Claims for Patent: 11,166,947

Summary for Patent: 11,166,947

Title:	Effective dosing of a child for the treatment of ADHD with methylphenidate
Abstract:	The present invention generally relates to treating attention-deficit disorders (e.g., ADHD) by providing an effective amount of an ADHD-effective agent to a patient in need thereof (e.g., a child).
Inventor(s):	Tengler; Mark (Colleyville, TX), Teuscher; Nathan (Trophy Club, TX)
Assignee:	Neos Therapeutics, LP (Grand Prairie, TX)
Application Number:	16/346,850
Patent Claims:	1. A method of treating an individual patient comprising administering to said individual patient a therapeutically effective amount for said patient of an oral dose form containing an ADHD-effective agent, wherein the oral dose form has an in vitro profile of: 30-33% of the ADHD-effective agent is released within the first 30 minutes after the oral dose form is introduced into an in vitro dissolution assay, 34-42% of the agent is released within 2 hours, 40-80% of the agent is released within 4 hours, and 80-100% of the agent is released within 24 hours, wherein conditions of the dissolution assay are an initial dissolution medium of 0.1 N HC1, and after 2 hours, the medium is adjusted to a pH of about 6.8; and the dissolution assay is performed using a USP Apparatus 2, wherein, for in vivo pharmacokinetic parameters of the oral dose form, at least one in vivo pharmacokinetic parameters selected from the group consisting of C.sub.max, AUC.sub.0-5, AUC.sub.5-12, AUC.sub.5-24, AUC.sub.5-1, AUC.sub.0-12, AUC.sub.0-24, AUC.sub.0-t, and AUC.sub.0-.infin. have a 90% confidence interval with upper and lower bounds within a range from 80%-125% of the value of the same parameter(s) for a bioequivalent reference composition, wherein the oral dose form comprises: (a) a sustained release racemic methylphenidate component comprising a water-insoluble, water permeable, pH-independent barrier coated, racemic methylphenidate-ion exchange resin complex in a polymeric matrix, wherein said barrier coating is over the racemic methylphenidate-ion exchange resin complex-matrix; (b) a first immediate release component which comprises an immediate release uncoated racemic methylphenidate-ion exchange resin complex; and (c) a second immediate release racemic methylphenidate component which comprises an uncomplexed racemic methylphenidate, and wherein the therapeutically effective amount of the oral dose form is correlated to the body weight of said individual patient as follows: TABLE-US-00008 Amount of Methylphenidate.cndot.HCl Body Weight Range equivalent <12 kg <26 lb 10 mg 12-33 kg 26-73 lb 20 mg 33-55 kg 73-121 lb 30 mg 55-77 kg 121-169 lb 40 mg 77-99 kg 169-218 lb 50 mg >99 kg >218 lb 60 mg 2. A method of assisting a physician in prescribing a dose of methylphenidate formulated in the oral dose form of claim 1 for the treatment of attention deficit hyperactivity disorder (ADHD) in an individual patient, comprising: a. determining the body weight of said individual patient; b. referring to a chart or reference tool that correlates a plurality of body weight ranges with a corresponding number of dosage amounts each having a different level of methylphenidate; c. identifying a single dosage amount corresponding to a particular weight range in which said individual patient's weight falls in the chart or reference tool; and d. administering to said individual patient the identified dosage amount, wherein the chart or reference tool includes the following correlations between body weight range and said dosage amount of methylphenidate hydrochloride equivalent: TABLE-US-00009 Amount of Methylphenidate.cndot.HCl Body Weight Range equivalent <12 kg <26 lb 10 mg 12-33 kg 26-73 lb 20 mg 33-55 kg 73-121 lb 30 mg 55-77 kg 121-169 lb 40 mg 77-99 kg 169-218 lb 50 mg >99 kg >218 lb 60 mg