Hasil untuk "Pharmacy and materia medica"

Arun Agarwal, Shailesh D. Dadge, Richa Garg et al.

Abstract Background Formononetin (FNT), a phytoestrogen, has shown osteogenic effects in ovariectomy-induced osteoporosis, but its therapeutic use is limited by poor bioavailability. This study aimed to compare the osteogenic potential of pure FNT and formononetin–piperine–phospholipid complex (FNT-PIP-PC) in OVX-induced osteoporosis and to quantify free FNT concentration in rat bone marrow. An in vivo study was conducted using an OVX-induced osteoporosis rat model. Adult female Sprague–Dawley (SD) rats were ovariectomized and treated orally with FNT or FNT-PIP-PC at 5mg/kg for 12 weeks. Therapeutic efficacy was evaluated using body composition analysis, µCT, L5 compression, bone markers, and pharmacokinetics parameters in the bone marrow via LC–ESI–MS/MS. Results FNT-PIP-PC treatment significantly restored trabecular bone volume and microarchitecture in the femur and tibia, improved uterine mass, increased osteocalcin (OCN), and reduced C-terminal telopeptide of type 1 collagen (CTX) levels. These findings aligned with enhanced mRNA expression of RUNX, RANKL, BMP2, and OPG. Additionally, FNT-PIP-PC improved pharmacokinetic parameters like Cmax, AUC0-t, and AUC0-∞ of free FNT from FNT-PIP-PC compared to pure FNT. Conclusion Oral administration of FNT through complexation with PIP reduced phase II metabolism and enhanced free FNT concentrations, leading to a significant increase in its bioavailability in bone marrow, supporting the targeted delivery. Furthermore, the FNT-PIP-PC complex demonstrated a marked improvement in the osteogenic potential of FNT on OVX-induced osteoporosis rats with no significant adverse effects. Collectively, these findings support the FNT-PIP-PC potential as a safe and effective therapeutic option for postmenopausal osteoporosis. Graphic abstract

Rugaved R. Gudadhe, Gaurav R. Sawarkar, Amol M. Deshpande

Hair plays a significant role in personality and aesthetics, with androgenetic alopecia affecting up to 80% of males. This case study evaluates the efficacy of palliative treatment and Viddhakarma (Puncture Therapy in Ayurveda) in managing androgenetic alopecia (Khalitya). A 37-year-old man presented with hair loss and a mild burning sensation on the scalp for six to seven years, primarily in the vertex and frontal regions. Treatment included Viddhakarma, Nilibhringadi Taila application (Shiroabhyanga), and palliative medications for four months, with weekly monitoring. New hair roots appeared within two weeks, existing hair improved in quality, and warmth sensation normalized after a month. Significant regrowth was observed without adverse effects, highlighting the effectiveness of personalized Ayurvedic management for androgenetic alopecia.

Anna Merwid-Ląd, Piotr Ziółkowski, Beata Nowak et al.

<b>Background/Objectives:</b> Inflammatory bowel disease significantly impairs the patient’s quality of life. In young individuals, both the disease and the drugs used for the treatment may impact fertility. Our study aimed to assess the action of new 1,3,4-oxadiazole derivatives of pyrrolo[3,4-d]pyridazinone on the rat testes in a model of TNBS-induced colitis in rats. <b>Methods:</b> In the current study, testes from eight randomly chosen rats were taken from each of the following groups: the control group (K), the colitis group (C), and the groups receiving compounds 7b, 10b, and 13b in higher doses (20 mg/kg). <b>Results:</b> Colitis did not affect the testicular index (expressed as a percentage of the body weight), but in group 13b, this parameter was significantly higher than in group K. No significant differences between groups were noticed in malondialdehyde, superoxide dismutase, interleukin-1, or metalloproteinase 9 levels. In the colitis group, lactate dehydrogenase activity in the testes was not increased; however, the administration of compound 10b significantly increased this parameter when compared to both groups K and C. Histological evaluation also did not reveal abnormalities, and the morphology of the testicular tissues was comparable in all groups. <b>Conclusions:</b> The results may suggest that the new 1,3,4-oxadiazole derivatives of pyrrolo[3,4-<i>d</i>]pyridazinone did not exert significant testicular toxicity.

Kazutaka Uchida, Keita Takahama, Kenshiro Higashi et al.

Abstract Background Cataract surgeries are increasing annually, making appropriate medical management essential. The routine use of systemic antimicrobial agents for preventing surgical site infections lacks strong evidence and may increase the risk of drug-resistant bacteria and adverse events. This study examined the impact of discontinuing cefazolin (CEZ) administration during the perioperative period of cataract surgery on the incidence of postoperative adverse events and medical costs. Methods Inpatient cataract surgery patients were divided into two groups: the CEZ-use group (April 2021 to March 2022) and the non-CEZ-use group (April 2022 to March 2023). The primary endpoints were the incidence of adverse events and medical costs, while the secondary endpoint was the incidence of endophthalmitis. Results A total of 265 patients were in the CEZ group, and 316 were in the non-CEZ group. Six postoperative adverse events (2.3%, 95% confidence interval: 0.8–4.9) occurred in the CEZ group, with an estimated 230 patients (80–490 from the 95% confidence interval) expected to experience adverse events per 10,000 patients using CEZ. The non-CEZ group had no adverse events and reduced drug costs by approximately 46,000 yen. Insurance claim amounts were also reduced. No cases of early postoperative endophthalmitis were observed in either group. Conclusions Discontinuation of CEZ prophylaxis during the perioperative period of cataract surgery effectively reduced the risk of adverse events. Medical for the period after discontinuing CEZ did not increase. Trial registration Retrospectively registered.

Gjeorgiev Blagoj, Miceva Dijana, Karpicarov Dino et al.

Medicine registration refers to evaluating a medical product's safety, efficacy, and quality, leading to the granting of a Marketing Authorization. Given the intense globalization of the pharmaceutical industry, harmonizing regulatory procedures between the European Medicines Agency (EMA) and the United States's Food and Drug Administration (FDA) is critical for accelerating the availability of new medicines. The EMA oversees three different procedures for medicine registration: Centralized, Decentralized and Mutual Recognition Procedure. Conversely, the FDA offers three registration applications - Investigational New Drug Application, New Drug Application and Abbreviated New Drug Application. A comparison between the FDA and EMA reveals numerous discrepancies within each system and highlights opportunities for harmonization. While both agencies achieve high concordance in their final decisions, the FDA is faster and more streamlined, benefiting from a centralized authority and expedited pathways. The EMA's structured approach ensures thorough evaluations but can delay approvals. Efforts to harmonize procedures, such as the FDA-EMA Parallel Scientific Advice program and the Mutual Recognition Agreement, aim to enhance alignment and reduce development resources, creating a global regulatory environment to streamline the registration of new medicines.

Takahiro Kato, Miki Kato, Kazuyo Nagashiba et al.

Background: Japanese pharmacists aim to improve efficiency and communication by simplifying work processes and developing protocols. While assistants and robots have been shown to improve drug dispensing, reports on the efficiency of pharmacies with automated dispensing systems are limited. This study explores factors affecting pharmacist efficiency in dispensing. Methods: 77Daily reports from our hospital pharmacy (December 1, 2020–November 30, 2021) were retrospectively analyzed. The primary outcome was the mean duration of drug dispensing. Multiple regression analyses identified factors affecting dispensing time. Strategies to address these factors were implemented, and outcomes were evaluated using data from December 1, 2021–November 30, 2022. Results: Univariate analysis identified that the prescription/pharmacist ratio, number of one-dose package (ODP) prescriptions, and powdered drugs significantly influenced dispensing time. Multivariate analysis confirmed that the prescription/pharmacist ratio (p < 0.001), ODP prescriptions (p < 0.001), and powdered drugs (p = 0.02) were key factors. A higher number of ODP prescriptions generally increased dispensing time. After implementing a new strategy for checking ODP, mean dispensing time decreased from 20.0 ± 4.0 to 18.5 ± 3.6 min (p < 0.001), and the percentage of tasks completed in under 20 min increased from 56.3 % to 73.6 % (p < 0.001). Dispensing times were reduced without changing staffing levels by reallocating tasks. Conclusions: Optimizing the ODP verification workflow enhances dispensing efficiency without increasing pharmacist workload, highlighting the importance of prioritizing ODP prescriptions and implementing support tools for final checks, while further multicenter studies are needed to confirm these findings across diverse settings.

Toshiyuki Hirai, Shunsuke Hanaoka, Yuusuke Terakado et al.

Treatment for diabetes includes anti-diabetic medication in addition to lifestyle improvements through diet and exercise. In Japan, protocol-based pharmacotherapy management allows drug treatment to be provided through cooperation between physicians and pharmacists, based on a protocol that is prepared and agreed upon in advance. However, there are no studies to clarify the relationship between patient characteristics and therapeutic effects after pharmacist intervention in protocol-based pharmacotherapy management for patients with diabetes. Therefore, this study aimed to use protocol-based reports from pharmacies to understand the status of outpatient diabetes medication compliance. We classified patients with diabetes on the basis of patient characteristics that can be collected in pharmacies and investigated the characteristics that impacted diabetes treatment. Patients were prescribed oral anti-diabetic drugs at outpatient clinics of Hitachinaka General Hospital, Hitachi, Ltd., from April 2016 to March 2021. Survey items included patient characteristics (sex, age, number of drugs used, observed number of years of anti-diabetic drug prescription, number of anti-diabetic drug prescription days, and presence or absence of leftover anti-diabetic drugs) and HbA1c levels. Graphical analyses indicated the relationship between each categorised patient characteristic using multiple correspondence analyses. Subsequently, the patients were clustered using K-means cluster analysis based on the coordinates obtained for each patient. Patient characteristics and HbA1c values were compared between the groups for each cluster. A total of 1,910 patients were included and classified into three clusters, with clusters 1, 2, and 3 containing 625, 703, and 582 patients, respectively. Patient characteristics strongly associated with Cluster 1 were ages between 65 and 74 years, use of three or more anti-diabetic drugs, use of 3 years or more of anti-diabetic drugs, and leftover anti-diabetic drugs. Furthermore, Cluster 1 had the highest number of patients with worsening HbA1c levels compared with other clusters. Using the leftover drug adjustment protocol, we clarified the patient characteristics that affected the treatment course. We anticipate that through targeted interventions in patients exhibiting these characteristics, we can identify those who are irresponsibly continuing with drug treatment, are not responding well to therapy, or both. This could substantially improve the efficacy of their anti-diabetic care.

Lucas A. Berenbrok, Annie Duchen, Tony Cyr et al.

This patient case report describes a first experience in late 2022 and early 2023 with over-the-counter (OTC) hearing aids for a 71-year-old male with self-perceived, age-related hearing loss. The patient reported no “red flag” medical conditions that would preclude him from safely using an OTC hearing aid device. After also meeting inclusionary criteria required to be printed on the device label, the patient was offered FDA registered OTC hearing aids. The first device pair was returned due to malfunction. The second device pair was an in-the-canal style, black in color, and powered by disposable batteries. He required help setting up the device from his spouse, an audiologist, and a pharmacist. Improved scores on the Self-Assessment of Communication and Significant Other Assessment of Communication were noted from the patient and his spouse. The patient continued to use the second device pair for 6 months after first use with no additional help. Our experience supports the pharmacist’s role in identifying appropriate candidates for OTC hearing aids, helping patients select a device, and supporting device setup and self-fitting processes at community pharmacies. Further experiences are needed to demonstrate how pharmacists can support OTC hearing aid purchases at community pharmacies.

Helena Moratin, Anna Thöle, Josephine Lang et al.

Inhalation is considered to be the most relevant source of human exposure to nanoparticles (NPs); however, only a few investigations have addressed the influence of exposing the respiratory mucosal barrier to subcytotoxic doses. In the nasal respiratory epithelium, cells of the mucosa represent one of the first contact points of the human organism with airborne NPs. Disruption of the epithelial barrier by harmful materials can lead to inflammation in addition to potential intrinsic toxicity of the particles. The aim of this study was to investigate whether subtoxic concentrations of zinc oxide (ZnO)- and silver (Ag)-NPs have an influence on upper airway barrier integrity. Nasal epithelial cells from 17 donors were cultured at the air–liquid interface and exposed to ZnO- and Ag-NPs. Barrier function, quantified by transepithelial electrical resistance (TEER), decreased after treatment with 10 µg/mL Ag-NPs, but FITC-dextran permeability remained stable and no change in mRNA levels of tight junction proteins and E-cadherin was detected by real-time quantitative PCR (RT-qPCR). The results indicate that subtoxic concentrations of Ag-NPs may already induce damage of the upper airway epithelial barrier in vitro. The lack of similar disruption by ZnO-NPs of similar size suggests a specific effect by Ag-NPs.

Bárbara Costa, Nuno Vale

The antiretroviral drug, the total level of viral production, and the effectiveness of immune responses are the main topics of this review because they are all dynamically interrelated. Immunological and viral processes interact in extremely complex and non-linear ways. For reliable analysis and quantitative forecasts that may be used to follow the immune system and create a disease profile for each patient, mathematical models are helpful in characterizing these non-linear interactions. To increase our ability to treat patients and identify individual differences in disease development, immune response profiling might be useful. Identifying which patients are moving from mild to severe disease would be more beneficial using immune system parameters. Prioritize treatments based on their inability to control the immune response and prevent T cell exhaustion. To increase treatment efficacy and spur additional research in this field, this review intends to provide examples of the effects of modelling immune response in viral infections, as well as the impact of pharmaceuticals on immune response.

Rania Elkeeb, Anomeh Avartoomian, Amira S. Gouda et al.

The aim of the study is to evaluate the effectiveness of the pediatric sofosbuvir weight-based dosing strategy in providing an equitable drug exposure compared to the marketed dose. The physiologically based pharmacokinetic (PBPK) modeling and simulation is a valuable tool in assessing drug dosing and toxicity in populations with physiological, pathological, and genetic pharmacokinetic (PK) variability. The PBPK model of the sofosbuvir compound was developed using Simcyp^® V20. The model was developed and verified using the published sofosbuvir’s physicochemical properties and clinical data from multiple studies on healthy adult volunteers, hepatitis C virus (HCV)-infected adults, and HCV-infected pediatrics. The AUC and C_max fold ratio of (predicted/observed) fell within the acceptable range of 0.5–2 in all tested adults’ data, confirming the successful development of the sofosbuvir Simcyp^® compound model. Using this model, a weight-based dosing regimen of 6 mg/kg in pediatric patients was simulated and compared to the 150 mg and 200 mg approved dose for 3–6 and 6–12 y/o pediatric patients, respectively. No dose adjustment was recommended in patients ages 6–12 y/o. However, compared to the approved 150 mg for 3–6 y/o, the weight base dose provided an equitable drug exposure to adults. Further clinical studies are warranted to verify this finding.

Kashif Haider, Mohd Shafeeque, Shaikh Yahya et al.

Cancer is one of the leading causes of death globally, around 10 million deaths are reported every year due to cancer. Some clinically approved anticancer drugs play a riveting role in its treatment. Still, due to the severe emergence of drug resistance, side effects, and multidrug-resistant cancers due to mutations, it creates a significant demand for novel, potent, and safe candidates as an anticancer agent with diverse mechanisms of action. In medicinal chemistry, several heterocyclic derivatives and hybrids are studied and reported as potent anticancer agents; Pyrazoline is one of the versatile and ubiquitous scaffolds for developing novel anticancer agents. Many pyrazoline scaffolds bearing drugs are used clinically for the treatment of cancer. Few are in the late phase of the clinical trial for treating various cancers, for example, Indibulin, a novel microtubule inhibitor and AT9283. The hybridization strategy of a pyrazoline scaffold with various heterocyclic rings is very promising to minimize the side effects and drug resistance. In light of this pyrazoline containing hybrids monopolize an important place in developing potent, safe and novel anticancer agents. The presented review outlined recent advances studied and reported towards developing pyrazoline-containing hybrids as potent anticancer agents. The review covers synthetic strategy, structure-activity relationship and anticancer activities of pyrazoline hybrid derivatives. The sole purpose is to shed light on the design and development of pyrazoline hybrids compounds with high efficacy and reduced toxicity.

Hak-Il Lee, Won-Kyu Rhim, Eun-Young Kang et al.

Drug-eluting balloons (DEBs) have been mostly exploited as an interventional remedy for treating atherosclerosis instead of cardiovascular stents. However, the therapeutic efficacy of DEB is limited due to their low drug delivery capability to the disease site. The aim of our study was to load drugs onto a balloon catheter with preventing drug loss during transition time and maximizing drug transfer from the surface of DEBs to the cardiovascular wall. For this, a multilayer-coated balloon catheter, composed of PVP/Drug-loaded liposome/PVP, was suggested. The hydrophilic property of 1st layer, PVP, helps to separate drug layer in hydrophilic blood vessel, and the 2nd layer with Everolimus (EVL)-loaded liposome facilitates drug encapsulation and sustained release to the targeted lesions during inflation time. Additionally, a 3rd layer with PVP can protect the inner layer during transition time for preventing drug loss. The deionized water containing 20% ethanol was utilized to hydrate EVL-loaded liposome for efficient coating processes. The coating materials showed negligible toxicity in the cells and did not induce pro-inflammatory cytokine in human coronary artery smooth muscle cells (HCASMCs), even in case of inflammation induction through LPS. The results of hemocompatibility for coating materials exhibited that protein adsorption and platelet adhesion somewhat decreased with multilayer-coated materials as compared to bare Nylon tubes. The ex vivo experiments to confirm the feasibility of further applications of multilayer-coated strategy as a DEB system demonstrated efficient drug transfer of approximately 65% in the presence of the 1st layer, to the tissue in 60 s after treatment. Taken together, a functional DEB platform with such a multilayer coating approach would be widely utilized for percutaneous coronary intervention (PCI).

Izaz Shaik, Malti Tulli, Priyanka Unnam et al.

This meta-analysis is intended to evaluate the reliability of evidences published in current regenerative endodontic publications in a critical way. This meta-analysis is used to summarize and analyze the various clinical and radiographic findings associated with nonvital immature permanent teeth which have been treated with regenerative endodontic techniques. We also intend to significantly evaluate the worth of facts provided in the previous published literature. A structured electronic search by authors was undertaken in August 2020 using MEDLINE and PubMed search engine. The chosen parameters studied in this systematic review were presented in flowcharts and were summarized. We observed a good accomplishment rates in terms of survival of the treated tooth and also in resolution of any associated pathology in the apical areas; on contrary, our results in relation to apex closure along with constant root development, our findings from various studies were quiet variable. Regenerative endodontic procedures are constantly being restructured and enhanced to benefit present-day dentistry in all likely ways. Still, many factors that are important for the success of regenerative endodontic treatment outcomes still remain unexplained. There are still numerous gaps in our expertise at the present stage of this study.

Hajer Alaa Obeid, Bahir Abdul Razzaq Mshimesh, Raghad Abdulmahdi Mohsin

Caraway seeds are widely used as spice for flavoring and seasoning foods, like bread and salads, because of their pungent and anise like flavor and aroma. Carum carvi was utilized in folk medicine for the management of many diseases. It is useful in hypothyroidism,   liver and gall bladder problems, common cold, fever, bronchitis, diarrhea, and eczema. It also relives GIT spasms, fullness feelings and relieves baby's flatulent colic. The extracts of caraway have diverse compounds, including carvone and limonene, linalool, γ-terpinene and α-pinene. One or combination of these compounds may participate in the pharmacologic effects of caraway. Aim of this study was to assess toxicity of caraway extract on female rats. Carium carvi extract submitted to chemical analysis (Phytochemical screening and Gas chromatography-mass spectrometry (GC-MS) analysis). Acute toxicity study has been performed using 24 female rats divided randomly in 4 groups (n=6 for each group) that received different doses of hydroalcoholic seed extract of caraway 1000, 3000 and ,5000 mg/kg for 14 days. On day 15, the rats were euthanized and whole blood collected to examine complete blood picture. The liver, kidney and the heart have been harvested for histopathologic study and relative organ weight changes. Caraway extract considered relatively safe on blood profile and immune system within the studied doses, as it shown a non-significant change on complete blood counts (CBCs) in a dose-dependent manner (Hb and RBCs increased slightly, while WBCs and PLTs decreased slightly) and without any change in body weight and relative weight percentage of different organs. As conclusion, hydroalcoholic extract of caraway seeds was relatively safe in rats at a dose up to 5000 mg/kg

Niken Yuliwati, Budiyanti Wiboworini, Vitri Widyaningsih

Background: Diabetes mellitus (DM) is a chronic metabolic disease with an increasing prevalence over the world. Aim and Objective: This research aimed to analyze the effect of strawberries, Rome beauty apples, and their combination on the low-density lipoprotein cholesterol (LDL-C) levels of Type 2 DM patients. Materials and Methods: This study was experimental research with randomized pre- and post-test group design. The subjects were 44 patients with Type 2 DM divided into four groups, namely, K (control, no treatment), P1 (200 g/day strawberry), P2 (300 g/day Rome beauty apple), and P3 (combination of 100 g/day strawberries and 150 g/day Rome beauty apple) for 14 days. Results: The results showed that the LDL-C level in DM patients was markedly high in all groups before the treatment. Treatment with only strawberry, Rome beauty apple and its combination significantly decreased the level of LDL-C compared to the control group. Furthermore, treatment with 300 g/day of Rome beauty apple exhibited a high decrease in LDL-C level compared to other treatment groups. Conclusion: These findings suggested that strawberries, Rome beauty apples, and their combinations could be used as promising functional food for DM therapy by lowering LDL-C levels. [Natl J Physiol Pharm Pharmacol 2020; 10(12.000): 1105-1109]

Pritee H Bhirud, Shrividya Chellam

Weber ZA, Kaur P, Hundal A et al.

Background: Diabetic retinopathy (DR) is a progressive, sight-threatening long-term complication of diabetes. Diabetes disease management reduces the risk of developing or progression to a severe form of DR. However, there are no reports of the potential role of pharmacists in DR progression. Objective: For this study, we performed a retrospective data analysis of patients with diabetes seen at cardiovascular risk reduction services provided by pharmacists with an objective to determine the potential role of pharmacists in the DR progression. These services involve pharmacists working in collaborative drug therapy management (CDTM), using a collaborative practice agreement (CPA) with primary care physicians. Methods: Patient records and ophthalmological notes were collected for 317 individuals seen by the pharmacists (intervention group) and 320 individuals seen only by a physician (control). Results: Statistical analysis was performed on 148 individuals in an intervention group and 120 individuals in the control group for which complete records were available. Retinopathy progression remained stable in 89.6 % of individuals in the intervention group compared to 87.9% in the control group. Moreover, the relative risk of retinopathy progressing to a severe form was 1.17 for the control group compared the intervention group. Conclusions: Our studies provide a proof-of-concept that pharmacists-managed care possesses a potential role in protection from DR, and paves a way for future pharmacists managed care with an emphasis on reducing diabetic complications.

David S. Riley