Related Experiment Video
Updated: Jul 25, 2025
08:06
Assessment of the Metabolic Effects of Isocaloric 2:1 Intermittent Fasting in Mice
Published on: November 27, 2019
9.0K
Methylphenidate Multiphasic Release Tablet: Bioequivalence Assessment between Two Formulations Administered under
Marcelo Gomes Davanço1, Jessica Meulman1, Thalita Martins da Silva1
1Medical Department, Adium S.A., São Paulo 04794-000, SP, Brazil.
Pharmaceutics
|June 28, 2023
Summary
This study found that Consiv®, a new methylphenidate hydrochloride extended-release tablet, is bioequivalent to Concerta®. This means Consiv® can be used interchangeably with Concerta® for treating attention deficit/hyperactivity disorder (ADHD).
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Regulatory Science
Background:
- Methylphenidate hydrochloride is a key treatment for attention deficit/hyperactivity disorder (ADHD) across age groups.
- Extended-release formulations aim to optimize drug delivery, particularly for pediatric patients during school hours.
- Evaluating bioequivalence is crucial for regulatory approval and ensuring therapeutic interchangeability.
Purpose of the Study:
- To assess the bioequivalence of a new methylphenidate hydrochloride 54 mg extended-release tablet (Consiv®) compared to the reference product (Concerta®).
- To meet the stringent bioequivalence requirements for pharmaceutical product registration in Brazil.
- To confirm therapeutic interchangeability between the test and reference formulations under fasting and fed conditions.
Main Methods:
- Two independent, open-label, randomized, single-dose, two-period crossover bioequivalence studies were conducted in healthy adult subjects.
- Participants received either the test (Consiv®) or reference (Concerta®) formulation under fasting and fed conditions, with a 7-day washout period.
- Plasma methylphenidate concentrations were quantified using a validated LC-MS/MS method, with pharmacokinetic parameters analyzed.
Main Results:
- The 90% confidence intervals for key pharmacokinetic parameters (Cmax, AUC0-t, AUC0-inf, partial AUCs) fell within the regulatory acceptance range of 80.00% to 125.00% for both fasting and fed studies.
- The test formulation (Consiv®) demonstrated bioequivalence to the reference formulation (Concerta®) under both tested conditions.
- Both methylphenidate hydrochloride formulations were found to be safe and well-tolerated following single-dose administration.
Conclusions:
- The methylphenidate hydrochloride extended-release 54 mg tablet (Consiv®) is bioequivalent to Concerta®.
- Consiv® can be considered interchangeable with Concerta® in clinical practice for ADHD treatment, meeting Brazilian regulatory standards.
- The study confirms the safety and tolerability profile of Consiv® upon single-dose administration.
Keywords:
attention deficit/hyperactivity disorder (ADHD)bioavailabilitybioequivalenceextended-releasemethylphenidatepharmacokineticsMore Related Videos
Related Concept Videos
01:16Bioequivalence: Overview
1.1K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.1K
01:02Noncompartmental Analysis: Mean Transit, Absorption and Dissolution Time
121
When drugs are administered extravascularly, a comprehensive evaluation through noncompartmental analysis becomes imperative. This analytical approach considers various parameters that play a crucial role in understanding the pharmacokinetics of these drugs.
One of the key parameters is the mean transit time (MTT), which refers to the total duration required for drug molecules to transit through the body. MTT is determined by calculating the ratio of the area under the moment curve to the area...
One of the key parameters is the mean transit time (MTT), which refers to the total duration required for drug molecules to transit through the body. MTT is determined by calculating the ratio of the area under the moment curve to the area...
121
01:23Nonlinear Pharmacokinetics: Dependence of Elimination Half-Life and Dose Clearance
211
The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
A study on guinea pigs examined the...
A study on guinea pigs examined the...
211
01:15Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
93
Circadian rhythms are cyclic changes that are crucial in plasma drug concentrations. Various standard circadian parameters, including core body temperature, heart rate, and other cardiovascular factors, directly impact disease states and the therapeutic response to drug therapy.
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
93