IP Library Granted Patent US 10,864,176
Granted Patent B2
US 10,864,176 · App. 16/140,105 · Granted Dec 15, 2020

Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

Inventors: Marino Nebuloni (Rho, IT); Patrizia Colombo (Trezzano sul Naviglio, IT)
Assignee: Tonix Pharma Holdings Limited
A61K31/135A61K9/145A61K9/1623A61K9/1688A61K9/1694A61K31/047A61K31/137A61K47/02A61K47/10A61K47/12A61K47/26A61K31/55
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Quick Facts
Patent No.
US 10,864,176
App. No.
16/140,105
Granted
Dec 15, 2020
Kind
B2
Abstract

The present invention relates to pharmaceutical compositions and methods of manufacturing the same, comprising a eutectic of Cyclobenzaprine HCl and mannitol or Amitriptyline HCl and mannitol.

Claims (11)

1. A pharmaceutical composition of comprising a eutectic of Amitriptyline HCl and mannitol, wherein the pharmaceutical composition comprises amounts of Amitriptyline HCl and mannitol selected from: 40%±2% Amitriptyline HCl and 60%±2% mannitol, 45%±2% Amitriptyline HCl and 55%±2% mannitol, 50%±2% Amitriptyline HCl and 50%±2% mannitol, 55%±2% Amitriptyline HCl and 45%±2% mannitol, 60%±2% Amitriptyline HCl and 40%±2% mannitol, 65%±2% Amitriptyline HCl and 35%±2% mannitol, 70%±2% Amitriptyline HCl and 30%±2% mannitol, 80%±2% Amitriptyline HCl and 20%±2% mannitol, 85%±2% Amitriptyline HCl and 15%±2% mannitol, and 90%±2% Amitriptyline HCl and 10%±2% mannitol by weight.

2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises 60%-90% Amitriptyline HCl and 40%-10% mannitol by weight.

3. The pharmaceutical composition of claim 1 , comprising 50%±2% Amitriptyline HCl and 50%±2% mannitol by weight.

4. The pharmaceutical composition of claim 1 , wherein the Amitriptyline HCl is micronized Amitriptyline HCl.

5. The pharmaceutical composition of claim 1 , further comprising a basifying agent.

6. The pharmaceutical composition of claim 5 , wherein the basifying agent is K 2 HPO 4 , Na 2 HPO 4 or anhydrous trisodium citrate.

7. The pharmaceutical composition of claim 1 , wherein the mannitol in the eutectic is β mannitol.

8. The pharmaceutical composition of claim 1 , wherein the mannitol in the eutectic is δ mannitol.

9. The pharmaceutical composition of claim 7 or 8 , wherein the Amitriptyline HCl is micronized Amitriptyline HCl.

10. The pharmaceutical composition of claim 7 or 8 , further comprising a basifying agent.

11. The pharmaceutical composition of claim 10 , wherein the basifying agent is K 2 HPO 4 , Na 2 HPO 4 or anhydrous trisodium citrate.

Assignments (5)
NOVATION AGREEMENT Recorded Jul 8, 2024
From: TONIX PHARMA HOLDINGS LIMITED
To: TONIX PHARMA LIMITED
Reel/Frame 068217/0592 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2020
From: TONIX PHARMACEUTICALS, INC.
To: TONIX PHARMA HOLDINGS LIMITED
Reel/Frame 052010/0959 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2018
From: NEBULONI, MARINO; COLOMBO, PATRIZIA
To: REDOX SRL
Reel/Frame 046954/0489 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2018
From: REDOX SRL
To: TONIX PHARMACEUTICALS, INC.
Reel/Frame 046954/0510 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 24, 2018
From: TONIX PHARMACEUTICALS, INC.
To: TONIX PHARMA HOLDINGS LIMITED
Reel/Frame 046954/0517 →
Continuity (3)
Division 14776624
Provisional Application 61792757 · Mar 15, 2013
Related Publication 20190022031A1 · Jan 24, 2019