IP Library Granted Patent US 9,155,734
Granted Patent B2
US 9,155,734 · App. 13/787,042 · Granted Oct 13, 2015

Stability of hydromorphone hydrochloride solutions

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Quick Facts
Patent No.
US 9,155,734
App. No.
13/787,042
Granted
Oct 13, 2015
Kind
B2
Abstract

The present invention relates generally to a sterile hydromorphone hydrochloride solution that is substantially free of buffer.

Claims (8)

1. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 25° C. and 60% relative humidity for at least 3 months.

2. The composition as recited in claim 1 , wherein said composition is suitable for intrathecal delivery.

3. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 30° C. and 65% relative humidity for at least 3 months.

4. A pharmaceutical composition consisting of a sterile aqueous solution of hydromorphone hydrochloride, wherein said composition is stable at 40° C. and 75% relative humidity for at least 3 months.

5. The composition as recited in claim 1 , wherein said composition is sterilized via aseptic processing.

6. The composition as recited in claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 10.0 mg/mL.

7. The composition as recited in claim 1 , having a liquid drug formulation wherein the concentration of hydromorphone hydrochloride is about 2.0 mg/mL.

8. A method of treating pain, the method comprising: intrathecal delivery of the pharmaceutical composition of claim 1 to a patient.

Assignments (13)
RELEASE OF SECURITY INTEREST Recorded Mar 16, 2026
From: HSBC BANK USA, NATIONAL ASSOCIATION
To: PIRAMAL CRITICAL CARE, INC.
Reel/Frame 074083/0930 →
RELEASE OF PATENT SECURITY INTERESTS RECORDED AT REEL 032480, FRAME 0001 Recorded Nov 16, 2023
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: THERAKOS, INC.; 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; IKARIA THERAPEUTICS LLC; INO THERAPEUTICS LLC
Reel/Frame 065609/0322 →
SECURITY INTEREST Recorded Dec 23, 2022
From: PIRAMAL CRITICAL CARE, INC.
To: HSBC BANK USA, NATIONAL ASSOCIATION, AS SECURITY AGENT
Reel/Frame 062195/0373 →
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 050225/0138 Recorded Sep 29, 2022
From: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
To: PIRAMAL CRITICAL CARE, INC.
Reel/Frame 061569/0097 →
RELEASE OF SECURITY INTEREST IN PATENT COLLATERAL RECORDED AT REEL 032480, FRAME 0001 AND REEL 039237, FRAME 0147 Recorded Oct 2, 2019
From: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
To: MALLINCKRODT LLC
Reel/Frame 050610/0463 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 4, 2019
From: PIRAMAL CRITICAL CARE LIMITED
To: PIRAMAL CRITICAL CARE, INC.
Reel/Frame 050256/0158 →
SECURITY INTEREST Recorded Aug 30, 2019
From: PIRAMAL CRITICAL CARE, INC.
To: JPMORGAN CHASE BANK, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 050225/0138 →
RELEASE OF SECURITY INTEREST Recorded Aug 28, 2019
From: STANDARD CHARTERED BANK
To: PIRAMAL CRITICAL CARE LIMITED
Reel/Frame 050201/0397 →
CORRECTIVE ASSIGNMENT TO CORRECT THE NAME OF THE ASSIGNOR, SHOULD BE PIRAMAL CRITICAL CARE LIMITED PREVIOUSLY RECORDED ON REEL 046181 FRAME 0425. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY AGREEMENT. Recorded Dec 18, 2018
From: PIRAMAL CRITICAL CARE LIMITED
To: STANDARD CHARTERED BANK
Reel/Frame 047949/0237 →
SECURITY AGREEMENT Recorded Jun 1, 2018
From: PIRAMEL CRITICAL CARE LIMITED
To: STANDARD CHARTERED BANK
Reel/Frame 046181/0425 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2017
From: MALLINCKRODT LLC
To: PIRAMAL CRITICAL CARE LIMITED
Reel/Frame 042612/0980 →
SECURITY INTEREST Recorded Mar 19, 2014
From: MALLINCKRODT INTERNATIONAL FINANCE S.A.; MALLINCKRODT CB LLC; MALLINCKRODT FINANCE GMBH; MALLINCKRODT US HOLDINGS INC.; MALLINCKRODT CARIBBEAN, INC.; MALLINCKRODT US POOL LLC; MALLINCKRODT INC.; LUDLOW CORPORATION; CNS THERAPEUTICS, INC.; ENTERPRISES HOLDINGS, INC.; MALLINCKRODT ENTERPRISES LLC; MALLINCKRODT LLC; LAFAYETTE PHARMACEUTICALS LLC; LIEBEL-FLARSHEIM COMPANY LLC; MALLINCKRODT BRAND PHARMACEUTICALS, INC; MALLINCKRODT VETERINARY, INC.; MALLINCKRODT US HOLDINGS LLC; IMC EXPLORATION COMPANY; MEH, INC; MALLINCKRODT ENTERPRISES HOLDINGS, INC.
To: DEUTSCHE BANK AG NEW YORK BRANCH
Reel/Frame 032480/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 7, 2013
From: FOSTER, JOHN J.; PRENTICE, THOMAS R.
To: MALLINCKRODT LLC
Reel/Frame 029937/0291 →