IP Library › Granted Patent US 12,274,791
Granted Patent B2
US 12,274,791 · App. 18/372,560 · Granted Apr 15, 2025

Multiple unit dosage form having a therapeutic agent in combination with a nutritional supplement

Inventor: James R. Komorowski (Trumbull, CT)
A61K9/209A23L33/15A61K9/00A61K9/0053A61K31/155A61K33/24A61K45/06A23V2002/00Y02A50/30
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Quick Facts
Patent No.
US 12,274,791
App. No.
18/372,560
Granted
Apr 15, 2025
Kind
B2
Abstract

Compositions and methods for combination therapy are provided. The compositions comprise a multiple unit dosage form having both a therapeutic agent and a nutritional supplement. The combination therapy is useful for restoring a nutrient depletion associated with a particular disease state. Additionally, the combination therapy can prevent or attenuate the depletion of a nutrient caused, in whole or in part, by the co-administrated therapeutic drug. Methods of manufacturing the formulations are likewise described.

Claims (11)

1. A dosage form for oral administration comprising:

a therapeutic agent layer;

a nutritional supplement layer; and

a middle barrier layer disposed between the therapeutic agent layer and the nutritional supplement layer,

wherein the therapeutic agent layer and the nutritional supplement layer are positioned on opposing sides of the middle barrier layer; and

wherein the therapeutic agent is selected from the group consisting of anti-inflammatories, macromolecules, antifungals, antidepressants, antipsychotics, anesthetics, anxiolytics, anticonvulsants, nervous system stimulants, antiemetics, bronchodilators, decongestants, antibiotics, anti-virals, immuno-suppressants, hormonal contraceptives, selective estrogen receptor modulators, fertility agents, hallucinogens, mood stabilizers, angiotensin converting enzyme inhibitors, antiarrhythmics, antianginals, anticoagulants, antiplatelets, beta blockers, diuretics, thrombolytics, antidiarrheals, laxatives, antirheumatics, corticosteroids, muscle relaxants, anti-histamines, anti-diabetics, alpha glucosidase inhibitors, DPP-4 inhibitors, antihypertensives, vasodilators, protease inhibitors, vaccines, anti-protozoals, antihelmintics and any combination thereof.

2. The dosage form of claim 1 , wherein the therapeutic agent is provided in a therapeutically effective amount.

3. The dosage form of claim 1 , wherein the therapeutic agent is selected from the group consisting of anti-inflammatoires, macromolecules, vaccines, and any combination thereof.

4. The dosage form of claim 1 , wherein the nutritional supplement is selected from the group consisting of essential fatty acids, essential fatty alcohols, essential metals, essential amino acids, vitamins, and dietary minerals, and combinations thereof.

5. The dosage form of claim 4 , wherein the nutritional supplement is folate.

6. The dosage form of claim 1 , wherein the middle barrier layer is comprised of a controlled-release, delayed-release, a sustained release matrix, or enteric coating.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2023
From: KOMOROWSKI, JAMES R.
To: NUTRITION 21, INC.
Reel/Frame 065073/0313 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2023
From: NUTRITION 21, INC.
To: N21 ACQUISITION HOLDING, LLC
Reel/Frame 065073/0434 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2023
From: N21 ACQUISITION HOLDING, LLC
To: JDS THERAPEUTICS, LLC
Reel/Frame 065085/0468 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 29, 2023
From: JDS THERAPEUTICS, LLC
To: BONAFIDE HEALTH, LLC
Reel/Frame 065072/0787 →
Continuity (10)
Continuation 17686827 · Mar 4, 2022
Continuation 17558763 · Dec 22, 2021
Division 16524591 · Jul 29, 2019
Division 15215979 · Jul 21, 2016
Continuation 14642243 · Mar 9, 2015
Continuation 13857813 · Apr 5, 2013
Continuation 12645124 · Dec 22, 2009
Continuation PCTUS2008067736 · Jun 20, 2008
Provisional Application 60946357 · Jun 26, 2007
Related Publication 20240016746A1 · Jan 18, 2024
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