Use of levocetirizine and montelukast in the treatment of traumatic injury
Inventors
Assignees
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Publication Number
US-9522148-B2
Publication Date
2016-12-20
Expiration Date
Abstract
The embodiments described herein include methods and formulations for treating lung and brain injury. The methods and formulations include, but are not limited to, methods and formulations for delivering effective concentrations of levocetirizine and montelukast to a patient in need. The methods and formulations can comprise conventional and/or modified-release elements, providing for drug delivery to the patient.
Core Innovation
The invention concerns a method of treating traumatic brain injury or a symptom of traumatic brain injury in a patient who suffered a primary injury to the head during a traumatic event resulting in physical damage. The method administers an effective amount of a combination of levocetrizine and montelukast, where the traumatic brain injury occurs as a result of a traumatic event selected from skull fracture and cerebral contusion.
The disclosed rationale describes synergy between levocetrizine and montelukast through H1 blockade and inhibition of leukotriene CysLT1 and LTD4 signaling. The document links these actions to reduced eosinophil migration and to modulation of IL-6 and IL-8, with downstream discussion including NF-kB and ICAM-1.
The disclosed treatment framework includes formulations and delivery options for levocetrizine and montelukast, including conventional or modified release approaches and multiple administration routes. The document describes oral/enteral delivery and mentions intravenous delivery as a possible option for emergency delivery.
Claims Coverage
The claim set centers on one independent method claim directed to treating traumatic brain injury or symptoms using an effective amount of a levocetrizine and montelukast combination for head trauma caused by skull fracture or cerebral contusion. Dependent claims refine timing, administration routes, and optionally add an additional active agent with broad class options, including a branch where the additional active agent is an antibiotic.
Treating traumatic brain injury by levocetrizine and montelukast for skull fracture or cerebral contusion
A method of treating traumatic brain injury or a symptom of traumatic brain injury in a patient with a primary head injury during a traumatic event, by administering an effective amount of a combination of levocetrizine and montelukast where the traumatic event is selected from skull fracture and cerebral contusion.
Route-restricted administration of levocetrizine and montelukast combination
The method further comprises administering the combination to a patient via one or more specified administration routes.
Onset-of-symptoms administration timing
The method further comprises administering the combination at the onset of symptoms.
Substantially simultaneous administration
The method further specifies that the claimed combination is administered in a substantially simultaneous manner.
Adding an additional active agent from a broad class list
The method further comprises an additional active agent selected from a group consisting of an antibiotic, antiviral, anti-parasitic, antifungal, vasopressor, diuretic, anticoagulant, anti-seizure medication, proton pump inhibitor, H2 receptor antagonist, antipyretic agent, anti-inflammatory drug, anti-neoplastic drug, and combinations thereof.
Antibiotic-specific additional active agent selection
The method further comprises using an additional active agent selected as an antibiotic from vancomycin, meropenem, amoxicillin/beta clauvulanic acid, levofloxacin, piperacillin/tazobactam, ceftriaxone, clindamycin, azithromycin, trimethoprim/sulfamethoxazole, doxycycline, or combinations thereof.
Overall, the inventive claim coverage is directed to administering an effective amount of a levocetrizine and montelukast combination to treat traumatic brain injury or symptoms arising from skull fracture or cerebral contusion, with claim refinements covering route restrictions, onset-of-symptoms timing, substantially simultaneous administration, and optional addition of an additional active agent.
Stated Advantages
Steroid-avoiding therapy positioning.
Rapid radiographic lung improvement.
Improved brain edema/contusions after adding the combination to brain trauma protocols.
Predicted reduction in ventilator time, length of stay, mortality, and secondary infection.
Documented Applications
Treatment context for trauma-associated acute lung injury/acute respiratory distress syndrome (ARDS) including aspiration pneumonia alongside brain trauma protocols.
Treatment context for traumatic brain injury from closed head injury and outcomes including brain edema/contusions.
Administration in emergency settings as part of delivery options.
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