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filingDate 2012-05-16-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationDate 2014-09-03-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber AR-089553-A1
titleOfInvention NASAL GELS OF CONTROLLED RELEASE OF TESTOSTERONE, METHODS AND SYSTEMS PRE-LOADED MULTIDOSIS APPLICATORS FOR PERNASAL ADMINISTRATION
abstract It also refers to methods and systems of airless, multi-dose applicators, pre-filled for pernasal administration of nasal testosterone gel. Claim 1: An intranasal testosterone gel for topical administration in a nasal cavity to control the release of testosterone for a period of at least approx. 6 hours after administration in the nasal cavity to provide a testosterone replacement in a man for the treatment of testosterone deficiency in man, without causing a sudden unacceptable peak in the blood level of testosterone in man during the lifespan of the dose, said intranasal testosterone gel comprises: (a) testosterone in an amount effective to treat testosterone deficiency in man; (b) at least one lipophilic or partially lipophilic vehicle; (c) a supersolvent to increase the solubility of testosterone in said intranasal testosterone gel; and (d) a viscosity regulating agent in an amount effective to control the release of said testosterone from said intranasal testosterone gel, wherein said intranasal testosterone gel does not need a surfactant. Claim 5: The intranasal testosterone gel according to claim 4, wherein said oil is selected from a group of oils consisting of castor oil, almond oil, linseed oil, canola oil, coconut oil, oil of corn, cottonseed oil, palm oil, peanut oil, poppyseed oil, soybean oil and mixtures of these. Claim 13: The intranasal testosterone gel according to claim 1, wherein said lipophilic vehicle is selected from a group of lipophilic vehicles consisting of a mineral oil, a paraffin, an isopropyl myristate, an isopropyl palmitate, a caprylate caprylate, a methyl stearate, a medium chain triglyceride, a propylene glycol, a dicaprilocaprate, a ketostearyl alcohol, a stearyl alcohol and mixtures thereof. Claim 18: The intranasal testosterone gel according to any one of claims 1 to 13, wherein said supersolvent is selected from a group consisting of dimethyl isosorbide, diethylene glycol monoethyl ether, glycerol, polyethylene glycol, 1-methyl 2-pyrrolidone and mixtures of these. Claim 24: The intranasal testosterone gel according to claim 23, wherein said thickening or gelling agent is selected from a group of thickening or gelling agents consisting of a cellulose, a cellulose derivative, a hydroxypropyl cellulose, a hydroxyethyl cellulose , a lipophilic gum, an acrylic polymer, carbopol, a polysaccharide, a carbomer, polyvinyl alcohol, povidone, a silicon dioxide, a cetyl alcohol, a stearic acid, a wax, a beeswax, a petrolatum, a triglyceride, lanolin , glyceryl behenate, inulin or a mixture of these.
priorityDate 2011-05-15-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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