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Suryaji Patil, Yong-Guang Gao, and Airong Qian
- Future Journal of Pharmaceutical Sciences, Vol 9, Iss 1, Pp 1-13 (2023)
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Peptide, PAMAM, Bone-targeting, Gene therapy, RNA therapeutics, Osteoporosis, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background Osteoporosis, among other bone diseases, has become a prevalent cause of decreased quality of life in older and postmenopausal women. Traditional anti-osteoporotic therapies, though widely prescribed, are limited by a lack of cell- or tissue-specific targeting ability and effectiveness without side effects. Gene therapy is rapidly replacing traditional therapeutics, primarily because of its specific targeting ability and efficiency. Among viral- and non-viral-based gene therapies, the latter is often preferred over the former due to lower cytotoxicity, immunogenicity, and ease of modification with different molecules to improve efficiency and extend gene expression. We designed and synthesized a multifunctional bone-targeting ribonucleic acid (RNA) delivery system based on polyamidoamine (PAMAM). PAMAM was modified with the serine-aspartate-serine-serine-aspartate (SDSSD) peptide to deliver antagomir 138-5p to osteoblasts (MC3T3-E1 cell line) in vitro and in vivo using the ovariectomized (OVX) mouse model. Results The results showed that this system was less cytotoxic than polyethylenimine (PEI) and could bind to RNA favorably while maintaining gene delivery ability in vitro. In vivo data showed that the distal tibia and femur of the mice in the PAMAM-SDSSD (PS) + RNA group had improved bone mineral density (BMD), bone mineral content (BMC), and bone volume compared to those in the PS + Negative Control (NC) or OVX groups. Moreover, the femurs of the PS + RNA group mice demonstrated a higher breaking point, stress, stiffness, and elasticity than those of the PS + NC or OVX mice, suggesting improved femur strength in the OVX mice treated with RNA delivered through SDSSD-modified PAMAM. Conclusion This study shows that SDSSD modification of PAMAM not only improves gene delivery capacity but also enhances the cell targeting efficiency of nanoparticles towards osteoblasts. The successful delivery of antagomir 138-5p to osteoblasts demonstrates cell-specificity and gene delivery to alleviate osteoporotic symptoms.
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Krishnaphanisri Ponnekanti and Ramreddy Godela
- Future Journal of Pharmaceutical Sciences, Vol 9, Iss 1, Pp 1-9 (2023)
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Olanzapine, Samidorphan, Stability representing, Simultaneous analysis, HSS C18, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Back ground The key objective of the research study is to develop a new stability-indicating RP-UPLC approach to determine the presence of Samidorphan and Olanzapine simultaneously in bulk and their combination. A successful separation of Samidorphan and Olanzapine was achieved by using HSS column C18 (100 × 2.1 mm), a mobile phase of 0.1% orthophospharic acid: Acetonitrile (70:30 v/v), flow rate of 0.3 mL/min, and detection wavelength of 230 nm. The stability of the analytes in bulk and dosage forms was evaluated using extreme forced conditions, such as hydrolysis with acid and base, peroxide oxidation, and heat degradation, following ICH guidelines. Results Olanzapine and Samidorphan had retention times of 0.46 and 0.93 min, respectively. Olanzapine and Samidorphan have linear responses from the proposed method in the concentration ranges of 5–30 µg/mL and 2.5–15 µg/mL, respectively. The computed detection and quantification limits for Olanzapine were 0.22 µg/mL and 0.471 µg/mL, and for Samidorphan were 0.12 µg/mL and 0.36 µg/mL. All method validation parameters have complied with the ICH guidelines' Q2 acceptance limits. The stability representing the feature of the approach has been seen with the excellent resolution among the Olanzapine and Samidorphan and degradation products. Conclusion The suggested RP-UPLC method was extremely sensitive, precise, and stable-indicating. The technique can potentially be used in the production of Olanzapine and Samidorphan for routine analysis in the quality control department. Graphical abstract
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Bhawani Sunkara and Ganesh Kumar Tummalapalli Naga Venkata
- Future Journal of Pharmaceutical Sciences, Vol 9, Iss 1, Pp 1-10 (2023)
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Process impurities, Dapagliflozin, HPLC, Xbridge Phenyl, Gradient elution, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background In the dapagliflozin (DPF) synthesis, 5-Bromo-2-chlorobenzoic acid (5-BC impurity) and 4-Bromo-1-chloro-2-(4-ethoxybenzyl) benzene (4-BC impurity) are used as starting and reagent sources, respectively. The presence of 5-BC and 4-BC impurities in DPF could potentially affect the effectiveness of the final DPF product. The purpose of this investigation was to develop a stability indicating HPLC methodology for the separation of DPF, its process-related impurities and degradants. The method of analysis was developed on Xbridge Phenyl C18 column of dimensions, 250 × 4.6 mm, 5 μm with gradient elution using mobile phase made up of 0.05% aqueous trifluoroacetic acid and acetonitrile (AcN). Results The method proposed indicates a good linearity (R 2 = 0.9996 and 0.9993), good system precision (RSD ≤ 2%), good method precision (RSD ≤ 2%), accuracy (50–150%), LOD (0.000053 ppm and 0.0000165 ppm) and LOQ (0.00016 ppm and 0.00005 ppm) for 4-BC impurity and 5-BC impurity, respectively. LC–MS was used to detect and characterise degradants that were obtained in acid and base condition were identified and characterised. A comparison of the fragmentation pattern of the [M + H] + ions of DPF and its degradation products revealed the most likely processes for the generation of degradation products. Conclusion DPF sample quality can be evaluated using the suggested method for the presence of 4-BC impurity, 5-BC impurity and 2-(3-(4-ethoxy benzyl)-4-chloro phenyl)-tetrahydro-6-(hydroxy methyl)-2H-pyran-3,4,5-triol.
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Hannah Wellington, Seeprarani Rath, Sagaran Abboo, and Isadore Kanfer
- AAPS Open, Vol 9, Iss 1, Pp 1-11 (2023)
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In vitro release testing (IVRT), Sameness, Pharmaceutical equivalence, Biowaivers, Topical clotrimazole creams, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract The October 2022 draft United States Food and Drug Administration (FDA) guidance presents an option of in vitro release test (IVRT) studies as a biowaiver for topical drug products submitted in abbreviated new drug applications (ANDAs). However, the product-specific guidance (PSG) for 1% clotrimazole (CLZ) topical cream does not provide an in vitro option for biowaiver and requires a clinical endpoint study to demonstrate bioequivalence (BE). Therefore, the main objective was to use IVRT to investigate pharmaceutical equivalence of several 1% CLZ topical creams from two countries — South Africa (SA) and Canada. This investigation aims at demonstrating the utility of IVRT to determine ‘sameness’ and/or differences between topical creams containing 1% CLZ and the potential of IVRT for supporting biowaivers, thereby obviating the necessity to conduct clinical endpoint studies in patients. A validated IVRT method was applied to conduct comparative IVRT runs on five generic products marketed in SA and one Canadian generic, which were compared against a relevant comparator product from their country of origin in accordance with the FDA’s acceptance criteria of 75–133.33%. All five SA-marketed generic creams showed pharmaceutical inequivalence to the SA comparator product indicating Q1/Q2/Q3 differences. Despite containing the same excipients as both comparator products, the Canadian generic showed substantially lower release rate compared to the comparator products which could be attributed to Q2/Q3 differences. The IVRT method displayed the requisite ability to assess the various 1% CLZ creams and confirmed the potential of the IVRT method to support a biowaiver for 1% CLZ topical creams. Graphical Abstract
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Hamadouk RM, Alshareif EM, Ibrahim OM, Albashair ED, and Yousef BA
- Integrated Pharmacy Research and Practice, Vol Volume 12, Pp 227-237 (2023)
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antibiotics, cefixime, community pharmacists, simulated patient, self-medication, Pharmacy and materia medica, and RS1-441
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Riham M Hamadouk,1,2 Einass M Alshareif,1 Omnia M Ibrahim,3 Esra D Albashair,1 Bashir A Yousef4 1Department of Clinical Pharmacy, Faculty of Pharmacy, University of Khartoum, Khartoum, Sudan; 2Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Almughtaribeen University, Khartoum, Sudan; 3Faculty of Pharmacy, Al-Neelain University, Khartoum, Sudan; 4Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Khartoum, SudanCorrespondence: Bashir A Yousef, Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, Al-Qasr Ave, Khartoum, 11111, Sudan, Tel +249155662037, Fax +249183780696, Email bashiralsiddiq@gmail.comBackground: Antibiotics play an important role in decreasing morbidity and mortality worldwide. However, inappropriate use of them by patients or healthcare professionals contributes to their resistance rendering them less efficacious. Community pharmacists (CPs) have a significant part in reducing antibiotic resistance. Therefore, this study aimed to investigate the dispensing of antibiotics without prescription in community pharmacies with an emphasis on cefixime dispensing.Methods: A cross-sectional, simulated patient (SP) study was conducted in the Khartoum locality. A total of 238 community pharmacies were randomly chosen using simple random sampling. One scenario of uncomplicated urinary tract infection was designed, and six female pharmacy students who were trained to act as SPs presented the scenario. Descriptive statistics were applied to report the study outcomes.Results: In the 238 pharmacy visits, at least one antibiotic was dispensed without a prescription in 69.3% of the simulated visits. Among the dispensed antibiotics, ciprofloxacin was the most dispensed antibiotic followed by cefixime representing 51.5% and 41.8%, respectively, of total dispensed antibiotics. Cefixime was dispensed as a first choice by CPs in 29% of the visits, and in the rest of the visits, only 37.3% of CPs refused to dispense cefixime after SP demand.Conclusion: The findings revealed a high rate of antibiotics dispensing without prescription by CPs in Khartoum state, and cefixime was obtained with ease before and after the patient’s demand. Urgent corrective actions such as imposing strict regulations, monitoring pharmacists’ practice, and endorsing educational programs for pharmacists are needed to prevent inappropriate antibiotic dispensing practices.Keywords: antibiotics, cefixime, community pharmacists, simulated patient, self-medication
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Veselina Goranova-Marinova, Daniela Grekova, Vania Georgieva, Kalina Andreevska, Yana Gvozdeva, Margarita Kassarova, and Zhanet Grudeva-Popova
- Pharmacia, Vol 70, Iss 4, Pp 1355-1362 (2023)
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Pharmacy and materia medica and RS1-441
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Aim. The aim of this study is to evaluate treatment retrospectively, response to the therapy and outcomes in patients with chronic myeloid leukemia (CML) and to what extent the European recommendations of LeukemiaNET (ELN) are followed at the Hematology Clinic, University Hospital “St. Georgi”, MU Plovdiv. Methods. All patients with Ph+, BCR-ABL1+ CML who were treated and observed between 01.01.2018 and 12.31.2022 at the clinic were included in the study and were analyzed retrospectively. Results. One hundred and eighty-eight patients with a mean age of 61.26 (21–91) years were analyzed. 151 (80.3%) were in chronic phase (CP), 27 (14.4%) in accelerating one and 10 (5.3%) in blast crisis. The actual overall survival rate was 79.26%, while for CP it is very high – 86.75%, and the mortality rate is 20.74%. All patients received some form of tyrosine kinase inhibitors therapy (TKIs-therapy). The first line TKI was imatinib in 120 patients (64%), and 68 (36%) received a second-generation TKI. Treatment response was monitored with TKIs by RT-qPCR. Conclusion. CML patients treated in the hematology clinic receive standard care in accordance with ELN and BMSH recommendations. Overall survival (OS) in routine care is comparable to published data from international studies. Molecular monitoring provides a good basis for disease control in CP. There are unmet needs in the treatment of patients in advanced stages.
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Noor Yousif Fareed and Hanan Jalal Kassab
- Pharmacia, Vol 70, Iss 4, Pp 1363-1371 (2023)
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Pharmacy and materia medica and RS1-441
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Background: Osteoarthritis is a chronic pathology of the joints causing disability and morbidity. Diacerein is a disease-modifying agent indicated for osteoarthritis management with enhanced performance and have much lower side effects profile than conventional non-steroidal anti-inflammatory drugs. Oral administration of Diacerein is associated with a laxative effect , thus causing treatment discontinuation. Aim: This study aimed to evaluate the activity of Diacerein novasome-based transdermal gel compared with standard oral treatment in the management of induced osteoarthritis in a rat model. Materials and methods: A single intra-articular injection of monosodium iodoacetate was administered to the left knee joint, resulting in the development of Osteoarthritis. Disease progression and the effect of both routes of Diacerein treatment were evaluated by morphological, biochemical, histological, and radiological studies. Results: Osteoarthritis was successfully induced in rats’ knee joints. Morphological studies revealed that both Diacerein treatments significantly reduced joint swelling as compared to the untreated group. The serum TNF-α and IL-1β levels were significantly lower in both Diacerein treatment groups as compared to the untreated group throughout the course of the study. Histological and radiological findings confirmed that transdermal Diacerein treatment protects against cartilage degradation like oral treatment. Conclusion: Novasomal technology proved its efficacy as a carrier for the transdermal delivery of Diacerein. The in-vivo study on an animal model of osteoarthritis showed that Diacerein transdermal gels provided sufficient pharmacological activity for the attenuation of the disease. This finding could support its use as an alternative to the standard oral treatment to avoid side effects.
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8. Formulation and development of a body gel scrub using Areca catechu L. seed extract and microbeads [2023]
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Jiraporn Chingunpitak, Attawadee Sae Yoon, Katanyoo Pannoi, Kittipoom Horkul, and Noppakrit Tungtongsakul
- Pharmacia, Vol 70, Iss 4, Pp 1373-1383 (2023)
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Pharmacy and materia medica and RS1-441
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The purpose of this study was to develop and evaluate an antioxidant body gel scrub formulation including Areca seed extract and Areca beads. The Areca seed ethanol extract had an IC50 of 183.30 µg/ml, a radical scavenging activity of 49.196%, and a total phenolic content of 21.21 ± 2.32 µg/ml. With a pH of 6.98 at 25 °C and a viscosity of 5,590.457 cP, the optimized formulation contained 1% w/w Areca seed extract, 5% w/w polyvinyl alcohol, 0.5% w/w Carbomer Ultrez 21, and 5% w/w Areca microbeads. The formulation had a radical scavenging efficiency of 68.66%. Stability tests were carried out under accelerated heating cooling conditions at 40 ± 2 °C, 75 % RH for 48 hours, followed by 4 °C for 48 hours each cycle for 24 days (6 cycles) and 30 days for 4 °C and 30 ± 2 °C, 75% RH, and no significant changes in physical or chemical properties were observed. This body gel scrub formulation shows potential for use in skincare applications due to its antioxidant activity and stability.
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9. Faculty publication trends in a Japanese national university: a diachronic document analysis [2023]
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Theron Muller, Miho Takano, and Nicole Gallagher
- Journal of Pharmaceutical Health Care and Sciences, Vol 9, Iss 1, Pp 1-5 (2023)
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Pharmaceutical faculty publication, Document analysis, Language of publication, Type of publication, Diachronic analysis, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background We previously demonstrated that in a Japanese national university’s medical faculty, overall paper publication frequency increased between 1979 –1980 and 2017–2018, while original paper publication did not increase. Further, publication language changed from predominantly Japanese to English. However, whether these trends are specific to medicine or representative of other faculties remains unclear. Methods We diachronically analyzed annual university library-produced publication reports for four pharmaceutical and three medical units between 1979 –1980 and 2019–2020, elucidating how publication frequency, type, and language medium changed. Results All publication types increased for the pharmaceutical faculty, from 2.87 per faculty member per year to 10.77. Publication of original papers more than doubled, from 1.06 per faculty member per year to 2.37. This increase was exclusively in English publication, with no publication of Japanese original papers in 2019–2020. This contrasts with medicine, which, while it demonstrated similar increases in all publication types combined, from 4.92 papers per faculty member per year to 12.78, did not demonstrate as striking an increase in total original paper publication (English and Japanese), from 1.21 papers per faculty member per year to 1.30. However, these two faculties observed similar trends in that English largely replaced Japanese original paper publication. That both faculties’ Japanese original paper publication decreased suggests English language original paper publication comes at the expense of publishing in Japanese. Concerning both faculties together, the increase in publishing frequency for all publication types more than tripled from 4.01 to 12.38. This was largely driven by changes in conference paper publication for the pharmaceutical sciences faculty, where English publication increased 2,775% (0.06 to 1.7 papers per faculty member per year) and Japanese language publication 258% (1.33 to 4.77). While conference paper publication did increase for the medical sciences, its change in total publication frequency was largely driven by ‘other’ types of publication, which increased from 0.51 publications per faculty member per year in 1979–1980 to 5.41 in 2019–2020, largely driven by Japanese language publication. Conclusion In 2019–2020, pharmaceutical sciences faculty members largely published original papers in English, so postgraduate education should consider the future likelihood of graduates needing to publish in English.
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Ryota Goto, Yuichi Muraki, Ryo Inose, Moeno Ichii, Keisuke Sawada, Kanako Mizuno, Ryuji Koizumi, Shinya Tsuzuki, Masahiro Ishikane, and Norio Ohmagari
- Journal of Pharmaceutical Health Care and Sciences, Vol 9, Iss 1, Pp 1-8 (2023)
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Teicoplanin, Database, Loading dose, Liver injury, Mortality, Methicillin-resistant Staphylococcus aureus, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background The loading dose of teicoplanin (TEIC) is recommended for implementation. However, there is significant discrepancy between the dose settings in the package insert and, in the guidelines, and the actual status of loading doses in Japan is unclear. Furthermore, TEIC causes liver injury as side effect. Although the risk of developing liver injury has not been reported to be increased following a loading dose based on the guidelines, there is a lack of reports in large populations. Therefore, we evaluated the trend in the loading dose and factors affecting the efficacy and safety of TEIC administration. Methods A Japanese administrative claims database was used in this study. Trends in loading doses were evaluated in target populations administered TEIC between 2010 and 2019. Patient characteristics were adjusted by propensity score matching based on the guideline group (total dose of 3 days > 1,600 mg) and non-guideline group (≤ 1,600 mg) of the loading dose. Finally, univariable and multivariable conditional logistic regression analysis was performed to evaluate factors affecting 30-day mortality and liver injury. Results A total of 10,030 patients were selected based on these criteria. The proportion of loading doses based on the recommended guidelines showed an increase over time, regardless of the implementation of therapeutic drug monitoring (TDM), but especially so in cases where TDM was implemented, the loading doses were administered in accordance with the recommendations of the guidelines. Conditional logistic regression analysis showed a relationship between drug management and guidance fees (odds ratio [OR]: 0.45, 95% confidence interval [CI]: 0.36‒0.55), a reimbursement indicating pharmacist intervention, and a reduction in 30-day mortality. In addition, loading doses based on the recommended guidelines had no influence on liver injury, and other factors were not significantly associated with increased incidence of liver injury. Conclusion Thus, this study implies the benefits of pharmacological management as indicated by drug management and guidance fee and supports the implementation of loading doses based on the guideline on TEIC administration.
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Satoshi Yoshikawa, Shinichi Yoshikawa, Akira Sato, and Tsukasa Matsumoto
- Journal of Pharmaceutical Health Care and Sciences, Vol 9, Iss 1, Pp 1-8 (2023)
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Tedizolid, Continuous hemodiafiltration, Methicillin-resistant Staphylococcus aureus, Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background Tedizolid is an oxazolidinone anti-MRSA drug with included in the National Health Insurance Drug Price List in 2018. The effect of hemodialysis on tedizolid phosphate concentrations has been reported; pre-dialysis concentrations decreased by 10% compared to post- dialysis concentrations. However, the material of the dialysis membrane remains unknown. In addition, there have been no reports on the effects of continuous hemodiafiltration. In this study, we investigated the effects of continuous hemodiafiltration on tedizolid using two types of dialysis membranes made of different materials. Methods The adsorption of tedizolid, linezolid, and vancomycin to two different dialysis membranes was investigated, and the clearance of each drug was calculated by experiments using an in vitro continuous hemodiafiltration model. Results The adsorption of tedizolid, linezolid, and vancomycin on the dialysis membranes was examined, and no adsorption was observed. Experimental results from the continuous hemodiafiltration model showed that linezolid and vancomycin concentrations decreased over time: after two hours, the respective decreases were 26.48 ± 7.14% and 28.51 ± 2.32% for polysulfone membranes, respectively. The decrease was 23.57 ± 4.95% and 28.73 ± 5.13% for the polymethylmethacrylate membranes, respectively. These results suggested that linezolid and vancomycin were eliminated by continuous hemodiafiltration. In contrast, tedizolid phosphate and tedizolid concentrations decreased slightly in the polysulfone and polymethylmethacrylate membranes. The decrease in concentrations were 2.10 ± 0.77% and 2.97 ± 0.60% for the polysulfone membranes, respectively. For the polymethylmethacrylate membranes, the decrease in concentration were 2.01 ± 0.88% and 1.73 ± 0.27%, respectively. Conclusion These results suggested that tedizolid should not be considered for dose control during continuous hemodiafiltration.
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12. Epidemical process and aetiological structure of salmonelloses in the Zaporizhzhia region [2023]
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N. M. Polishchuck, N. L. Kolycheva, A. S. Dehen, O. V. Melnikova, and N. P. Kryazheva
- Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Vol 16, Iss 3, Pp 260-264 (2023)
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salmonellosis, salmonella, incidence rate, epidemics, Pharmacy and materia medica, and RS1-441
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The aim of the work is to conduct a comparative analysis of the salmonellosis epidemic process caused by non-typhoidal salmonellae in the Zaporizhzhia region for improving the system of epidemiological surveillance. Materials and methods. The retrospective epidemiological analysis of salmonellosis incidence in the Zaporizhzhia region was conducted using the annual reports from 2018 to 2022. The data sources included the “Report on Individual Infections and Parasitic Diseases” and “Infectious Morbidity of the Population in Ukraine”. The analysis employed standard statistical methods commonly used in medical research to evaluate the gathered results. Results. The findings suggest that the Zaporizhzhia region recorded a total of 1392 cases of salmonellosis between 2018 and 2022. Notably, the incidence rates for 2020 and 2021 significantly exceeded the national averages in Ukraine, while in 2022, there was a notable decrease of almost 2 times in the region’s salmonellosis incidence rates. Although adults accounted for the majority of cases (53.4 %), the prevalence of salmonellosis among children was alarmingly high. Among the pathogens causing salmonellosis, Enteritidis, Blegdam, and Typhimurium serovars were the most dominant. Notably, the region harbors salmonella strains that exhibit resistance to cephalosporins, ampicillin, and fluoroquinolones, reflecting concerns over antibiotic resistance patterns. Conclusions. The elevated prevalence of salmonellosis infection rates within the population of the Zaporizhzhia region underscores the pressing nature of the epidemic disease control challenge, particularly considering the heightened vulnerability of children. An additional threat to the epidemic’s well-being is the circulation of antibiotic-resistant salmonella.
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O. H. Aleksieiev
- Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Vol 16, Iss 3, Pp 265-271 (2023)
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pharmaceutical activity, criminal responsibility, pharmacists, professional liability, Pharmacy and materia medica, and RS1-441
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A separate segment in the activity of streamlining, stability, and protection of relations arising in the pharmaceutical sphere should be noted the state’s reaction to criminal offenses and, accordingly, the assessment of the actions of persons who commit such offenses. The aim of the work – is to study the current issues of regulatory and legal support of criminal liability in the pharmaceutical sector. Results. The theoretical nature of the criminal responsibility of pharmaceutical workers is revealed from not only legal but also social and moral positions. The legal basis for the status of pharmaceutical workers as distinct subjects of criminal activity is underscored. It has been proven that the object of crimes committed by pharmaceutical workers as a special subject is, first of all, social relations arising in the sphere of human life and health protection; public health (public health); relations arising during the circulation of narcotic drugs, psychotropic substances, and precursors. Differences in terminology defining the object of pharmaceutical crimes are emphasized. Conclusions. The main aspects determining the problem of the qualification of crimes committed in the pharmaceutical sector of the healthcare industry were analyzed. From the standpoint of criminal law theory, the object, subject, objective, and subjective sides of pharmaceutical crimes were characterized.
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L. I. Kucherenko, I. V. Nizhenkovska, N. V. Sholoiko, L. O. Hala, and N. O. Datsiuk
- Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Vol 16, Iss 3, Pp 272-276 (2023)
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pharmaceutical preparations, reference prices, external reference pricing, health technology assessment, Pharmacy and materia medica, and RS1-441
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Compared to the previous year, the share of healthcare expenditure in the state budget of Ukraine has decreased, which is associated with increased funding for the security and defense sector. In terms of gross domestic product, healthcare spending has reduced to 2.8 %, which corresponds to the figures for 2019. These circumstances indicate the importance of proper budget utilization, including effectively regulating medicine prices. One of the key elements of rational healthcare budget usage is the development and implementation of external reference pricing (ERP). A well-formulated and implemented ERP policy for pharmaceuticals contributes to improving patient access to essential medicines (EMs). The aim of this study is to analyze the current status of ERP implementation in Ukraine and provide recommendations for improving this policy. Materials and methods. During the research process, an analysis of the ERP’s current regulatory framework was conducted, and ERP implementation in Ukraine was assessed according to adherence to the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015. Results. In Ukraine, ERP has been introduced for medicines from the National Essential Medicine Lists (NEML) and the “Affordable Medicines” program. The Ministry of Health (MoH) of Ukraine has approved a Register of marginal wholesale prices for medicines purchased with state budget funds and subject to price regulation. Currently, the register includes 1239 medicinal products, of which 1233 are from NEML and 6 have undergone Health Technology Assessment (HTA). Approximately 58 % of medicines have a set price through ERP, 24 % are regulated by internal reference pricing (IRP), and nearly 18 % have declared prices. This indicates a lack of uniformity in approaches to price regulation for medicines and requires further improvements. According to the latest update of the Register of medicines for reimbursement under the state medical guarantees program, there are 486 medicines, including 72 insulins and 21 immunosuppressive medicines (184 medicines are provided with co-payment). Different approaches, including different reference countries and price calculation algorithms, are applied for the price regulation of medicines in NEML and the “Affordable Medicines” program. An assessment of the implementation of the ERP system in Ukraine based on the 14 best practice principles of ERP proposed by Sullivan, Kanavos & Kalo in 2015 showed that the current policy does not adhere to all principles. Conclusions. The analysis revealed different approaches to pricing for medicines NEML and the “Affordable Medicines” program, indicating the need for harmonizing pricing policies for different lists. The adoption of a unified positive list can contribute to improving pricing policies and efficient resource utilization. Collecting, disseminating, and exchanging data on drug prices is crucial to support transparency in pricing and its control. Regular monitoring of prices in the market will help ensure compliance with pricing policies and take appropriate measures in case of violations. The implementation of a unified pricing regulation policy for medicines in Ukraine is an important step towards European integration and compliance with international standards.
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N. O. Tkachenko, T. V. Mahanova, H. I. Makurina, and N. V. Hrinivetska
- Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Vol 16, Iss 3, Pp 277-283 (2023)
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cosmetic techniques, hair removal, pharmaceutical care, pharmacist-cosmetologist, professional competence, Pharmacy and materia medica, and RS1-441
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In modern cosmetology, the issue of the availability of highly qualified specialists in accordance with the needs of the industry and the implementation of effective cosmetology procedures is acute, which actualizes research on the formation of a patient-centered model of providing medical and pharmaceutical assistance of aesthetic cosmetology. The aim of the work is to substantiate the role and place of the pharmacist-cosmetologist in the selection and provision of a cosmetology procedure for hair removal (CPHR) based on a conjoint analysis of consumer preferences for the specified service. Materials and methods. The main research material for this study included publications by both domestic and foreign scientists concerning aesthetic cosmetology services, consumer behavior regarding cosmetology procedures, professional competencies expected of a pharmacist-cosmetologist, as well as the results of a sociological survey conducted by the CPHR. The research methods employed in this study encompassed information search, synthesis, generalization, formalization, modeling, questionnaires, and regular conjoint analysis. Results. The most attractive methods of epilation were determined – electro epilation, elos epilation and laser epilation. It was established that the majority of consumers do not need a preliminary cosmetologist consultation, but want a consultation after. An algorithm for accompanying CPHR by a pharmacist-cosmetologist was developed. The relevant aspects of pharmaceutical care of CPHR were defined. Conclusions. The conducted conjoint analysis indicates that women are primarily focused on the effectiveness of CPHR (electro epilation, elos epilation, and laser epilation are considered the most effective) and its cost, and then – on the supporting component of the service. The specialist can offer the client (patient) the choice of a method and directly carry out the procedure, having knowledge and experience in diagnosing the condition of the skin and its appendages and understanding the specifics of CPHR against the background of the pharmacoeconomic analysis. The modern Ukrainian model of pharmacist-cosmetologist training allows marketing requirements and accompanying the customer at CPHR. Prospects for further research – formation of an information array and development of pharmaceutical care (assistance) protocols for a pharmacist-cosmetologist in various cosmetic procedures.
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N. A. Bilousova and A. V. Kabachna
- Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki, Vol 16, Iss 3, Pp 284-290 (2023)
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mental health, pharmaceutical care, psychosocial support, good pharmacy practice, pharmaceutical provision, Pharmacy and materia medica, and RS1-441
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The implementation of the National Mental Health Gap Action Program (mhGAP), which aims to broaden the management of patients with mental disorders in primary care, should involve not only primary care physicians but also pharmacists. Pharmacists play a crucial role by providing medications within the expanded Medical Guarantee Program for drug reimbursement in outpatient treatment of mental and behavioral disorders. Additionally, they offer pharmaceutical care for patients dealing with stress disorders and insomnia, adhering to the Good Pharmacy Practice (GPP) standards. The aim of the work is the study of national information, scientific databases, and scientometric databases of Scopus, Web of Science, PubMed, Cochrane Library in order to identify, generalize, and systematize the source based on providing pharmaceutical care in the field of mental health care of patients and predicting the future vector of research on the specified topic. Materials and methods. General scientific methods such as analysis, synthesis, comparison, and data generalization from domestic information and scientific databases were employed in this study. To search for scientific publications, the VOS viewer visualization program, the PubMed search engine, and the Cochrane Library were used. The keywords “mental health” and “pharmacy” were used for the search within the scientometric databases of Scopus and Web of Science. Results. The analysis of the main strategies for the development of pharmaceutical care for mental health care in pharmaceutical practice was carried out. The most researched clusters of mental health care were singled out. Modern trends in the development of pharmaceutical care for mental health care were summarized. Conclusions. The initiative for enhancing mental health care for the country’s population hinges on the principles of a novel, sustainable, patient-centered pharmacy model. This approach necessitates the realization of an expanded role for pharmacists, aligning with the standards outlined in Good Pharmacy Practice.
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Anselmania Kartini Dhey, Eka Rasuna Andriani, Berliana Mardawati, Bunga Nur Annisa, Rhesi Kristiana, Vera Permatasari, Gian Primahana, Muhammad Eka Prastya, Puspa Dewi Narrij Lotulung, Tjandrawati Mozef, Akhmad Darmawan, Sofa Fajriah, Chairil Anwar, and Winarto Haryadi
- Pharmacia, Vol 70, Iss 4, Pp 1329-1334 (2023)
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Pharmacy and materia medica and RS1-441
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Aglaia foveolata Pannell (A. foveolata) is a type of plant that has many benefits, including the skin, leaves, roots, and seeds as medicinal ingredients. The potential of this plant is inseparable from the content of various bioactive compounds. This study aims to isolate, characterize the active compound from the stem bark of A. foveolata and test its activity as an antioxidant with the ABTS method, cytotoxic (MCF-7 cancer cells) with the MTT method, and antibacterial (bacterial strains ATCC and MDR) with the MIC. There are four isolated compounds obtained, namely (1) 17,24-epoxy-25-hydroxybaccharan-3-one, (2) β-stigmasterol glucoside, (3) Eichlerianic acid, and (4) 17,24-epoxy-25 -hydroxy-3- oxobaccharan-21-oic acid, which is a class of triterpenoid and steroid compounds. The best activity as an antioxidant was compound 3 (25.68 µg/mL); cytotoxic activity against MCF-7 cells namely compound 4 (94.59 µg/mL); antibacterial activity against ATCC strains: (1) P. aeruginosa namely compound 3 (29.4 µg/mL), (2) E. coli, (3) S. aureus, (4) B. subtilis for compounds 1, 2, and 4 have the same activity (62.5 µg/mL) while compound 3 was not active; MDR bacterial strains: (1) P. aeruginosa namely compound 4 (62.5 µg/mL), (2) E. coli namely compound 3 (62.5 µg/mL), (3) S. aureus namely compound 4 (62 .5 µg/mL), (4) B. subtilis namely compound 4 (62.5 µg/mL) and (5) K. pneumoniae namely compound 1 (125 µg/mL).
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Beyza Ozgen, Sefika Pinar Senol, Dilsah Ezgi Yilmaz, Meryem Temiz-Resitoglu, Omer Bahceli, and Bahar Tunctan
- Pharmacia, Vol 70, Iss 4, Pp 1345-1354 (2023)
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Pharmacy and materia medica and RS1-441
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Objectives: This study aimed to investigate the effect of the gasdermin D (GSDMD) and mixed lineage kinase domain-like pseudokinase (MLKL) inhibitor, necrosulfonamide (NSA), on lipopolysaccharide (LPS)-induced hyperalgesia in mice. Methods: Reaction time to a thermal stimulus within 30 seconds was measured in male mice injected with saline, LPS, and/or NSA after 6 hours using the hot plate test. Immunoblotting studies were performed to determine changes in caspase-11/GSDMD-mediated pyroptosis, receptor-interacting serine/threonine-protein kinase (RIPK) 1/RIPK3/MLKL necrosome-mediated necroptosis, demyelination, and remyelination in the brains and spinal cords of animals. Results: NSA demonstrated significant antinociceptive activity compared with LPS-treated mice. In the tissues of LPS-treated mice, NSA decreased expression of caspase-11 p20, p30-GSDMD, interleukin-1β, high-mobility-group-box 1, and semaphorin 3A, and activity of RIPK1, RIPK3, and MLKL. NSA also increased the expression of myelin proteolipid protein. Conclusion: Therefore, NSA may have therapeutic potential in the treatment of inflammatory painful conditions due to bacterial infections.
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Ruswanto Ruswanto, Richa Mardianingrum, Ade Dwi Septian, and Arry Yanuar
- Pharmacia, Vol 70, Iss 4, Pp 1335-1344 (2023)
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Pharmacy and materia medica and RS1-441
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The SIRT1 is overexpressed in a number of cancers. As a result, inhibiting SIRT1 may be used as a cancer treatment technique. Modification of 1-benzoyl-3-methylthiourea derivatives was carried out in this study by changing the aromatic side. The designed compounds (94) were subjected to in silico docking, pharmacokinetics, and preclinical testing. In the docking sample, the (4-decyl-N-(methylcarbamothioyl)benzamide (91), 2-(benzyloxy)-N-(methylcarbamo-thioyl)benzamide (93) and N-(methylcarbamothioyl)-2-naphthamide (94) were predicted to display better inhibition of SIRT1, so they were chosen for subsequent molecular dynamic studies. The compound 93 is proposed as a possible anticancer candidate that inhibits SIRT1 based on the screening results from molecular docking, pharmacokinetic predictions, and molecular dynamics.
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Saniya Jawed and C. S. Satish
- Future Journal of Pharmaceutical Sciences, Vol 9, Iss 1, Pp 1-12 (2023)
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Mucoadhesive strength (ex-vivo), Pharmacokinetic evaluation (in-vivo), X-ray radiography, HPLC analysis, Montelukast sodium (MTS), In-vitro in-vivo correlation (IVIVC), Therapeutics. Pharmacology, RM1-950, Pharmacy and materia medica, and RS1-441
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Abstract Background The current research aims to determine the pharmacokinetic parameters, mucoadhesive strength, and IVIVC correlation of the novel chronotherapeutic drug delivery system of montelukast sodium (MTS) loaded Parteck® SRP80 and hypromellose system. To accomplish this, an HPLC method was developed which is highly sensitive, precise, and rapid for quantifying pure MTS in rabbit plasma. Mucoadhesive strength and time-dependent mobility of developed formulation were established by ex-vivo study and X-ray radiography, respectively. Using a fraction of drug absorbed (FDA) and a fraction of drug released (FDR), Level-A in-vitro in-vivo correlation (IVIVC) was developed. According to ICH Q1A (R2) standards, stability experiments were conducted for 180 days. Result MTS retention time came as 3.971 min with a mobile phase of methanol: acetonitrile: 0.2 mM sodium acetate buffer (5:90:5). In-vitro dissolution showed pulsatile release of the drug up to 24 h with two lag phases. The in-vivo study showed a C max of 490.16 ± 33.95 ng/ml, T max of 9 h, and MRT of 14.08 ± 1.21 h. The correlation coefficient of 0.9899 confirmed the level-A IVIVC. Uncoated matrix tablet of Parteck® SRP 80 displayed mucoadhesive strength 1.25-fold higher than hypromellose. Stability experiments found no significant changes in drug content, physical appearance, and cumulative percentage release with a similarity factor of 87–90. Conclusion A single oral dose in-vivo study proved the sustained release of the drug for 24 h with satisfactory mucoadhesive strength. Moreover, X-ray radiography has confirmed the time-dependent presence of formulation at the needed spot. This study fulfilled all the requirements for chronotherapy of asthma and can be scaled up in the future. Graphical abstract
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