You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 16, 2025

Claims for Patent: 11,752,103


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 11,752,103
Title:Tramadol hydrochloride solution
Abstract:Disclosed herein is an analgesic solution for the treatment of pain comprising a pain-relieving effective amount of tramadol or a pharmaceutically acceptable salt thereof, a method of treating pain by administering said analgesic solution to a subject in need thereof, a kit that includes containers of the analgesic solution, and a dosing regimen for the analgesic solution.
Inventor(s):H. Greg Thomas, Richard Levasseur, Jeffrey S. Kiel
Assignee:Athena Bioscience LLC
Application Number:US17/304,091
Patent Claims: 1. An aqueous oral solution comprising: (a) from about 4.5 mg/mL to 5.5 mg/mL of tramadol hydrochloride as the sole active ingredient; (b) propylene glycol; (c) from about 10% w/v to about 30% w/v of glycerin, (d) water, and (e) a sufficient amount of a buffer to maintain the pH of the oral solution from about 4.5 to about 5.5.

2. The aqueous oral solution of claim 1, wherein the amount of propylene glycol ranges from about 4% w/v to about 10% w/v.

3. The aqueous oral solution of claim 2, wherein the amount of propylene glycol ranges from about 5% w/v to about 7% w/v.

4. The aqueous oral solution of claim 1 further comprising sucralose.

5. The aqueous oral solution of claim 1 further comprising a flavoring agent.

6. The aqueous oral solution of claim 1 further comprising sodium benzoate.

7. The aqueous oral solution of claim 6, wherein the amount of sodium benzoate ranges from about 0.1% w/v to about 1% w/v.

8. The aqueous oral solution of claim 1, wherein the aqueous oral solution is free or substantially free of polyethylene glycol.

9. The aqueous oral solution of claim 1, wherein the aqueous oral solution is free or substantially free of non-ionic surfactants and co-solvents.

10. The aqueous oral solution of claim 1, wherein the aqueous oral solution is free or substantially free of sugars, parabens, castor oil, ethanol, polyethylene glycol, povidone, copovidone, sorbitan monolaurate, mint oil, aniseed flavor, saccharin and salts thereof, sodium cyclamate, and polyoxyl 40 hydrogenated castor oil.

11. The aqueous oral solution of claim 1, wherein the solution exhibits an amount of tramadol hydrochloride of from about 0.45% w/v to about 0.55% w/v after storage at 25±2° C. and 40±5% relative humidity for 24 months.

12. A method of treating pain in a subject in need thereof, which comprises administering to the subject an effective amount of the aqueous oral solution of claim 1.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.