medikinet

PURPOSE: This study aims to evaluate early changes in retinal structure and BMP2 expression in the retina and crystalline lens by comparing streptozotocin-induced diabetic pigs and normal control group pigs. METHODS: Five eye samples from five diabetic Micro-pigs (Medikinetics, Pyeongtaek, Korea) and five eye samples from five control pigs bred in a specific pathogen-free area were used. Diabetes was developed through intravenous injection of nicotinamide and streptozotocin, and the average fasting glucose level was maintained at 250 mg/dL or higher for 16 weeks...

BACKGROUND: Treatment responses to methylphenidate by adults with ADHD are generally monitored against DSM-IV/DSM-V symptomatology, rating scales or interviews during reviews. AIMS: To evaluate the use of single- and dual-dimension processing-speed and efficiency measures to monitor the effects of pharmacological treatment with methylphenidate after a short period off medication. METHODS: A Quick Test of Cognitive Speed (AQT) monitored the effects of immediate-release methylphenidate in 40 previously diagnosed and medicated adults with ADHD...

A previously presented physiologically-based pharmacokinetic model for immediate release (IR) methylphenidate (MPH) was extended to characterize the pharmacokinetic behaviors of oral extended release (ER) MPH formulations in adults for the first time. Information on the anatomy and physiology of the gastrointestinal (GI) tract, together with the biopharmaceutical properties of MPH, was integrated into the original model, with model parameters representing hepatic metabolism and intestinal non-specific loss recalibrated against in vitro and in vivo kinetic data sets with IR MPH...

BACKGROUND: Attention-Deficit/Hyperactivity Disorder (ADHD) is a common psychiatric disorder in children and adolescents. Immediate-release methylphenidate (IR-MPH) is the medical treatment of first choice. The necessity to use several IR-MPH tablets per day and associated potential social stigma at school often leads to reduced compliance, sub-optimal treatment, and therefore economic loss. Replacement of IR-MPH with a single-dose extended release (ER-MPH) formulation may improve drug response and economic efficiency...

BACKGROUND: The stimulant methylphenidate (MPH) has been a mainstay of treatment for attention-deficit/hyperactivity disorder (ADHD) for many years. Owing to the short half-life and the issues associated with multiple daily dosing of immediate-release MPH formulations, a new generation of long-acting MPH formulations has emerged. Direct head-to-head studies of these long-acting MPH formulations are important to facilitate an evaluation of their comparative pharmacokinetics and efficacy; however, to date, relatively few head-to-head studies have been performed...

This multi-centre, open-label, non-interventional study evaluates effectiveness, safety and adherence to treatment of a specific extended-release methylphenidate with a 50 % immediate and a 50 % extended-release component (Medikinet(®) retard) in the clinical routine treatment of 381 adolescents with ADHD and a mean age of 14.0 ± 1.9 years. ADHD and associated psychiatric symptoms, medication status and dosage frequency, treatment adherence and adverse events were assessed at baseline and after a median treatment length with Medikinet(®) retard of 70 days...

INTRODUCTION: Attention-deficit hyperactivity disorder (ADHD) is a common neurobehavioral disorder of which the main features are inattention, hyperactivity and impulsivity. Methylphenidate (MPH) is the mainstay of treatment, but its short duration of action and consequent need for multiple administrations has been problematic for children attending school. Extended-release (ER) formulations have been developed to help overcome the drawbacks associated with immediate-release (IR) preparations...

DAYAS is a new two-part rating scale that assesses: (1) ADHD and ODD symptoms (externalising symptom ratings) and (2) symptomatology potentially related to ADHD medication (potentially medication-related symptoms) in real-world settings at different time periods throughout a normal school day. Data from a proof-of-concept study and two observational trials (Medikinet(®) retard [methylphenidate] and the Equasym XL(®) [methylphenidate] OBSEER study) evaluated: (1) validity of weekly externalising symptom ratings using DAYAS, in place of daily ratings; (2) reliability and internal consistency of DAYAS ratings for externalising symptoms and potentially medication-related symptoms; and (3) convergent and divergent validity of the externalising symptom ratings with existing validated scales...

OBJECTIVE: The comparison of the efficacy of Medikinet(®) retard and Concerta(®) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years). The duration of the study per patient was 3 weeks...

BACKGROUND: To explore the clinical outcomes of children/adolescents with ADHD who transitioned from extended-release methylphenidate (ER MPH, Medikinet Retard) to osmotic release oral system (OROS) MPH (Concerta). Medikinet Retard is a registered trade name of Medice, Bad Iserlohn, Germany. Concerta is a registered trade name of Janssen-Cilag GmbH, Neuss, Germany. METHODS: This prospective, non-interventional study included patients aged 6 to 18 years with a confirmed diagnosis of ADHD who experienced insufficient clinical response and/or poor tolerability on ER MPH...

OBJECTIVES: The primary objective of this study was to demonstrate efficacy of Ritalin(®) LA 20 mg by showing superiority to placebo and noninferiority to Medikinet(®) Retard in a laboratory classroom setting. Secondary objectives included safety/tolerability and further efficacy parameters. METHODS: A total of 147 children with attention-deficit/hyperactivity disorder (ADHD) diagnosed by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) and aged 6-14 (81% males) and known to be methylphenidate (MPH) responders were enrolled in this multicenter, double-blind, randomized, placebo/active-controlled, three-period (7 days each) crossover study...

INTRODUCTION: The objective of the study was to assess the efficacy of extended-release methylphenidate (Mph-ER) (Medikinet; MEDICE Arzneimittel Pütter GmbH & Co KG, Iserlohn, Germany) in the pediatric population with attention deficit/hyperactivity disorder (ADHD); a parallel analysis of the validity of various tools for monitoring short-term clinical response to treatment was made. METHODS: This was a retrospective analysis of 94 children with ADHD who received treatment with Mph-ER...

OBJECTIVE: To assess bioequivalence between Equasym Retard and Medikinet retard containing 20 mg methylphenidate (MPH) hydrochloride in a fed state. MATERIALS: Equasym Retard 20 mg capsules (UCB, Monheim, Germany) and Medikinet retard 20 mg capsules (Medice, Iserlohn, Germany). METHODS: This was an open, single-center, randomized, 2-period, 2-sequence, balanced cross-over study with a wash-out period of 1 week between administrations in 14 healthy male and female volunteers, aged 18 - 45 years...

The purpose of this review is to facilitate discussion on drug selection for the treatment of ADHD by using only clinically relevant selection criteria and providing an up-to-date overview. The InforMatrix method was used to select drugs to treat attention deficit hyperactivity disorder (ADHD). The following selection criteria were applied: clinical efficacy, safety, tolerability, ease of use, applicability, and cost. The drugs approved for ADHD in the Netherlands were included in the analysis, namely: atomoxetine, immediate-release methylphenidate, and various formulations of slow-release methylphenidate (Concerta, Equasym and Medikinet)...

OBJECTIVES: Primary objective was to investigate bioequivalence of Ritalin LA(R); 40 mg compared to Medikinet retard 40 mg in healthy male volunteers under fasted and fed conditions. Secondary objectives included assessment of tolerability and determination of further pharmacokinetic parameters. The difference between the kinetic profiles of Ritalin LA(R) and Medikinet retard with respect to breakfast intake was additionally explored. METHODS: 28 subjects were randomized in this open-label, four-treatment, cross-over-design study...

Given its high heritability, ADHD frequently affects both children and their parents. In addition to co-morbid psychiatric disorders, adults with ADHD often complain of psychosocial difficulties, including family conflicts and poor parenting skills. Inconsistent childrearing practices and parent-child conflicts negatively affect the course of ADHD in children. Moreover, in the case of parental ADHD, the efficacy of parent training as part of the treatment for the child's ADHD seems to be reduced. This article presents a review of the impact of ADHD in mothers on the treatment of their ADHD children...

INTRODUCTION: Aggression is frequently observed in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The aim of this study was to assess the efficacy with regard to oppositional and aggressive behavior of a new long-acting methylphenidate preparation (Medikinet retard, MPH-MR), with equal portions of the immediate-release and the sustained-release active substance, and especially to look at correlations between either teacher or parent assessment of aggression and ADHD sub-symptomatology...

OBJECTIVE: To assess bioequivalence between an intact capsule and the content of a capsule sprinkled on applesauce. MATERIALS: Medikinet retard 20 mg capsules were obtained from Medice (Iserlohn, Germany). METHODS: This was a single-center, completely randomized, open, 2-period, 2-sequence, balanced crossover study with a washout period of 1 week between administrations, in 12 healthy male and female subjects, aged 18-45 years. Blood samples were collected over 24 hours and methylphenidate plasma concentration-time data were used to calculate pharmacokinetic parameters for both administrations...

OBJECTIVES: In order to treat children with Attention-deficit/Hyperactivity Disorder (ADHD) with a once-a-day stimulant several galenic approaches have been tried. The long acting methylphenidate (MPH, Medikinet-Retard) is a preparation with a two-step dynamic to release MPH (step one: acute; step two: prolonged). The efficacy of Medikinet-Retard, a new long-acting methylphenidate preparation, is analyzed based on the assessment of parents in the afternoon. METHODS: In a multicenter drug treatment study (placebo controlled, randomized, double-blind) 85 children (normal intelligence, age 6 to 16 years, diagnosis of ADHD according to DSM-IV) were investigated over 4 weeks with weekly visits...

BACKGROUND: Given the dosing limitations of methylphenidate short-acting preparations in treating ADHD, galenics with longer release of the substance were developed mainly to avoid drug intake during school hours. OBJECTIVES: This investigation was conducted to assess the efficacy and the duration of action of a new extended-release formulation of methylphenidate (Medikinet retard) as a once-daily treatment for children with attention-deficit hyperactivity disorder (ADHD)...