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Irvine, CA, United States

Khandai M.,P.A. College | Chakraborty S.,Pharmacy Development | Ghosh A.K.,IFTM University
Powder Technology | Year: 2014

The objective behind this study is to ameliorate the flowability, compressibility and tableting properties of aceclofenac by developing a prolonged release microparticulate system using an algino-carbopol polymeric blend. Prepared microspheres were subjected to various physico-chemical studies along with in vitro drug release studies to optimize the concentration of the polymeric blend required to sustain the drug release for 12. h. Optimize formulation was further subjected to different flowability and compressibility studies to observe the impact of microspheres on improvements of flow properties. All the microsphere formulations exhibited good entrapment efficiency and showed prolonged drug release. SEM study revealed that the microspheres were almost spherical in shape with rough outer surface containing small pores. The findings of micromeritic studies suggested that the flowability and compressibility properties of the pure drug were significantly improved by the microsphere formulation. Heckel analysis also suggested that the microspheres exhibited better plasticity and die filling behavior as compared to pure drug. The tablets containing optimized microspheric formulation showed better handling properties than pure drug and no significant difference in drug release when compared with the marketed product. So the present study concluded that encapsulation of aceclofenac into microparticulate system not only enhanced its flowability, compressibility and tableting properties but also simultaneously helped to improve the patient compliance by sustaining the drug release for a prolonged period of time to manage pain and its symptoms. © 2013 Elsevier B.V. Source

Conner T.A.,Pharmacy Development | McQuade C.,University of New Mexico | Olp J.,University of New Mexico | Pai A.B.,Albany College of Pharmacy and Health Sciences
BioMetals | Year: 2012

Reticuloendothelial blockade in hemodialysis patients prevents optimal intravenous (IV) iron utilization. Vitamin C has emerged as a potential therapy to improve anemia treatment by enhancing iron mobilization. However, Vitamin C can act as a prooxidant in the presence of iron. This was a prospective, open-label, crossover study. Thirteen patients with endstage renal disease on hemodialysis and four healthy controls were assigned to receive 100 mg of IV iron sucrose (IS) or 100 mg of IV IS co-administered with 300 mg of IV Vitamin C (IS + C) in random sequence. Serum samples for IL-1, IL-6, TNF-a and IL-10 and non-transferrin bound iron were obtained at baseline, 45 min and 105 min post study medication administration. Peripheral blood mononuclear cells were isolated at the same time points and stained with fluorescent probes to identify intracellular reactive oxygen species and mitochondrial membrane potential (δψm) by flow cytometry. Lipid peroxidation was assessed by plasma F2-isoprosatane concentration. Both IS and IS + C were associated with increased plasma F2-isoprostanes concentrations post-infusion. Maximal plasma F2-isoprostane concentrations after IS + C were significantly elevated from baseline (234 ± 0.04 vs. 0.198 ± 0.028 ng/mL, p = 0.02). After IS + C, IL-1, IL-6, IL- 10, and TNF-alpha were significantly elevated compared to baseline. After IS alone only IL-6 was noted to be elevated. Intracellular production ofH2O2 and loss of mitochondrial membrane potential (δψm) was observed after IS while IS + C was associated with increased O2 .- production. Both IS and IS + C induced serum cytokine activation accompanied by lipid peroxidation, however, IS + C induced higher plasma concentrations of F2-isoprostanes, IL-1, IL-10, and TNF-a post-infusion. Long-term safety studies of IV iron coadministered with Vitamin C are warranted. © Springer Science+Business Media B.V. (outside the USA) 2012. Source

Sonawane L.V.,Pharmacy Development
Medicinal Chemistry Research | Year: 2011

The peroxisome proliferator-activated receptor gamma (PPAR-c) is member of a large family of ligandactivated nuclear transcription factors. The first compounds reported as high-affinity PPAR-c agonists were a class of antidiabetic agents known as thiazolidinediones or "glitazones". Quantitative structure activity relationship (QSAR) analyses used to understand the structural factors responsible for PPAR-c agonistic activity of some thiazolidinedione derivatives. Several pharmacophore-based models indicated the importance of steric, hydrophobic, and hydrogen bond acceptor groups to agonistic activity. The 3D-QSAR analysis was carried out by PHASE program and a statistically reliable model with good predictive power (r 2 = 0.9702, q 2 = 0.8216) was achieved. The 3D-QSAR plots illustrated insights into the structure activity relationship of these compounds which may helps in the design and development of potent thiazolidinedione derivatives as antidiabetic agents. © Springer Science+Business Media, LLC 2010. Source

Chockalingam V.,Pharmacy Development | Suryakiran Kadali S.D.V.,P.A. College | Gnanasambantham P.,A And G Pharmaceutical, Inc.
Indian Journal of Pharmacology | Year: 2012

Objective: The present investigation was performed to evaluate the antiproliferative and antioxidant activity of Aegle marmelos leaves in Dalton's Lymphoma Ascites (DLA)-bearing mice. Materials and Methods: The DLA cells maintained in vivo in Swiss albino mice were used for developing ascitic tumor in mice by intraperitoneal transplantation. The standardized 50% ethanolic extract of A. marmelos leaves (AMEE) was administered intraperitoneally in dose levels 200 and 400 mg/kg, after 24 hours of tumor inoculation in mice for two weeks. Results: The AMEE treatment significantly prevented (P<0.001) the increase in body weight due to tumor cell growth and increased the mean survival time of the tumor-bearing mice as compared to the untreated DLA control mice. The treatment of DLA-bearing mice brought down the Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), and alkaline phosphatase to normal levels. The extract decreased the levels of hepatic lipid peroxidation and increased the levels of hepatic antioxidants Glutathione, Superoxide Dismutase (SOD), and catalase. All the changes observed with AMEE treatment were dose dependent. Conclusion: The hydroalcoholic extract of A. marmelos exhibits strong antitumor and antioxidant activities in DLA-bearing mice. Source

Jacobs M.S.,Truveris | Johnson K.A.,Pharmacy Development
American Health and Drug Benefits | Year: 2012

Background: Specialty injectables and protein-based biologic therapies represent the fastest growing segment of the drug trend for many plan sponsors. Coupled with the decline in spending on traditional pharmaceuticals and so-called blockbuster drugs coming off patent, the upward trend of specialty drug spending continues at an unprecedented rate, precipitating a shift in the focus of payers who manage prescription drugs. Objectives: To characterize the current and future specialty drug spending and describe contemporary trends among payers for managing cost and quality in this segment, as well as to elucidate the shortcomings of the current efforts and to explore a comprehensive approach for addressing the cost and quality concerns directly associated with specialty injectables and protein-based biologics through interrelated management interventions. Discussion: Although a notable decrease in spending on traditional pharmaceuticals was realized in 2010, disproportionate increases in specialty drug utilization and cost per unit fueled the continuing growth of the injectable and biologic markets. Each course of these therapies can cost in the tens of thousands of dollars, and this upward trend of specialty spending represents an escalation of an already significant spending for payers, employers, and members. Beyond the high cost and growing utilization of specialty pharmaceuticals, current management efforts have been met with variable degrees of success and have often proved challenging and, in some cases, even counterproductive. Common interventions used by payers nationwide for addressing specialty drug spending trend include specialty drug formularies, provider reimbursement strategies, distribution channel management, benefit design modifications, utilization management, and operational and administrative improvements such as postclaim edits. Although often overlooked, appropriate implementation of these tactics, and the extent to which they are integrated with overall drug benefit management, are key to the success of the pharmaceutical management program. Conclusion: Conventional specialty pharmaceutical management initiatives offer promise in various areas, but incentives for the best protocols may be misaligned when they are applied individually. Conversely, a comprehensive approach that integrates effective components of the specialty pharmaceutical management interventions can improve the quality of care and control costs associated with these agents, with significant specialty drug management expertise and access to benchmarking data serving as the foundation for appropriate decision-making. © 2010-2011 Engage Healthcare Communications, LLC. All rights reserved. Source

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