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Improved Pharmacokinetic Profiles of methylphenidate for ADHD (09-22)

University of Arkansas for Medical Sciences
Drug delivery, novel time release

Mechanism of action

Sustained-release formulations - novel pharmaceutical composition

Full description

Improved Pharmacokinetic Profiles of methylphenidate for ADHD

Applications:  A pharmaceutical dosage form comprising both immediate release and extended release doses of methylphenidate

Most drugs are administered orally in formulations that dissolve quickly in the gastrointestinal tract and are absorbed quickly into the blood stream.  Thus, the administered dose is quickly dissipated and the effective concentration of the drug in the blood stream is transient and necessitates frequent dosing.    For many drugs a timed release or delayed release pharmaceutical formulation would be preferred for improved efficacy and patient compliance.

Sustained-release formulations avoid or lessen these problems and decrease the number and frequency of doses, resulting in steadier concentrations of the drug in the blood stream.  Methylphenidate (MPH) is the most commonly prescribed psychostimulant and is used for the treatment of attention-deficit hyperactivity disorder (ADHD) found largely in the child population. Banded names for methylphenidate are Ritalin, Adderall or Vyanse.  Annual U.S. sales for MPH totaled about $4.8 billion in 2008.  All these formulations are instant- release racemic mixtures of MPH.

University researchers have developed a pharmaceutical composition capable of releasing methylphenidate which yields a novel pharmacokinetic profile. Upon administering the drug a peak concentration is achieved in approximately 1.75 hours, after which a sustained release rate is maintained over an extended period of time.   In vitro data is available that demonstrates the sustained release determined for MPH is predicted by computer simulation of the expected pharmacokinetic profile in vivo. 

This novel controlled release is superior to both the CONCERTA® and the FOCALIN XR® administration of methylphenidate, especially in children who are not permitted to possess extra doses of their needed drug at school and require the supervision of the school nurse.   Better patient compliance and efficacy are anticipated with the pharmacokinetic profile anticipated for this drug.

Currently, research is ongoing to secure the human pharmacokinetic profiles of the descending rate of the mean concentrations of methylphenidate in the circulatory system.

            Patent Pending

            Available for Exclusive Licensing

09-22 KIM

Development status

Preclinical

Patent information

Pending - U.S. Proivisiona Application filed 07/13/2009

Type of business relationship sought

Seeking developmental partner who will commercialize this innovation.

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