Claims for Patent: 9,861,647

Summary for Patent: 9,861,647

Title:	Calcium glycerophosphate for treating and preventing respiratory diseases or conditions
Abstract:	Calcium glycerophosphate is found to be effective in treating and preventing a disease, disorder and/or condition of the respiratory system. The disease, disorder and/or condition is related to an obstructive or a restrictive condition of the respiratory airway. The disease, disorder and/or condition can be a respiratory airway inflammatory disease, a respiratory airway stenosis or a nasal cavity inflammatory disease, such as an asthma, a chronic obstructive pulmonary disease (COPD), an emphysema, a reactive airway disease (RADS), rhinitis, bronchitis, bronchiolitis, congestion, sinusitis, tonsillitis, or laryngitis, post-nasal drip (PND) and a related complication thereof, inflamed degranulating and non-degranulating mast cell activity, any irritation occasioning mucus secretion from goblet cells breathing difficulty, restriction, obstruction; airways constriction or closure or mucus interference with air passage; sleep apnea, snoring, inflammatory or non-inflammatory responses to an airborne or non-airborne allergen or irritant; nasal or non-nasal airway inflammation or irritation caused by a problem in any area of the body; and a physical damage to the respiratory system. Methods, compositions and devices are described for using calcium glycerophosphate to treat and prevent the disease, disorder and/or condition of the respiratory system.
Inventor(s):	Kligerman; Alan E. (Egg Harbor Township, NJ), Weis; Margaret T. (Amarillo, TX)
Assignee:	Prelief, Inc. (Egg Harbor Township, NJ)
Application Number:	15/151,574
Patent Claims:	1. A method of treating rhinitis, bronchial asthma, allergic asthma or chronic obstructive pulmonary disease (COPD) in a subject in need thereof, the method comprising nasally administering to the respiratory system of the subject an effective amount of calcium glycerophosphate in a dosage of about 440 .mu.g to about 88 mg of calcium glycerophosphate per administration, wherein the effective amount of calcium glycerophosphate alleviates or improves the rhinitis, bronchial asthma, allergic asthma or chronic obstructive pulmonary disease (COPD) in the subject, and wherein the calcium glycerophosphate is administered to the subject in a composition comprising about 0.05%-10% (w/w) calcium glycerophosphate. 2. The method of claim 1, wherein the composition comprises about 0.5%-7.5% (w/w) calcium glycerophosphate. 3. The method of claim 1, wherein the rhinitis is selected from the group consisting of allergic rhinitis, pollinosis, acute rhinitis, chronic rhinitis, hypertrophic rhinitis, and deflected septum. 4. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject by inhalation. 5. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject by intranasal instillation. 6. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject in a formulation of a powder, gel, microsphere, or suspension, and the formulation provides an extended release of calcium glycerophosphate into the airway of the subject, wherein the extended release results from a higher than soluble amount of the calcium glycerophosphate in a local environment of the respiratory system. 7. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject in a formulation that provides an improved absorption of calcium glycerophosphate into the airway of the subject. 8. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject by a nasal drop, a nasal spray, a nasal lavage, an inhaled powder, a mechanized intermittent fluid pulser, an inhaler, a respirator, a transpirator, an atomizer, a vaporizer, an air mask, a means for direct physical or mechanical application, or an insufflator. 9. The method of claim 1, wherein the calcium glycerophosphate is administered to the subject using a metered dose inhaler (MDI), a dry powder inhaler (DPI), a nebulizer, or a cotton swab. 10. The method of claim 1, further comprising administering to the respiratory system of the subject an analgesic. 11. The method of claim 10, wherein the analgesic is selected from the group consisting of ibuprofen, acetominophen, aspirin, naproxen, and capsaicin. 12. The method of claim 1, wherein the subject is a human subject selected from the group consisting of a pediatric patient, an elderly patient, a pregnant woman, and a patient who has frequent need of a relief agent and/or preventive agent for the disease, disorder and/or condition of the respiratory system. 13. The method of claim 1, further comprising administering to the respiratory system of the subject one or more medications for a disease, disorder and/or condition of the respiratory system. 14. The method of claim 13, wherein the one or more medications are selected from the group consisting of a beta-2 agonist, a long-acting beta-2-agonist ("LABA"), an inhaled corticosteroid, an alpha agonist, a bronchodialator, a glucocorticoid, a leukotriene modifier, a mast cell stabilizer, an antimuscarinic/anticholinergic, a methylxanthine, an antihistamine, omalizumab, methotrexate, tianeptine, albuterol, and cromolyn. 15. The method of claim 1, further comprising nasally administering to the respiratory system of the subject an additional agent. 16. The method of claim 15, wherein the agent and the calcium glycerophosphate are administered simultaneously or sequentially to the respiratory system of the subject. 17. The method of claim 15, wherein the agent and the calcium glycerophosphate are administered to the respiratory system of the subject in separate formulations. 18. The method of claim 15, wherein the composition comprises about 0.5%-7.5% (w/w) calcium glycerophosphate.

Details for Patent 9,861,647

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	06/20/2003		2027-08-30
Genentech, Inc.	XOLAIR	omalizumab	Injection	103976	09/28/2018		2027-08-30