Use of glycopyrrolate for treating tachycardia

Abstract

The invention relates to a novel use of the antimuscarinic agent glycopyrrolate, for example the salt glycopyrronium bromide. In particular, the invention relates to glycopyrrolate for use as a heart rate lowering agent and more particularly, but not exclusively, for use in patients suffering from respiratory conditions such as chronic obstructive pulmonary disease.

1 - 50 . (canceled) 
     
     
         51 . An inhalable pharmaceutical composition comprising glycopyrrolate or a pharmaceutically acceptable salt thereof for use as a heart rate lowering agent, or for use as a heart rate suppression agent under resting conditions. 
     
     
         52 . An inhalable unit dose comprising the pharmaceutical composition as defined in  claim 51  for use in the treatment or prophylaxis of tachycardia. 
     
     
         53 . The unit dose as defined in  claim 52 , which comprises a capsule. 
     
     
         54 . The unit dose as defined in  claim 52 , wherein the unit dose comprises a capsule made with hypromellose (HPMC) or another cellulose or cellulose derivative. 
     
     
         55 . An inhalation delivery device comprising one or more unit doses as defined in  claim 52  for use in the treatment or prophylaxis of tachycardia. 
     
     
         56 . The delivery device as defined in  claim 55 , wherein the delivery device is an inhaler. 
     
     
         57 . The delivery device as defined in  claim 56 , wherein the delivery device is a dry powder inhaler, a pressurized metered dose inhaler, or a nebulizer. 
     
     
         58 . The delivery device as defined in  claim 57 , wherein the device comprises means for protecting the composition from moisture. 
     
     
         59 . A pharmaceutical composition as defined in  claim 51 , contained in a package which further comprises instructions for administering said composition to a patient in need of a heart rate lowering agent, or in anticipation of the need of a heart rate lowering agent. 
     
     
         60 . The pharmaceutical composition according to  claim 59 , wherein the instructions are for administering said composition to a patient suffering from tachycardia or in need of prophylaxis of tachycardia. 
     
     
         61 . A method of treatment or prophylaxis of a condition or disorder characterised by an increased heart rate, said method comprising administering to a patient in need of such treatment or prophylaxis, an effective amount of an inhalable pharmaceutical composition comprising glycopyrrolate or a pharmaceutically acceptable salt thereof. 
     
     
         62 . The method according to  claim 61 , wherein the composition is administered to a patient suffering from a respiratory condition selected from chronic obstructive pulmonary disease (COPD), asthma, cystic fibrosis (CF) and related airway diseases. 
     
     
         63 . The method, according to  claim 62 , wherein the patient has COPD. 
     
     
         64 . The method, according to  claim 61 , wherein the patient has tachycardia that has been pharmaceutically induced. 
     
     
         65 . The method, according to  claim 64 , wherein the tachycardia has been induced by administration of salbutamol. 
     
     
         66 . The method, according to  claim 61 , wherein the patient has tachycardia that is induced by an endocrine disorder. 
     
     
         67 . The method, according to  claim 61 , wherein the patient has a form of tachycardia selected from the group consisting of ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, AV nodal reentrant tachycardia (AVNRT), AV reentrant tachycardia (AVRT) and junctional tachycardia. 
     
     
         68 . The method, according to  claim 61 , wherein the patient has a resting heart rate of greater than 90 beats per minute. 
     
     
         69 . The method, according to  claim 61 , wherein the glycopyrrolate or a pharmaceutically acceptable salt thereof comprises glycopyrronium bromide. 
     
     
         70 . The method, according to  claim 61 , wherein glycopyrrolate is present within the composition in an amount of between 10 and 500 pg. 
     
     
         71 . The method, according to  claim 70 , wherein glycopyrrolate is present within the composition in an amount of 20 pg. 
     
     
         72 . The method, according to  claim 70 , wherein glycopyrrolate is present within the composition in an amount of 400 pg. 
     
     
         73 . The method according to  claim 61 , wherein the glycopyrrolate is administered once daily. 
     
     
         74 . The method, according to  claim 61 , wherein the pharmaceutical composition is formulated as a dry powder formulation. 
     
     
         75 . The method, according to  claim 61 , wherein the composition additionally comprises a force control agent. 
     
     
         76 . The method, according to  claim 75 , wherein the force control agent comprises a metal stearate, or a derivative thereof. 
     
     
         77 . The method, according to  claim 76 , wherein the force control agent comprises zinc stearate, magnesium stearate, calcium stearate, sodium stearate or lithium stearate. 
     
     
         78 . The method, according to  claim 77 , wherein the force control agent comprises magnesium stearate. 
     
     
         79 . The method, according to  claim 61 , wherein the composition further comprises lactose. 
     
     
         80 . The method, according to  claim 79 , wherein the composition comprises 1% (w/w) glycopyrronium bromide and 99% (w/w) lactose. 
     
     
         81 . The method, according to  claim 79 , wherein the composition comprises 1.05% (w/w) glycopyrronium bromide, 98.8% (w/w) lactose and 0.15% (w/w) magnesium stearate, or 1% (w/w) glycopyrronium bromide, 98.8% (w/w) lactose and 0.2% (w/w) magnesium stearate. 
     
     
         82 . The method, according to  claim 61 , wherein the composition further comprises indacateral. 
     
     
         83 . The method, according to  claim 61 , wherein the composition further comprises a beta agonist. 
     
     
         84 . The method, according to  claim 61 , wherein the patient is receiving concomitant treatment with a beta agonist.