Turkish Journal of Pharmaceutical Sciences最新文献

{"title":"Validated Stability-Indicating RP-HPLC Method for Daclatasvir in Tablets.","authors":"Hemlata M Nimje,&nbsp;Smita J Pawar,&nbsp;Meenakshi N Deodhar","doi":"10.4274/tjps.galenos.2022.87393","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.87393","url":null,"abstract":"<p><strong>Objectives: </strong>The current study goal was to create a precise, sensitive, and validated reverse phase-high performance liquid chromatography (RP-HPLC) method for assessing the direct-acting antiviral daclatasvir (DCV) as well as to evaluate the stability of DCV in both drug and tablet formulations. The current investigation was to display stability indicating methods under different stress conditions, including hydrolysis (acidic, basic, and neutral), oxidation, and photolysis.</p><p><strong>Materials and methods: </strong>All experiments were performed on HPLC Agilent 1100 with a stainless steel Hypersil C₁₈ column having a particle size of 5 μm and a dimension of 4.6 x 250 mm. The mobile phase chosen was acetonitrile: 0.05% o-phosphoric acid (50:50 <i>v/v</i>) in isocratic mode with 0.7 mL/min flow rate and wavelength 315 nm was selected for detection.</p><p><strong>Results: </strong>This method was validated for linearity and range, accuracy, precision, limit of detection, limit of quantification, and robustness in accordance with International Council for Harmonisation (ICH) requirements. The results were satisfactory. It was observed that retention time (t_R) was 3.760 ± 0.01 min. In acidic conditions, DCV degradans show t_R at 3.863, 4.121, and 4.783 min and tandem mass spectrometry (MS/MS) spectra scans had <i>m/z</i> 339.1, 561.2 fragment ions. In basic condition, DCV degradans show t_R at 5.188, 5.469 min and MS/MS spectra scans having <i>m/z</i> 294.1, 339.1, 505.2, 527.2 fragment ions. In oxidation conditions, DCV degradans shows t_R at 4.038 min and MS/MS spectra scans having <i>m/z</i> 301.1 and 339.1 fragment ions were observed.</p><p><strong>Conclusion: </strong>All the mass fragments exhibited additional degradation observed for different stress conditions. This will help to identify the structure of the degradant and its pathways. No degradation was observed in neutral and photolytic conditions.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 4","pages":"218-225"},"PeriodicalIF":1.7,"publicationDate":"2023-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10445227/pdf/TJPS-20-218.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10421181","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}

{"title":"Thermoreversible Gel Formulation for the Intranasal Delivery of Salmon Calcitonin and Comparison Studies of <i>In Vivo</i> Bioavailability.","authors":"Abdullah Levent Alparslan,&nbsp;Gülbeyaz Yıldız Türkyılmaz,&nbsp;Leyla Didem Kozacı,&nbsp;Ercüment Karasulu","doi":"10.4274/tjps.galenos.2022.09482","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.09482","url":null,"abstract":"<p><strong>Objectives: </strong>We developed original thermoreversible (sol-gel) formulations of salmon calcitonin (sCT) for nasal applications. The sol-gel has been compared with commercial intranasal sprays <i>in vitro</i> and <i>in vivo</i> studies. The aim of studying sol-gel form is to arrange the viscosity of formulations for a reversible adequate fluidity at different temperatures. This situation may facilitate the use of drugs as sprays and increase the bioadhesive ability to mucosa.</p><p><strong>Materials and methods: </strong>Characterization of optimum formulations was studied. Validated analytical assays determined the number of sCT. An approximately equal number of commercial and sol-gel dosages were sprayed into the nostrils of the rabbits. Blood samples were collected from the ear veins of rabbits and determined by enzyme immunoassay plates. These plates were evaluated by Thermo Labsystem Multiscan Spectrum at 450 nm. Thanks to Winnonlin 5.2, pharmacokinetic data were evaluated by a non-compartmental method.</p><p><strong>Results: </strong>The absolute bioavailability of the formulation at pH 4 and the commercial product (CP) was compared by evaluating the primary pharmacokinetic data area under the curve 0→t_last. The absolute bioavailability of the commercial intranasal spray was measured 1.88 based on maximum concentration (C_max) assessment. C_max of the sol-gel formulation pH 4 was calculated as 0.99 and the relative bioavailability was obtained 53.3%.</p><p><strong>Conclusion: </strong><i>In vivo</i> pharmacokinetic data of sol-gel formulation with pH 3 showed significantly higher volume of distribution parameter than the CP (111167>35408). It is thought that the formulation adhered to the nasal mucosa releases sCT slowly and less.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"127-140"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337020/pdf/TJPS-20-127.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10164627","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}

{"title":"Development and Evaluation of <i>In Situ</i> Gel Formation for Treatment of Mouth Ulcer.","authors":"Nikita Harekrishna Gurav,&nbsp;Prerana Shantinath Husukale","doi":"10.4274/tjps.galenos.2022.25968","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.25968","url":null,"abstract":"<p><strong>Objectives: </strong>Mouth ulcers are one of the most prevalent conditions that can be caused by a range of circumstances. Many formulations, such as solutions, suspensions, and ointments are available commercially. However, because there is no long-term effect, no medication can be regarded as totally effective for treating mouth ulcers. The use of bioadhesive methods can boost the therapy efficacy. Because it is easier to administer than prepared gel formulations, the phenomenon of the sol-to-gel conversion can be beneficial. The major goal of this study was to develop and test <i>in situ</i> gels for treating mouth ulcers using choline salicylate and borax as model medicines.</p><p><strong>Materials and methods: </strong>Because a thermosensitive polymer was employed in this formulation, the sol-to-gel change was thermally reversible, and the frequency of administration was reduced by using the mucoadhesive polymer carbopol. Gelation temperature, pH, gel strength, spreadability, <i>in vitro</i> mucoadhesion, and <i>in vitro</i> drug release were all measured in the formulations.</p><p><strong>Results: </strong>The experimental section indicated that viscosity of sols and gel strength increased with increasing temperature, <i>i.e</i>., gel can be created at the site of application owing to body temperature. When poloxamer 407 was used at a concentration of 14 to 16 percent <i>w/v</i>, the gelling temperature was close to the body temperature (35-38 °C), but when carbopol 934P was added, the gelling temperature was raised. All formulations had pH between 5.5 and 6.8. All formulations had viscosities of less than 1000 cps, allowing for simple administration of the formulation to a mouth ulcer.</p><p><strong>Conclusion: </strong>As a result, a correctly developed <i>in situ</i> gel for oral ulcers can extend the duration spent at the application site and minimize the frequency of administration. These findings show that the developed technology is a viable alternative to traditional drug delivery systems and can help patients comply.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"185-197"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337022/pdf/TJPS-20-185.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10183573","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}

{"title":"Applications of Dietary Supplements and Aromatherapy for Prophylactic and Treatment Purposes During COVID-19 Pandemic.","authors":"Methiye Mancak,&nbsp;Ufuk Koca Çalışkan","doi":"10.4274/tjps.galenos.2022.21370","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.21370","url":null,"abstract":"<p><strong>Objectives: </strong>The lack of a specific proven treatment for coronavirus disease-2019 (COVID-19) has led individuals to use different treatment options. Although their effects on COVID-19 have not been proven, interest in dietary supplements and aromatherapy has increased during the pandemic period. In this study, use of dietary supplements and aromatherapy was investigated for COVID-19 among individuals living within the borders of Türkiye.</p><p><strong>Materials and methods: </strong>This cross-sectional survey study was conducted among 310 individuals. The questionnaire was prepared using online Google Forms and communicated to the participants via social media platforms. The data obtained from the study were analyzed with the statistical program.</p><p><strong>Results: </strong>The analyzes of the survey revealed that participants increased the usage of supplements mostly prophylactic and for treatment purposes during COVID-19 pandemic, 31.9% individuals declared that they consumed herbal tea/products, 38.1% of them used vitamin/mineral supplements (multivitamin-mineral, vitamins B1, B6, B12, C, D, calcium, coenzyme Q10, iron, magnesium, selenium, and zinc), and 18.4% of the individuals applied aromatherapy (meaning treatment with essential oils). As a result of the study, the most commonly used supplement was vitamin D, the most commonly consumed tea was green tea, the essential oil was thyme oil, and the most eaten vegetable was garlic. Moreover, other frequently used herbal products were found to contain ginger and onion as food and peppermint and eucalyptus oils as aromatherapeutics. Participants often reported that they found it safe to use elevated levels of herbs or herbal products against COVID-19.</p><p><strong>Conclusion: </strong>Among the individuals participating in this study, it has been observed that the use of dietary supplements has increased during the COVID-19 pandemic period. The study revealed that vitamin D is prominent in self-medication use. Moreover, interest in aromatherapy and dietary supplements has increased. Among aromatherapeutics, thyme stood out over the applied essential oils.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"176-184"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337021/pdf/TJPS-20-176.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10183580","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}

{"title":"<i>Trachystemon orientalis</i> (L.) G. Don as a Valuable Source of Rosmarinic Acid: Biological Activities and HPLC Profiles.","authors":"Burak Bıyık,&nbsp;Sezen Yılmaz Sarıaltın,&nbsp;Alper Gökbulut,&nbsp;Tülay Çoban,&nbsp;Maksut Çoşkun","doi":"10.4274/tjps.galenos.2022.14265","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.14265","url":null,"abstract":"<p><strong>Objectives: </strong><i>Trachystemon orientalis</i> (L.) G. Don, colloquially known in Türkiye as \"kaldırık\", is an edible plant belonging to the Boraginaceae. This plant has been practiced in traditional medicine for many years for its various therapeutic benefits. The effectiveness and chemical composition of plants can vary depending on their parts, age, and extraction solvent. Therefore, the current study aimed to define the biological activities of various parts and extracts of <i>T. orientalis</i>, which were collected in distinct seasons as young and mature, and investigate the main component responsible for these biological effects.</p><p><strong>Material and methods: </strong>Plant material was collected in different seasons from the northwest of Türkiye. 2,2'-Azinobis-(3-ethylbenzothiazoline-6-sulphonic acid) (ABTS) and 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radical scavenging activities were investigated to assess antiradical and antioxidant potential of the extracts. Anti-inflammatory activity of the extracts was also tested using human red blood cell membrane stabilizing method. Folin-Ciocalteu test was conducted to determine the total phenolic content. Reverse phase-high performance liquid chromatography-photodiode array detector (RP-HPLC-PDA) analysis was performed.</p><p><strong>Results: </strong>Both methanol and aqueous extracts exhibited significant radical scavenging and anti-inflammatory activities compared with control (<i>p</i><0.05). The highest percentage of inhibition on ABTS and DPPH free radicals was obtained in aqueous extracts of the mature herbs and roots, respectively. Methanol extracts of the mature roots and herbs exhibited the strongest anti-inflammatory capacity. Rosmarinic acid possessed a much higher antioxidant and anti-inflammatory effect than the reference compounds used in each assay in our study. High rosmarinic acid content of the extracts suggests that the compound responsible for the great biological activity potential is rosmarinic acid.</p><p><strong>Conclusion: </strong>To the best of our knowledge, the presence of rosmarinic acid in herbs and roots of <i>T. orientalis</i> was shown for the first time in our present study. Phytochemical composition and effective biological activities of <i>T. orientalis</i> explain its traditional use and indicate its significant potential in pharmaceutical industry applications.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"141-148"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337024/pdf/TJPS-20-141.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10164625","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}

{"title":"Analytical Quality by Design Driven Development and Validation of UV-Visible Spectrophotometric Method for Quantification of Xanthohumol in Bulk and Solid Lipid Nanoparticles.","authors":"Harish Vancha,&nbsp;Devesh Tewari,&nbsp;Rajesh Kumar,&nbsp;Pilli Govindaiah,&nbsp;Sharfuddin Mohd,&nbsp;Sachin Kumar Singh,&nbsp;Monica Gulati","doi":"10.4274/tjps.galenos.2022.05335","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.05335","url":null,"abstract":"<p><strong>Objectives: </strong>Xanthohumol (XH) is a prenylated chalcone available naturally and has diverse pharmacological activities. It has some limitations in the physiological environment such as biotransformation and less gastrointestinal tract absorption. To overcome the limitations, we prepared nanoformulations [solid lipid nanoparticles (SLNs)] of XH. Therefore, an analytical method is required for the estimation of XH in the bulk nanoformulations, so we developed and validated a quality by design (QbD)-based ultraviolet (UV)-spectrophotometric method as <i>per</i> the International Conference of Harmonization (ICH) Q2 (R1) guidelines.</p><p><strong>Materials and methods: </strong>The new analytical Qbd based UV-visible spectrophotometric technique is developed and validated for estimation of XH in bulk and SLNs as <i>per</i> ICH guidelines Q2 (R1). Critical method variables are selected on the basis of risk assessment studies. Optimization of method variables was performed using the a central composite design (CCD) model.</p><p><strong>Results: </strong>Multiregression ANOVA analysis showed an R2 value of 0.8698, which is nearer to 1, indicating that the model was best fitted. The optimized method by CCD was validated for its linearity, precision, accuracy, repeatability, limit of detection (LOD), limit of quantification (LOQ), and specificity. All validated parameters were found to be within the acceptable limits [% relative standard deviation (RSD) <2]. The method was linear between 2-12 g/mL concentration with R2 value 0.9981. Method was accurate with percent recovery 99.3-100.1%. LOD and LOQ were found to be 0.77 and 2.36 μg/mL, respectively. The precision investigation confirmed that the method was precise with %RSD <2.</p><p><strong>Conclusion: </strong>The developed and validated method was applied to estimate XH in bulk and SLNs. The developed method was specific to XH, which was confined by the specificity study.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"165-175"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337025/pdf/TJPS-20-165.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9862696","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}

{"title":"HERPUD1, a Member of the Endoplasmic Reticulum Protein Quality Control Mechanism, may be a Good Target for Suppressing Tumorigenesis in Breast Cancer Cells.","authors":"Yalçın Erzurumlu,&nbsp;Yağmur Doğanlar,&nbsp;Hatice Kübra Doğan,&nbsp;Deniz Çataklı","doi":"10.4274/tjps.galenos.2022.71643","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.71643","url":null,"abstract":"<p><strong>Objectives: </strong>Breast cancer is the most frequently diagnosed cancer type and the second leading cause of cancer-related death in women. Recent studies have highlighted the importance of the endoplasmic reticulum (ER) protein quality control mechanism for the survival of many cancers. It has also been recommended as a good target for the treatment of many cancer types. Homocysteine inducible ER protein with ubiquitin-like domain 1 (HERPUD1) functions as one of the main components of ER-associated degradation, which is an ER-resident protein quality mechanism. Today, the association of HERPUD1 with breast carcinogenesis is still not fully understood. Herein, we evaluated the possibility of HERPUD1 as a potential therapeutic target for breast cancer.</p><p><strong>Materials and methods: </strong>The effects of HERPUD1 silencing on epithelial-mesenchymal transition (EMT), angiogenesis, and cell cycle proteins were analyzed by immunoblotting studies. To test the role of HERPUD1 on tumorigenic features, WST-1-based cell proliferation assay, wound-healing assay, 2D colony formation assay, and Boyden-Chamber invasion assay were performed in human breast cancer cell line MCF-7. The statistical significance of the differences between the groups was determined by Student's <i>t</i>-test.</p><p><strong>Results: </strong>Our results displayed that suppressing HERPUD1 expression reduced the cell cycle-related protein levels, including cyclin A2, cyclin B1, and cyclin E1 in MCF-7 cells. Also, silencing of HERPUD1 remarkably decreased expression levels of EMT-related N-cadherin and angiogenesis marker vascular endothelial growth factor A. Moreover, we determined that cell proliferation, migration, invasion, and colony formation of MCF-7 cells were significantly limited by silencing of HERPUD1.</p><p><strong>Conclusion: </strong>Present data suggest that HERPUD1 may be an effective target for biotechnological and pharmacological strategies to be developed to treat breast cancer.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"157-164"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337018/pdf/TJPS-20-157.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10183576","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}

{"title":"A Systematic Review of Healthcare Professionals' Knowledge, Attitudes, and Practices Regarding Adverse Drug Reaction Reporting in Ethiopia.","authors":"Zelalem Gebretsadik Anbeo,&nbsp;Nurettin Abacıoğlu","doi":"10.4274/tjps.galenos.2022.28034","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.28034","url":null,"abstract":"<p><p>Adverse drug reactions (ADRs) are a prominent cause of morbidity and mortality and higher healthcare expenditures. Healthcare professionals (HCPs) play a crucial role in ADR reporting through spontaneous reporting systems, but under-reporting is their major limitation. The goal of this study is to evaluate HCPs' knowledge, attitude, and practice regarding ADR reporting as well as the factors that influence reporting using research papers that are currently available. A literature search was conducted using sources such as PubMed, Scopus, and Google Scholar to find studies that evaluated HCPs' knowledge, attitudes, and practices regarding ADRs reporting in Ethiopia. A standard procedure of systematic review protocol was used to conduct this review. Demographic factors, sample size, response rate, survey delivery, HCP working setting, and encouraging and discouraging factors of ADR reporting were extracted from articles. A total of 17 articles were included in the systematic review out of 384. The number of HCPs in the included studies ranged from 62 to 708. Response rate ranges from 76.1% to 100%. Most of the research included in this evaluation looked at HCPs, who worked in hospitals. When pharmacists were compared to other HCPs, they were more likely to report ADRs; because they had higher knowledge, attitude, and practice. Lack of understanding, unavailability of reporting forms, uncertainty about the causal relationship between the drug and ADR, and failure to report because the ADR was well known were among the common hurdles to ADR reporting identified in research. To improve reporting, educational initiatives and continued training in pharmacovigilance and ADRs are frequently recommended considerations. In Ethiopia, there is a pressing need to close the gap in HCP knowledge, attitudes, and practice regarding PV and ADR reporting. To address this point, specific educational interventions based on existing gaps in ADR reporting should be developed and integrated into the health education curriculum or provided as in-service training after graduation.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"198-209"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337023/pdf/TJPS-20-198.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10183577","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}

{"title":"Preparation and Characterization Studies of Dorzolamide-Loaded Ophthalmic Implants for Treating Glaucoma.","authors":"Samet Özdemir,&nbsp;Egemen Çakırlı,&nbsp;Bilge Sürücü,&nbsp;Cemre İrem Aygüler,&nbsp;Burcu Üner,&nbsp;Ali Rıza Cenk Çelebi","doi":"10.4274/tjps.galenos.2022.95752","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.95752","url":null,"abstract":"<p><strong>Objectives: </strong>This study constructed dorzolamide (DRZ)-loaded ophthalmic implants for extended drug delivery and increased drug retention.</p><p><strong>Materials and methods: </strong>Carboxymethyl cellulose (CMC) and chitosan (CHI) were used to describe the ophthalmic implants. The implants were prepared by the solvent casting technique in presence of polyethylene glycol 6000 (PEG 6000) as plasticizer. Physicochemical characterization studies including mechanical characteristics [tensile strength (TS), elongation at break, and Young's modulus], bioadhesion studies, and <i>in vitro</i> and <i>ex vivo</i> drug release studies were conducted.</p><p><strong>Results: </strong>TS of drug-loaded ophthalmic implants was 10.70 and 11.68 MPa, respectively. Elongation at break of CMC and CHI implants was 62.00% and 59.05%, respectively. The <i>in vitro</i> release profiles fit into Higuchi type kinetic model. <i>Ex vivo</i> release study results for both implants were correlated with <i>in vitro</i> release investigations.</p><p><strong>Conclusion: </strong>CMC and CHI-based implants provide extended drug delivery. Implants prepared using CMC provided a significantly slower <i>in vitro</i> release rate, and drug retention on ocular surfaces increased. Thus, it has been concluded that DRZ-loaded CMC implants could provide effective treatment for glaucoma.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 3","pages":"149-156"},"PeriodicalIF":1.7,"publicationDate":"2023-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10337019/pdf/TJPS-20-149.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10183578","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}

{"title":"The Bioequivalence Study of Two Dexketoprofen 25 mg Film-Coated Tablet Formulations in Healthy Males Under Fasting Conditions.","authors":"Fırat Yerlikaya,&nbsp;Aslıhan Arslan,&nbsp;Hilal Baş,&nbsp;Onursal Sağlam,&nbsp;Sevim Peri Aytaç","doi":"10.4274/tjps.galenos.2022.95994","DOIUrl":"https://doi.org/10.4274/tjps.galenos.2022.95994","url":null,"abstract":"<p><strong>Objectives: </strong>Dexketoprofen is a non-steroidal analgesic/anti-inflammatory drug and its trometamol salt is extensively preferred in mild or moderate pain due to its rapid onset of relief. A new formulation of 36.9 mg of dexketoprofen trometamol (equivalent to 25 mg dexketoprofen) tablet has been developed and its bioequivalence to the reference product was proven.</p><p><strong>Materials and methods: </strong>An open-label, single-dose, randomized, two-period, and cross-over bioequivalence study was conducted with healthy males under fasting conditions for two different tablet formulations of 25 mg dexketoprofen. To prove the bioequivalence of the test product with the reference product, a comparison study has been performed in compliance with regulations in force under Good Clinical Practice principles. A single-center clinical study was run and blood samples of the participants were withdrawn at specified time points, before and after dosing, to measure the plasma concentrations of dexketoprofen trometamol. A validated analytical method has been developed using an liquid chromatography with tandem mass spectrometry. Instrument to assess the plasma concentrations of the test and reference products.</p><p><strong>Results: </strong>Forty-seven volunteers completed clinical phase of the study. For the test and reference products, the mean ± standard deviations (SD) of C_max were found 2543.82 ± 655.42 ng/mL and 2539.11 ± 662.57 ng/mL, and the mean ± SD of area under the curve (AUC) from time 0 to the last measurable concentration (AUC_0-tlast) were found 3483.49 ± 574.42 h.ng/mL and 3560.75 ± 661.83 h.ng/mL, respectively. The primary target variables data demonstrate the bioequivalence of test and reference products with regard to 90% confidence interval for C_max of 92.45-108.53% and for AUC_0-tlast of 95.57-100.87%. The geometric mean ratios were found as 100.16% and 98.18% for C_max and AUC_0-tlast, respectively. There were no serious adverse events or adverse reactions reported throughout the study.</p><p><strong>Conclusion: </strong>After statistical evaluation of the analytical results, the test and reference products were considered bioequivalent. Both products were well tolerated and considered as safe.</p>","PeriodicalId":23378,"journal":{"name":"Turkish Journal of Pharmaceutical Sciences","volume":"20 2","pages":"115-120"},"PeriodicalIF":1.7,"publicationDate":"2023-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10176624/pdf/TJPS-20-115.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9452390","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}