IP Library › Granted Patent US 9,636,408
Granted Patent B2
US 9,636,408 · App. 14/214,433 · Granted May 2, 2017

Eutectic formulations of cyclobenzaprine hydrochloride and amitriptyline hydrochloride

Inventors: Marino Nebuloni (Rho, IT); Patrizia Colombo (Trezzno sul Naviglio, IT)
Assignee: TONIX PHARMA HOLDINGS LIMITED
A61K47/26A61K9/145A61K9/1623A61K9/1688A61K9/1694A61K31/047A61K31/135A61K31/137A61K47/02A61K47/10A61K47/12
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Quick Facts
Patent No.
US 9,636,408
App. No.
14/214,433
Granted
May 2, 2017
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 (6)

1. A pharmaceutical composition comprising a eutectic composition of 25%±2% by weight of mannitol and 75%±2% by weight of Cyclobenzaprine HCl, wherein the euteutic composition melts at 143° C.±3° C.

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

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

4. A method of manufacturing the pharmaceutical composition of claim 1 , wherein the method comprises mixing or milling a composition of 25%±2% by weight of mannitol and 75%±2% by weight of Cyclobenzaprine HCl.

5. The method of claim 4 , wherein the method further comprises adding a basifying agent to the pharmaceutical composition.

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

Assignments (6)
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 May 31, 2016
From: NEBULONI, MARINO; COLOMBO, PATRIZIA
To: REDOX SRL
Reel/Frame 038747/0302 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 31, 2016
From: REDOX SRL
To: TONIX PHARMACEUTICALS, INC.
Reel/Frame 038747/0320 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 31, 2016
From: TONIX PHARMACEUTICALS, INC.
To: TONIX PHARMA HOLDINGS LIMITED
Reel/Frame 038747/0334 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 30, 2014
From: NEBULONI, MARINO; COLOMBO, PATRIZIA
To: TONIX PHARMACEUTICALS, INC.
Reel/Frame 033422/0889 →
Continuity (2)
Provisional Application 61792757 · Mar 15, 2013
Related Publication 20140336264A1 · Nov 13, 2014