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Pharmaceutical and Biomedical Research - Volume:5 Issue: 4, Dec 2019

Pharmaceutical and Biomedical Research
Volume:5 Issue: 4, Dec 2019

  • تاریخ انتشار: 1398/08/10
  • تعداد عناوین: 8
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  • Zohreh Fasili, Hossein Ali Ebrahimi, Elham Mohammad Khanlou, Farzad Kahrizi, Fereshteh Mehri, Ahmad Salimi* Pages 1-20

    Viral infections can cause of death in humans worldwide, despite the tremendous progress in human medicine. Particle size is a very important physical characteristic that can affect bioavailability and circulation time of nanoparticles. The ratio of large surface area and volume of nanoparticle enhanced solubility of poorly soluble drug compounds, optimum surface charge of the nanoparticle with the possibility of encapsulation, and large drug cargo are some of nanoformulation advantages. This study reviewed the various nanocarriers and new smart delivery technologies such as liposomes and immunoliposomes, polymeric nanoparticles, nanoemulsions, nanosuspensions, dendrimers, solid lipid nanoparticles, etc., to overcome the problems of traditional formulations and resistance to currently available therapies. the concerns about the potential toxicities of nanoparticles to human have been raised, therefore, the present study was also aimed at reviewing cytotoxic effects of nanoparticles has been published in literatures. Due to the high prevalence of viruses, we need to develop of novel treatment strategies and deliver the site-specific delivery of antiviral agents at the viral reservoirs.

    Keywords: Nanoparticles, Nanoformulation, Nanosuspensions, Cytotoxic effects, Anti-viral
  • Mohammad Reza Gheini, Mohammad Ali Sahraian, Amir Reza Azimi, Naser Mmoghadasi, Mahmud Abdoli, Gelareh Rahimi, Monir Ghazaeian* Pages 21-26

    This study aims to compare the clinical efficacy and safety profile of Ziferon (interferon beta-1b) and Betaferon. A total of 41 patients with relapsing forms of multiple sclerosis (MS) are selected from the MS outpatient clinic affiliated to Tehran University of Medical Sciences, Tehran, Iran. The patients are randomly assigned to two groups. Each group either receives Ziferon 250 mcg subcutaneously (SC) on alternate days or Betaferon 250 mcg SC on alternate days. Clinical and para-clinical outcomes, such as mean relapse rate/year score, mean expanded disability status scale (EDSS)/year score, the cumulative number, and the volume of gadolinium-enhancing lesions, in addition to the cumulative number of new T2 lesions and safety profile, are evaluated for each group during the years of treatment. There are no significant differences in the magnetic resonance imaging (MRI) outcomes (change in total lesion volume, new lesion per T2-weighted scan, and gadolinium-enhancing lesions per T1-weighted scan from baseline; P = 0.236, P = 0.56 and P = 0.496 respectively were observed). There is no significant difference in the relapse rate between the Ziferon and Betaferon treated groups (P = 0.56). No unexpected safety events occur. The number of patients who discontinued the study due to adverse events is almost the same between the two groups. The evidence gained demonstrates the non-inferiority and bio-similarity of Ziferon to Betaferon, in terms of efficacy and safety profile.

    Keywords: Interferon-beta (INF-β)1b, Relapsing-Remitting Multiple Sclerosis (RRMS), Outcome measure
  • Panoraia I. Siafaka, Emre Şefik Cağlar, Katerina Papadopoulou, Vasilios Tsanaktsis, Ioannis D. Karantas, Neslihan Üstündağ Okur*, Hatice Yeşim Karasulu Pages 27-34

    Glibenclamide is a lipophilic drug molecule widely used in type II Diabetes treatment. Its low bioavailability limits its use; thus, novel formulations should be applied to improve it. This study aimed to develop alternative carriers for oral delivery of Glibenclamide. For this purpose, two biocompatible polymers  of poly(e-caprolactone) and poly(butylene adipate) were formulated as microparticles (MPs) capable to load the antidiabetic drug. In this regard, a microparticle fabrication approach as a modified emulsion-solvent evaporation method was applied. Physicochemical evaluation of the prepared MPs included the examination of their morphology, degradation rate and thermal properties. Drug entrapment, drug loading and particle size were also investigated. Simulated intestinal medium and simulated body fluid at 37 oC were selected as dissolution media. Differential Scanning Calorimetry (DSC) was used to investigate the crystal properties of the MPs and drug. The developed MP size was between 0.5 and 4 μm. Poly(butylene adipate) MPs had a smooth surface whereas poly(ε-caprolactone) MPs showed a porous surface. The DSC thermogram demonstrated the amorphization of the drug. Hydrolysis results showed very low mass loss, while in-vitro release results showed that the dissolution rate of MPs was higher than that of pure Glineclamide and prolonged pattern which is ideal to minimize the daily dose of Glibenclamide. In this study, novel carriers for Glibenclamide were successfully prepared and characterized revealing their possible future use.

    Keywords: Glibenclamide, Microparticles, In-vitro release, Aliphatic polyesters
  • Ye Htut Linn*, Myat Myat Soe, K Khine Thu, Thida Tun, Mi Kun Kaw San, Nyein Chan Pyae, Nu Nu Aye Pages 35-44

    Tramadol is one of the most commonly used analgesics, thanks to its efficacy and safety. It is widely used in Myanmar for postoperative and cancer pain control. The use of generic drugs has been steadily increasing worldwide, mostly in developing countries. Generic drugs should have efficacy and safety comparable to their innovators or other approved generic products. This study aims to compare the bioequivalence of locally producing, Tramadol BPI® capsule (test product) with the Tramazac® capsule (reference product) in healthy Myanmar volunteers. The bioequivalence was determined in 16 healthy Myanmar volunteers after a single oral administration of 100 mg tramadol (under fasting condition) in a randomized, open-label, two-period, and two-treatment crossover study with a two-week washout period. Blood samples were collected at specified times, and plasma tramadol concentrations were measured with a validated high-performance liquid chromatography method with a fluorescence detector. Pharmacokinetic parameters were determined using the plasma concentration-time data in a non-compartmental model. The analysis of variance of the logarithmically transformed parameters (Cmax, AUC0–t, and AUC0–∞) revealed no sequence, period, and formulation effects between the test and reference products. Significant differences were found between the subjects within the sequence for both AUC0–t, and AUC0–∞, indicating a substantial inter-subject variation. The geometric mean ratio of test/reference and their 90% confidence interval were within the ASEAN bioequivalence acceptance interval of 80% to 125%. Tramadol BPI® and Tramazac® capsules, after a single oral administration of 100 mg, were bioequivalent in respect of their rate and extent of absorption under fasting condition.

    Keywords: Bioequivalence, Bioavailability, Tramadol, Pharmacokinetics, High-performance liquid chromatography (HPLC)
  • Kundan Bora*, Mahamedha Medha Pages 45-52

    Presently, the use of herbal medicines is expanding rapidly across the world. While considering source materials, authentication and standardization are prerequisites for herbal formulation in any system of medicine. The plant Clerodendrum wallichii Merr. (Family: Lamiaceae) has been used for various ailments in traditional systems of medicines, particularly in the treatment of diarrhea, skin infection, inflammation and fever. The present study was designed to establish the pharmacognostic standards and perform the physicochemical analysis of C. wallichii leaves. Macroscopic and microscopic studies were performed using the simple and trinocular microscope, respectively. The World Health Organization guidelines were followed for the physicochemical analysis of the plant. Fluorescence analysis was observed at daylight, short UV light, and long UV light. The leaves of C. wallichii were found dark green on the upper surface and light green in the lower surface which is odorless and bitter. The leaves are oblong to oblong-lanceolate with a smooth surface. The size of leaves varies from 11 to 18 cm in length and 2.5 to 4 cm in diameter. Powdered microscopy showed the various characters like rare multicellular covering trichome, xylem vessels (reticulate), fiber, trichome base, stellate trichome, adaxial epidermal cell (rectangular), abaxial epidermal cell (irregular), vessels, stomata (anisocytic), calcium oxalate crystals (square and cubic). Physicochemical parameters like moisture content of dry powder of the plant was determined 9.3% w/w. The total ash, acid-insoluble, and water-soluble ash values were calculated as 10.48%, 1.08%, and 8.17%, respectively. The loss on drying was calculated as 9.3% w/w. Extractive values by cold and hot maceration method were also determined. Our obtained data help to authenticate the plant and establish its pharmacopoeial standards.

    Keywords: Clerodendrum wallichii, Pharmacognostic standardization, Physicochemical analysis
  • Samad Alimohammadi*, Milad Allahmoradi, Hadi Cheraghi Pages 53-62

    Artichoke (Cynara scolymus) possesses bioactive components with antioxidant effects. This plant has been widely used in traditional medicine. The current study aimed to examine the protective activity of hydroethanolic extract of Cynara scolymus (HECS) against experimentally-induced hemolytic anemia in rats. Hemolytic anemia was induced by intraperitoneal injection of Phenylhydrazine (PHZ) 40 mg/kg for 2 days. PHZ induces oxidative stress and reactive oxygen species formation, which causes hemolytic anemia. Thirty male Wistar rats were divided into 5 groups (n = 6 for each group). Group 1 (normal control) was injected with normal saline. Group 2 (anemic control) received only PHZ. Groups 3 to 5 were injected with 100, 200, 400 mg/kg of the HECS by gavage, respectively, daily from day 2 to day 15 after PHZ administration. At the end of the treatment period, their blood and liver samples were collected for biochemical and histopathological analysis. The results indicated that serum ALP, ALT, AST, and LDH levels in the PHZ group were significantly higher than those in the control group (P<0.05). A significant decrease in serum liver enzymes was determined in rats treated with HECS at different doses compared with the untreated anemic rats (P<0.05). Also, HECS significantly attenuated body weight loss in the PHZ group (P<0.05). Besides, based on the histopathological evaluation, HECS improved disarrangements of the liver parenchyma due to PHZ-induced hepatotoxicity. Therefore, HECS has hepatoprotective effects against PHZ-induced toxicity presumably by its antioxidative activity.

    Keywords: Phenylhydrazine, Hemolytic Anemia, Cynara scolymus, Rat
  • Zahra Heidari, Shabnam Mohammadi*, Mahdieh Yousefi Taba Pages 63-68

    Curcumin is the most active ingredient in turmeric root of Curcuma longa of the Zingiberaceae family and has a potent antioxidant activity. This study aimed at investigating the effects of curcumin with various doses on the density of dark neurons in the hippocampus of induced D-galactose aging mice model. This experimental study was conducted on 40 adult male BALB/c mice. We randomly divided animals into 5 groups: D-galactose, control, and curcumin 1, curcumin 2, and curcumin 3 groups. D-galactose (300 mg/kg) was intraperitoneally injected into the D-galactose group for 6 weeks. D-galactose and doses of 25, 50, and 100 mg of curcumin were administrated, respectively, to the curcumin groups 1 to 3 every day for 14 days. After 6 weeks, the mice's brains were stained with toluidine blue after tissue passage. Then, the mean dark neuron volume density in each unit of the ​​tissue was assessed using stereological formulas. The obtained data were analyzed by Analysis of variance (ANOVA) in SPSS. Compared with the control group, the average number of dark neurons in the hippocampus significantly increased following the administration of D-galactose (P = 0.001). The average dark neurons frequency in the hippocampus significantly decreased in the 50 and 100 mg/kg curcumin-treated groups (P=0.001 for both) compared to that of the D-galactose treated animals. The results of this study showed that treatment with 100 mg/kg of curcumin reduced the number of dark neurons in the hippocampus of the aging mice. It seems that curcumin decreases dark neurons via the reduction of apoptosis. Also, curcumin is a powerful antioxidant and affects the level of antioxidant status in the brain.

    Keywords: Curcumin, Aging, Hippocampus, Dark neuron
  • Shayesteh Gheibi, Aliasghar Farsavian, Maryam Nabati, Gohar Eslami * Pages 69-74
    Introduction

    Prosthetic valve thrombosis is a rare and severe complication of valve replacement, most often encountered with a mechanical prosthesis. The significant morbidity and mortality associated with this condition warrant rapid diagnostic evaluation. Although surgery is the first-line therapy in symptomatic obstructive mechanical valve thrombosis, thrombolytic therapy has been used as an alternative.

    Case Description

    In this case report, we describe a 46-year-old man with a history of the mitral valve and aortic valve replacement 2 years ago. In echocardiography, we detected a mobile mass on the atrial side of the mitral valve prosthesis and a fixed one on the leaflet of the mechanical aortic valve with a high gradient. To save his life, we used double thrombolytic therapy considering the patient’s hemodynamic situation and the risk of bleeding. Although a routine dose of reteplase and streptokinase was considered, we administered these two thrombolytic drugs together within 72 hours.

    Conclucsion

    Ultimately we succeeded with this method without any significant or life-threatening adverse effects, and the patient was discharged after an optimal anticoagulation therapy.

    Keywords: Mitral valve, Aortic valve, Thrombolytic, Reteplase, Streptokinase