Aerosolization apparatus with removable mouthpiece

Abstract

An aerosolization apparatus comprises a body having an inlet, an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber. The apparatus further includes a connection mechanism to provide selective connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect or disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber. When a user inhales, air enters into the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet. The connection mechanism prevents inadvertent disconnection of the endpiece from the body.

1 - 35 . (canceled) 
     
     
         36 . An aerosolization apparatus comprising:
 a body having an inlet;   an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber;   a connector to provide connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect and to disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber;   a cap insertable over the endpiece such that a user is prevented from applying a rotational force between the endpiece and the body when the cap is inserted over the endpiece; and   a puncturing mechanism capable of providing an opening in the capsule;   whereby when a user inhales, air enters the chamber through the inlet so that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet.   
     
     
         37 . The aerosolization apparatus of  claim 36 , wherein the connector comprises engageable threads. 
     
     
         38 . The aerosolization apparatus of  claim 37 , wherein the engageable threads extend for fewer than two complete turns around the body. 
     
     
         39 . The aerosolization apparatus of  claim 37 , wherein the engageable threads have a thread angle of less than about 9 degrees. 
     
     
         40 . The aerosolization apparatus of  claim 37 , wherein the engageable threads include a recessed portion. 
     
     
         41 . The aerosolization apparatus of  claim 40 , wherein the recessed portion is recessed at an angle of less than about 75 degrees. 
     
     
         42 . The aerosolization apparatus according to  claim 36  wherein the inlet is shaped to provide a swirling air flow in the chamber. 
     
     
         43 . The aerosolization apparatus according to  claim 36  wherein the body has a plurality of inlets. 
     
     
         44 . The aerosolization apparatus according to  claim 36  wherein the puncturing mechanism is adapted to puncture a single end of the capsule. 
     
     
         45 . The aerosolization apparatus according to  claim 36  wherein the chamber is elongated and has a longitudinal axis, and wherein the longitudinal axis of the chamber and the longitudinal axis of the capsule form an angle of less than about 45 degrees during use. 
     
     
         46 . The aerosolization apparatus according to  claim 36  wherein the chamber is elongated, wherein the capsule is received lengthwise within the elongated chamber, and wherein the width of the chamber is less than the length of the capsule. 
     
     
         47 . The aerosolization apparatus of  claim 36 , wherein the connector comprises a protrusion that is receivable within a slot, the slot comprising a longitudinally extending portion and a transversely extending portion. 
     
     
         48 . The aerosolization apparatus according to  claim 47  wherein the slot comprises means for securing the protrusion within the slot. 
     
     
         49 . The aerosolization apparatus according to  claim 47  wherein the slot comprises a bump on the transversely extending portion configured to secure the protrusion within the slot. 
     
     
         50 . The aerosolization apparatus according to  claim 47  wherein the slot comprises one or more sloping surfaces configured to secure the protrusion within the slot. 
     
     
         51 . The aerosolization apparatus according to  claim 47  wherein the slot comprises a second longitudinally extending portion. 
     
     
         52 . A method of administering a pharmaceutical formulation to a patient, the method comprising:
 inserting a capsule containing a pharmaceutical formulation into a chamber in a body of an aerosolization apparatus, the body comprising an inlet, the chamber being sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber;   connecting an endpiece having an outlet to the body by a connector configured to provide connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect and to disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber;   puncturing the capsule;   administering the pharmaceutical formulation to the patient by inhalation such that when the patient inhales through the outlet, air enters the chamber through the inlet such that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the user through the outlet; and   connecting a cap about the body such that the cap is inserted over the endpiece to cover at least a portion of the inlet and a user is prevented from applying a rotational force between the endpiece and the body when the cap is inserted over the endpiece.   
     
     
         53 . The method of  claim 52 , further comprising, after administering the pharmaceutical formulation to the patient and prior to connecting the cap about the body, disconnecting the endpiece from the body, removing the punctured capsule from the chamber, and reconnecting the endpiece to the body. 
     
     
         54 . A method of administering a pharmaceutical formulation to a patient, the method comprising:
 providing a body having an inlet;   providing an endpiece having an outlet, the endpiece being connectable to the body to define a chamber, wherein the chamber is sized to receive a capsule containing a pharmaceutical formulation in a manner which allows the capsule to move within the chamber;   providing a connector to provide connection of the endpiece to the body, wherein a rotational force between the endpiece and the body is needed to connect and to disconnect the endpiece from the body, the rotational force being applied about an axis passing through the chamber;   providing a cap insertable over the endpiece such that a user is prevented from applying a rotational force between the endpiece and the body when the cap is inserted over the endpiece; and   providing a puncturing mechanism capable of providing an opening in the capsule;   removing the cap to expose the endpiece;   disconnecting the endpiece from the body by the connector;   inserting the capsule into the chamber;   reconnecting the endpiece to the body by the connector;   puncturing the capsule; and   administering the pharmaceutical formulation to the patient by inhalation such that when the patient inhales through the outlet, air enters the chamber through the inlet such that the pharmaceutical formulation is aerosolized within the chamber and the aerosolized pharmaceutical formulation is delivered to the patient through the outlet.   
     
     
         55 . The method of  claim 54 , further comprising, after administering the pharmaceutical formulation to the patient, disconnecting the endpiece from the body, removing the punctured capsule from the chamber, reconnecting the endpiece to the body, and inserting the cap over the endpiece.