Effective Dosing of a Child for the Treatment of ADHD with Methylphenidate
AssigneeNeos Therapeutics, LP
InventorsMark TENGLER, Nathan TEUSCHER
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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).
Claims32
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 the conditions of the dissolution assay are an initial dissolution medium of 0.1 N HCl, 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.
A method of treating a patient in need thereof (e.g., a child) with a therapeutically effective amount of an oral dose form of a composition comprising methylphenidate which provides a plasma profile bioequivalent to a reference composition.
A method of treating a patient in need thereof (e.g., a child) with a therapeutically effective amount of an oral dose form of a composition comprising methylphenidate which provides a serum profile bioequivalent to a reference composition.
A method of treating a patient in need thereof (e.g., a child) with a therapeutically effective amount of an oral dose form of a composition comprising methylphenidate which provides a bloodstream profile bioequivalent to a reference composition.
A method of treating ADHD comprising administering to an individual patient a therapeutically effective amount for said individual patient of an oral dose form, wherein, for in vivo pharmacokinetic parameters of the composition, at least one in vivo pharmacokinetic parameters selected from the group consisting of Cmax, AUC0-5, AUC5-12, AUC5-24, AUC5-t, AUC0-12, AUC0-24, AUC0-t, and AUC0-∞ 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.
A composition comprising methylphenidate hydrochloride for use in treating ADHD, wherein the composition 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 the conditions of the dissolution assay are an initial dissolution medium of 0.1 N HCl, 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 that produces an in vitro profile of at least one in vivo pharmacokinetic parameters selected from the group consisting of Cmax, AUC0-5, AUC5-12, AUC5-24, AUC5-t, AUC0-12, AUC0-24, AUC0-t, and AUC0-∞ having 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.
A method of assisting a physician in prescribing a dose of methylphenidate 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 identified dosage amount includes an amount equivalent to about 10 to about 60 mg of methylphenidate hydrochloride.
A method of assisting a physician in prescribing a dose of methylphenidate 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:
- Amount of Methylphenidate•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
A method for generating a dosage chart based on a pharmacokinetic-pharmacodynamic correlation for a particular drug formulation comprising:
- (a) measuring serum concentration at various times after dose administration in a first test population for a pharmaceutical active component in a drug formulation in accordance with to a serum concentration profile for the drug formulation,
- (b) generating a pharmacokinetic equation corresponding to said serum concentration profile of step (a) comprising a finite number of pharmacokinetic parameters specific to the drug formulation,
- (c) generating a correlation between the pharmacokinetics and pharmacodynamics of the drug formulation for a second test population comprising:
- (i) measuring the pharmacodynamic effect of the active component in the drug formulation at various times in the second test population,
- (ii) calculating a predicted serum concentration of the active component in the drug formulation in the second test population based on the generated pharmacokinetic equation,
- (iii) fitting the measured data of the pharmacodynamic effect and the predicted data of the pharmacokinetic equation for each point in time to produce a pharmacokinetic-pharmacodynamic correlation, and
- (d) generating a dosage chart, based on the correlation between the pharmacokinetics and pharmacodynamics of the drug formulation, which specifies an effective amount of the drug formulation.
Dependencies are inferred from the claim text.