><strong>Conclusion: </strong>Ethylparaben hydrazide-hydrazone compounds in our study were found to have antimicrobial activities. Ethylparaben is currently used as an antibacterial agent and preservative for preparations. These studies are necessary since they detect the relationship between the substitutions and activity.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986940/pdf/TJPS-20-35.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10866129","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}
Objectives: Olmesartan medoxomil (OLM) and metoprolol succinate (MPS) in fixed-dose combination (FDC) tablet formulation prescribed extensively. Stability indicating (SI) method for impurities and related substance (RS) test quantitates the amount of these analytes in formulation; the manuscript presents SI/RS-ultra-high performance liquid chromatography-photodiode array (UHPLC-PDA) method for OLM and MPS and their impurities.
Materials and methods: Well-resolved separation of all analytes was achieved with gradient elution on a Shimadzu on Shimpack GIST-C18 (100 mm x 2.1 mm, 2 µm) column maintained at 25°C. Mobile phase-A consist of 0.1% orthophosphoric acid in water and mobile phase-B was acetonitrile at a flow rate of 0.4 mL/min, data integrated at 225 nm and 16 min of short runtime for satisfactory elution of all peaks.
Results: The proposed SI/RS-UHPLC-PDA method was developed and validated as per International Conference on Harmonisation (ICH) of Technical Requirements guidelines. The system suitability test complied by all eluted peaks of the interest with acceptable linearity, recovery, and precision. Specificity, robustness, and method sensitivity parameters were determined; all the parameters were found to be within the limits. All the impurities and stress-degraded peaks were well resolved.
Conclusion: The proposed method was found to be simple, fast, linear, and accurate. Further, the method is precise, robust, and specific; suitable for routine IPQC during active pharmaceutical ingredient manufacturing, stability and impurity profiling studies of the titled bulk analytes. Furthermore, the method can be extended to assess the levels of impurities formed during life cycle of new FDCs of titled analytes.
目的:奥美沙坦酯(OLM)和琥珀酸美托洛尔(MPS)在固定剂量复合制剂(FDC)片剂中被广泛使用。杂质稳定性指示(SI)方法和相关物质(RS)测试可定量检测这些分析物在制剂中的含量;本手稿介绍了 OLM 和 MPS 及其杂质的 SI/RS- 超高效液相色谱-光电二极管阵列(UHPLC-PDA)方法:采用岛津 Shimpack GIST-C18 (100 mm x 2.1 mm, 2 µm)色谱柱,在 25°C 下进行梯度洗脱,实现了所有分析物的良好分离。流动相 A 为 0.1%正磷酸水溶液,流动相 B 为乙腈,流速为 0.4 mL/min,在 225 nm 波长下进行数据整合,运行时间为 16 分钟,所有色谱峰均得到满意的洗脱:所提议的 SI/RS-UHPLC-PDA 方法是根据国际协调会议(ICH)的技术要求指南开发和验证的。所有洗脱峰均符合系统适用性测试的要求,线性、回收率和精密度均可接受。测定了特异性、稳健性和方法灵敏度参数,发现所有参数都在限值之内。所有杂质和应力降解峰都得到了很好的分辨:结论:所提出的方法简单、快速、线性、准确。此外,该方法还具有精确、稳健和特异性的特点,适用于活性药物成分生产过程中的常规 IPQC、稳定性和有标题的散装分析物的杂质分析研究。此外,该方法还可扩展用于评估有标分析物新 FDC 生命周期中形成的杂质水平。
{"title":"Development and Validation of SI/RS-UHPLC-PDA Method for Olmesartan Medoxomil and Metoprolol Succinate-Related Substance.","authors":"Nirmal Thakker, Gajanan Shinde, Abhay Dharamsi, Vishnu Choudhari","doi":"10.4274/tjps.galenos.2022.57384","DOIUrl":"10.4274/tjps.galenos.2022.57384","url":null,"abstract":"<p><strong>Objectives: </strong>Olmesartan medoxomil (OLM) and metoprolol succinate (MPS) in fixed-dose combination (FDC) tablet formulation prescribed extensively. Stability indicating (SI) method for impurities and related substance (RS) test quantitates the amount of these analytes in formulation; the manuscript presents SI/RS-ultra-high performance liquid chromatography-photodiode array (UHPLC-PDA) method for OLM and MPS and their impurities.</p><p><strong>Materials and methods: </strong>Well-resolved separation of all analytes was achieved with gradient elution on a Shimadzu on Shimpack GIST-C18 (100 mm x 2.1 mm, 2 µm) column maintained at 25°C. Mobile phase-A consist of 0.1% orthophosphoric acid in water and mobile phase-B was acetonitrile at a flow rate of 0.4 mL/min, data integrated at 225 nm and 16 min of short runtime for satisfactory elution of all peaks.</p><p><strong>Results: </strong>The proposed SI/RS-UHPLC-PDA method was developed and validated as <i>per</i> International Conference on Harmonisation (ICH) of Technical Requirements guidelines. The system suitability test complied by all eluted peaks of the interest with acceptable linearity, recovery, and precision. Specificity, robustness, and method sensitivity parameters were determined; all the parameters were found to be within the limits. All the impurities and stress-degraded peaks were well resolved.</p><p><strong>Conclusion: </strong>The proposed method was found to be simple, fast, linear, and accurate. Further, the method is precise, robust, and specific; suitable for routine IPQC during active pharmaceutical ingredient manufacturing, stability and impurity profiling studies of the titled bulk analytes. Furthermore, the method can be extended to assess the levels of impurities formed during life cycle of new FDCs of titled analytes.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986946/pdf/TJPS-20-39.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10859880","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}
Pub Date : 2023-03-02DOI: 10.4274/tjps.galenos.2022.85054
Margarida Espírito-Santo, Tânia Nascimento, Ezequiel Pinto, M Dulce Estêvão
Objectives: The consumption of medicines has been increasing over the last decades. The lack of medication knowledge (MK) may affect the process of medication use and, consequently, may lead to negative health outcomes. This study carried out a pilot study using a new tool to assess MK in older patients in a daily clinical practice.
Materials and methods: An exploratory cross-sectional study was conducted, including older patients (≥65 years), taking two or more medicines, followed in a regional clinic. Data were collected during a structured interview, which included an algorithm for assessing MK regarding the identification of the medicines and its use and storage conditions. Health literacy and treatment adherence were also assessed.
Results: The study enrolled 49 patients, mainly between 65 and 75 years (n: 33; 67.3%) and polymedicated (n: 40; 81.6%), taking a mean of 6.9 ± 2.8 medicines per day. A lack of MK (score <50%) was observed in 15 (30.6%) participant patients. "Drug strength" and "storage conditions" were the items which presented the lowest score. MK was positively correlated with higher scores for health literacy and treatment adherence. Younger patients (age <65 years old) also had a higher MK score.
Conclusion: This study showed that the applied tool could evaluate the MK of the participants and identified specific gaps regarding MK within the process of medicine use. Further studies, with more participants, will allow the confirmation of these findings and will stimulate the development of specific strategies to improve MK, thus contributing to better health outcomes.
{"title":"Knowledge Assessment During the Medication Process Use by Older Patients on Clinical Routine: A Pilot Study.","authors":"Margarida Espírito-Santo, Tânia Nascimento, Ezequiel Pinto, M Dulce Estêvão","doi":"10.4274/tjps.galenos.2022.85054","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.85054","url":null,"abstract":"<p><strong>Objectives: </strong>The consumption of medicines has been increasing over the last decades. The lack of medication knowledge (MK) may affect the process of medication use and, consequently, may lead to negative health outcomes. This study carried out a pilot study using a new tool to assess MK in older patients in a daily clinical practice.</p><p><strong>Materials and methods: </strong>An exploratory cross-sectional study was conducted, including older patients (≥65 years), taking two or more medicines, followed in a regional clinic. Data were collected during a structured interview, which included an algorithm for assessing MK regarding the identification of the medicines and its use and storage conditions. Health literacy and treatment adherence were also assessed.</p><p><strong>Results: </strong>The study enrolled 49 patients, mainly between 65 and 75 years (n: 33; 67.3%) and polymedicated (n: 40; 81.6%), taking a mean of 6.9 ± 2.8 medicines <i>per</i> day. A lack of MK (score <50%) was observed in 15 (30.6%) participant patients. \"Drug strength\" and \"storage conditions\" were the items which presented the lowest score. MK was positively correlated with higher scores for health literacy and treatment adherence. Younger patients (age <65 years old) also had a higher MK score.</p><p><strong>Conclusion: </strong>This study showed that the applied tool could evaluate the MK of the participants and identified specific gaps regarding MK within the process of medicine use. Further studies, with more participants, will allow the confirmation of these findings and will stimulate the development of specific strategies to improve MK, thus contributing to better health outcomes.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986945/pdf/TJPS-20-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9111959","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}
Pub Date : 2023-03-02DOI: 10.4274/tjps.galenos.2021.26529
Ashwini K Bawankule, Amol A Tatode, Pranali S Patil, Milind J Umekar
Paclitaxel (PTX) is used as a viable cancer medication in the chemotherapy of breast, ovarian, lung, bladder, neck, head, and esophageal tumors. The focus of this review is to survey various folate-targeting PTX-loaded nanopreparations in both research and clinical applications. There are diverse nanopreparations, including liposomes, micelles, polymeric nanopreparations, lipid nanopreparations, lipoprotein nanocarriers, and other inorganic nanopreparations for folate-associated PTX tumor targeting. Here, the folate targeting PTX-loaded nanopreparations, which have promising results in the constructive treatment of cancer by reducing toxic side-effects and/or improving effectiveness, was mainly reviewed.
{"title":"Folate-Mediated Paclitaxel Nanodelivery Systems: A Comprehensive Review.","authors":"Ashwini K Bawankule, Amol A Tatode, Pranali S Patil, Milind J Umekar","doi":"10.4274/tjps.galenos.2021.26529","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2021.26529","url":null,"abstract":"<p><p>Paclitaxel (PTX) is used as a viable cancer medication in the chemotherapy of breast, ovarian, lung, bladder, neck, head, and esophageal tumors. The focus of this review is to survey various folate-targeting PTX-loaded nanopreparations in both research and clinical applications. There are diverse nanopreparations, including liposomes, micelles, polymeric nanopreparations, lipid nanopreparations, lipoprotein nanocarriers, and other inorganic nanopreparations for folate-associated PTX tumor targeting. Here, the folate targeting PTX-loaded nanopreparations, which have promising results in the constructive treatment of cancer by reducing toxic side-effects and/or improving effectiveness, was mainly reviewed.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986944/pdf/TJPS-20-58.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10866126","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}
Pub Date : 2023-03-02DOI: 10.4274/tjps.galenos.2022.47690
Deniz Demirhan
Objectives Determination of the drug substance (DS) and drug product (DP) stability is especially important for biosimilar monoclonal antibodies since it can affect the quality, efficacy, and safety of the drugs. The main objective of this study was to determine the stability of the biosimilar candidate (TUR01) using state-of-the-art (current) analytical techniques. Materials and Methods Analytical techniques used in this study were isoelectric focusing on capillary electrophoresis, capillary electrophoresis-sodium dodecyl sulfate, size exclusion chromatography-ultra-high performance liquid chromatography, binding affinity, and physicochemical and microbiological tests. DS was kept in polyethylene terephthalate copolyester, glycol modified (PETG) bottles at ≤-65.0°C and 5.0 ± 3.0°C for 18 months, where the pre-filled syringe stability study was conducted at 5.0 ± 3.0°C for 24 months and 25.0 ± 2.0°C/60% ± 5 relative humidity (RH) for 6 months. The accelerated condition for DS was accepted as 5.0 ± 3.0°C, while it was 25.0 ± 2.0°C for the DP. Results The results indicated that TUR01 DS was stable when it was stored under long-term storage conditions at ≤-65°C and at 5 ± 3°C at least 18 months. Also, TUR01 DP was stable at 5 ± 3°C for 24 months and at 25 ± 2°C with 60.5% RH for 2 months without any significant changes. Conclusion State-of-the-art analytical techniques proved to be invaluable tools for evaluate the stability of the TUR01 DS and drug product.
{"title":"Stability Evaluation of the Biosimilar Monoclonal Antibody Using Analytical Techniques.","authors":"Deniz Demirhan","doi":"10.4274/tjps.galenos.2022.47690","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.47690","url":null,"abstract":"Objectives\u0000Determination of the drug substance (DS) and drug product (DP) stability is especially important for biosimilar monoclonal antibodies since it can affect the quality, efficacy, and safety of the drugs. The main objective of this study was to determine the stability of the biosimilar candidate (TUR01) using state-of-the-art (current) analytical techniques.\u0000\u0000\u0000Materials and Methods\u0000Analytical techniques used in this study were isoelectric focusing on capillary electrophoresis, capillary electrophoresis-sodium dodecyl sulfate, size exclusion chromatography-ultra-high performance liquid chromatography, binding affinity, and physicochemical and microbiological tests. DS was kept in polyethylene terephthalate copolyester, glycol modified (PETG) bottles at ≤-65.0°C and 5.0 ± 3.0°C for 18 months, where the pre-filled syringe stability study was conducted at 5.0 ± 3.0°C for 24 months and 25.0 ± 2.0°C/60% ± 5 relative humidity (RH) for 6 months. The accelerated condition for DS was accepted as 5.0 ± 3.0°C, while it was 25.0 ± 2.0°C for the DP.\u0000\u0000\u0000Results\u0000The results indicated that TUR01 DS was stable when it was stored under long-term storage conditions at ≤-65°C and at 5 ± 3°C at least 18 months. Also, TUR01 DP was stable at 5 ± 3°C for 24 months and at 25 ± 2°C with 60.5% RH for 2 months without any significant changes.\u0000\u0000\u0000Conclusion\u0000State-of-the-art analytical techniques proved to be invaluable tools for evaluate the stability of the TUR01 DS and drug product.","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9986942/pdf/TJPS-20-48.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10866130","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}