Patent Abstract:
A bottle for two-component extemporaneous products, of the type that comprises: a container for a first component, which is provided with an upper mouth; a reservoir for containing a second component, which is inserted substantially coaxially in the mouth, is open upward and has a bottom constituted by a diaphragm; a perforator, which can be inserted in the reservoir and is adapted to pierce the diaphragm in order to mix the two components; and a removable cap for closing the container in an upward region; the cap comprises a lower annular portion that is fixed to the container and an upper cylindrical portion that cooperates with the perforator and is rigidly coupled to the annular portion at an intermediate weakened region suitable to act as sealing means, a downward pressure on the cylindrical portion being adapted to disengage it from the annular portion and to make the perforator slide in the reservoir in order to pierce the underlying diaphragm.

Full Description:
This Application is a DIV of Ser. No. 10/399,282 filed on Apr. 16, 2003, now U.S. Pat. No. 7,025,200, which is a 371 of PCT/EP01/12300 filed on Oct. 24, 2001. 

   BACKGROUND OF THE INVENTION 
   The present invention relates to a bottle for two-component extemporaneous products. 
   In the pharmaceutical sector there are products composed of two substances that are mixed together just before administering the products; the individual separated substances in fact remain stable longer than the product obtained from them. 
   One of the two substances is generally in powder or granular form and the other is in liquid form; the former dissolves or disperses in the latter. 
   Single- or multiple-dose bottles for two-component extemporaneous products are known which comprise a container for one of the two components that is provided with a mouth in which a reservoir of the other component is inserted hermetically; the reservoir is open in an upward region and its bottom is constituted by a membrane-like diaphragm that separates the reservoir from the container. 
   Known bottles further comprise a closure cap that is fixed to the container and is provided with a perforator that is internal and coaxial thereto and is partially inserted hermetically in the reservoir. 
   The cap is usually constituted by three portions: a lower annular portion, which is fixed to the outer walls of the mouth of the container; an upper portion, which is constituted by a hood that is coaxial to the perforator; and an intermediate portion, which is constituted by sealing means such as a removable annular band that is connected to the lower and upper portions along respective fracture lines and is provided with a grip tab; the elimination of such band by tearing disengages the upper portion from the lower one. 
   In order to prepare the product to be administered, it is necessary to tear off and eliminate the band and apply pressure to the head of the hood; the hood moves towards the container, while the perforator descends into the reservoir and tears its diaphragm-like bottom. 
   In this manner, the component contained in the reservoir is poured into the container, where it mixes with the other component in order to prepare the product to be administered. 
   As an alternative, the cap is partially screwed onto the outer walls of the mouth of the container and is provided with sealing means such as an annular band; in order to prepare the product, it is necessary to eliminate the sealing means and screw the cap more tightly in order to make the perforator descend into the reservoir until it tears the diaphragm-like bottom. 
   In single-dose bottles, the perforator is fixed to the cap; the elimination of the cap in order to open the bottle accordingly entails extracting the perforator from the reservoir. 
   In this last case, however, the torn diaphragm tends to return to a substantially horizontal position, thus hindering the complete dispensing of the prepared product. 
   Known types of bottle, therefore, are not devoid of drawbacks, including the fact that they make it very time-consuming and difficult to prepare the two-component product to be administered and they entail significant consumption and waste of materials. 
   Preparation of the product in fact entails a first operation for eliminating the sealing means (the annular band) and a second operation for moving the hood towards the container, by pushing or screwing it on, so that the perforator tears the diaphragm. 
   The sealing means to be eliminated entail consumption of material and constitute waste material that is difficult to recover. 
   Another disadvantage of known types of single-dose bottle is constituted by the fact that they do not allow complete dispensing of the product prepared in them, since after the perforator is eliminated together with the cap the diaphragm tends to close the reservoir again. 
   SUMMARY OF THE INVENTION 
   The aim of the present invention is to eliminate the above noted drawbacks of known bottles by providing a bottle for two-component extemporaneous products that allows the preparation of the product to be administered to become quick, simple and manually easy and allows to contain the consumption and waste of material. 
   An object of the present invention is to allow full dispensing of the products prepared in individual administration doses, thus ensuring that they are taken fully by their users. 
   Within this aim, another object of the present invention is to provide a structure that is simple, relatively easy to provide in practice, safe in use, effective in operation, and relatively low in cost. 
   This aim and these and other objects which will become better apparent hereinafter are achieved by the present bottle for two-component extemporaneous products, of the type that comprises: a container for a first component, which is provided with an upper mouth; a reservoir for containing a second component, which is inserted substantially coaxially in said mouth, is open upward and has a bottom constituted by a diaphragm; a perforator, which can be inserted in said reservoir and is suitable to pierce said diaphragm in order to mix the two components; and a removable cap for closing the container in an upward region, characterized in that said cap comprises a lower annular portion that is fixed to said container and an upper cylindrical portion that is suitable to cooperate with said perforator and is rigidly coupled to said annular portion at an intermediate weakened region suitable to act as sealing means, a downward pressure on said cylindrical portion being suitable to disengage it from said annular portion and to make said perforator slide in said reservoir in order to pierce the underlying diaphragm. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further characteristics and advantages of the present invention will become better apparent from the detailed description of a preferred but not exclusive embodiment of a bottle for two-component extemporaneous products, illustrated only by way of non-limitative example in the accompanying drawings, wherein: 
       FIG. 1  is a longitudinal sectional view of a bottle according to the invention before the preparation of the product to be administered; 
       FIG. 2  is an enlarged-scale view of the upper portion of the bottle of  FIG. 1  after piercing the diaphragm to prepare the product to be administered; 
       FIG. 3  is a view of the upper portion of the bottle of  FIG. 2 , open in order to dispense the prepared product; 
       FIG. 4  is a perspective view of the bottle of  FIG. 1 ; 
       FIG. 5  is a longitudinal sectional view of the perforator of the bottle of  FIG. 1 ; 
       FIG. 6  is a longitudinal sectional view of the reservoir of the bottle of  FIG. 1 ; 
       FIG. 7  is a longitudinal sectional view of the closure cap of the bottle of  FIG. 1 ; 
       FIG. 8  is a longitudinal sectional view of a further embodiment of the bottle according to the invention before the preparation of the product to be administered; 
       FIG. 9  is a view of the bottle of  FIG. 8  after piercing the diaphragm to prepare the product to be administered; 
       FIG. 10  is a view of the bottle of  FIG. 9 , open in order to dispense the prepared product; 
       FIG. 11  is a longitudinal sectional view of the container of the bottle of  FIG. 8 ; 
       FIG. 12  is a longitudinal sectional view of the closure cap of the bottle of  FIG. 8 ; 
       FIG. 13  is a longitudinal sectional view of the reservoir of the bottle of  FIG. 8 . 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   With reference to the figures, the reference numeral  1  generally designates a bottle for two-component extemporaneous products such as, for example, pharmaceutical products and drugs composed of two substances, generally one in powder form P and one in liquid form L, which are mixed at the time of their first administration in order to produce a final product S. 
   In the embodiment shown in  FIGS. 1 to 7 , the bottle  1  comprises a container  2  that is filled with a preset amount of liquid L and is provided, in an upward region, with a neck  3  in which a mouth  4  is formed. 
   A reservoir  5 , which contains a preset amount of powder P, is inserted hermetically in the mouth  4 ; the reservoir  5  is shaped like a hollow cylinder and is coaxial to the mouth  4 , has an open upper face  5   a  and a lower face  5   b  that is closed by a diaphragm  6  that separates it and isolates it from the container  2 , and is provided externally with longitudinal ridges  7  for resting on the upper rim of the neck  3 . 
   The diaphragm  6  is like a membrane that is connected peripherally to the edge of the lower face  5   b  along a preset tear line  8 . 
   A perforator  9 , such as a tubular body, is inserted coaxially and slidingly in the reservoir  5  and has, in an upward region, an abutment collar  10  and, in a downward region, a beveled piercing profile  11  that is suitable to tear the diaphragm  6  at the line  8 . 
   The bottle  1  further comprises a removable cap  12  that closes in an upward region the container  1  and is constituted by a lower annular portion  13 , which externally surrounds the neck  3  to which it is fixed, and by an upper cylindrical portion  14 , which is suitable to cooperate with the perforator  9 ; the inside diameter of the annular portion  13  is greater than the outside diameter of the cylindrical portion  14 . 
   The two portions  13  and  14  are arranged coaxially to the reservoir  5  and, by having different diameters, form a horizontal annular base  15  at which they are mutually coupled along a weakened intermediate region constituted for example by a prefracture line  16  that is suitable to act as a means for sealing the bottle. 
   The annular portion  13  is fixed to the neck  3  by way of interlocking coupling means that are constituted by an annular tooth  17  that is provided so as to protrude on the inner lateral wall of the annular portion  13  and enters by interlocking in a corresponding recess  18  formed at the base of the outer side wall of the neck  3 . 
   The cylindrical portion  14  is shaped like a hollow cylindrical body, whose upper end  14   a  is closed and whose lower end  14   b  is open and protrudes inside the annular portion  13 . 
   A frustum-shaped circumferential expansion  19  is formed on the outer lateral wall of the cylindrical portion  14 ; its smaller end face is directed towards the upper end  14   a  and its larger end face is coupled to the annular base  15  at the prefracture line  16 . 
   A downward axial pressure on the cylindrical portion  14  is sufficient to uncouple it from the annular portion  13  by breaking the sealing means formed by the line  16 . 
     FIG. 1  illustrates a bottle  1  as packaged before the preparation of the product S, in which the annular portion  13  is fixed to the neck  3  and is still rigidly coupled to the cylindrical portion  14 , whose lower end  14   b  is partially inserted in the top of the perforator  9 . 
   By applying a downward pressure to the cylindrical portion  14  ( FIG. 2 ), the sealing means formed by the line  16  are broken and the cylindrical portion  14  is uncoupled from the annular one  13 , which remains anchored to the neck  3 . 
   By continuing to apply the pressure, the uncoupled cylindrical portion  14  slides inside the annular portion  13  and the lower end  14   b  penetrates further into the perforator  9  until the larger end face of the expansion  19  abuts against the collar  10 . 
   Then the perforator  9 , pushed by the cylindrical portion  14 , slides inside the reservoir  5 , descending and piercing the diaphragm  6  along the line  8 . 
   The sliding stroke of the perforator  9  is determined by a stroke limiting surface  20 , which is formed on the inner wall of the reservoir  5  and against which the collar  10  abuts; said stroke is such as to tear the diaphragm  6  along a preset circular arc, so that the tom diaphragm  6  remains attached to the reservoir  5  at at least one point  21 . 
   The lower end face  5   b  of the reservoir is thus opened and the powder P is poured by gravity into the container  2 , where it mixes with the liquid L; the product S is ready for administration. 
   Advantageously, the reservoir  5  is internally provided with a seat  22  for the interlocking insertion of the collar  10 , which is formed at the stroke limiting surface  20 ; once the diaphragm  6  has been torn, the collar  10  interlocks in the seat  22 , stably anchoring the perforator  9  to the reservoir  5 . 
   The bottle  1  is opened ( FIG. 3 ) by pulling out and removing the cylindrical portion  14 : the perforator  9  remains fixed to the reservoir  5  and thus keeps the torn diaphragm  6  lowered, preventing it from closing the lower flat surface  5   b  and hindering the dispensing of the product S. 
   The cylindrical portion  14  can be used to reclose the open bottle  1 , since its lower end  14   b  can be inserted hermetically in the perforator  9 . 
     FIGS. 8 to 13  illustrate an alternative embodiment of the bottle  1 . 
   In such alternative embodiment, the bottle  1  comprises a container  23  for the liquid L that is provided, in an upward region, with a neck  24  in which a mouth  25  is formed. 
   A reservoir  26 , which contains the powder P, is inserted hermetically in the mouth  25 ; the reservoir  26  is shaped like a hollow cylinder whose upper end face  26   a  is open and whose lower end face  26   b  is closed by a diaphragm  27  that isolates it and separates it from the container  23 . 
   The diaphragm  27  is of the membrane type and is connected to the edge of the lower end face  26   b  along a preset fracture line  28 . 
   The bottle  1  further comprises a removable cap  29 , which closes in an upward region the container  23  and is constituted by a lower annular portion  30 , which externally surrounds the neck  24  to which it is fixed, and by an upper cylindrical portion  31 . 
   The two portions  30  and  31  are coaxial to the reservoir  26  and are mutually coupled at a weakened intermediate region  32  constituted by a prefracture line  33 . 
   The annular portion  30  is fixed to the neck  24  by way of interlocking coupling means constituted by an annular tooth  34  that is formed so as to protrude on its inner lateral surface and interlocks in a corresponding recess  35  formed in the outer side wall of the neck  24 . 
   The annular base  32  is internally provided with a vertical circumferential tooth  36  that engages a corresponding notch  37  formed in the upper rim of the reservoir  26 . 
   The cylindrical portion  31  is constituted by an internally hollow elongated cylindrical body  38 , in which the upper end  38   a  is closed and the lower end  38   b  is open and protrudes into the annular portion  30  and directly enters the reservoir  26  coaxially and slidingly; the edge of the lower end  38   b  is constituted by a beveled piercing profile  39 . 
   The lower end  38   b  thus acts as a perforator; in this embodiment of the bottle  1 , therefore, the upper cylindrical portion of the closure cap and the perforator of the diaphragm are provided monolithically as the body  38 . 
   Conveniently, on the outer side wall of the lower end  38   b  there is a lower annular step  40  and an upper annular step  41 , while the reservoir  26  is internally provided with a complementary annular seat  42 . 
     FIG. 8  illustrates the bottle  1  in the alternative embodiment, as packaged before preparing the product S. 
   The annular portion  30  is fixed to the neck  24  and is rigidly coupled to the body  38  at the line  33 ; the lower piercing end  38   b  of the body  38  is slidingly inserted in the reservoir  26  and the lower step  40  is engaged in the annular seat  42 . 
   By applying a downward axial pressure to the top of the body  38 , the sealing means formed by the line  33  are broken and the body  38  is disengaged from the annular portion  30 , which remains anchored to the neck  24 . 
   By continuing to apply the pressure ( FIG. 9 ), the body  38  slides within the reservoir  26  and the profile  39  tears the diaphragm  27  at the line  28 . 
   The profile  39  is such as to tear the diaphragm  27  along a circular arc, so that once it has been torn it remains attached to the rim of the lower end face  26   b  in at least one point  43 . 
   The sliding of the body  38  stops when the upper step  41  engages the annular seat  42 . 
   The lower end face  26   b  of the reservoir is thus open and the powder P pours by gravity into the container  23 , where it mixes with the liquid L. 
   The bottle  1  ( FIG. 10 ) is opened by pulling out and removing the body  38  from the reservoir  26 . 
   Conveniently, the body  38  can be inserted again in the reservoir  26  and removed from it to subsequently close and open the bottle  1  and can be used as a measurer for the product S, since it is provided with a plurality of reference notches  44  for the level of the product S. 
   In practice it has been found that the described invention achieves the proposed aim and objects. 
   The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims. 
   All the details may further be replaced with other technically equivalent ones. 
   In practice, the materials employed, as well as the shapes and the dimensions, may be any according to requirements without thereby abandoning the scope of the protection of the appended claims. 
   The disclosures in Italian Patent Application No. MO2000A000233 from which this application claims priority are incorporated herein by reference.

Technology Classification (CPC): 0