Abstract:
A package for receiving a vial may include an inner portion folded into a first shape configured to receive the vial; an outer portion folded into a second shape configured to removably receive the first shape of the inner portion; and an identifying mark or label disposed on the inner portion and viewable when the inner portion is disposed within the outer portion. The inner portion may include top, bottom, and first and second side portions that define a first aperture configured to receive the vial, and a top flap securable to the top or first or second side portions so as to retain the vial within the first aperture. A second aperture defined in the top flap may permit access to contents of the vial without removing the vial from the inner portion, e.g., may have a diameter selected to permit the vial top to protrude therethrough.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Patent Application No. 61/714,536, filed Oct. 16, 2012 and entitled “Packaging for Clinical Trials,” and U.S. Provisional Patent Application No. 61/830,259, filed Jun. 3, 2013 and entitled “Packaging for Clinical Trials,” the entire contents of both of which are incorporated by reference herein. 
    
    
     BACKGROUND OF THE INVENTION 
     1. The Names of the Parties to a Joint Research Agreement 
     There has been no joint research agreements entered into with any third parties. 
     2. Field of the Invention 
     Embodiments of the present invention relate generally to packaging for clinical trials. In particular, embodiments of the present invention are directed to customized packaging for vials (injectable compounds) designed to facilitate labeling and distribution of clinical or commercial supplies. 
     3. Description of the Related Art 
     Packaging, and more specifically, packaging of vials, is well known in the art. 
     There are many challenges related to the packaging of products in vials and pooled supplies. Lined cartons often have issues with size. Also, packaging a pooled supply for vials has its problems in the prior art. A problem also arises when package supplies require an ancillary label at the point of distribution. This is because doing so would require a complete unpackaging of the kit. 
     Some prior art packagings include a removable dosage unit, which may be removed from an outer pack to prepare the medication. However, the purpose of these prior art packagings is to allow for rapid visual inspection and to be consumer friendly. These prior art packages do not allow for reduced labeling to support clinical trials. 
     There exists a need for a new package that can allow for reduced labeling to support clinical trials or commercial use. 
     SUMMARY OF THE INVENTION 
     Embodiments of the present invention provide a package that can allow for reduced labeling to support clinical trials or commercial use. 
     Under one aspect, a package for receiving a vial includes an inner portion constructed out of a first piece of material folded into a first shape configured to receive the vial therein; an outer portion constructed out of a second piece of material folded into a second shape configured to removably receive the first shape of the inner portion; and an identifying mark or label disposed on the inner portion and being viewable when the first shape of the inner portion is disposed within the second shape of the outer portion. 
     In some embodiments, the inner portion includes a top portion, a bottom portion, and first and second side portions that define a first aperture configured to receive the vial, and a top flap securable to at least one of the top portion and the first and second side portions so as to retain the vial within the first aperture, the top flap having defined therein a second aperture configured to permit access to contents of the vial without removing the vial from the inner portion. The second aperture may have a diameter selected to permit a top of the vial to protrude therethrough. 
     Some embodiments further include a cap protector configured to be disposed over the inner portion and including an indented portion sized to accommodate and protect a top of the vial. 
     In some embodiments, a side aperture is defined within the side portion of the inner portion, the vial being viewable through the side aperture. 
     Some embodiments further include one or more tape panels that seal the inner portion in the first shape so as to evidence tampering with the inner portion. 
     In some embodiments, the outer portion further includes side portions that include cutouts to ease in removal of the inner portion from the outer portion. 
     In some embodiments, an inside of the first shape of the inner portion includes a vial support configured to stabilize the vial within the inner portion. 
     In some embodiments, at least one of the inner and outer portions includes a tab, slot, or flap configured to interlock the first shape of the inner portion with the second shape of the outer portion so as to permit partial removal of the inner portion from the outer portion and to inhibit complete removal of the inner portion from the outer portion. 
     In some embodiments, the inner and outer portions respectively are formed using a single piece of material. 
     Under another aspect of the present invention, a kit for preparing a package for receiving a vial includes an inner portion that is folded flat and is foldable into a first shape configured to receive the vial therein; and an outer portion that is folded flat and is foldable into a second shape configured to removably receive the first shape of the inner portion. Preferably, the inner portion has an area for receiving an identifying mark or label that is viewable when the inner and outer portions respectively are folded into the first and second shapes and the first shape is disposed within the second shape so as to form the package. 
     In some embodiments, the first shape into which the inner portion is foldable includes a top portion, a bottom portion, and first and second side portions that define a first aperture configured to receive the vial, and a top flap securable to at least one of the top portion and the first and second side portions so as to retain the vial within the first aperture, the top flap having defined therein a second aperture configured to permit access to contents of the vial without removing the vial from the inner portion. The second aperture may have a diameter selected to permit a top of the vial to protrude therethrough. 
     Some embodiments further include a cap protector configured to be disposed over the inner portion and including an indented portion sized to accommodate and protect a top of the vial. 
     In some embodiments, a side aperture is defined within the side portion of the inner portion, the vial being viewable through the side aperture. 
     Some embodiments further include one or more tape panels for use in sealing the inner portion in the first shape so as to evidence tampering with the inner portion. 
     In some embodiments, the outer portion further includes side portions that include cutouts to ease in removal of the inner portion from the outer portion. 
     In some embodiments, an inside of the first shape of the inner portion includes a vial support configured to stabilize the vial within the inner portion. 
     In some embodiments, at least one of the inner and outer portions includes a tab, slot, or flap configured to interlock the first shape of the inner portion with the second shape of the outer portion so as to permit partial removal of the inner portion from the outer portion and to inhibit complete removal of the inner portion from the outer portion. 
     In some embodiments, the inner and outer portions respectively are formed using a single piece of material. 
     Under another aspect of the present invention, a method of packaging a vial includes constructing an inner portion by folding a first piece of material into a first shape configured to receive the vial therein; disposing the vial within the first shape of the inner portion; constructing an outer portion by folding a second piece of material into a second shape configured to removably receive the first shape of the inner portion; and inserting the inner portion into the outer portion. Preferably, the inner portion has an area for receiving an identifying mark or label that is viewable when the inner and outer portions respectively are folded into the first and second shapes and the first shape is disposed within the second shape so as to form a package. 
     In some embodiments, the inner portion includes a top portion, a bottom portion, and first and second side portions that define a first aperture configured to receive the vial, and a top flap, the method including securing the top flap to at least one of the top portion and the first and second side portions so as to retain the vial within the first aperture, the top flap having defined therein a second aperture permitting access to contents of the vial without removing the vial from the inner portion. In some embodiments, the second aperture has a diameter selected to permit a top of the vial to protrude therethrough. 
     Some embodiments further include disposing a cap protector over the inner portion, the cap protector including an indented portion sized to accommodate and protect a top of the vial. 
     In some embodiments, a side aperture is defined within the side portion of the inner portion, the vial being viewable through the side aperture. 
     Some embodiments further include sealing the inner portion in the first shape using one or more tape panels that evidence tampering with the inner portion. 
     In some embodiments, the outer portion further includes side portions that include cutouts to ease in removal of the inner portion from the outer portion. 
     In some embodiments, an inside of the first shape of the inner portion includes a vial support that stabilizes the vial within the inner portion. 
     Some embodiments further include interlocking the first shape of the inner portion with the second shape of the outer portion with a tab, slot, or flap on at least one of the inner and outer portions so as to permit partial removal of the inner portion from the outer portion and to inhibit complete removal of the inner portion from the outer portion. 
     In some embodiments, the inner and outer portions respectively are formed using a single piece of material. 
     Other embodiments of the present invention include packaging including an inner portion that includes a top portion, a bottom portion, and a side portion. The inner portion further includes a top flap, where the top flap includes a small top aperture, and a large top aperture capable of receiving a vial. The packaging further includes an outer portion. The inner portion is constructed out of at least one piece of material, where the one piece of material is folded into a desired shape capable of receiving a vial therein. The inner portion engages with the outer portion such that an identifying mark or label is capable of being viewed on the inner portion, or on a medium included in the inner portion through an aperture on the inner portion, while the inner portion and outer portion are so engaged. 
     Yet another embodiment of the present invention is directed to a kit for a package including at least three separate components, including: an inner portion; an outer portion; and a cap protector. The inner portion and the outer portion are folded flat, and the inner portion is capable of being refolded into a shape that is capable of receiving a vial therein. The outer portion is capable of being refolded into a shape that is capable of receiving the inner portion therein. Assembly of the package includes engaging the three components of the kit by placing the cap protector on the inner portion, and placing the inner portion within the outer portion, where the cap protector is disposed between a portion of the inner portion and a portion of the outer portion. 
     Other embodiments of the present invention further include a method of packaging a vial including folding a first component into an inner portion, where the inner portion includes a top portion, a bottom portion, and a side portion. The inner portion further includes a top flap, where the top flap includes a small top aperture, and a large top aperture capable of receiving a vial. The method of packaging a vial further includes folding a second component into an outer portion, inserting a vial into the large top aperture of the inner portion, sealing the vial within the inner portion by closing the top flap, inserting a cap protector on the inner portion, and inserting the inner portion into the outer portion. 
     Yet another embodiment of the present invention is directed to a package including an inner portion, where the inner portion includes a vial holding portion. The vial holding portion includes a plurality of sides and a hollow space capable of including at least a portion of a vial therein, where at least a portion of a top of the vial is accessible when the vial is disposed in the vial holding portion. The inner portion further includes a cooperating portion capable of slidably engaging with an outer portion, the cooperating portion including a base, a rear, and sides. The sides of the cooperating portion include flaps. The package further includes an outer portion with a front surface, a top surface, a bottom surface, and two side surfaces, where a cavity is formed within the outer portion. A cutout is formed on the side surfaces of the outer portion, which also includes an engagement portion capable of engaging the flaps. The inner portion can be slidingly engaged with the outer portion by being slid into the cavity of the outer portion. The flaps of the inner portion engage with the engagement portion of the outer portion thereby holding the inner portion within the cavity of the outer portion. An area of the sides of the cooperating portion of the inner portion are exposed through the cutout formed on the side surfaces of the outer portion when the inner portion is disposed within the cavity of the outer portion. A user may disengage the inner portion from the outer portion by grabbing the area of the sides of the cooperating portion of the inner portion that is exposed and pulling the inner portion away from the cavity of the outer portion. 
     Other embodiments of the present invention further include a kit for a package including at least two separate components, where the two separate components include an inner portion and an outer portion. The inner portion and the outer portion are folded flat, and the inner portion is capable of being refolded into a shape that is capable of forming a vial holding portion for receiving a vial therein and a cooperating portion for slidably engaging with the outer portion. The outer portion is capable of being refolded into a shape that is capable of receiving the inner portion in a cavity included in the outer portion. Assembly of the package includes engaging the two components of the kit by sliding the inner portion within the cavity of the outer portion. 
     Yet another embodiment of the present invention is directed to a method of packaging a vial including folding a first component into an inner portion, where the inner portion includes a vial holding portion with a plurality of sides and a hollow space capable of receiving at least a portion of a vial therein. At least a portion of a top of the vial is accessible when the vial is disposed in the vial holding portion. The inner portion further includes a cooperating portion capable of slidably engaging with an outer portion, the cooperating portion including a base, a rear, and sides, where the sides include flaps. The method of packaging a vial further includes inserting the inner portion into the outer portion. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Preferred features of embodiments of the present invention are disclosed in the accompanying drawings, wherein similar reference characters denote similar elements throughout the several views, and wherein: 
         FIGS. 1A and 1B  respectively are front views of a package with flat labeling and with booklet labeling, according to an embodiment of the present invention. 
         FIG. 2  is a perspective view of a vial and a package in an unassembled state, according to an embodiment of the present invention. 
         FIG. 3  is a perspective view of a vial and an inner portion of a package in a partially assembled state, according to an embodiment of the present invention. 
         FIGS. 4 and 5  respectively are side and front views of an inner portion of a package in a partially assembled state and having a vial disposed therein, according to an embodiment of the present invention. 
         FIGS. 6 and 7  respectively are front and side views of an inner portion of a package fully assembled and closed and having a vial disposed therein, according to an embodiment of the present invention. 
         FIG. 8  is a perspective view of a cap protector for use with an inner portion of a package having a vial disposed therein, according to an embodiment of the present invention. 
         FIG. 9  is a perspective view of a cap protector engaged with a top portion of an inner portion of a package having a vial disposed therein, according to an embodiment of the present invention. 
         FIG. 10  is a front view of an inner portion and an outer portion of a package positioned near one another before the inner portion is slid into the outer portion, according to an embodiment of the present invention. 
         FIG. 11  is a side view of an inner portion partially slid into an outer portion of a package, according to an embodiment of the present invention. 
         FIGS. 12-14  respectively are side/rear, rear, and rear/side perspective views of an inner portion of a package having a vial disposed therein and including a tape-panel, according to an embodiment of the present invention. 
         FIGS. 15-20A  respectively are front, top, bottom, first side, second side, and rear views of an alternative package, according to an embodiment of the present invention. 
         FIG. 20B  is a rear view of an alternative package that includes a booklet label, according to an embodiment of the invention. 
         FIG. 21  is a front view of an inner portion and an outer portion of an alternative package positioned near one another before the inner portion is slid into the outer portion, according to an embodiment of the present invention. 
         FIGS. 22-24  respectively are first side, second side, and rear perspective views of an outer portion of an alternative package, according to an embodiment of the present invention. 
         FIGS. 25 and 26  respectively are front and bottom perspective views of an inner portion of an alternative package having a vial disposed therein, according to an embodiment of the present invention. 
         FIGS. 27 and 28  both are top/side perspective views of an inner portion of an alternative package having a vial disposed therein, according to an embodiment of the present invention. 
         FIGS. 29-32  respectively are top/rear perspective, rear, front, and top views of an inner portion of an alternative package having a vial disposed therein, according to an embodiment of the present invention. 
         FIG. 33  is a perspective view of an inner portion partially slid into an outer portion of an alternative package, according to an embodiment of the present invention. 
         FIGS. 34-38  respectively are front, rear, top, first side, and second side views of a partially assembled inner portion of an alternative package, according to an embodiment of the present invention. 
         FIGS. 39-41  respectively are side, top, and rear views of an alternative partially assembled inner portion of an alternative package, according to an embodiment of the present invention. 
         FIGS. 42-44  are side and perspective views of another partially assembled alternative inner portion of an alternative package, according to an embodiment of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     Embodiments of the present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the illustrated embodiments set forth herein. Rather, these illustrated embodiments are provided so that this disclosure will be thorough and complete and will convey the scope of the invention to those skilled in the art. 
     In the following description, like reference characters designate like or corresponding parts throughout the Figures. Additionally, in the following description, it is understood that terms such as “top,” “bottom,” “side,” “front,” “back,” “inner,” “outer,” and the like, are words of convenience and are not to be construed as limiting terms. 
     Packagings of the prior art include vials that are labeled and packaged into an outer carton. In the prior art, the vials are considered the primary container and would need to be unpacked at the point of distribution to be further labeled with any ancillary Annex 13 label that may be required. Thus, the prior art design is not desirable for clinical trials. Additionally, many packagings of the prior art do not include features that allow a person to see the contents of the vials contained therein when the vials are still located in the packagings. 
     Embodiments of the present invention are directed to a carton (packaging) that may hold a vial within. An embodiment of the present invention allows a materials supply chain to label only a single level of packaging. Embodiments of the present invention are designed in a manner that will allow practitioners to prepare and administer the contents of the vial without removing the immediate container from the outer packaging. Another embodiment of the present invention includes a packaging that holds a vial (or similar), where the vial cannot be removed without intentionally destroying the internal components of the packaging (for example, the components shown in  FIGS. 4 and 27 ). 
     Embodiments of the present invention allow for a clinical trial pooled supply for vial based/injectable compounds. Embodiments of the present invention also dramatically reduce packaging and labeling costs. Embodiments of the present invention can be used for clinical trials in countries/regions that must comply with Annex 13 requirements. Additionally, embodiments of the present invention are capable of being used in countries that have other requirements (in addition to, or in replace of, Annex 13 requirements). 
     Embodiments of the present invention include sealing individual vials into a primary container. In embodiments of the present invention, sealing vials into the container allows a materials supply chain to apply an Annex 13 compliant label only to the container. 
     Embodiments of the present invention are described throughout this application as being used to hold vials. Vials, as used throughout this application include any type of container, and are not limited to the traditional definition of vials. The contents of the vials included within the packages of embodiments of the present invention may be anything that a person skilled in the art would desire to be present in a container. The vials may also be empty. The vials that may be included within the packages of embodiments of the present invention may include caps and/or rubber stoppers or the like. The caps may include flip tops, twist tops, plug tops, or the like. The rubber stoppers, caps, or the like may be made of a material that is meant to be punctured by a needle for containing an injectable medicament or the like. 
     Moreover, embodiments of the present invention may be used to package other items instead of, or in addition to, vials. 
     As shown in the figures, in an embodiment of the present invention, when the package is opened, the protective flip-cap and rubber stopper are fully accessible for preparation, dosing, and administration of the contents. 
     An embodiment of the present invention includes a die cut top flap. It will be apparent to one skilled in the art that the top flap may include an aperture that is made through other methods other than die cutting as well. The die cut top flap ensures the vial cannot be removed after the top is folded over the top of the vial (e.g., the neck of the vial). 
     Embodiments of the present invention may also include tape panels. In an embodiment of the present invention, the tape panels include an aggressive tamper evident tape/adhesive that acts to effectively seal the primary container in a closed position. In an embodiment of the present invention, the only way to remove the vial is to destroy the package. 
     Preferably, when an embodiment of the present invention is assembled, the carton has only one side which needs to be sealed, which may be the top side of the carton (unlike most prior art cartons, which are sealed both at the top and on the bottom). 
     As described in greater detail below with reference to the figures, multiple apertures are included in certain embodiments of the present invention. The apertures are present to facilitate preparation for dosing by allowing a viewing window for the practitioner to inspect the contents of the vial before dosing. The apertures may have additional purposes as well, which would be apparent to a person of ordinary skill. 
     Embodiments of the present invention may include an outer cover that provides protection from light and any other elements during storage and shipment. 
     An embodiment of the present invention includes a carton that has been developed for the purpose of reducing the labeling required for parenteral dosage forms. 
     As used throughout this application, the package of embodiments of the present invention may be similar to a carton. That is, embodiments of the present invention may be constructed out of similar materials that are used for constructing the cartons of the prior art. Therefore, carton and package may be used synonymously throughout this application when referring to embodiments of the present invention. However, the packages of embodiments of the present invention may also be constructed out of different materials, including, but not limited to, paper or wood products, plastic, metal, glass, fiberboard, composite materials, and the like. One skilled in the art will understand that different materials, other than the materials described herein, may be utilized to construct the packages of embodiments of the present invention, and embodiments of the present invention are not limited to the materials described herein or shown in the figures. 
       FIG. 1A  is a front view of a package  1  constructed according to an illustrative embodiment of the present invention, which includes a pack-out design for injectable, vial based compounds. The package  1  shown in  FIG. 1A  includes an inner portion  100  having a vial disposed therein (vial not visible in  FIG. 1A ), and an outer portion  200 . As shown in  FIG. 1A , the inner portion  100  may be fully inserted within the outer portion  200 ; as described in greater detail below with reference to  FIG. 10 , the inner portion may be fully or partially disengaged from the outer portion  200 , which may occur through a sliding motion or the like. Embodiments of the present invention also include packages in which the inner portion  100  and the outer portion  200  are engaged through means other than a sliding motion, for example, including, but not limited to, the outer portion  200  wrapping around the inner portion  100 . The outer portion  200  includes a back portion  202  (not visible in  FIG. 1A ), side portions  203  optionally having cutouts  207  defined therein, a top portion  204 , and a bottom portion  205 . The inner portion  100  includes a front portion  101 , a back portion  102  (not visible in  FIG. 1A ), a top portion  104 , a bottom portion  105 , and side portions  103 . As described in greater detail below with reference to  FIGS. 8 and 9 , and optional cap protector may be arranged over the top of a vial disposed within the inner portion  100  (vial not visible in  FIG. 1A ). In the illustrated embodiment, the outer portion  200  acts as an outer sleeve for the inner portion  100  and optional cap protector  10  to be received within. 
     As shown in  FIG. 1A , a label  2  may be affixed to the front portion  101  of the inner portion  100  of the package  1 , preferably which is viewable regardless of the relative arrangement spatial arrangement of inner portion  100  and outer portion  200 , e.g., may be seen even before the inner portion  100  is removed (separated/slid out) from the outer portion  200 . The label  2  may include any information that a person skilled in the art would contemplate being present on a label. For example, the label may include identifying marks such as Protocol identification  4 , lot identification  5 , medication identification  6 , subject identification  7 , dates  8 , barcodes  9  (e.g., QR codes), warnings, designs, symbols, pictures, or anything that one skilled in the art may desire to be present on such a package  1 . The label  2  may be flat or planar, as illustrated in  FIG. 1A , or alternatively may be a booklet label, which may include one or more leaflets that include study information and/or regulatory information. Preferably, the booklet label may be prominently visible and accessible at all times during shipment and storage. For example,  FIG. 1B  depicts a generic booklet label  2   a  affixed to the front portion  101  of the inner portion  100  of the package  1 , which is viewable regardless of the relative spatial arrangement of inner portion  100  and outer portion  200 , e.g., may be seen even before the inner portion  100  is removed (separated/slid out) from the outer portion  200 . A flat label such as label  2  illustrated in  FIG. 1A  may be applied to a generic booklet label  2   a  such as illustrated in  FIG. 1B . Alternatively, the booklet label or the information therein may be affixed within inner portion  100  (primary container), e.g., may be affixed to the back side of front portion  101  of the inner portion  100 , so that the label or information may be seen only when the inner portion  100  is partially or fully removed from the outer portion  200 . 
     One skilled in the art would readily understand that the package  1  may be any color or variety of colors, and the label  2  may be any color or variety of colors. Further, an embodiment of the present invention may not include a label on the front portion  101  of the inner portion  100 . 
     As shown in the embodiment illustrated in  FIG. 1A , the side portions  203  of the outer portion  200  may include cutouts  207  to ease in removing the inner portion  100  from the outer portion. Additionally, as shown in  FIG. 1A , the package  1  further may include a cap protector  10 , which is a thick protective portion disposed between the top portion  104  of the inner portion  100  and the top portion  204  of the outer portion. 
       FIG. 2  is a perspective view of a vial  3  and of the components of the package  1  in an unassembled state, according to an embodiment of the present invention. As depicted in  FIG. 2 , the package  1  may include many apertures that may serve a variety of distinctive functions. For example, in an embodiment of the present invention, the cap protector  10  may include a thickness that accommodates an indented portion  11 . The indented portion  11  may be sized to fit a vial top  12  within in order to protect said vial top  12 . In an embodiment, package  1  is designed so that it can be shipped to a vendor or distributor as three flat components (the inner portion  100 , the outer portion  200 , and the cap protector  10 ), which may then be assembled to form the package  1  such as illustrated in  FIG. 1A . Preferably, such components also may include specific training and support materials so that a packaging vendor or distributor can utilize the three flat components and form the package  1 . 
       FIG. 3  depicts the inner portion  100  of the package  1  in a semi-assembled state. After the inner portion  100  (which may also be referred to in the art as the primary container) is partially assembled, the vial  3  is placed into the inner portion  100  through the top portion  104 . More specifically, in the embodiment shown in  FIG. 3 , the top portion  104  of the inner portion  100  includes a large top aperture  106  and a top flap  108  with a small top aperture  107 . The large top aperture  106  is sized such that the vial  3  can be inserted into the inner portion  100  through the large top aperture  106 . The top flap  108  then may be lowered over the vial and sealed into place, e.g., using glue, a tape-panel, pressure-sensitive adhesive, or the like, as described in greater detail below with reference to  FIG. 6 . The small top aperture  107  is sized such that the vial top  12  protrudes through the small top aperture  107  when the top flap  108  is lowered over the vial; optionally, cap protector  10  then may be disposed over vial top  12  such that indented portion  11  engages with vial top  12 , such that vial  3  can thus optionally be further protected by the cap protector  10 , in addition to protection provided by inner portion  100 . 
     For example, as further shown in  FIGS. 3 ,  4 , and  5 , in which the inner portion  100  is partially assembled and is disengaged from outer portion  200 , the inside of the inner portion  100  may include vial supports  110  to help stabilize the vial when it is disposed inside the inner portion  100 . The outside of the inner portion  100  may also include additional apertures. For example, the outside of the inner portion  100  may include a vial label viewing aperture  111  and a side tab aperture  112 . The outside of the inner portion  100  in an embodiment of the present invention may also include a side tab  113 . Side tab aperture  112  and side tab  113  may be used to lock inner portion  100  to outer portion  200 . 
       FIGS. 6 and 7  show the inner portion  100  of the package  1  fully assembled and closed. In the illustrated embodiment, the top flap  108  overhangs approximately 0.25 inches, and folds over a portion of the inner portion  100  (primary container), which may be the front portion  101 , back portion  102 , or side portion  103 . When an inner portion  100  of an embodiment of the present invention is assembled, the top flap  108  may be secured by glue, a tape-panel, a pressure sensitive adhesive strip that may be exposed when the liner is removed by a packager, or other suitable method of securement. 
     In embodiments of the present invention, one skilled in the art will readily understand that more or less apertures may be added to the inner and outer portions, and the number of apertures present is not limited to the number shown in the figures. For example, there may be additional apertures relative to those shown in  FIG. 6 . These additional apertures may increase the amount of incoming light in order to facilitate preparation of the compound for further preparation and administration. 
       FIG. 8  depicts the cap protector  10 , which may serve as a protector for vial top  12  as well as the top flap  108 . In an embodiment of the present invention, the cap protector  10  may be utilized as a spacer to ensure a snug fit of the inner portion  100  within the outer portion  200 . The cap protector  10  protects the vial top  12 , which may include a vial flip-cap.  FIG. 9  shows the cap protector  10  engaged with the top portion  104  of the inner portion  100  of the package  1  in an embodiment of the present invention. 
     As shown in  FIGS. 10 and 11 , in an embodiment of the present invention, the inner portion  100  (primary container) slides into the outer portion  200  (outer sleeve). An embodiment of the present invention may include a locking feature on the outer portion  200  to prevent the inner portion  100  from inadvertently falling out. In another embodiment of the present invention, the locking feature is located on the inner portion  100  of the package  1 . The locking feature may include, but is not limited to, an adhesive, a flap, a latch, a notch, a punch, or the like. In some embodiments, the inner and outer portions include features that lock to one another so as to inhibit full removal of the inner portion  100  from the outer portion  200  after the inner portion  100  is inserted into the outer portion  200 . 
       FIGS. 12-14  depict an inner portion  100  that include additional security features, according to an embodiment of the present invention. Specifically, in the exemplary embodiment shown in  FIGS. 12-14 , an inner portion  100  of an embodiment of the present invention that includes tape panels  114 . The tape panels  114  may include an aggressive tamper evident tape/adhesive that acts to effectively seal the inner portion  100  in a closed position, as shown in  FIG. 12-14 . In an embodiment of the present invention, the only way to remove the vial is to destroy the inner portion  100 . 
     One of the potential uses of embodiments of the present invention may be for drug companies&#39; products that are contained in vials for commercial use, or for use in global clinical studies including, but not limited to, pooled supplies. Embodiments of the present invention allow a materials supply chain or similar to have supplies permanently sealed into a secondary package so that companies do not have to label both levels of packaging (i.e., vials and cartons and/or both primary and secondary packages) with trial- and country-specific labeling. In doing so, embodiments of the present invention will reduce the cost of packaging and labeling. Embodiments of the present invention also may facilitate the packaging of pooled supplies by ensuring that all labeling is easily accessible for labeling at the point of distribution while maintaining global regulatory compliance, including, but not limited to, Annex 13 compliance (for investigational medicinal products). Additionally, embodiments of the present invention may ensure that there is empty space surrounding the vial, which can reduce the risk of breakage without requiring a separate cell divider, foam liner, or the like. 
     The use of embodiments of the present invention in pooled supplies, e.g., for use in clinical trials or for commercial use, will now be discussed. 
     Embodiments of the present invention may be packaged and labeled at a vendor, e.g., a packaging or distribution vendor, with appropriate labeling with the exception of study specific Annex 13 information, which prohibits pooling by making the labeling protocol specific (Protocol/Study Number, European Union Drug Regulating Authorities Clinical Trials Number and sponsor information). The generically labeled kits that may be included in the packaging of embodiments of the present invention may be kept in inventory as pooled supplies until they are requested for a specific study. When a shipping request is raised, a Just In Time (JIT) label may be printed at the point of distribution, and may include the Annex 13 information. This label may be applied to embodiments of the present invention just before shipping to a clinical trial site. Using embodiments of the present invention, a packaging or distribution vendor will only need to apply one label. Traditional packaging of the prior art would require that a packaging or distribution vendor generates two labels, open each kit, apply a label to the immediate container (vial), repack the vial in the carton, seal the carton, and apply a label to the carton. 
     The use of embodiments of the present invention in non-pooled supplies, e.g., for use in clinical trials or for commercial use, will now be discussed. 
     In non-pooled supplies, vials may be sealed into the packaging of embodiments of the present invention and a single label may be applied to a portion of the package Embodiments of the present invention will allow a materials supply chain to have supplies permanently sealed into a secondary package so that they do not have to label both levels of packaging (vials and cartons). Thus, embodiments of the present invention will reduce the cost of packaging and labeling. Traditional packaging would require that the vendor apply a label to the immediate container (vial), place a liner in the carton (if needed), pack the vial in the carton, seal the carton, and apply a label to the carton. 
     In an embodiment of the present invention, the finished goods may be stored at the point of distribution labeled with a generic booklet label (without any protocol/study specific information in the case of a clinical trial, or without any patient-specific information in the case of a commercial product). The Protocol Number and European Union Drug Regulating Authorities Clinical Trials Number, or any other patient-specific information, may be printed on an ancillary label which may be affixed to the booklet cover at the point of distribution just before shipment to the clinical or commercial site. 
     An alternate embodiment of the present invention is shown in  FIGS. 15-41 . 
     As shown in the figures, in an embodiment of the present invention, when the package is opened, the top of the vial is fully accessible for preparation, dosing, and administration of the contents. 
     When an embodiment of the present invention is assembled, the inner portion is held within the outer portion to form a carton. The carton can release the inner portion from the outer portion through a user squeezing side tabs and sliding the inner portion out from engagement with the outer portion. 
     As shown in the figures, multiple windows may be included in an embodiment of the present invention. The windows are present to facilitate preparation for dosing by allowing a viewing area for the practitioner to inspect the contents of the vial before dosing. The windows may have additional purposes as well, which would be apparent to a person of ordinary skill. 
       FIGS. 15-19  respectively illustrate the front, top, bottom, first side, and second side, views of a package design for injectable, vial based compounds according to a preferred embodiment of the present invention, and  FIGS. 20A-20B  respectively illustrate rear views of such a package design having either a flat label or a booklet label. The package  21  shown in  FIGS. 15-20B  includes an inner portion  300  and an outer portion  400 , although only outer portion  400  is readily visible in  FIGS. 15 ,  16 , and  17 . As shown in these figures and perhaps best seen in  FIGS. 18 ,  19 , and  20 A, when the inner portion  300  is engaged with the outer portion  400  such that cavity  401  defined within outer portion  400  receives the inner portion, only the rear  301  and a small area of the cooperating portion sides  302  of the inner portion  300  are visible. The rear  301  of the inner portion  300  is visible because of the cavity  401  in the rear of the outer portion  400 . The outer portion  400  includes a front surface  402 , side surfaces  403 , a top surface  404 , and a bottom surface  405  that collectively define cavity  401 . The cooperating portion sides  302  of the inner portion  300  are visible because of cutouts  408  included on the side surfaces  403  of the outer portion  400 . The side surfaces  403  of the outer portion  400  also include substantially semicircular shaped slits  406 , which create substantially semicircular flaps  407  that engage with the inner portion  300  as explained in more detail below. In an embodiment of the present invention, the outer portion  400  acts as an outer sleeve for the inner portion  300  to be received within. 
     As shown in  FIG. 17 , the bottom surface  405  of the outer portion  400  includes a label  22  in a preferred embodiment of the present invention. The label  22  may include any information that a person skilled in the art would contemplate being present on a label. For example, the label may include identifying marks such as Protocol identification, lot identification, medication identification, subject identification, dates, barcodes, warnings, designs, symbols, pictures, manufacturer information, supplier information, physician information, or anything that one skilled in the art would desire to be present on such a package  21 . The label  22  may be flat or planar, or alternatively may include a booklet label, which may comprise study information and/or regulatory information, such as described above with reference to  FIG. 1A . Moreover, only ancillary label text may be included on the label  22  shown in  FIG. 17 , while the main label  399  or  399   a  of a preferred embodiment of the present invention is affixed to the inner portion  300 , shown, for example, in  FIG. 20A  or  20 B respectively (i.e., the rear  301  of the inner portion  300 ). In other words, in a preferred embodiment of the present invention the main clinical label is applied to the inner portion  300 . Applying the label to the exterior face (the rear  301  of the inner portion  300 ) when the inner portion  300  is engaged to the outer portion  400  will allow the pharmacist to see the label when the supplies are on the shelf, e.g., as illustrated in  FIG. 20A  or  20 B. Alternatively, if a main label such as illustrated in  FIG. 17  is applied only to the bottom surface  306 , the label may not be visible when the supplies are packaged on a shelf.  FIG. 26  shows another label  305  disposed on the bottom surface  306  of the inner portion  300 . This label  305  may include ancillary label text in an embodiment of the present invention. 
     One skilled in the art would readily understand that the package  21  may be any color or variety of colors, and the label  22  may be any color or variety of colors. Further, an embodiment of the present invention may not include a label. 
     As shown in  FIGS. 21-38 , the inner portion  300  in a preferred embodiment of the present invention holds a vial  23 . In its assembled state, the inner portion  300  includes a vial holding portion  320  and a cooperating portion  310  designed to engage with the outer portion  400 . The cooperating portion  310  includes the rear  301  and cooperating portion sides  302  of the inner portion  300 . In other words, the cooperating portion  310  allows the inner portion  300  to engage with the outer portion  400  in an embodiment of the present invention. Specifically, in an embodiment of the present invention, the sides  302  are made from the same piece as the rear  301  and are folded inward to create a box shape that can be slid into the cavity  401  of the outer portion  400 . In fact, in a preferred embodiment of the present invention, the entire inner portion  300  is a single component that can be folded and adhered to form the shape shown in the figures. The cooperating portion sides  302  include substantially rectangular flaps  303 , perhaps best seen in  FIG. 29 , that are folded down and adhered to the rear portion of the cooperating portion sides  302  in order to cooperate with the substantially semicircular shaped slits  406  formed on the outer portion  400 , perhaps best seen in  FIGS. 22 and 23 , when the inner portion  300  is slid into the cavity  401  of the outer portion  400 . The substantially rectangular flaps  303  may be adhered to the cooperating portion sides  302  by glue, tape, or the like. In an embodiment of the present invention, the substantially rectangular flaps  303  are adhered to the cooperating portion sides  302  by a foam glue composite  330  that enables the flaps  303  to project slightly from the cooperating portion sides  302 .  FIG. 34-38  illustrate various views of the inner portion  300  in partially assembled states, so as to further illustrate relationships between the various components of the inner portion. 
     The base  304  of the cooperating portion  310  also acts as a base for the vial holding portion  320 . The bottom surface  306  of the base  304  optionally includes a label  305  in an embodiment of the present invention, as perhaps best seen in  FIG. 26 . The label  305  may include the same information as the label  22  on the outer portion  400 , or it may include different information. 
     The vial holding portion  320  is part of the single component that also makes up the cooperating portion  310  in an embodiment of the present invention. A portion extending from the base  304  is folded numerous times to form the shape of the vial holding portion  320  shown in the figures. Specifically, the vial holding portion  320  includes a front  321 , sides  322 , a top  323 , and a vial support  324  that rests on the base  304 . In an embodiment of the present invention, the vial holding portion  320  further includes a viewing window  325  that may be integrally coupled with the single component that creates the inner portion  300 . The viewing window  325  may be constructed out of a clear or translucent material so that the contents of the vial  23  (or an optional label on the vial  23 ) are visible. The viewing window  325  may also simply be formed from cutouts in the front  321  and/or sides  322  of the vial holding portion  320 . The sides  322  of the vial holding portion  320  may be secured onto extensions  326  of the rear, top, and/or bottom portion in order to form a substantially rectangular box shape, which may be accomplished through the use of an adhesive, tape, or the like. In an embodiment of the present invention, the top  323  of the vial holding portion  320  includes a top aperture  327  such that the vial top  24  protrudes therethrough. The extensions  326  may include, or may be replaced by, a receiving flap to secure closure of the vial holding portion sides  322  in an embodiment of the present invention. 
     In a preferred embodiment of the present invention, the vial top  24  is exposed from the vial holding portion  320  of the inner portion  300  such that a user may utilize the contents of the vial  23  while keeping the vial inside of the inner portion  300 . In an embodiment of the present invention, removal of the vial  23  will cause the package  21 , and more specifically the inner portion  300 , to be destroyed. In this manner the package  21  is tamper evident. For example, vial holding portion  320  may include one or more tape-panels such as described above with reference to  FIGS. 12-14 . 
     As perhaps best seen in  FIG. 33 , when the inner portion  300  is slid into the outer portion  400 , the substantially rectangular flaps  303  travel past the substantially semicircular shaped slits  406 , and the ends  328  of the flaps  303  engage the slits  406  thereby holding the inner portion  300  inside of the outer portion  400 . The slits  406  and flaps  407  are part of reusable locking system that works with the flaps  303  of the cooperating portion sides  302  to secure the inner portion  300  to the outer portion  400  in an embodiment of the present invention. In a preferred embodiment of the present invention, to remove the inner portion  300  from the outer portion  400 , a user simultaneously presses the substantially semicircular flaps  407  on the outer portion  400 , which then presses the substantially rectangular flaps  303  toward the cooperating portion sides  302  of the inner portion  300  and out of engagement with the substantially semicircular shaped slits  406 . A user may then slide the inner portion  300  out from the outer portion  400 . In an embodiment of the present invention, a user may not remove the inner portion  300  from the outer portion  400  without pressing the flaps  407 . In another embodiment of the present invention, simply pulling the exposed portion of the cooperating portion sides  302  of the inner portion  300  with ample force will remove the inner portion  300  from the outer portion  400 . 
       FIGS. 39-41  depict an inner portion  300  constructed in accordance with yet another embodiment of the present invention. The inner portion  300 , shown in various states of partial assembly in these figures, includes vial holding portion sides  322  that have tabs  331  that fit into slots  332  on the rear of the vial holding portion  320  in order to create the shape of the vial holding portion  320 . In other words, the sides  322  of the vial holding portion  320  in this embodiment are not secured onto extensions in order to form a substantially rectangular box shape, but are instead secured via the tabs  331  being inserted into slots  332 . In an embodiment of the present invention, the tabs  331  may be part of a dagger locking mechanism, where the tabs  331  are dagger locking tabs and the slots  332  are designed to accept the dagger locking tabs. Additionally, the embodiment of the present invention shown in  FIGS. 39-41  optionally includes a metallic-appearing laminated finish, although one skilled in the art will recognize that the appearance and finish of the packagings described herein is not limited by what is shown in the figures. Moreover, the embodiment of the present invention shown in  FIGS. 39-41  optionally includes a label  305  located on the rear  301  of the inner portion  300 . One skilled in the art will recognize that a label may be affixed to many portions of embodiments of the present invention and the label location is not limited to the locations shown/described herein. 
       FIGS. 42-44  depict a partially assembled inner portion  300  constructed in accordance with another embodiment of the present invention that is similar to the embodiment shown in  FIGS. 39-41 , but also includes additional support structures on the vial support  324  in the form of vertical support flaps  333 . The vertical support flaps  333  are located on both sides of the vial support  324  to enhance the strength of the vial support  324 . The vertical support flaps  333  are in the form of vertical fold-down flaps that provide added strength/support when engaged and locked into place when the inner portion  300  of the package  21  is erected/assembled and the vial holding portion sides  322  are assembled using the tabs  331  and slots  332  and/or the extensions  326  or the like. A person of ordinary skill will recognize that any suitable embodiment of the present invention may include vertical support flaps  333  to assist in strengthening the vial support  324 , and the vertical support flaps  333  are not limited to the embodiment shown in  FIGS. 42-44 . 
     An embodiment of the present invention is designed so that it can be shipped to a vendor as two substantially flat components (the inner portion  300  and the outer portion  400 ), which may then be assembled to form the package  21 . Embodiments of the present invention may include specific training and support materials so that a packaging vendor can utilize the two flat components and form the package  21 . 
       FIGS. 34-41  depict the inner portion  300  of the package  21  in a semi-assembled state. The vial  23  is placed into the vial holding portion  320  of the inner portion  300  through openings in the side  322  of the vial holding portion  320  (before the sides  322  of the vial holding portion  320  are secured in place forming a substantially rectangular box shape). 
       FIG. 21  depicts the inner portion  300  removed from the outer portion  400 . 
     As depicted in  FIG. 24 , in an embodiment of the present invention, the outer portion  400  is made from one solitary piece that is folded over itself for enhanced strength. The inner portion  300  may be similarly constructed. 
     In embodiments of the present invention, one skilled in the art will readily understand that other types of adhesives may be used other than tape or glue to hold the package  21  in the correct shape. Additionally, other securing means may be used altogether, such as clips, docking means, buttons, tabs, friction fits, hook and loop, joint fit, wedge fit, and the like. 
     As shown in  FIG. 33 , in an embodiment of the present invention, the inner portion  300  slides into the outer portion  400 . An embodiment of the present invention may include a locking feature on the outer portion  400  to prevent the inner portion  300  from inadvertently falling out. The locking feature may be the flaps  303 ,  407  and slits  406  explained herein, or any other means known to a person of ordinary skill in the art, such as an adhesive, a flap, a latch, a notch, tabs, a punch, or the like. 
     Embodiments of the present invention may include tape panels  329  as a means for adhering to the desired shape of the package  21 . The tape panels  329  may include an aggressive tamper evident tape/adhesive that acts to effectively seal the inner portion  300  in its desired configuration. In an embodiment of the present invention, the only way to remove the vial  23  is to destroy the inner portion  300 . 
     Embodiments of the present invention also include the methods of making the packages described herein, as well as the methods of using the packages in supplying clinical or commercial sites and the like. 
     While preferred embodiments of the invention are described herein, it will be apparent to one skilled in the art that various changes and modifications may be made. For example, although embodiments of the present invention offer advantages when used for shipping to clinical sites for use in clinical trials, one skilled in the art will understand that the embodiments of the present invention may also be used for other purposes, including but not limited to commercial use. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention. 
     LIST OF REFERENCE NUMBERS INCLUDED IN FIGURES 
     The following is a list of reference numbers used in the attached Figures for embodiments of the present invention: 
     
       
         
               
               
             
           
               
                   
                   
               
             
             
               
                   
                  (1) Package 
               
               
                   
                  (2) Label 
               
               
                   
                  (2a) Booklet 
               
               
                   
                  (3) Vial 
               
               
                   
                  (4) Protocol ID 
               
               
                   
                  (5) Lot ID 
               
               
                   
                  (6) Medication ID 
               
               
                   
                  (7) Subject ID 
               
               
                   
                  (8) Date 
               
               
                   
                  (9) Barcode 
               
               
                   
                  (10) Cap Protector 
               
               
                   
                  (11) Indented Portion 
               
               
                   
                  (12) Vial Top 
               
               
                   
                  (21) Package 
               
               
                   
                  (22) Label 
               
               
                   
                  (23) Vial 
               
               
                   
                  (24) Vial Top 
               
               
                   
                 (100) Inner Portion 
               
               
                   
                 (101) Front Portion 
               
               
                   
                 (102) Back Portion 
               
               
                   
                 (103) Side Portion 
               
               
                   
                 (104) Top Portion 
               
               
                   
                 (105) Bottom Portion 
               
               
                   
                 (106) Large Top Aperture 
               
               
                   
                 (107) Small Top Aperture 
               
               
                   
                 (108) Top Flap 
               
               
                   
                 (110) Vial Support 
               
               
                   
                 (111) Vial Label Viewing Aperture 
               
               
                   
                 (112) Side Tab Aperture 
               
               
                   
                 (113) Side Tab 
               
               
                   
                 (114) Tape Panel 
               
               
                   
                 (200) Outer Portion 
               
               
                   
                 (202) Back Portion 
               
               
                   
                 (203) Side Portion 
               
               
                   
                 (204) Top Portion 
               
               
                   
                 (205) Bottom Portion 
               
               
                   
                 (207) Cutout 
               
               
                   
                 (300) Inner Portion 
               
               
                   
                 (301) Rear 
               
               
                   
                 (302) Cooperating Portion Side 
               
               
                   
                 (303) Flaps 
               
               
                   
                 (304) Base 
               
               
                   
                 (305) Label 
               
               
                   
                 (306) Bottom Surface 
               
               
                   
                 (310) Cooperating Portion 
               
               
                   
                 (320) Vial Holding Portion 
               
               
                   
                 (321) Front 
               
               
                   
                 (322) Vial Holding Portion Side 
               
               
                   
                 (323) Top 
               
               
                   
                 (324) Vial Support 
               
               
                   
                 (325) Viewing Window 
               
               
                   
                 (326) Extensions 
               
               
                   
                 (327) Top Aperture 
               
               
                   
                 (328) Ends (Flaps) 
               
               
                   
                 (329) Tape Panel 
               
               
                   
                 (330) Foam Glue Composite 
               
               
                   
                 (331) Tabs 
               
               
                   
                 (332) Slots 
               
               
                   
                 (333) Vertical Flaps 
               
               
                   
                 (333′) Alternative Vertical Flaps 
               
               
                   
                 (400) Outer Portion 
               
               
                   
                 (401) Cavity 
               
               
                   
                 (402) Front Surface 
               
               
                   
                 (403) Side Surface 
               
               
                   
                 (404) Top Surface 
               
               
                   
                 (405) Bottom Surface 
               
               
                   
                 (406) Slits 
               
               
                   
                 (407) Flaps 
               
               
                   
                 (408) Cutout