Safety profile of a high-dose extended-release formulation of donepezil in patients with moderate-to-severe Alzheimer's already being treated with donepezil immediate-release Tablets

2010 ◽  
Vol 6 (4) ◽  
pp. S305
Author(s):  
M. Moline ◽  
J. Yardley ◽  
Q. Wang ◽  
H. Zou ◽  
E. Brand-Schieber ◽  
...  
Keyword(s):  
Safety Profile ◽  
Extended Release ◽  
Immediate Release ◽  
High Dose ◽  
Release Formulation ◽  
Extended Release Formulation

Pharmacokinetic simulation for switching from galantamine immediate-release to extended-release formulation

2005 ◽  
Vol 21 (4) ◽  
pp. 483-487 ◽  
Author(s):  
Jeremy P. Hing ◽  
Vladimir Piotrovsky ◽  
Hui Kimko ◽  
H. Robert Brashear ◽  
Qinying Zhao
Keyword(s):  
Extended Release ◽  
Immediate Release ◽  
Release Formulation ◽  
Extended Release Formulation

scholarly journals Pramipexole and its Extended Release Formulation for Parkinson's Disease

2011 ◽  
Vol 3 ◽  
pp. JCNSD.S5210 ◽  
Author(s):  
Paul S. Fishman
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Immediate Release ◽  
Motor Fluctuations ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Release Preparation ◽  
Early Parkinson’S Disease ◽  
Release Form

Pramipexole has been a widely used dopamine agonist for the last decade. Recently an extended release formulation of pramipexole has been introduced as both monotherapy for patients with early Parkinson's disease as well as for patients with more advanced disease, as an adjunct to L-DOPA. Along with the enhanced patient compliance seen with once a day dosing, there are other potential advantages of extended release preparations of dopamine agonists. Patients initiated on pramipexole have a lower incidence of developing motor fluctuations including dyskinesia than those initiated on L-DOPA. Pramipexole requires a prolonged dose titration compared to L-DOPA, and generally does not have the efficacy of L-DOPA. The extended release form of pramipexole shows comparable mean and peak serum levels with once a day dosing as seen with three times a day dosing of the immediate release preparation. The extended release preparation has been studied in randomized multicenter clinical trial against both placebo and the immediate release preparation in the setting of early Parkinson's disease as monotherapy and in more advanced patients with motor fluctuations on L-DOPA. In both settings the extended release preparation was superior to placebo and comparable to the immediate release form in efficacy with a similar side effect profile including nausea, sleepiness, leg edema, dyskinesias, hallucinations and impulse control disorders.

scholarly journals Tacrolimus Intrapatient Variability After Switching From Immediate or Prolonged-Release to Extended-Release Formulation, After an Organ Transplantation

2021 ◽  
Vol 12 ◽  
Author(s):  
Arnaud Del Bello ◽  
Clotilde Gaible ◽  
Nathalie Longlune ◽  
Anne-Laure Hebral ◽  
Laure Esposito ◽  
...  
Keyword(s):  
Extended Release ◽  
Organ Transplant ◽  
Immediate Release ◽  
Prolonged Release ◽  
Solid Organ ◽  
Safe Procedure ◽  
Release Formulation ◽  
Blood Concentrations ◽  
Extended Release Formulation ◽  
Before And After

Background and Purpose: Several formulations of tacrolimus are available, but evidence of the benefit of changing to the most recent formulations is lacking. Tacrolimus intra-patient variability (tacrolimus IPV) is an emerging risk factor associated with poor graft outcomes after solid organ transplantations. Here, we examined the modifications of tacrolimus IPV after switching to a different formulation of tacrolimus.Experimental Approach: We identified 353 solid organ transplant recipients that were switched in our center from immediate-release (IR-tacrolimus) or prolonged-release tacrolimus (PR-tacrolimus) to extended-release, LCP-tacrolimus (LCP-tacrolimus). Among them, 54 patients underwent at least 3 available tacrolimus blood concentrations before and after the switch, allowing us to investigate tacrolimus IPV.Key Results: The switch was considered as a safe procedure since only four of the 353 patients presented a graft rejection after the switch, and no patient was hospitalized for tacrolimus overdose. The tacrolimus IPV estimated by the coefficient of variation (CV-IPV) was stable before and after the switch to LCP-tacrolimus (CV-IPV: 29.0% (IQR 25–75 (15.5; 38.5) before and 24.0% (15.8; 36.5) after the switch, p = 0.65).Conclusion and Implications: Switching from IR- or PR-tacrolimus to LCP-tacrolimus is a safe procedure. However, the CV-tacrolimus IPV was not impacted by the change of formulation.

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 Pramipexole Extended Release: A Novel Treatment Option in Parkinson's Disease

2010 ◽  
Vol 2010 ◽  
pp. 1-7 ◽  
Author(s):  
Wolfram Eisenreich ◽  
Bernd Sommer ◽  
Sebastian Hartter ◽  
Wolfgang H. Jost
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Dopamine Agonist ◽  
Extended Release ◽  
Plasma Concentrations ◽  
Safety Data ◽  
Immediate Release ◽  
Efficacy And Safety ◽  
Release Formulation ◽  
Extended Release Formulation

Pramipexole, the most commonly prescribed dopamine agonist worldwide, meanwhile serves as a reference substance for evaluation of new drugs. Based on numerous clinical data and vast experiences, efficacy and safety profiles of this non-ergoline dopamine agonist are well characterized. Since October 2009, an extended-release formulation of pramipexole has been available for symptomatic treatment of Parkinson's disease. Pramipexole administration can be cut down from three times to once a day due to the newly developed extended-release formulation. This is considerable progress in regard to minimizing pill burden and enhancing compliance. Moreover, the 24 h continuous drug release of the once-daily extended-release formulation results in fewer fluctuations in plasma concentrations over time compared to immediate-release pramipexole, given three times daily. The present study summarizes pharmacokinetics and all essential pharmacological and clinical characteristics of the extended-release formulation. In addition, it provides all study data, available so far, with regard to transition and de-novo administration of extended-release formulation for patients with Parkinson's disease. It further compares efficacy and safety data of immediate-release pramipexole with the extended-release formulation of pramipexole.

scholarly journals PHARMACOKINETIC STUDY OF OLOPATADINE 10 MG EXTENDED RELEASE TABLET IN COMPARISON WITH OLOPATADINE 5 MG IMMEDIATE RELEASE TABLET IN INDIAN POPULATION

2021 ◽  
pp. 70-74
Author(s):  
SAIYED ZEYAUL ABRAR HUSAIN ◽  
ARSHAD KHUROO ◽  
AMIT MARWAH ◽  
DIVYA VOHORA
Keyword(s):  
Extended Release ◽  
Safety Issue ◽  
Plasma Concentrations ◽  
Immediate Release ◽  
Serious Adverse Events ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Significant Difference ◽  
Olopatadine Hydrochloride ◽  
Release Tablet

Objective: This study was designed to assess the pharmacokinetics of single dose of olopatadine hydrochloride 10 mg extended release (ER) tablet of Ranbaxy laboratories limited (two test formulations) with two doses of Allelock® 5 mg immediate release (IR) tablets of Kyowa Hakko Kogyo Co. Ltd. (reference formulation R), in healthy, adult, Indian male subjects under fed condition. Methods: Fifteen healthy male volunteers, 26.07±6.62 y in age and 57.17±6.68 kg in body weight, were divided into three groups and received either olopatadine hydrochloride 10 mg ER tablet or two doses of Allelock® 5 mg tablets in each period. Blood samples were taken at predetermined time points and plasma concentrations of olopatadine were monitored by liquid chromatography mass spectrometric (LCMS/MS). Pharmacokinetic (PK) parameters AUC0-t, AUC0-24, AUC0-∞, and Cmax were calculated for olopatadine using WinNonlin. A statistical analysis was performed on PK data using SAS system. Results: The ER formulations showed a similar AUC as compared to the IR formulation and there was no statistically significant difference in AUC of test formulation A and B and reference R. The ratios of AUC0-t, AUC0-24 and AUC0-∞ for A/R were 91.08, 94.90 and 91.32 and for B/R were 89.63, 93.95 and 89.63 respectively. The ER formulations reported a higher Cmax value as compared to IR formulation. The ratios of Cmax for A/R and B/R were 151.09 and 167.96 respectively. But these higher Cmax values did not pose any safety issue as there were no serious adverse events reported during the study. Conclusion: In conclusion, we can say that though the study drugs did not meet the bioequivalence criteria set by regulatory agencies, but this study gave an insight about PK properties of olopatadine extended release formulation and given an idea about effect of smoking on the PK profile of olopatadine which can be studied in future.

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