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AU2009319963A1 - Light blocking container with content viewing window and contrast background - Google Patents

Light blocking container with content viewing window and contrast background Download PDF

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Publication number
AU2009319963A1
AU2009319963A1 AU2009319963A AU2009319963A AU2009319963A1 AU 2009319963 A1 AU2009319963 A1 AU 2009319963A1 AU 2009319963 A AU2009319963 A AU 2009319963A AU 2009319963 A AU2009319963 A AU 2009319963A AU 2009319963 A1 AU2009319963 A1 AU 2009319963A1
Authority
AU
Australia
Prior art keywords
container
interior
composition
viewing window
layer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
AU2009319963A
Inventor
Robert L. Berger
Michael L. Turini
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Sharp and Dohme LLC
Original Assignee
Merck Sharp and Dohme Ltd
Merck Sharp and Dohme LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merck Sharp and Dohme Ltd, Merck Sharp and Dohme LLC filed Critical Merck Sharp and Dohme Ltd
Publication of AU2009319963A1 publication Critical patent/AU2009319963A1/en
Assigned to MERCK SHARP & DOHME CORP. reassignment MERCK SHARP & DOHME CORP. Alteration of Name(s) of Applicant(s) under S113 Assignors: SCHERING CORPORATION
Abandoned legal-status Critical Current

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D25/00Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/54Inspection openings or windows
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D1/00Rigid or semi-rigid containers having bodies formed in one piece, e.g. by casting metallic material, by moulding plastics, by blowing vitreous material, by throwing ceramic material, by moulding pulped fibrous material or by deep-drawing operations performed on sheet material
    • B65D1/02Bottles or similar containers with necks or like restricted apertures, designed for pouring contents
    • B65D1/0207Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features
    • B65D1/0215Bottles or similar containers with necks or like restricted apertures, designed for pouring contents characterised by material, e.g. composition, physical features multilayered
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00Details of bottles or jars not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00Details of bottles or jars not otherwise provided for
    • B65D23/02Linings or internal coatings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D23/00Details of bottles or jars not otherwise provided for
    • B65D23/08Coverings or external coatings
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2201/00Means or constructions for testing or controlling the contents

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Ceramic Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)

Description

WO 2010/062741 PCT/US2009/063074 LIGHT BLOCKING CONTAINER WITH CONTENT VIEWING WINDOW AND CONTRAST BACKGROUND FIELD OF THE INVENTION [0001] The present invention relates to containers for housing compositions, such as compositions containing active pharmaceutical agents (APAs) and the like. BACKGROUND [0002] Certain drug products that contain compositions with active pharmaceutical agents, such as those in liquid or powder form, may be stored in containers clear, white or opaque containers. Desirably, the user of the drug product is able to view the contents of the interior of the container to determine amount remaining and whether there is enough of the composition to administer a dosage. Many active pharmaceutical agents (APAs) are housed in either colored glass containers, or in opaque plastic containers, which may present difficulties to the user in determining the level of APA compound contained therein. This is especially problematic when the composition containing the APA is a light or clear colored liquid, which may be difficult to see when housed in a clear container. [0003] Storing APA containing compositions in light colored or clear containers may also affect photosensitive APAs, which must be kept below a particular level of light exposure in order to prevent degradation or unwanted reactions. In particular, certain APA containing compositions may experience lessened efficacy, increased degradation products or even a complete loss of efficacy, after exposure to ultraviolet rays from light. It is important for such compositions to be housed in a container that shields the APA from exposure to light. [0004] It is desired to provide a container which allows a user to effectively and accurately view the contents of APA containing compositions and yet also protect photosensitive APA containing compositions, if such compositions are contained therein.
WO 2010/062741 PCT/US2009/063074 SUMMARY OF THE INVENTION [0005] In several aspects of the invention, there is provided a container for housing a composition comprising at least one active pharmaceutical agent, the container comprising an interior for housing the composition comprising at least one active pharmaceutical agent; a container wall having an inner surface and an outer surface, wherein the inner surface is in communication with the interior; and a viewing window extending through the container wall so as to permit viewing of the interior from the outside of the container; wherein the container wall includes a colorant so as to define a background in the interior, the background defining a contrasting backdrop to the composition when viewed through the viewing window. The composition may be a light or clear liquid. The composition may include at least one active pharmaceutical agent, such as mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, budesonide, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. [0006] The outer surface may include titanium and/or at least one material selected from the group consisting of high density polyethylene, polypropylene, polyester, cyclic olefin copolymer and combinations thereof. The inner surface may include a material selected from the group consisting of high density polyethylene, polypropylene, polyester, cyclic olefin copolymer and combinations thereof. The window may include a material selected from the group consisting of polypropylene, cyclic olefin copolymer and combinations thereof. A particularly useful material for the window is a cyclic olefin copolymer. [0007] Other embodiments provide a container for housing a composition comprising at least one active pharmaceutical agent, the container comprising an interior region, which comprises a main body portion; and a bottom portion having a tapered interior surface; and a viewing window extending from the bottom of the main body portion to the top of the main body portion, allowing a user to view the interior region wherein the main body portion includes a colorant so as to define a background in the interior region, the background defining a contrasting backdrop to the composition when viewed through the viewing window. 2 WO 2010/062741 PCT/US2009/063074 [0008] Still other embodiments provide a drug product comprising a composition comprising at least one active pharmaceutical agent; an interior for housing the composition; a container wall having an inner surface and an outer surface, wherein the inner surface is in communication with the interior; and a viewing window extending through the container wall so as to permit viewing of the interior from the outside of the container; wherein the container wall includes a colorant so as to define a background in the interior, the background defining a contrasting backdrop to the composition when viewed through the viewing window. The composition may be a light or clear liquid and it may include at least one photosensitive active pharmaceutical agent, such as mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, budesonide, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. The at least one photosensitive active pharmaceutical agent may be mometasone furoate, such as mometasone furoate monohydrate, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. 3 WO 2010/062741 PCT/US2009/063074 BRIEF DESCRIPTION OF THE DRAWINGS [0009] FIG. 1 is one embodiment of a container formed in accordance with the subject invention. [0010] FIG. 2 is a cross-sectional view of a container of FIG. 1. [0011] FIG. 3 is a cross-sectional view of a container formed in accordance with a second embodiment of the subject invention. [0012] FIG. 4 is a cross-sectional view of a container with a viewing window formed in accordance with a second embodiment of the subject invention. [0013] FIG. 5 is a side view of a container formed in accordance with another embodiment of the subject invention. [0014] FIG. 6 is a cross-sectional view of a container of FIG. 5. 4 WO 2010/062741 PCT/US2009/063074 DETAILED DESCRIPTION [0015] With reference to the figures, several embodiments of the present invention are directed to a container, which may be used to house liquids, including chemical compounds, and in particular APA-containing compositions. Any APA-containing composition may be housed in the container, and in particular, the APA-containing compositions may include APAs in liquid form. Further, the APA-containing compositions may include light or dark colored compounds, or substantially transparent compounds. The APA-containing composition may be a photosensitive compound. As used herein, the term "photosensitive" may include any composition that reacts or degrades in the presence of light, and in particular may include compounds that react in the presence of ultraviolet rays. The term "photosensitive" is not limited to compounds that become completely ineffective in the presence of light, and may include compounds that only slightly react and/or lose effectiveness after exposure to light. [0016] The composition may be a light or clear liquid and it may include at least one active pharmaceutical agent, such as mometasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, budesonide, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. Photosensitive compounds may be suitable with various embodiments of the present invention, including, but not limited to, mometasone furoate monohydrate, which is sold under the trademark NASONEX@ and is sold by Schering Corporation of Kenilworth, N.J. Another example of a photosensitive compound is oxymetazoline, which is sold under the trademark AFRIN@ by Schering Corporation of Kenilworth, N.J. Another example of a photosensitive compound is fluticasone furoate, which is sold under the trademark VERAMYST@ by GlaxoSmithKline. [0017] The container described herein may be used to simply store the APA containing compositions, or it may be used in conjunction with a delivery system. Such delivery systems include droppers, sprayers, injectors, and the like. The container described herein is particularly well-suited to be used in conjunction with a nasal dispensing device, however it will be understood that the container may be any type or shape of container, including but not limited to nasal dispensing devices. Nasal dispensers of this type are well known in the art. Examples of such dispensers are 5 WO 2010/062741 PCT/US2009/063074 shown, for example, in U.S. Pat. Nos. 4,274,560; 4,944,429; and 5,433,343; the entire disclosures of which are incorporated herein by reference. [0018] With reference to Figure 1, there is provided a container 10, designed to house a APA-containing composition therein. The APA-containing composition may be colored or it may be clear. In several embodiments, the APA-containing composition is a light-colored or substantially clear liquid composition. The container 10 may be any shape, including cylindrical, box-shaped, irregular, or any other desired shape. The container 10 includes a container wall 20, which forms the region into which the composition may be housed. The container wall 20 may be made of any desired materials, including glass or polymeric materials. Suitable materials for the container wall 20 include high density polyethylene (HDPE), polypropylene, polyester (such as PET, PETg), COC, and other similar materials In general, it is desirable to use a material that provides a good vapor barrier, while maintaining acceptable clarity levels and is not brittle. The container wall 20 may be made of a polymeric material such as HDPE. [0019] The container 10 includes a top portion 40 and a bottom portion 50. The container wall 20 and the bottom portion 50 may be formed as separate pieces or may be formed as one piece. It is desired that the container 10 be fluid-tight to ensure safety and efficacy of the APA composition contained therein. The container wall 20 desirably provides a color to its interior, and more desirably is opaque. The container wall 20 may include one or more colorants or opacifiers to provide the colored or opaque look of the interior of the container 10. The interior of the container wall 20 may be a color that is contrasting to the color of the APA-containing composition contained therein. By the term "contrasting" is it understood that the interior of the container wall 20 is any color that is sufficiently different than the color of the APA containing compound. For example, the APA-containing composition may be light or white in color, and the interior of the container wall 20 may be dark colored. Alternatively, the APA-containing compound may be dark colored, and the interior of the container wall 20 may be light or white in color. As used herein, the term "dark colored" does not necessarily refer to a black or similar color. The term "dark colored" refers to a color that is darker than the color of the APA composition or the interior of the container wall 20. For slightly colored APA compositions, the interior of the 6 WO 2010/062741 PCT/US2009/063074 container 10 may be any darker color, for example, a reddish or brown color as desired, and vice versa. Regardless of whether the APA-containing compound is light or dark in color, the interior of the container wall 20 and the APA composition should form a contrast in colors. [0020] The container wall 20 includes at least one viewing window 30, which extends from approximately the bottom region 50 to approximately the top region 40. The viewing window 30 is substantially transparent, and extends through the entire thickness of the container wall 20 so as to permit viewing of the contents of the container 10 from the outside. The viewing window 30 may have a sufficient length to allow the top surface of the APA-containing composition housed in the interior 60 of the container 10 to be viewed. The container wall 20 and the viewing window 30 may be made of the same materials or they may be made of different materials. For example, the viewing window 30 may be made from monolayer or multi-layered cyclic olefin copolymer (COC), HDPE, COC, polypropylene, or combinations thereof. In one embodiment, the viewing window 30 is a multi-layered configuration, which includes more than one layer of material. In other embodiments, the viewing window may be made from COC with an over-molded PET layer. [0021] The container wall 20 and the viewing window 30 may be co-molded together or may be attached together as two separate pieces. In one particular embodiment, the container wall 20 may include an outer casing made from three layers of HDPE and a viewing window 30 made from COC. In this embodiment, the materials used may be bonded together naturally. In another embodiment, the container wall 20 may be covered by an opaque label, the label having an open portion forming the viewing window 30. In other embodiments, the container wall 20 may include a plurality of layers of HDPE with a clarified polypropylene stripe forming the viewing window 30. [0022] As may be seen in Figure 2, the container 10 includes a container wall 20 having an interior surface 25 and an exterior surface 26. The container 10 includes an interior region 60, which houses the APA composition. The container 10 further includes a viewing window 30, which is integrally formed with the container wall 20, which may extend the entire thickness of the container wall 20 (i.e., from the interior surface 25 to the exterior surface 26). When the interior surface 25 of the container 7 WO 2010/062741 PCT/US2009/063074 wall 20 is opaque, the user may still view the interior 60 of the container 10 through the viewing window 30. [0023] In such embodiments incorporating a viewing window 30, the interior surface 25 of the container wall 20 may be a contrasting colored and/or opaque wall, which blocks a substantial amount of light from entering the interior 60 of the container 10. As explained above, the interior surface 25 of the container wall 20 and the APA composition housed in the interior 60 should form a contrast in colors. The interior surface 25 of the container wall 20 may include one or more colorants or opacifiers, to create the contrasting or opaque interior surface 25 of the container wall 20. In addition, the container wall 20 may include one or more UV protectant materials to further protect the APA containing composition contained therein. If desired, exterior surface 26 of the container wall 20 may include indicia or other markings identifying the materials contained therein. [0024] The incorporation of a contrasting colored and/or opaque interior surface 25 creates a shadowing effect into the interior 60 of the container 10, which increases the visibility of the APA compositions when viewed through the viewing window 30. This allows the user to more clearly see the APA composition housed in the interior 60 of the container 10, and more accurately determine whether there is enough of the composition to administer a dosage, or whether more should be obtained. The viewing window 30 may have a width that is substantially less than the overall circumference of the container wall 20. In particular, the viewing window 30 should have a width that is less than 5% of the circumference of the container wall 20. [0025] In embodiments where the APA-containing composition housed within the container 10 is photosensitive, it has been found that as long as the viewing window 30 is of a small dimension and thickness with respect to the container 10, there will not be an excessive level of light that enters the container 10. The overall dimensions (width, height, thickness) of the viewing window 30 along with the inherent materials thereof affect the ability of the viewing window 30 to transmit light therethrough. A low level of light exposure to photosensitive compositions may not significantly or harmfully reduce the effectiveness of such photosensitive compositions. [0026] The interior surface 25 of the container wall 20 and the viewing window 30 may come into contact with the APA-containing composition in the container 10. As 8 WO 2010/062741 PCT/US2009/063074 such, it is desired that these components be made from a material that is compatible with the APA-containing composition, and in particular should be void of any contaminants that may harm the APA composition. If desired, the container 10 may include one or more liners covering the interior surface 25 of the container wall 20 and/or the viewing window 30. [0027] With reference to FIG. 3, one embodiment of the container is depicted, which includes a multi-layered wall arrangement. This multi-wall arrangement may be useful, for example, when the colorant or opacifier used has potential to contaminate or otherwise harm the APA composition contained therein. In this embodiment, there is provided a container 110, having multiple layers to allow for enhanced viewing of the APA compound and simultaneously protect the contents from contamination. The container 110 may have at least two layers, or three layers. The container 110 includes a first layer 112, a second layer 114, and optionally a third layer 116. More layers may be incorporated if desired. The first layer 112 is located closest to the interior 118 of the container 110, while the second layer 114 is disposed at a location further away from the interior 118 of the container 110. The container 110 may be any shape, including cylindrical, box-shaped, irregular, or any other desired shape. The container 110 includes an interior region 118, which is configured to house the APA-containing composition. The interior 118 (and the APA-containing composition housed therein) may be in contiguous contact with an inner surface 111 of the first layer 112. Thus, the inner surface 111 of the first layer 112 should be made of a material that is inert to the APA-containing composition. [0028] In one embodiment, the first layer 112 is sufficiently transparent to permit viewing therethrough, and is made from inert material that will not contaminate the APA-containing composition. As with the embodiment described above, the first layer 112 may be made of plastic, glass, or any other desired material. Suitable materials for the first layer 112 include HDPE, COC, polypropylene, PET, and combinations thereof. Since the first layer 112 is in contact with the APA-containing composition, it preferably does not include any material which may potentially contaminate the APA containing composition housed therein. The second layer 114 may contain a light protecting element, and may be made of plastic or other material. As with the embodiment described above, the second layer 114 may be made of plastic, glass, or 9 WO 2010/062741 PCT/US2009/063074 any other desired material. Suitable materials for the second layer 114 include HDPE, COC, polypropylene, PET, and combinations thereof. The second layer 114 may include a light-protecting material, such as colorants or UV-protectant material. In several embodiments, the second layer 114 is a contrasting-colored layer and/or opaque layer, which substantially restricts light into the interior 118 of the container. As explained above, the term "contrasting" refers to a color that is in contrast to the color of the composition housed in the interior 118 of the container 110. The second layer 114 includes an inner surface 115 and an outer surface 117. The inner surface 115 of the second layer 114 is in contact with the outer surface 113 of the first layer 112. [0029] The container may be a mono-layer and may be dark colored as to provide a contract for the composition contained therein. [0030] Finally, if desired, the container 110 may include an optional third layer 116. The optional third layer 116 may be made from any desired material, and in one embodiment is made from a plastic material, such as HDPE, COC, polypropylene, PET, and combinations thereof. The optional third layer 116 includes an inner surface 119 and an outer surface 121. The inner surface 119 of the third layer 116 is in contact with the outer surface 117 of the second layer 114. The outer surface 121 of the third layer 116 is exposed to the outside of the container 110. While the third layer 116 is most desirably transparent, the third layer 116 may or may not include a light protecting material or colorant, depending on the user's preference. Any of the three layers, including the first layer 112, the second layer 114, and the optional third layer 116, may be any color or have any opacity level. In several embodiments, at least one of the layers 112, 114, 116 is sufficiently contrasting to the APA composition to be housed therein and/or opaque to form the contrasting effect described above. [0031] The layers, including the first layer 112, the second layer 114, and the optional third layer 116, may be formed via any desired process. In one embodiment, the layers 112, 114, 116 are made from plastic and are co-extruded in the arrangement described above. In this fashion, the first layer 112, which is in contact with the APA containing composition, avoids potential leach-through of the colorant material formed with the second layer 114. In another embodiment, the various layers may be formed separately and then applied to each other. For example, in one method of formation, the first layer 112 may be formed first, and the second layer 114 then applied to the 10 WO 2010/062741 PCT/US2009/063074 outer surface 113 of the first layer 112. Similarly, if desired, the optional third layer 116 may then be applied to the outer surface 117 of the second layer 114. Any method for application of the various layers may be used. For example, the second layer 114 may be applied to the outer surface 113 of the first layer 112 as a paste, or it may be applied as a sticker onto the outer surface 113 of the first layer 112. Similarly, the third layer 116 may be applied to the outer surface 117 of the second layer 114 as a paste or as a sticker. Again, in this fashion, the first layer 112 avoids potential leach-through of the light-protecting material of the second layer 114. [0032] As depicted in FIG. 4, the multi-wall container 110 may include a narrow viewing window 120, which extends through at least a portion of each of the layers 112, 114, 116 of the container 110, and allows the user to view the interior 118 from the outside. As explained above, the viewing window 120 allows for a shadow effect, giving the user a clearer and more accurate view of the light-colored contents in the interior 118. The viewing window 120 may either be integrally formed with the layers 112, 114, 116, or the viewing window 120 may be a separate piece and fitted into the container 110. The viewing window 120 may be made from any material. In one embodiment, the viewing window 120 is made from a polymeric material, such as HDPE, COC, polypropylene, PET, and combinations thereof. The inner surface 122 of the viewing window 120 may be in contact with the interior 118, and thus may be in contact with the APA-containing composition contained therein. Thus, to avoid contamination of the APA-containing composition, the viewing window 120 should be made of an inert material, or it should be void of contaminants. [0033] In a various embodiments, the viewing window 120 extends through each of the layers of the container, such that it allows the user to view the interior 118 through the outside. The viewing window 120 may be any shape or design, including linear, circular, box shaped, curved, irregular, or any other desired shape which will allow viewing through the viewing window 120. Desirably, the viewing window 120 is located at a position close to the bottom of the container 110, so that the user will be able to view low levels of any contents contained in the container 110. The viewing window 120 may have sufficient length to allow the top surface of the APA-containing composition housed in the interior 118 of the container 110 to be viewed. With the ability to view the top surface of the APA-containing composition, the amount of the 11 WO 2010/062741 PCT/US2009/063074 APA-containing composition may effectively be evaluated. Since the container 110 includes the viewing window 120, the user may view the contents of the container 110 without having to open the container 110 and expose the APA-containing composition to potentially harmful elements outside the container 110. [0034] In such embodiments incorporating a viewing window, any of the layers, including the first layer 112, the second layer 114, and/or the third layer 116 may be a contrasting colored layer as described above, which blocks a substantial amount of light from entering the interior 118 of the container 110. The second layer 114 may be a contrasting colored and/or opaque layer. The second layer 114 may be opaque, thus blocking all light from passing through it. The second layer 114 may include one or more colorants or opacifiers, to create the contrasting or opaque second layer 114. In addition, the second layer 114 may include one or more UV protectant materials to further protect the APA containing composition contained therein. [0035] As explained above, the incorporation of a contrasting colored or opaque layer in conjunction with the viewing window 120 creates a shadow into the interior 118 of the container 110, which increases the visibility of APA-containing compositions contained therein through the clear viewing window 120. This allows the user to more clearly see the interior 118 of the container 110, and more accurately determine whether there is enough of the white or light-colored APA-containing composition to administer, or whether more should be obtained. [0036] The container 110 may include one or more UV protectant materials applied to the surface of any of the three layers 112, 114, 116. The use of UV protectant materials may be useful when the APA-containing composition housed in the container 110 is a photosensitive composition. The UV protectant materials may be applied to the surfaces 112, 114, 116 at any time, and may be applied in any desired form, including by spraying, extruding, dipping, coating, or other similar methods. [0037] The invention described herein may further include an access opening and/or delivery system. This embodiment may be used in either the single-wall or multi-wall design described above. For description purposes only, reference will be made to the multi-wall container 110, although it should be appreciated that the embodiments described herein may be used with the single-wall container 10 described above. The container 110 may include an access opening, providing access into the 12 WO 2010/062741 PCT/US2009/063074 interior 118 of the inner casing 110. The access opening is normally covered, such that the APA-containing composition cannot be removed unless the user physically manipulates the container 110 to remove the APA-containing composition. [0038] In one embodiment, a dispensing (e.g., nasal dispenser) or dropping mechanism as explained above may be fixed to the container 110 so as to have access to the interior 118 via the access opening. In this configuration, there may be a nasal dispenser in communication with the interior 118 of the container 110. The dispenser may be configured to urge doses of the APA-containing composition from the interior 118 and into the nasal cavity of the user. The dispenser and the container 110 collectively define a device for dispensing doses of liquid into a user's nasal cavity. In other embodiments, the container 110 may include a lid or other mechanism to allow the user to seal off the interior 118 (e.g., seal off the access opening) of the container 110. [0039] In some embodiments, the container 110 may be used in conjunction with a dual component system. For example, the system may include multiple casings, where the container 110 of the present invention forms the inner casing, and thus housing the APA containing composition, and having a separate outer casing surrounding the inner casing. [0040] In another embodiment, a container has a tapered bottom portion to reduce the amount of APA overage. As depicted in Figures 5 and 6, there is provided a container 200, having an interior 215, designed for housing a APA-containing composition 240. The APA containing composition 240 may be liquid in form, but other forms are contemplated such as powders. The container 200 includes a main body portion 210 and a base portion 230. The main body portion 210 and the base portion 230 may be made of the same materials or may be made of different materials, which may include any material compatible with the APA containing composition 240 housed therein. The main body portion 210 and the base portion 230 may be made of polymeric materials, such as HDPE, COC, PET, polypropylene and combinations thereof. The main body portion 210 and the base portion 230 may be colored or they may be clear. In one embodiment, the main body portion 210 and the base portion 230 are a color that is in contrast to the color of the composition housed therein, and may be 13 WO 2010/062741 PCT/US2009/063074 opaque. As with the containers described above, the container 200 may include indicia on its body indicating the contents housed therein. [0041] The main body portion 210 and the base portion 230 may be formed together as a single-piece molded unit, or they may be formed as separately molded pieces and fitted together. As will be appreciated by one of skill in the art, in view of the components of each portion of the container 200, forming the main body portion 210 and the base portion 230 as separate pieces may offer significant manufacturing advantages. The main body portion 210 and the base portion 230 may be attached together by any known means, including by ultrasonic welding, mechanical attachment, adhesives, or other desired means. When fitted together, the main body portion 210 and the base portion 230 form an integrally connected container 200, which is fluid tight to safely and effectively house the APA containing composition 240 housed therein. [0042] The main body portion 210 includes a visible viewing window 220, which allows the user to view the contents in the interior 215 of the container 200. The viewing window 220 may be in the form of a vertical stripe, however other geometric configurations are contemplated, including ovals, blocks, and other desired figures. The viewing window 220 may be disposed on any side of the main body portion 210, including the front, back, or side. There may be more than one viewing window 220 disposed on the main body portion 210 if desired. It is desired that the viewing window 220 be of a relatively thin size, to allow viewing of the contents in the container 200, while allowing the main body portion 210 to form the majority of the container 200 body. In one embodiment, the thickness of the viewing window 220 is less than approximately 5% of the circumference of the container 200 body. The viewing window 220 may have any desired length, and in one embodiment, the viewing window begins at or near the location where the base portion 230 is joined with the main body portion 210. The viewing window 220 may be of a sufficient length that it extends at or near the top of the main body portion 210. In one embodiment, the container 200 body includes a label or sticker applied to the outer surface, the label being sufficiently opaque or contrasting colored and further including a viewing window 220 as part of the label. 14 WO 2010/062741 PCT/US2009/063074 [0043] In one particular embodiment, as can be seen in Figure 6, the base portion 230 includes a tapered bottom 235. The tapered bottom 235 may extend towards the interior 215 as much as desired. The tapered bottom 235 may extend approximately to the area where the base portion 230 and the main body portion 210 are joined. The APA containing composition 240 is housed in the interior 215 of the container 200, and is further contained in the area formed by the tapered bottom 235 of the base portion 230. [0044] The tapered bottom 235 of the base portion 230 is useful in reducing the amount of overage of APA containing composition 240 that may be left in the container 200 after the user believes that the container 200 is empty. This configuration is especially useful when a delivery system (not shown) is attached to the container 200, and is particularly useful when the delivery system includes a spray attachment. In typical spray bottle configurations, the delivery system includes a hose that extends into the container. The hose typically is unable to effectively remove the composition that rests at the very bottom of the container. With a typical configuration, the bottom is flat, which leaves a large region for excess composition to remain. In some instances, it has been found that there may be enough composition left to administer as many as 8 10 dosages remaining unused in such typical containers. [0045] In contrast, with the tapered bottom 235 of the present invention, the base region 230 provides much less area in the interior 215 of the container 200, and thus greatly reduces the amount of APA containing composition 240 remaining in the container 200 after use. In fact, it has been determined that there is typically remaining enough of the composition 240 to provide about 2-4 dosages unused in the container 200. The invention provided herein thus reduces the wasted amount of APA containing composition 240 to about 25% of the prior art devices. In addition, the viewing window 220 may be configured to extend only to the top of the tapered bottom 235, so the user is not aware that the small amount of composition 240 remains, and thus will not attempt to provide a dosage when the level of composition 240 is not sufficiently high to reach the delivery system. [0046] The descriptions of the embodiments of the invention have been presented for purpose of illustration and description. They are not intended to be exhaustive or to 15 WO 2010/062741 PCT/US2009/063074 limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. 16

Claims (22)

1. A container for housing a composition comprising at least one active pharmaceutical agent, the container comprising: a. an interior for housing the composition comprising at least one active pharmaceutical agent; b. a container wall having an inner surface and an outer surface, wherein the inner surface is in communication with the interior; and c. a viewing window extending through the container wall so as to permit viewing of the interior from the outside of the container; wherein the container wall includes a colorant so as to define a background in the interior, the background defining a contrasting backdrop to the composition when viewed through the viewing window.
2. The container of claim 1, wherein the container comprises a plastic material.
3. The container of claim 1, wherein the container wall is opaque.
4. The container of claim 1, wherein the colorant is dark-colored.
5. The container of claim 1, wherein the colorant is an opacifier.
6. The container of claim 1, further comprising a UV protectant material.
7. The container of claim 1, comprising a spraying mechanism attached to the container and providing access to the interior.
8. The container of claim 1, wherein the container wall comprises a first layer forming the inner surface and a second layer forming the second surface.
9. The container of claim 8, wherein the second layer comprises the colorant.
10. The container of claim 8, further comprising a third layer, the third layer applied to an outer surface of the second layer.
11. The container of claim 1, wherein the viewing window is substantially free of colorant.
12. The container of claim 1, wherein the outer surface comprises titanium.
13. The container of claim 1, wherein the outer surface comprises at least one material selected from the group consisting of high density polyethylene, polypropylene, polyester, cyclic olefin copolymer and combinations thereof. 17 WO 2010/062741 PCT/US2009/063074
14. The container of claim 1, wherein the inner surface comprises a material selected from the group consisting of high density polyethylene, polypropylene, polyester, cyclic olefin copolymer and combinations thereof.
15. The container of claim 1, wherein the window comprises a material selected from the group consisting of polypropylene, cyclic olefin copolymer and combinations thereof.
16. The container of claim 1, wherein the window is a cyclic olefin copolymer.
17. A container for housing a composition comprising at least one active pharmaceutical agent, the container comprising: a. an interior region, which comprises: i. a main body portion; and ii. a bottom portion having a tapered interior surface; and b. a viewing window extending from the bottom of the main body portion to the top of the main body portion, allowing a user to view the interior region wherein the main body portion includes a colorant so as to define a background in the interior region, the background defining a contrasting backdrop to the composition when viewed through the viewing window.
18. The container of claim 17, comprising a spraying mechanism attached to the container and providing access to the interior.
19. A drug product comprising: a. a composition comprising at least one active pharmaceutical agent; b. an interior for housing the composition; c. a container wall having an inner surface and an outer surface, wherein the inner surface is in communication with the interior; and d. a viewing window extending through the container wall so as to permit viewing of the interior from the outside of the container; wherein the container wall includes a colorant so as to define a background in the interior, the background defining a contrasting backdrop to the composition when viewed through the viewing window.
20. The drug product of claim 19, wherein the composition is a light or clear liquid. 18 WO 2010/062741 PCT/US2009/063074
21. The drug product of claim 19, wherein the composition comprises at least one photosensitive active pharmaceutical agent.
22. The drug product of claim 19, wherein the at least one photosensitive active pharmaceutical agent is selected from the group consisting of mometasone furoate monohydrate, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations thereof. 19
AU2009319963A 2008-11-03 2009-11-03 Light blocking container with content viewing window and contrast background Abandoned AU2009319963A1 (en)

Applications Claiming Priority (3)

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US11089908P 2008-11-03 2008-11-03
US61/110,899 2008-11-03
PCT/US2009/063074 WO2010062741A1 (en) 2008-11-03 2009-11-03 Light blocking container with content viewing window and contrast background

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CA2741364A1 (en) 2010-06-03
US20120024742A1 (en) 2012-02-02
WO2010062741A8 (en) 2011-01-06
WO2010062741A1 (en) 2010-06-03
AR074266A1 (en) 2011-01-05
CN102202979A (en) 2011-09-28
JP2012510931A (en) 2012-05-17
EP2352678A1 (en) 2011-08-10

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