US2020000791A1PendingUtilityA1
Oral pharmaceutical dosage forms
Est. expiryNov 3, 2028(~2.3 yrs left)· nominal 20-yr term from priority
A61P 25/00A61K 31/4458A61K 9/1623A61K 9/1617A61K 9/4808A61K 9/4858A61K 9/5084A61K 9/0053
66
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Claims
Abstract
Controlled release oral dosage forms suitable for administration of methylphenidate are provided. Abuse-resistant controlled release oral dosage forms suitable for administration of methylphenidate are also provided. Methods of treating ADD and ADHD using the oral dosage forms are also provided.
Claims
exact text as granted — not AI-modified1 .- 57 . (canceled)
58 . A formulation comprising:
methylphenidate; sucrose acetate isobutyrate (SAIB); a rheology modifier; a network former; a solvent; a viscosity enhancing agent; and a saturated polyglycolized glyceride, wherein the formulation does not include hydroxyethylcellulose (HEC).
59 . The formulation of claim 58 , wherein the methylphenidate is present in the formulation at about 5 wt % to about 30 wt % relative to the total weight of the formulation.
60 . The formulation of claim 58 , wherein the SAIB is present in the formulation at about 30 wt % to about 45 wt % relative to the total weight of the formulation.
61 . The formulation of claim 58 , wherein the rheology modifier comprises isopropyl myristate (IPM).
62 . The formulation of claim 61 , wherein the IPM is present in the formulation at about 2 wt % to about 15 wt % relative to the total weight of the formulation.
63 . The formulation of claim 58 , wherein the network former comprises cellulose acetate butyrate (CAB).
64 . The formulation of claim 63 , wherein the CAB is present in the formulation at about 2 wt % to about 10 wt % relative to the total weight of the formulation.
65 . The formulation of claim 58 , wherein the solvent comprises triacetin.
66 . The formulation of claim 65 , wherein the triacetin is present in the formulation at about 15 wt % to about 40 wt % relative to the total weight of the formulation.
67 . The formulation of claim 58 , wherein the viscosity enhancing agent comprises a stiffening agent.
68 . The formulation of claim 58 , wherein the viscosity enhancing agent comprises silicon dioxide (SiO 2 ).
69 . The formulation of claim 68 , wherein the SiO 2 is present in the formulation at about 0.1 wt % to about 2 wt % relative to the total weight of the formulation.
70 . The formulation of claim 58 , wherein the saturated polyglycolized glyceride is present in the formulation at about 0.01 wt % to about 5 wt % relative to the total weight of the formulation.
71 . A formulation comprising:
methylphenidate; sucrose acetate isobutyrate (SAIB); a rheology modifier; a network former; a solvent; a viscosity enhancing agent; a saturated polyglycolized glyceride; and a stabilizer.
72 . The formulation of claim 71 , wherein the methylphenidate is present in the formulation at about 5 wt % to about 30 wt % relative to the total weight of the formulation.
73 . The formulation of claim 71 , wherein the SAIB is present in the formulation at about 30 wt % to about 45 wt % relative to the total weight of the formulation.
74 . The formulation of claim 71 , wherein the rheology modifier comprises isopropyl myristate (IPM).
75 . The formulation of claim 74 , wherein the IPM is present in the formulation at about 2 wt % to about 15 wt % relative to the total weight of the formulation.
76 . The formulation of claim 71 , wherein the network former comprises cellulose acetate butyrate (CAB).
77 . The formulation of claim 76 , wherein the CAB is present in the formulation at about 2 wt % to about 10 wt % relative to the total weight of the formulation.
78 . The formulation of claim 71 , wherein the solvent comprises triacetin.
79 . The formulation of claim 78 , wherein the triacetin is present in the formulation at about 15 wt % to about 40 wt % relative to the total weight of the formulation.
80 . The formulation of claim 71 , wherein the viscosity enhancing agent comprises a stiffening agent.
81 . The formulation of claim 71 , wherein the viscosity enhancing agent comprises silicon dioxide (SiO 2 ).
82 . The formulation of claim 81 , wherein the SiO 2 is present in the formulation at about 0.1 wt % to about 2 wt % relative to the total weight of the formulation.
83 . The formulation of claim 71 , wherein the saturated polyglycolized glyceride is present in the formulation at about 0.01 wt % to about 5 wt % relative to the total weight of the formulation.
84 . The formulation of claim 71 , wherein the stabilizer comprises an antioxidant.
85 . The formulation of claim 84 , wherein the stabilizer comprises at least one compound selected from sodium citrate, ascorbyl palmitate, vitamin A, and propyl gallate, ascorbic acid, vitamin E, sodium bisulfite, butylhydroxyl toluene (BHT), butylhydroxyl acid (BHA), acetylcysteine, monothioglycerol, phenyl-alpha-naphthylamine, lecithin, and ethylenediaminetetraacetic acid (EDTA).
86 . The formulation of claim 85 , wherein the stabilizer comprises BHT.Join the waitlist — get patent alerts
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