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King Of Prussia, PA, United States

Baxter International and Prism Pharmaceuticals | Date: 2008-05-27

Injectable pharmaceutical preparation for use in acute cardiac and circulatory disorders.

Baxter International and Prism Pharmaceuticals | Date: 2008-07-01

Pharmaceuticals, namely, preparations in injectable, solution and tablet form for the prevention, treatment and management of cardiovascular diseases.

Cushing D.J.,Prism Pharmaceuticals | Souney P.F.,Prism Pharmaceuticals | Cooper W.D.,Prism Pharmaceuticals | Mosher G.L.,CyDex Pharmaceuticals | And 3 more authors.
Clinical and Experimental Pharmacology and Physiology | Year: 2012

1.PM103 is an intravenous formulation of clopidogrel being developed as an alternative to oral clopidogrel to provide for dosing flexibility in the emergent clinical setting. The present first-in-human study assessed the pharmacokinetic and pharmacodynamic effects of PM103 and its safety in 144 healthy human subjects. 2.The present was a randomized open-label parallel-group trial. Single intravenous doses of PM103 (0.1, 1.0, 10, 30, 100 or 300mg) were administered to each group (n=24 subjects per group). Platelet aggregation was assessed at baseline and then 15 and 30min and 2, 5 and 24h after drug administration. Determination of plasma concentrations of clopidogrel, clopidogrel carboxylic acid metabolite and the clopidogrel thiol metabolite were assessed at baseline and at 1, 5, 10, 20 and 30min and 1, 2, 3, 4, 6, 8, 12 and 24h after drug administration. 3.PM103 produced a rapid, persistent and dose-related inhibition of platelet aggregation. The onset of the ant platelet effect paralleled the appearance in plasma of the clopidogrel thiol active metabolite. PM103 was well tolerated and no subjects discontinued treatment because of adverse events. 4.These data suggest that PM103 may be a suitable alternative to oral clopidogrel for patients in whom the desired clinical management would include administration of clopidogrel after coronary angiography but prior to percutaneous coronary intervention. © 2011 The Authors. Clinical and Experimental Pharmacology and Physiology © 2011 Blackwell Publishing Asia Pty Ltd. Source

Cushing D.J.,Prism Pharmaceuticals | Cooper W.D.,Prism Pharmaceuticals | Gralinski M.R.,CorDynamics
Clinical and Experimental Pharmacology and Physiology | Year: 2010

Hypotension frequently occurs with use of intravenous amiodarone and is managed by slowing the rate of administration. This response has been attributed to the cosolvents in the formulation and is believed to be solely related to the initial loading dose. The present study was performed to determine whether intravenous amiodarone-induced hypotension persists beyond the loading dose and into the maintenance infusion period and also whether hypotension occurs with maintenance level dosing alone. 2. Anaesthetized beagle dogs (n = 7/group) were instrumented to assess haemodynamics. Animals were treated with the human-equivalent dosing regimen (loading dose followed by maintenance infusion) of intravenous amiodarone or control (5% dextrose in water). 3. No haemodynamic changes were observed in the control group during the 6 h study. In contrast, administration of the standard intravenous amiodarone regimen produced rapid and significant decreases in mean aortic pressure, cardiac output and maximum rate of change of left ventricular pressure that persisted throughout the 6 h maintenance infusion period. Administration of amiodarone as the maintenance infusion dose alone produced haemodynamic changes that were similar in magnitude to those observed with administration of the full dosing regimen, but were delayed in onset by approximately 60 min. 4. Dosing with a cosolvent-free formulation of amiodarone (PM101) caused no haemodynamic effects during the 6 h dosing period, indicating that the cardiodepressant effects of intravenous amiodarone were due to its cosolvents. 5. These data suggest that consideration should be given to intravenous amiodarone as a potential cause for sustained hypotension during prolonged infusion. © 2010 Blackwell Publishing Asia Pty Ltd. Source

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