Patent Publication Number: US-2009236258-A1

Title: Pharmaceutical capsule container vial with window

Description:
This application claims priority to U.S. Provisional Application 61/031,041 61/039,980 filed 25 Feb. 2008, the entire disclosure of which is incorporated by reference. 
    
    
     TECHNICAL FIELD 
     The present invention relates to the field of pharmaceutical capsule or tablet containers that have child-resistant safety caps, containers of the type used for filling pharmaceutical prescriptions in retail pharmacies. 
     BACKGROUND OF THE INVENTION 
     Filling a prescription in a retail pharmacy for pharmaceutical capsules or tablets requires re-packaging an appropriate number of the pharmaceutical capsules or tablets into a child-resistant sealable container. This process requires re-verification, by a pharmacist, for every prescription filled. The pharmacist must verify that the filled container contains capsules or tablets of the exact type and strength as specified in the prescription. Pharmaceutical capsule or tablet containers used in the pharmaceutical industry typically consist of a cylindrical vial, and a child-resistant safety cap for sealing the container. In the disclosure and claims herein below, the term “capsule” shall be interpreted to cover either one of “capsule” and “tablet”. Likewise, the term “capsules” shall be interpreted to cover either one of “capsules” and “tablets”. 
     The usual process of filling a prescription begins by a pharmacy technician generating a prescription-specific label and affixing the label to an empty vial. The technician then counts or pours capsules from a pharmacy stock bottle into the labeled vial, and closes the labeled vial by fitting a child-resistant safety-cap to make a filled and sealed container. The filled and sealed container is then passed to the pharmacist who among other things is responsible for verifying that the filled and sealed container contains capsules of the exact type and strength as specified in the prescription. To do this, the pharmacist must remove the cap in order to view at least one capsule and check its identity, either against the stock bottle it came from, or against an image of the medication on a computer screen. Typically the pharmacist will pour a sample out into the cap for viewing. 
     The pharmacist must remove the cap in order to see at least one capsule because (i) the standard vial used for dispensing medications in retail pharmacies in the United States is made of a translucent plastic material that is colored amber to protect the medication inside from light, which makes it difficult to discern indicia and impossible to verify color; (ii) the pharmacy label typically wraps around a large part of the cylindrical wall of the vial making it difficult for the pharmacist to view the capsules through the wall; (iii) most safety caps include indicia to indicate the directions for removing the safety cap, so caps that are white and opaque and also carry print to display the pharmacy name, are impossible to see though, and caps that are colored amber and have indicia molded in relief into an inner or outer surface make it difficult or impossible for the pharmacist to accurately discern the color code or the identification number of the capsules when attempting view capsules through the cap. 
     Many medications have multiple strengths differing only by the tablet&#39;s color and imprint. Furthermore, the requirement on the pharmacist to repeatedly remove safety caps from their containers to re-verify the contents of a sealed container, increases the burden on the pharmacist, and increases the risk of error during re-verification. Also, it has been observed that molded relief features in safety caps create chafing and discomfort on the hands of pharmacists who must open and close a great number of vials during the course of a work day. Even worse, the pharmacist runs the risk of serious internal repetitive motion injury. 
     A problem arises when a pharmacy gets busy. When a pharmacy gets busy, the demand for the pharmacist to verify a prescription increases quickly. In response, pharmacists tend to bypass the cap removal in favor of viewing the medication through the bottom of the sealed container. This may be adequate in most circumstances, but it is dangerous. 
     A container that would permit a pharmacist to re-verify a prescription without needing to remove and replace the cap would provide the following benefits:
         1. Decrease errors especially in high volume busy pharmacies.   2. Decrease the time needed to filled a medication for a patient.   3. Allow the pharmacist more time to do other important things such as evaluating drug interactions and patient counseling.   4. Decrease repetitive motion injuries sustained from removing and replacing the child resistant caps. (In a busy pharmacy, a pharmacist verifies from 200 to 300+ prescriptions in an 8 hour shift.)       

     SUMMARY OF THE INVENTION 
     The invention provides a novel pharmaceutical capsule container comprising (i) a novel vial having a closed-bottom window formed from a transparent polymer, and a side-wall formed from a light-blocking polymer, and (ii) a safety cap. The vial is made as one piece by dual injection molding. The window serves as a clear-view window through which a pharmacist may view capsules inside a closed capsule container. In a preferred embodiment the window serves as a magnifying lens for easier recognition of capsule indicia. A pharmacist uses the invention to re-verify the type and strength of the capsules in a filled, closed capsule container against the type and strength specified in the prescription by viewing the capsules in the filled, closed capsule container. The pharmacist holds the capsule container upright and looks up to view the capsules in the container through the window in the bottom of the vial This enables the pharmacist to re-verify a prescription without being required to remove and replace the safety cap every time a prescription is filled. 
     The foregoing has outlined, rather broadly, the preferred feature of the present invention so that those skilled in the art may better understand the detailed description of the invention that follows. Additional features of the invention will be described hereinafter that form the subject of the claims of the invention. Those skilled in the art should appreciate that they can readily use the conception and specific embodiment as a base for designing or modifying the structures for carrying out the same purposes of the present invention and that such other features do not depart from the spirit and scope of the invention in its broadest form. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS  
       Other aspects, features, and advantages of the present invention will become mores fully apparent from the following detailed description, the appended claims, and the accompanying drawings. 
         FIG. 1  is an exploded oblique view of a first preferred embodiment, in accordance with the present invention, showing a pharmaceutical capsule container with its vial and associated safety cap, the vial having a transparent closed bottom end defining a window in the shape of a magnifying lens; 
         FIG. 2  is an exploded oblique view of second embodiment, in accordance with the present invention, showing a pharmaceutical capsule container with its vial and associated safety cap, the vial having a transparent closed bottom end defining a planar window; 
         FIG. 3  is a view of the bottom of a vial with a rectangular lens; 
         FIG. 4  is a sectional view of a plano convex lens where the flat plano surface of the lens is at the bottom of a vial; 
         FIG. 5  is a sectional view of a plano convex lens where the convex surface of the lens is at the bottom of a vial; 
         FIG. 6  is a sectional view of a convex lens where the convex surface of the lens is at the bottom of a vial; 
         FIG. 7  is a sectional view of the bottom of a vial where the convex portion of a plano convex magnifying lens is the bottom surface of a vial and is positioned to allow a vial to stand on end without rocking; and 
         FIG. 8  is a view of a user lifting a vial from a table to see the contents of the vial by looking into the window at the bottom of the vial. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A pharmaceutical capsule container is disclosed having a child-resistant safety cap and a window for facilitating the process of filling pharmaceutical prescriptions in retail pharmacies.  FIG. 1  shows an exploded oblique view of a first preferred embodiment of the invention. 
       FIG. 1  further shows vial  10  having a rigid, substantially cylindrical side-wall  12  with an open end  14  for receiving pharmaceutical capsules, and a closed end  16 , opposite open end  14 , formed in the shape of a magnifying lens  17 . Magnifying lens may have upper and lower surfaces each of which is convex, or the lens may have a shape where the upper surface is substantially flat and the lower surface is convex which is referred to as a plano convex lens. Therefore, where the lower surface of the lens is convex, the lens is recessed a short distance  30  beyond the lower edge of the vial to allow the vial to sit upright on a flat surface without rocking or tilting. The magnifying lens may be the full lower surface or a portion of the lower surface and may be circular, square or rectangular. 
     Referring to  FIG. 3 , there is shown a bottom view of a vial where the magnifying lens  32  is rectangular in shape. The magnifying lens may be a plano convex lens where the plano surface  34  is on the bottom of the vial as shown in  FIG. 4 , or the convex surface  36  may be on the bottom of the vial as shown in  FIG. 5 . In still anther embodiment the magnifying lens may have two convex surfaces  38 ,  40  where convex surface  40  is the bottom surface of the vial as shown in  FIG. 6 . 
     Referring to  FIG. 7 , when the bottom surface  42  of the magnifying lens is convex, the lens can be formed to insure that the thick portion  44  of the lens does not extend beyond the lower edges  46  of the side of the vial. It is to be noted that when the magnifying lens is a plano convex lens as shown in  FIG. 7  the bottom surface of the vial interior is substantially flat. 
     Returning to  FIG. 1 , closed end portion  17  forms a window that is transparent to visible light, such that when the container is filled and closed, a user can view the contents of the container through the window to re-verify the contents of vial  10 . 
     Referring to  FIG. 8 , there is shown a user  50  lifting a vile  52  up from a table  54  and holding the vile above his/her eyes to look into the vile through the bottom window. 
     In this first preferred embodiment, the window is formed as a magnifying lens for easier recognition of capsule indicia, such that when the container is filled and closed, a user can view a magnified image of the contents of the container through the transparent window to re-verify the contents of vial  10 . 
     Vial  10  of the first preferred embodiment is formed in one piece from two different materials in a “dual injection molding” process. In this process two different materials are molded in one mold. The “dual injection molding” process is a well-known high-end precision process used to make soft-grip toothbrushes, etc. It is also known as “2K molding” or “Co-molding”. The molding process uses two barrels to inject two different materials into one mold. The process includes two injection steps performed in sequence. As used to make the first preferred embodiment of the present invention, a first injection step injects a first moldable material into a first part of a mold. Then the mold is repositioned. Then a second injection step injects a second moldable material into a second part of the mold. The dual injection molding process is similar to insert molding, but it uses only one mold, not two. 
     The window portion of the vial of the first preferred embodiment is formed of a moldable transparent polymer, preferably clarified polypropylene. Polypropylene tends to be cloudy. Polypropylene that has undergone a standard clarification process is preferred for forming a viewing window to ensure reliable re-verification. However, polypropylene could be used, or a transparent polymer that is less cloudy than polypropylene could be used. 
     The side-wall portion of the vial of the first preferred embodiment is molded in one piece from a single tinted polymer, preferably an amber-tinted polypropylene in accordance with standard requirements of light-transmissivity for pharmaceutical containers specified by the United States Pharmacopeia Convention, Inc. This organization is located at 12601 Twinbrook Parkway, Rockville, Md. 20852. 
     In a first alternative embodiment, the side-wall portion includes a transparent wall having a light-blocking skin layer, the side-wall formed in a simultaneous-injection co-molding process using a first barrel containing polypropylene and a second barrel containing a mix of polypropylene and an amber-colored material. In this process the polypropylene and the mix are injected to form a transparent wall having light-blocking skin layer. The polypropylene and the mix are injected simultaneously. The mix that is to form the skin layer is injected via a centerline port. The co-molding process for forming a skin layer by centerline feed is a known injection molding process. See “2K Injection Molding of Phase Separating Blends”, Keestera, Anderson &amp; Meijer, Eindhoven University of Technology, Department of Mechanical Engineering, NL. 
     In other embodiments, a layer of suitable light-blocking material such as amber color material is deposited onto the surface of a transparent side-wall by spraying or dipping, or a strip of suitable light-blocking material such as a wrap, a sleeve, a blank stick-on label, or a printed stick-on label is applied adhesively to the outer or inner surface of the transparent side-wall. Whichever method is used the layer or strip should cover substantially all of the cylindrical wall not covered by the cap. 
     In another embodiment, the side wall portion is molded in one piece from a suitable polymer to make a side-wall part, and a closed end portion defining a window is molded in one piece from a suitable transparent polymer to make a window part. Then the two parts are joined by chemical or thermal bonding to make a vial. 
       FIG. 1  further shows cap  20  having a substantially flat top portion  22  and an outer skirt  24 . Cap  20  may be formed from polypropylene tinted amber, or it may be formed from an opaque material. The cap is removably secured to the vial to provide a safety cap locking mechanism. One such safety vial has a tab to the side which is depress to enable the cap to turn. There are caps which screw on in a typical bottle way which a user must pressed down on to enable the outer surface of the cap to engage with the inner surface of the cap. There are also other caps such as caps that are on an aspirin bottle which simply must be rotated to a specific position and then popped off. 
       FIG. 2  shows a second embodiment of the invention, wherein transparent closed end  16  defines planar window  19 . 
     Note that the clear-bottomed container of the present invention blocks light penetration when the container is placed upright on a shelf. 
     A combination container and safety cap with operation similar in principle to that of the present invention is shown in each of U.S. Pat. No. 5,449,078, and U.S. Pat. No. 5,938,005. The disclosure of each of these patents is hereby incorporated herein in their entirety by reference. 
     A pharmacist uses the invention to re-verify the type and strength of the capsules in the filled and closed capsule container against the type and strength specified in the prescription by viewing the capsules in the filled and capsule container via a window in the bottom of the vial. The pharmacist preferably views the capsules in the container from below so that the capsules are close to the window for better viewing, and so that light from above is less likely to enter the window This procedure enables the pharmacist to re-verify a prescription without being required to remove and replace the cap every time a prescription is filled. 
     The preferred procedure for using of the invention is as follows: (a) generating a prescription-specific label; (b) affixing the label to an empty vial; (c) drawing capsules from stock, including verifying the type and strength of the capsules drawn from stock against the type and strength specified in the prescription; (d) counting and depositing the capsules drawn from stock into the vial, including verifying the quantity of capsules deposited against the quantity specified in the prescription; (e) closing the vial by fitting a cap to make a filled, closed capsule container, filled in accordance with the prescription; and (f) re-verifying the type and strength of the capsules in the filled capsule container against the type and strength of capsule specified in the prescription, the pharmacist holding the capsule container upright and looking up to view the capsules in the container through the window in the bottom of the vial. 
     Note that steps (a) to (e) may be performed by a non-pharmacist, but step (f) must be performed by a pharmacist. 
     Although a few examples of the present invention have been shown and described, it would be appreciated by those skilled in the art that changes might be made in these embodiments without departing from the principles and spirit of the invention, the scope of which is defined in the claims and their equivalents.