![]() ![]() ![]() All animals were kept in a temperature-controlled environment (22 ± 2 ℃) with a 12 h light-dark cycle. All animals were treated in accordance with the Guide for the Care and Use of Laboratory Animals, from the National Institutes of Health (USA). Six male beagle dogs (12 ± 7 kg) and six mini-pigs (20 ± 5 kg) were used in the pharmacokinetic studies. 11 12 Large fluctuations in plasma lacosamide concentrations can also produce these unwanted side effects, which limit the usefulness of oral lacosamide in some patients. These include visual disturbances and prolongation of the P-R electrocardiogram interval between the start of atrial systole and the start of ventricular systole, leading to AV (atrioventricular) node blockage. 8 Moreover, the rapid and complete absorption of lacosamide after oral administration poses a problem as it can lead to a high C max followed by a high steady-state concentration, resulting in a greater frequency of adverse pharmacological events. 1 5 However, This is not optimal because patient compliance decreases as the dosing frequency of a drug increases. Lacosamide has an elimination half-life of about 13 h, making it an ideal candidate for twice daily dosing with an immediate release formulation. T max usually occurs between 1 and 4 h after administration and food does not affect the rate or extent of absorption. 6 7 Lacosamide has an aqueous solubility of about 27 g/L, and is rapidly and completely absorbed by the body following firstorder kinetics. ![]() After single-dose oral or intravenous administration, the plasma concentration of lacosamide increases in a dose-dependent manner with oral doses up to 800 mg and intravenous doses up to 300 mg. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.) Filing date Publication date Priority to SIP-201400310 priority Critical Priority to SI201400310A priority patent/SI24807A/en Application filed by Dejan Lamesic filed Critical Dejan Lamesic Priority to PCT/SI2015/000029 priority patent/WO2016039698A1/en Assigned to LAMESIC, Dejan reassignment LAMESIC, Dejan ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).The pharmacokinetic profile of lacosamide exhibits low intra- and inter-patient variability. ( en Inventor Dejan Lamesic Zoran Lavric Ilija Ilic Odon Planinsek Original Assignee Dejan Lamesic Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.) Active Application number US15/510,970 Other versions US20170239184A1 Google Patents Particles of spherically agglomerated lactose for direct compression and method of preparation thereofĭownload PDF Info Publication number US10568837B2 US10568837B2 US15/510,970 US201515510970A US10568837B2 US 10568837 B2 US10568837 B2 US 10568837B2 US 201515510970 A US201515510970 A US 201515510970A US 10568837 B2 US10568837 B2 US 10568837B2 Authority US United States Prior art keywords particles lactose spherically agglomerated mixture spherically Prior art date Legal status (The legal status is an assumption and is not a legal conclusion. Google Patents US10568837B2 - Particles of spherically agglomerated lactose for direct compression and method of preparation thereof US10568837B2 - Particles of spherically agglomerated lactose for direct compression and method of preparation thereof
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