Abstract:
A pharmaceutical dispenser including a tube having an open end and a space filled with a composition, and an applicator including a first end removably coupled to the open end of the tube and a longitudinal portion with at least one aperture is described. The dispenser can also include a removable cover extending longitudinally and having a bore surrounding the longitudinal portion of the applicator. The composition may be an anal medication. A single dosage unit of the composition is usually contained in the tube, and the tube, applicator, and cover are disposable after use. Methods of using the dispenser include squeezing the tube, allowing the composition to exit the aperture of the applicator, and applying the composition to a target area.

Description:
RELATED APPLICATIONS 
     This application is a Continuation of U.S. application Ser. No. 11/649,794, filed on Jan. 5, 2007 now abandoned, which is a Continuation of U.S. application Ser. No. 10/330,889, filed on Dec. 26, 2002 now abandoned. These applications are incorporated herein in their entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates to dispensers and, more particularly, to a container and applicator for dispensing a composition such as a pharmaceutical composition. 
     BACKGROUND 
     Containers used to hold compositions can perform various functions beyond that of simply housing the composition. For example, containers can be sized to dispense a specified dosage of the composition, as well as to assist in the application of the composition to a target area. 
     For example, in the context of medications used to treat anal ailments such as hemorrhoids, anal fissures, pruritis ani and similar conditions of the anal area (collectively, “hemorrhoids”), current packaging and application methods of compositions have generally been large, re-useable, bulky tubes accompanied by screw-on, multiple use applicators. See, for example, the applicator disclosed in U.S. Pat. No. 4,808,166 to Davidov. Treatments employing this historic methodology have generally resulted in unpleasant and inconvenient incidents for patients and potentially ineffective treatments. The unpleasant incidents include leaky and messy tubes containing the pharmaceutical compound and leaky and dirty applicators resulting from repeated use. Another inconvenience arises from the absolute necessity, for sanitary purposes, of thoroughly cleaning and drying a multiple use applicator after each treatment. Further, since the pharmaceutical is being dispensed from a large, multiple use tube, the potential for a patient to under or over-medicate his or herself exists because dosing amounts cannot be ascertained accurately. 
     It is therefore desirable to provide a dispenser and method for dispensing a composition that are sanitary, convenient to use, and provide accurate dosage amounts. 
     SUMMARY 
     The present invention relates to dispensers and, more particularly, to a container and applicator for dispensing a composition such as a pharmaceutical composition. 
     According to one aspect of the invention, a pharmaceutical dispenser includes a tube including an open end and defining a space filled with a composition, and an applicator including a first end removably coupled to the open end of the tube and longitudinal portion defining at least one aperture. The dispenser also includes a removable cover extending longitudinally and defining a bore surrounding the longitudinal portion of the applicator. 
     According to another aspect of the invention, a kit for application of anal medication includes a tube including an open end and defining a space filled with a composition; an applicator including a first end configured to mate with the open end of the tube and a longitudinal portion defining at least one aperture; and a sealed package defining an interior sized to accommodate the tube and the applicator. 
     According to yet another aspect of the invention, a method for dispensing a pharmaceutical includes: providing a tube including an open end and defining a space filled with a composition; removing a cap from the open end of the tube; mating a first end of an applicator with the open end of the tube; and dispensing the composition through an aperature defined by a longitudinal portion of the applicator onto a target area. 
     The above summary is not intended to describe each disclosed embodiment or every implementation of the present invention. The figures and the detailed description which follow more particularly exemplify these embodiments. 
    
    
     
       DESCRIPTION OF THE DRAWINGS 
       The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which: 
         FIG. 1  is a top view of an example pharmaceutical dispenser made in accordance with the present invention; 
         FIG. 1A  is a top view of the dispenser of  FIG. 1  with the cover removed; 
         FIG. 2  is a side view of an example container including a cap made in accordance with the present invention; 
         FIG. 3  is a side view of the container of  FIG. 2  with the cap removed; 
         FIG. 4  is a perspective view of an example applicator made in accordance with the present invention; 
         FIG. 5  is a cross-sectional view taken along line  5 - 5  of the applicator of  FIG. 4 ; 
         FIG. 6  is a perspective view of an example cover made in accordance with the present invention; 
         FIG. 7  is a cross-sectional view taken along line  7 - 7  of the cover of  FIG. 6 ; 
         FIG. 8  is a top view of an example package enclosing a container, an applicator, and a cover in accordance with the present invention; 
         FIG. 9  is a side view of the package of  FIG. 8 ; and 
         FIG. 10  is an end view of the package of  FIG. 8 . 
     
    
    
     While the disclosed subject matter is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention. 
     DETAILED DESCRIPTION 
     The present invention relates to dispensers and, more particularly, to a container and applicator for dispensing a composition such as a pharmaceutical composition. 
     Generally, the present invention is directed to a pharmaceutical dispenser including a container and an applicator. The container includes an interior for holding a composition, and an open end. The applicator includes a first end coupled to the open end of the container, and at least one aperture. The composition is dispensed out of the container, through the applicator, and out the aperture to a target area. 
     In the examples shown, the composition may be any composition used to treat anal ailments such as, for example, hemorrhoids, anal fissures, pruritis ani and similar conditions of the anal area (collectively, “hemorrhoids”). In the embodiment shown, the composition used is AnaMantle® HC available from Kenwood Therapeutics, a division of Bradley Pharmaceuticals, Inc. of Fairfield, N.J. AnaMantle® HC contains lidocaine HCl 3% and hydrocortisone acetate 0.5% microdispersed in an AcidMantle vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-. Other anal medications may also be selected as the composition, as desired. The example containers described herein hold a single dosage unit of the composition to be used for the relief of symptoms common to hemorrhoids, including swelling and inflammation of the anal area and rectal discomfort and itching. 
     Referring now to  FIGS. 1 and 1A , an example pharmaceutical dispenser  100  is shown. The dispenser  100  includes a container, in the illustrated embodiment a tube  110 , as well as an applicator  120  and a cover  130 . A first end  122  of the applicator  120  is coupled to the tube  110 , and the cover  130  is coupled to and surrounds a portion of the applicator  120 . 
     Referring now to  FIGS. 2 and 3 , the example tube  110  is shown in more detail. The tube  110  includes an interior space  210  that is filled with the composition. A first end  220  of the tube  110  is sealed, while a second end  230  is open. The tube  110  is shown with a cap  240  screwed onto the open end  230  of the tube  110  in  FIG. 2 , and with the cap  240  removed in  FIG. 3 . With the cap  240  secured onto the open end  230  of the tube  110 , the composition is maintained within the space  210  of the tube  110 . When the cap  240  is removed, the tube  110  can be squeezed to dispense the composition out of the open end  230 . In the example shown, the space  210  of the tube  110  is sized to hold a single dosage unit of the composition. Other dosage amounts may also be used. The example tube  110  is approximately 5.5-6.5 cm in length, although other dimensions for the tube may be used. 
     Referring now to  FIGS. 4 and 5 , the example applicator  120  is shown in more detail. The first end  122  of the applicator  120  is open and includes a threaded bore  510  sized to screw onto the open end  230  of the tube  110  (see  FIGS. 1 and 1A ). An outer surface  420  of the first end  122  is ribbed to assist a user in screwing the applicator  120  onto the tube  110 . The applicator  120  also includes a longitudinal portion  430  extending from the first end  122  to a second end  432 . The longitudinal portion  430  is tapered as it extends from the first end  122  to the second end  432 . An aperture  434  is defined at the second end  432 . Further, additional apertures  436  may be positioned about the longitudinal portion  430 . In the embodiment shown, the eight apertures  436  are positioned in a staggered-pair arrangement about the longitudinal portion  430 . An internal cavity  540  formed within the applicator  120  (see  FIG. 5 ) is fluidly coupled to the threaded bore  510 , and the apertures  434  and  436  extend through the longitudinal portion  430  into the cavity  540 . A circumferential rib  450  (see  FIG. 4 ) is positioned about the outer circumference of the longitudinal portion  430  to hold the cover  130  in position on the applicator  120 , as described further below. In the example shown, the applicator  120  is made of low density polyethylene and is approximately 4.5-5.0 cm in length. Other materials and lengths may also be used. 
     With the applicator  120  screwed onto the tube  110  and the cover  130  is removed (see  FIG. 1A ), the tube  110  can be squeezed, causing the composition to exit the open end  230  of the tube  110  and enter the bore  510 . As the bore  510  is filled with the composition, the composition moves into the cavity  540  and is eventually forced out of the apertures  434  and  436  and onto a target area. As described further below, the applicator  120  is advantageously shaped for applying the pharmaceutical to the target area. 
     Referring now to  FIGS. 6 and 7 , the example cover  130  is shown in more detail. The cover  130  includes an open end  610  and cavity  720  sized to fit over and accept a portion of the longitudinal portion  430  of the applicator  120  (see  FIG. 1 ). An opposite end  612  is closed. Circumferential ribs  730 ,  732 , and  734  are formed on the interior surface of the cavity  720 . The rib  734  is positioned to pass over the rib  450  of the applicator  120  as the cover  130  is slid over the applicator and thereby hold the cover  130  onto the applicator  120  by an interference fit. An optional protrusion  740  may extend from the end  612  to engage and partially extend through the aperture  434  formed in the second end  432  of the applicator  120  to further hold the cover  130  in place. In the example shown, the cover  130  is made of low density polyethylene and is approximately 3.5-4.0 cm in length. Other materials and lengths may also be used. 
     The cover  130  functions to protect and maintain the applicator  120  until use. In addition, the cover  130  (as well as the protrusion  740 , if included) at least partially plugs the apertures  434  and  436  of the applicator  120  to reduce an amount of the composition that escapes the applicator  120  when the cover  130  is in place. In alternative embodiments, the cover  130  need not be used. 
     Referring now to  FIGS. 8-10 , an example package  810  is shown to hold the tube  110 , applicator  120 , and cover  130  for distribution. The package includes a base  820  (approximately 86.25 mm long and 61.00 mm wide in the embodiment shown) and an upper plastic bubble  930  surrounding the components of tile dispenser  100 . In the example shown, the plastic bubble  930  rises approximately 17.50 mm above the base  820  and is made of 12-mil polyvinyl chloride plastic laminate. Also included in the example shown is a 1-mil child resistant aluminum foil that seals the package  810 . The seal includes perforations  840  located at each corner of the base  820  to allow the seal to be peeled from the bubble  930  to provide access to the dispenser  100 . The example package  810  can be obtained from Slispak, Inc. of Whippany, N.J., control number 2370. Another configuration for a package that may be used to house the dispenser is disclosed in U.S. Pat. No. 3,912,082 to Gerner et al., which is hereby incorporated by reference. Other configurations for packages used to hold the dispenser  100  may also be used. 
     An example method for using the dispenser  100  is a follows. First, the components of the dispenser  100  are removed from the package  810 . Next, the cap  240  is removed from the tube  110 , and the applicator  120  (with the cover  130  in place) is screwed firmly onto the open end  230  of the tube and tightened. While holding the tube  110 , the cover  130  is then removed from the applicator  120 , and the tube is squeezed to fill the applicator  120  until a small amount of the composition exits the apertures  434  and  436  formed in the applicator and lubricates the outer surface of the applicator  120  with the composition. Next, in the context of anal medication, the applicator is gently inserted into the anal area, and the tube  110  is squeezed as the applicator is moved around the target area. Once the application of the composition is completed, the dispenser  100 , including the tube  110 , the applicator  120 , and the cover  130 , is configured to be disposable. 
     There are many advantages to the dispenser  100  made in accordance with the present invention. For example, each tube can be a single-use tube that is filled with a precisely-measured single dosage unit of the composition to reduce errors associated with incorrect dosage applications. Further, because the dispenser  100  contains a single dosage unit and is disposable, it can be used for a prescribed treatment and thereafter discarded in its entirety by the user, thereby increasing sanitation. The tube is sealed, sanitary and has an easy-to-use screw-off top. The shape of the applicator, including the long, tapered longitudinal portion and smooth, closed sides allows for easy application of the composition. Further, because of the package and dispenser size, it is easily portable and can easily be carried in a user&#39;s pocket, small purse or small bag. 
     Although the composition has been described herein as an anal medication, it should be understood that other substances could also be used as the composition. For example, any other composition that is in a form such that it can be placed in the container and delivered by the applicator to a target area may also be used, such as other pharmaceutical agents, cosmetics, etc. 
     The present invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the disclosed subject matter as fairly set out in the attached claims. For example, although the illustrated embodiments describe a threaded connection between the container and the applicator, other methods of connecting the two components, such as a snap-fit connection, may also be used. Various other modifications, equivalent processes, as well as numerous structures to which the present invention may be applicable will be readily apparent to those of skill in the art to which the present invention is directed upon review of the instant specification.