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Öğe Applying quality by design approach for the determination of potent paclitaxel loaded poly(lactic acid) based implants for localized tumor drug delivery(Taylor and Francis, 2022) Özcan Bülbül, Ece; Üstündağ Okur, Neslihan; Mısırlı, Duygu; Cevher, Erdal; Tsanaktsis, Vasilios; Bingöl Özakpınar, Özlem; Siafaka, Panoraia I.In the present study, poly(lactic acid) (PLA) and poly(ethylene succinate) (PESu) or poly(ethylene glycol) (PEG) under the framework of quality by design, were blended to produce effective sustained-release matrices for Paclitaxel delivery. A complete physicochemical characterization including weight variation, thickness, water uptake, moisture absorption, moisture loss, and hydrolytic degradation under physiological conditions, was performed. Quality by design approach was applied to study the critical parameters. In vitro cancer toxicity was studied in human cancer cell lines including lung and breast adenocarcinoma. The developed Paclitaxel-loaded films can act as a promising alternative topical matrix as an implant for breast and lung cancer treatment. © 2022 Taylor & Francis Group, LLC.Öğe Pharmacogenomics for clinical trials of COVID-19 medicines: Why is this important now?(OMICS, 2021) Şardaş, Semra; Özdemir, VuralHistorically, pharmacogenomics has origins in biochemical genetics in the 20th century and astute observations on unusual clinical responses to medicines. Extreme drug response phenotypes observed in the clinic have triggered molecular research on mechanisms of personto-person variations in drug safety and efficacy (Kalow, 1962; Ozdemir et al., 2009), and paved the way for the contemporary field of pharmacogenomics.Öğe Early effects of low molecular weight heparin therapy with soft-mist inhaler for COVID-19-induced hypoxemia: a phase iib trial(MDPI, 2021) Erelel, Mustafa; Kaskal, Mert; Akbal-Dağıstan, Özlem; İşsever, Halim; Ertürk, AybigeIn COVID-19-induced acute respiratory distress syndrome, the lungs are incapable of filling with sufficient air, leading to hypoxemia that results in high mortality among hospitalized patients. In clinical trials, low-molecular-weight heparin was administered via a specially designed soft-mist inhaler device in an investigator initiated, single-center, open-label, phase-IIb clinical trial. Patients with evidently worse clinical presentations were classed as the “Device Group”; 40 patients were given low-molecular-weight heparin via a soft mist inhaler at a dose of 4000 IU per administration, twice a day. The Control Group, also made up of 40 patients, received the standard therapy. The predetermined severity of hypoxemia and the peripheral oxygen saturation of patients were measured on the 1st and 10th days of treatment. The improvement was particularly striking in cases of severe hypoxemia. In the 10-day treatment, low-molecular-weight heparin was shown to significantly improve breathing capability when delivered via a soft-mist inhaler. © 2021 by the authors. Licensee MDPI, Basel, Switzerland.Öğe An updated review for the diabetic wound healing systems(Bentham Science, 2021) Okur, Mehmet Evren; Özcan Bülbül, Ece; Mutlu, Gökçe; Eleftheriadou, Kalliopi; Karantas, Ioannis D.; Üstündağ Okur, Neslihan; Siafaka, Panoraia I.Background & objective: Diabetes is a global health problem associated with millions of deaths; the most common of diabetes complications is that wounds of diabetic patients tend to heal more slowly or non-healed at all, leading to undesirable facts. Diabetic wounds if become chronic and infected could provoke lower extremities amputation, sepsis even death. Hence, early detection, careful examination, debridement, cleaning, and prevention or controlling the infection of diabetic wounds are important factors for the successful outcome of the case. During the years, various promising wound dressings incorporating antimicrobial molecules, growth factors, and wound healing agents have been developed, targeting diabetic wounds. Nonetheless, the choice of dressing is mainly based on the experience of each clinician. Summary: This review summarizes the main points of diabetes complications, diabetic wounds, and infections. In further, an overview of the current drug delivery systems for topical wound delivery of various active ingredients has been performed. This update could be helpful for scientists and especially clinicians who desire to plan and work with new strategies for the healing of diabetic wounds.Öğe Preliminary study for the development of potent hydrogels for local drug delivery applications(DergiPark, 2021) Özcan Bülbül, Ece; Saıfaka, Panoraıa; Okur Üstündağ, NeslihanCurrently, design and development of formulations for the oral cavity and local application is a rather challenging process since the components should be non-irritant and provide relief. Hydrogels-based drug delivery systems have been proposed as suitable candidates for oral mucosal (eg, buccal, sublingual, palatal, gingival) and local (dermal) drug delivery (eg, wound dressings). Herein, the hydrogels were prepared by Carbopol 934, Sodium carboxymethyl cellulose as well as their combination blends to develop efficient hydrogels with tunable activities. The hydrogels were characterized in terms of tensile testing, and physicochemical properties (pH, clarity). Fourier-Transformed Infrared Spectroscopy (FT-IR) was used to evaluate any possible interactions between the components or any newly developed by-products which can lead to toxicity. The F2/F5 formulation, pH (5.86±0.084), viscosity (13305±1209), firmness (39.92±0.77), consistency (356.27±9.01), cohesiveness (-28.58±0.81), and work of cohesion (-231.31±15.02) values were found to be the most suitable formulation. According to the results and the use of biocompatible ingredients, the prepared hydrogels present promising characteristics being suitable candidates for mouth application. Future studies will involve the loading of active molecules and studying their properties.Öğe Current status of mucoadhesive gel systems for buccal drug delivery(Bentham Science, 2021) Üstündağ Okur, Neslihan; Özcan Bülbül, Ece; Yağcılar, Ayşe Pınar; Siafaka, Panoraia I.Background: Buccal drug delivery is a fascinating research field. Gel-based formulations present potent characteristics as buccal systems since they have great physicochemical properties. Methods: Among the various gels, in situ gels that are viscous colloidal systems consisted of polymers when physiological conditions change (pH, temperature, ion activation) shift to the gel phase. These systems can improve bioavailability. Other systems such as nanogels or emulgels can be also applied for buccal delivery with promising results. Polymeric gel-based systems can be produced by natural, semisynthetic, and synthetic polymers. Their main advantage is that the active molecules can be released in a sustained and controllable manner. Several gels based on chitosan are produced for the entrapment of drugs demonstrating efficient retention time and bioavailability, due to chitosan mucoadhesion. Besides polysaccharides, poloxamers and Carbopol are also used in buccal gels due to their high swelling ability and reversed thermal gelation behavior. Results: Herein, the authors focused on the current development of mucoadhesive gel systems used in buccal drug delivery. After explaining buccal drug delivery and mucoadhesion, various studies with hydrogels, in situ gels, and nanogels were analyzed as buccal gel systems. Various mucoadhesive gel studies with mucoadhesive polymers have been studied and summarized. This review is presented as valuable guidance to scientists in formulating buccal mucoadhesive drug delivery systems. Conclusions: This review aimed to assist researchers working on buccal drug delivery by summarizing buccal drug delivery, mucoadhesion, and buccal mucoadhesive gel systems recently found in the literature.Öğe Preparation and detailed characterization of fusidic acid loaded in situ gel formulations for ophthalmic application(Marmara University, 2021) Rencber, Seda; Özcan Bülbül, Ece; Üstündağ Okur, Neslihan; Ay Senyiğit, ZeynepThis study aimed to assess the potential usage of fusidic acid in situ ocular gels for bacterial conjunctivitis treatment. The in situ gelling systems were applied to improve the bioavailability and residence time of fusidic acid in the ocular mucosa. Temperature-triggered in situ ocular gel formulations were prepared by the cold method with Poloxamer 407 and sodium carboxymethyl cellulose. The in situ gels were evaluated for pH, clarity, gelation temperature, rheological properties, mechanical properties, and in vitro drug release. The gelation temperatures of fusidic acid loaded the formulations were between 29–33°C. All prepared in situ gels showed non-Newtonian pseudoplastic flow (shear thinning system) like tear fluid at 32 ± 0.1ºC. The results of in vitro dissolution studies showed that at least 65% of fusidic acid released in 12 hours. As a result of this study, it was concluded that fusidic acid loaded in situ gels might be offered as a promising ocular tool for the treatment of bacterial conjunctivitis.Öğe Detecting and targeting neurodegenerative disorders using electrospun nanofibrous matrices: current status and applications(2020)cteristics. Such nanofibrous matrices can be delivered through different administration routes in order to target various diseases. In this review, the most recent advancements in electrospun nanofibrous systems that target or detect multiple neurodegenerative diseases have been enlightened and an introduction to the general aspects of neurodegenerative diseases and the electrospinning process has been made. Finally, future perspectives of neurodegeneration targeting were also discussed.Öğe Panvigilance: integrating biomarkers in clinical trials for systems pharmacovigilance(Mary Ann Liebert, Inc, 2019) Şardaş, Semra; Kendirci, AslıgülDrug safety and pharmacovigilance are rapidly changing with biomarkers and new technologies such as artificial intelligence. However, we need new ideas and application contexts for integration of biomarkers and emerging technologies in modern pharmacovigilance. A new concept, panvigilance, has been recently introduced for proactive "stress testing" of new drug candidates in panels of patients or healthy volunteers identified by biomarkers, and who are situated in population edges in terms of pharmacokinetic (PK) and/or molecular target interindividual variability. Panvigilance aims to provide upper and lower bound estimates for drug performance under conditions that mimic population edges. Subsequently, it becomes easier to extrapolate pharmacovigilance signals with regard to individuals who reside in between the population edges. In this expert review, we explain that the prefix "pan," meaning everything or all, refers to the three-pronged panvigilance goals to (1) decipher the full population scale variability in medicinal product PKs and molecular target variability, (2) empower forecasting of pharmacovigilance signals within and across populations through knowledge of biomarker variations worldwide, and (3) integration of pharmacovigilance signals across government ministries, civil society organizations, and other stakeholders through, for example, institutional innovation such as centers for panvigilance. We note that panvigilance and pharmacovigilance are complementary, and underscore the added value of panvigilance for global clinical trials. Panvigilance offers a new opportunity for meaningful biomarker application in clinical trials beyond traditional contexts such as personalized medicine. In sum, panvigilance is a systems approach to pharmacovigilance and poised to innovate risk governance in medicinal product development and clinical trials.
