Methods and compositions to inhibit tolerance to opioids
Inventors
Iversen, Jacqueline • Dahl, Thomas A.
Assignees
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Publication Number
US-11911355-B2
Publication Date
2024-02-27
Expiration Date
Abstract
The present invention provides a method of inhibiting tolerance to an opioid by a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject during opioid therapy. The pharmaceutical composition comprises a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.
Core Innovation
The invention relates to inhibiting tolerance to an opioid by a human subject in need thereof during opioid therapy. A pharmaceutical composition is administered to the subject during opioid therapy, and the composition consists of an NSAID that is ibuprofen, a co-agent that is ketotifen or salt thereof, and a pharmaceutical carrier, pharmaceutical excipient, and other formulation ingredients. The disclosed purpose is to inhibit tolerance to an opioid in the human subject.
The invention also relates to inhibiting tolerance to an opioid by administering the pharmaceutical composition during an opioid withdrawal period. In this context, the composition consists of about 1200 mg to about 1600 mg of ibuprofen and about 0.5 mg to about 3 mg ketotifen, together with a pharmaceutical carrier, pharmaceutical excipient, and additional ingredients including sweetening, flavoring, and taste masking ingredients, as well as excipients and buffers. The disclosed purpose remains inhibiting tolerance to an opioid in the human subject.
The disclosed pharmaceutical compositions are described in oral solid dosage forms such as tablet, lozenge, and chewing gum. The detailed description further frames the invention as using an NSAID plus a co-agent selected from fexofenadine, ketotifen, desloratadine, or cetirizine (including salts and combinations) to address opioid tolerance during opioid therapy and to reduce gastrointestinal withdrawal-related adverse symptoms. The core concept is a co-administered combination centered on NSAID co-agent selection, including ketotifen, in a formulated pharmaceutical composition administered to the subject.
Claims Coverage
The independent claims are directed to methods of inhibiting opioid tolerance in a human subject by administering specific NSAID/co-agent pharmaceutical compositions. Across the independent claims, the main inventive features are the NSAID being ibuprofen, the co-agent being ketotifen or a salt thereof, the composition being formulated with specified pharmaceutical carriers/excipients/ingredients, and the timing context of opioid therapy versus an opioid withdrawal period.
Ibuprofen NSAID plus ketotifen co-agent for inhibiting opioid tolerance during opioid therapy
A method of inhibiting tolerance to an opioid by a human subject by administering an effective amount of a pharmaceutical composition during opioid therapy, wherein the pharmaceutical composition consists of an NSAID that is ibuprofen, a co-agent that is ketotifen or salt thereof, and a pharmaceutical carrier/excipient and formulation ingredients, wherein tolerance to an opioid is inhibited in the human subject.
Ibuprofen plus ketotifen composition administered during an opioid withdrawal period
A method of inhibiting tolerance to an opioid by a human subject by administering to the subject an effective amount of a pharmaceutical composition during an opioid withdrawal period, wherein the pharmaceutical composition consists of about 1200 mg to about 1600 mg of ibuprofen, about 0.5 mg to about 3 mg ketotifen, and a pharmaceutical carrier/excipient and formulation ingredients, wherein tolerance to an opioid is inhibited in the human subject.
Both independent claims cover inhibiting opioid tolerance by administering an NSAID-based pharmaceutical composition with ibuprofen and ketotifen (or ketotifen salt) to a human subject, with one claim focused on opioid therapy and the other focused on an opioid withdrawal period. Each claim further defines the composition as including specified pharmaceutical carriers/excipients and additional formulation-related ingredients.
Stated Advantages
Inhibiting tolerance to an opioid in a human subject.
Reduced gastrointestinal withdrawal-related adverse symptoms are asserted in the disclosed summary.
Documented Applications
Reducing opioid tolerance during opioid therapy in a human subject.
Inhibiting opioid tolerance during an opioid withdrawal period.
Reduction of gastrointestinal withdrawal-related adverse symptoms during opioid withdrawal/detoxification contexts.
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