Claims for Patent: 10,568,841

Summary for Patent: 10,568,841

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Vargas Rincon; Ricardo Alberto (Mississauga, CA), Reiz; Joseph (Markham, CA)
Assignee:	PURDUE PHARMA L.P. (Stamford, CT)
Application Number:	16/422,177
Patent Claims:	1. A method of treating attention deficit hyperactivity disorder ("ADHD") in a subject in need thereof, the method comprising administering to the subject a methylphenidate hydrochloride oral dosage form means including: an immediate release component for providing, in a fasted state, an in vivo methylphenidate T.sub.max0-4 of about 1.63 hours in the subject in need thereof; and a controlled and delayed release component for providing, in a fasted state, an in vivo methylphenidate T.sub.max8-16 of about 12.5 hours in the subject in need thereof, wherein the oral dosage form means further provides efficacious treatment of ADHD for 16 hours after a single oral administration. 2. The method of claim 1, wherein the oral dosage form means provides 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride. 3. A methylphenidate hydrochloride oral dosage form means including: an immediate release component for providing, in a fasted state, an in vivo methylphenidate T.sub.max0-4 of about 1.63 hours; and a controlled and delayed release component for providing, in a fasted state, an in vivo methylphenidate T.sub.max8-16 of about 12.5 hours, wherein upon oral administration, the methylphenidate oral dosage form means provides efficacious treatment of ADHD for 16 hours after a single oral dose. 4. The oral dosage form means of claim 3, wherein the oral dosage form means provides 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride. 5. A method of treating ADHD in a subject in need thereof, the method comprising administering to the subject an effective amount of an oral dosage form comprising: a) 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride, wherein a portion of the 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride is provided immediately upon oral administration; and b) a controlled and delayed methylphenidate hydrochloride delivery means for providing, in a fasted state, an in vivo methylphenidate T.sub.max8-16 of about 12.5 hours in the subject, such that the dosage form provides efficacious treatment of ADHD for 16 hours after a single oral administration. 6. The method of claim 5, wherein about 20% by weight of the 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride is released immediately upon oral administration. 7. The method of claim 6, wherein the controlled and delayed methylphenidate hydrochloride delivery means provides about 80% by weight of the 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride. 8. A methylphenidate hydrochloride dosage form comprising: a) 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride, wherein a portion of the 25, 30, 35, 45, 55, 70, 85, or 100 mg methylphenidate hydrochloride is provided immediately upon oral administration; and b) a controlled and delayed release methylphenidate hydrochloride delivery means for providing, in a fasted state, an in vivo methylphenidate T.sub.max8-16 of about 12.5 hours, such that the dosage form provides efficacious treatment of ADHD for 16 hours after a single oral dose.