Efficacy and Tolerability of SPN-804, a Novel, Once-Daily Extended-Release Formulation of Oxcarbazepine as Adjunctive Therapy in Patients with Refractory Partial Seizures (P06.101)

Neurology ◽  
2012 ◽  
Vol 78 (Meeting Abstracts 1) ◽  
pp. P06.101-P06.101
Author(s):  
P. Baroldi ◽  
S. Brittain ◽  
D. Louro ◽  
J. Johnson
Keyword(s):  
Adjunctive Therapy ◽  
Extended Release ◽  
Partial Seizures ◽  
Release Formulation ◽  
Once Daily ◽  
Extended Release Formulation

scholarly journals Pharmacokinetics of Rifampin and Clarithromycin in Patients Treated for Mycobacterium ulcerans Infection

2010 ◽  
Vol 54 (9) ◽  
pp. 3878-3883 ◽  
Author(s):  
J. W. C. Alffenaar ◽  
W. A. Nienhuis ◽  
F. de Velde ◽  
A. T. Zuur ◽  
A. M. A. Wessels ◽  
...  
Keyword(s):  
Extended Release ◽  
Controlled Trial ◽  
Mycobacterium Ulcerans ◽  
Pharmacokinetic Parameters ◽  
Time Curve ◽  
Release Formulation ◽  
Once Daily ◽  
Extended Release Formulation ◽  
Liquid Chromatography Tandem Mass ◽  
Tandem Mass Spectroscopy

ABSTRACT In a randomized controlled trial in Ghana, treatment of Mycobacterium ulcerans infection with streptomycin (SM)-rifampin (RIF) for 8 weeks was compared with treatment with SM-RIF for 4 weeks followed by treatment with RIF-clarithromycin (CLA) for 4 weeks. The extent of the interaction of RIF and CLA combined on the pharmacokinetics of the two compounds is unknown in this population and was therefore studied in a subset of patients. Patients received CLA at a dose of 7.5 mg/kg of body weight once daily, rounded to the nearest 125 mg. RIF was administered at a dose of 10 mg/kg, rounded to the nearest 150 mg. SM was given at a dose of 15 mg/kg once daily as an intramuscular injection. Plasma samples were drawn at steady state and analyzed by liquid chromatography-tandem mass spectroscopy. Pharmacokinetic parameters were calculated with the MW/Pharm (version 3.60) program. Comedication with CLA resulted in a 60% statistically nonsignificant increase in the area under the plasma concentration-time curve (AUC) for RIF of 25.8 mg·h/liter (interquartile ratio [IQR], 21.7 to 31.5 mg·h/liter), whereas the AUC of RIF was 15.2 mg·h/liter (IQR, 15.0 to 17.5 mg·h/liter) in patients comedicated with SM (P = 0.09). The median AUCs of CLA and 14-hydroxyclarithromycin (14OH-CLA) were 2.9 mg·h/liter (IQR, 1.5 to 3.8 mg·h/liter) and 8.0 mg·h/liter (IQR, 6.7 to 8.6 mg·h/liter), respectively. The median concentration of CLA was above the MIC of M. ulcerans, but that of 14OH-CLA was not. In further clinical studies, a dose of CLA of 7.5 mg/kg twice daily should be used (or with an extended-release formulation, 15 mg/kg should be used) to ensure higher levels of exposure to CLA and an increase in the time above the MIC compared to those achieved with the currently used dose of 7.5 mg/kg once daily.

scholarly journals Levetiracetam Extended Release as Adjuvant Therapy for the Control of Partial-onset Seizures

2011 ◽  
Vol 3 ◽  
pp. JCNSD.S4126
Author(s):  
Hasan H. Sonmezturk ◽  
Nabil J. Azar
Keyword(s):  
Animal Studies ◽  
Extended Release ◽  
Immediate Release ◽  
Brand Name ◽  
First Line ◽  
Release Formulation ◽  
Once Daily ◽  
Seizure Reduction ◽  
Extended Release Formulation ◽  
Clonic Seizures

Extended release (XR) formulation of levetiracetam (LEV) is approved by the Food and Drug Administration as an add-on to other antiepileptic drugs (AEDs) for adults with partial onset seizures. This is based on class-I evidence demonstrating significant seizure reduction in once daily dosing. Keppra-XR is marketed with the brand name of Keppra XR since 2008 (UCB Pharma). Its original immediate release (IR) formulation has been in the market since 2000. LEV has a unique molecular structure which is chemically unrelated to existing AEDs. The precise mechanism of action is unknown. Animal studies showed binding to synaptic vesicle protein SV2A, thought to be involved in modulating synaptic neurotransmitter release. LEV-IR is proven effective as adjunctive therapy for partial-onset seizures, primary generalized tonic-clonic seizures and myoclonic seizures. It was shown to be equivalent to carbamazepine as first-line treatment for partial-onset seizures. The extended release formulation added advantages such as better tolerance and increased compliance.

scholarly journals Once-Daily Tacrolimus Extended-Release Formulation: 1 Year after Conversion in Stable Pediatric Kidney Transplant Recipients

2011 ◽  
Vol 2011 ◽  
pp. 1-4 ◽  
Author(s):  
Lars Pape ◽  
Nele Heidotting ◽  
Thurid Ahlenstiel
Keyword(s):  
Kidney Transplantation ◽  
Extended Release ◽  
Individual Variability ◽  
Kidney Transplant Recipients ◽  
Release Formulation ◽  
Once Daily ◽  
Extended Release Formulation ◽  
Pediatric Kidney Transplantation ◽  
Kidney Recipients ◽  
Trough Levels

It is speculated that a once-daily dosage of immunosuppression can increase adherence and thereby graft survival. Until now, there have been no studies on once-daily use of Tacrolimus extended-release formulation (TAC-ER) in children following pediatric kidney transplantation. In 11 stable pediatric kidney recipients >10 years, efficacy, safety, and tolerability of a switch to TAC-ER were observed over one year. Adherence was determined by use of the BAASIS-Scale Interview and comparison of individual variability of Tacrolimus trough levels. Over the observation period, two acute rejections were observed in one girl with nonadherence and repeated Tacrolimus trough levels of 0 ng/m. Beside this, there were no acute rejections in this trial. TAC dose was increased in 3/11 patients and decreased in 2/11 patients within the course of the study. Six patients did not require a dose adjustment. All but one patient had a maximum of 1 dose change during therapy. Mean Tacrolimus dose, trough levels, and Glomerular filtration rates were also stable. Adherence, as measured by BAASIS-Scale Interview and coefficient of variation of Tacrolimus trough levels, was good at all times. It is concluded that conversion to Tac-ER is safe in low-risk children following pediatric kidney transplantation.

Metoprolol Succinate Combination in the Treatment of Hypertension

Angiology ◽  
2008 ◽  
Vol 60 (5) ◽  
pp. 608-613 ◽  
Author(s):  
Dimitris P. Papadopoulos ◽  
Vasilios Papademetriou
Keyword(s):  
Extended Release ◽  
Plasma Concentrations ◽  
Release Formulation ◽  
Metoprolol Succinate ◽  
Once Daily ◽  
Extended Release Formulation ◽  
Adrenergic Antagonist ◽  
Constant Rate ◽  
Treatment Of Hypertension ◽  
Extended Release Tablet

Metoprolol is a selective β(l)-adrenergic antagonist extensively used since 1975. Metoprolol has proven its efficacy in reducing cardiovascular events and mortality in patients with hypertension and coronary heart disease. A recently developed controlled release/extended-release formulation of metoprolol succinate was designed to provide relatively constant metoprolol plasma concentrations and β(l)-blockade while retaining the convenience of once daily administration. A 100-mg metoprolol controlled/extended-release tablet contains 95 mg of metoprolol succinate and is considered to have equivalent activity of 100 mg metoprolol tartrate. After ingestion, the tablet disintegrates into individual pellets and each pellet acts as a diffusion cell releasing the drug at a relatively constant rate over a period of approximately 20 hours. The aim of this review was to determine the pharmacokinetic and pharmacodynamic properties of metoprolol succinate and to apply those properties in combination with other drugs mainly diuretics in the treatment of hypertension.

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