IP Library Granted Patent US 11,033,508
Granted Patent B2
US 11,033,508 · App. 16/002,285 · Granted Jun 15, 2021

Delayed sustained release pharmaceutical compositions

Inventors: Tsz Chung Lai (Webster Groves, MO); Alexander Brian Lippold (Webster Groves, MO); Rebecca Sue Walker (Webster Groves, MO); Jae Han Park (Webster Groves, MO)
Assignee: SpecGX LLC
A61K9/5026A61K9/1623A61K9/1676A61K9/2081A61K9/4808A61K9/5078A61K31/137A61K9/5047
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Quick Facts
Patent No.
US 11,033,508
App. No.
16/002,285
Granted
Jun 15, 2021
Kind
B2
Abstract

Delayed sustained release pharmaceutical compositions that provide therapeutic effects over extended periods of time (i.e., 14-16 hours).

Claims (11)

1. A pharmaceutical composition consisting of:

a plurality of immediate release beads, each immediate release bead consisting of an amphetamine core, wherein the amphetamine core consists of at least one amphetamine salt and an optional binder layered onto or incorporated into an inert core;

a plurality of delayed release beads, each delayed release bead consisting of an immediate release bead and a delayed release coating layered thereover, wherein the delayed release coating consists of a copolymer of methacrylic acid and ethyl acrylate and an optional excipient, and is present at a coating level of about 25% to about 30% by weight of the bead; and

a plurality of delayed sustained release beads, each delayed sustained release bead consisting of an immediate release bead, a sustained release coating layered over the immediate release bead, and a delayed release coating layered over the sustained release coating, wherein the sustained release coating consists of ethyl cellulose and is present at a coating level from about 5% to about 9% by weight of the bead, and the delayed release coating consists a copolymer of methacrylic acid, methyl methacrylate, and methyl acrylate and an optional excipient, and is present at a coating level from about 20% to about 25% by weight of the bead;

wherein the pharmaceutical composition has a d-amphetamine T max from 7.9 hours to 8.8 hours after administration of a 30 mg dose of the pharmaceutical composition to a fasting human subject.

2. The pharmaceutical composition of claim 1 , wherein the at least one amphetamine salt is dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate, or mixtures thereof, and the at least one amphetamine salt is present in the pharmaceutical composition in an amount from 12.5 mg to 75 mg.

3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition has a d-amphetamine C max from about 41 ng/ml to about 44 ng/mL, and a d-amphetamine AUC inf from about 884 ng·h/mL to about 934 ng·h/mL after administration of a 30 mg dose of the pharmaceutical composition to a fasting human subject.

4. The pharmaceutical composition of claim 1 , wherein the pluralities of immediate release beads, delayed release beads, and delayed sustained release beads are incorporated into a capsule.

5. The pharmaceutical composition of claim 1 , wherein the pluralities of immediate release beads, delayed release beads, and delayed sustained release beads are incorporated into a tablet.

6. The pharmaceutical composition of claim 1 , wherein each of the pluralities of immediate release beads, delayed release beads, and delayed sustained release beads comprises 33.3% by weight of the at least one amphetamine salt.

7. A method for treating for treating attention deficit hyperactivity disorder (ADHD), the method comprises administering to a patient in need thereof the pharmaceutical composition of claim 1 .

Assignments (13)
RELEASE OF SECURITY INTEREST Recorded Aug 14, 2025
From: ACQUIOM AGENCY SERVICES LLC
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
Reel/Frame 072324/0740 →
INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 31, 2025
From: SPECGX LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS COLLATERAL AGENT
Reel/Frame 072313/0063 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 060434, FRAME 0536 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; VTESSE LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; SUCAMPO PHARMA AMERICAS LLC
Reel/Frame 065601/0347 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 049823, FRAME 0233 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS LLC (F/K/A MALLINCKRODT US HOLDINGS INC.); MALLINCKRODT CARRIBEAN, INC.; MALLINCKRODT US POOL LLC; MNK 2011 LLC (F/K/A MALLINCKRODT INC.); LUDLOW LLC (F/K/A LUDLOW CORPORATION); CNS THERAPEUTICS, INC.; MALLINCKRODT ENTERPRISES HOLDINGS LLC (F/K/A MALLINCKRODT ENTERPRISES HOLDINGS, INC.); MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS LLC (F/K/A MALLINCKRODT BRAND PHARMACEUTICALS, INC.); MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC.; MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC (F/K/A VTESSE INC.); MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING D.A.C.); INFACARE PHARMACEUTICAL CORPORATION; ST SHARED SERVICES LLC; THERAKOS, INC.; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0629 →
RELEASE OF SECURITY INTERESTS IN PATENTS AT REEL 060389/FRAME 0913 Recorded Nov 15, 2023
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS LLC (F/K/A OCERA THERAPEUTICS, INC.); MALLINCKRODT LLC; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
Reel/Frame 065583/0465 →
SECURITY INTEREST Recorded Nov 15, 2023
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; OCERA THERAPEUTICS LLC; SPECGX LLC; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC
To: ACQUIOM AGENCY SERVICES LLC
Reel/Frame 065595/0376 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jun 22, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 060434/0536 →
RELEASE OF SECURITY INTEREST Recorded Jun 17, 2022
From: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
To: OCERA THERAPEUTICS, INC.; MALLINCKRODT LLC; MALLINCKRODT ARD IP UNLIMITED COMPANY (F/K/A MALLINCKRODT ARD IP LIMITED); MALLINCKRODT HOSPITAL PRODUCTS IP UNLIMITED COMPANY (F/K/A MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED); MALLINCKRODT PHARMA IP TRADING UNLIMITED COMPANY (F/K/A MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY); SPECGX LLC; STRATATECH CORPORATION; VTESSE LLC (F/K/A VTESSE INC.)
Reel/Frame 060389/0839 →
SECURITY INTEREST Recorded Jun 17, 2022
From: MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; SPECGX LLC; OCERA THERAPEUTICS, INC.; STRATATECH CORPORATION; SUCAMPO PHARMA AMERICAS LLC; VTESSE LLC; MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 060389/0913 →
SECURITY INTEREST Recorded Dec 10, 2019
From: MALLINCKRODT ARD IP LIMITED; MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED; SPECGX LLC; OCERA THERAPEUTICS, INC.; MALLINCKRODT PHARMA IP TRADING DESIGNATED ACTIVITY COMPANY; STRATATECH CORPORATION; VTESSE INC.; MALLINCKRODT LLC
To: WILMINGTON SAVINGS FUND SOCIETY, FSB, AS SECOND LIEN COLLATERAL AGENT
Reel/Frame 051256/0829 →
NOTICE OF GRANT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY Recorded Jul 22, 2019
From: SPECGX LLC
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 049823/0233 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2018
From: LAI, TSZ CHUNG; LIPPOLD, ALEXANDER BRIAN; WALKER, REBECCA SUE; PARK, JAE HAN
To: MALLINCKRODT LLC
Reel/Frame 047841/0620 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 14, 2018
From: MALLINCKRODT LLC
To: SPECGX LLC
Reel/Frame 047225/0034 →
Cited By (1)
US 12,599,563