Use of levocetirizine and montelukast in the treatment of autoimmune disorders
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Publication Number
US-9669026-B2
Publication Date
2017-06-06
Expiration Date
Abstract
The embodiments described herein include methods and formulations for treating autoimmune disorders. 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 relates to treating an autoimmune disorder or a symptom of an autoimmune disorder in a patient in need thereof by administering an effective amount of a combination of levocetirizine and montelukast. The autoimmune disorder is idiopathic thrombocytopenia purpura (ITP), and the disclosure also encompasses autoimmune neutropenia as an autoimmune disorder context for combination therapy.
The disclosed approach uses an administered combination of levocetirizine and montelukast with a mechanistic rationale centered on anti-inflammatory and synergistic concepts. The rationale emphasizes effects associated with NF-κB/steroid-model concepts and inhibition of the leukotriene CysLT1 pathway, including LTD4/LTC4/LDE4-related activity, with downstream relevance to inflammatory mediator effects such as eosinophil migration/quantity and immune responses including T-cell and B-cell responses.
The disclosure further supports drug delivery and administration arrangements for the levocetirizine and montelukast combination, including conventional or modified-release forms and different timing patterns such as onset, sequential, or substantially simultaneous administration. The disclosure also describes multiple administration routes and embodiments that optionally include additional active agents, including glucocorticoids and other agent classes.
Claims Coverage
The independent claim provides core coverage for methods of treating an autoimmune disorder (idiopathic thrombocytopenia purpura) or a symptom thereof by administering an effective amount of a combination of levocetirizine and montelukast. The family includes dependent claim refinements directed to timing, administration routes/logistics, and optional addition of other active agents (including categories and named examples).
Levocetirizine and montelukast combination treatment of idiopathic thrombocytopenia purpura
A method of treating an autoimmune disorder or a symptom of an autoimmune disorder in a patient in need thereof by administering an effective amount of a combination of levocetirizine and montelukast, wherein the autoimmune disorder is idiopathic thrombocytopenia purpura.
Administration at symptom onset
The method further specifies administering the combination at the onset of symptoms.
Administration via selected one or more routes
The method specifies that the combination is administered to a patient via one or more routes selected from enteral, intravenous, intraperitoneal, inhalation, intramuscular, subcutaneous, and oral.
Same route for levocetirizine and montelukast
The method is carried out by administering levocetirizine and montelukast using the same route.
Optional addition of an immunosuppressant active agent
The method further includes an additional active agent that is an immunosuppressant.
Ferrous gluconate as an additional supplement
The supplement used is ferrous gluconate.
Overall, the claim set covers treating idiopathic thrombocytopenia purpura using an effective amount of a levocetirizine and montelukast combination, with dependent refinements for symptom-onset timing, allowable administration routes (and whether both drugs share the same route), and optional combination with additional active agents including immunosuppressants and named supplement ferrous gluconate.
Stated Advantages
Stated safety advantages including Pregnancy Category B and use in approved pediatric age down to 6 months.
Minimal monitoring is indicated as an advantage.
Reduced steroid-related side effects is stated as an advantage, including steroid-sparing.
An adjunct use approach is described, implying benefit as part of combination therapy with additional active agents.
Documented Applications
Treatment of idiopathic thrombocytopenia purpura (ITP) using combination therapy is illustrated by an ITP case with a sustained platelet count increase after starting levocetirizine and montelukast.
Treatment context for autoimmune neutropenia is illustrated by an autoimmune neutropenia case with normalized/stabilized white blood cell counts and resolution of steroid-induced diabetes following tapering prednisone after initiation of the combination therapy.
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