Patent Publication Number: US-2012031401-A1

Title: Light blocking container with viewing window for photosensitive compounds

Description:
FIELD OF THE INVENTION 
     The present invention relates to containers for housing photosensitive materials, such as active pharmaceutical agents (APAs) and the like. 
     BACKGROUND 
     Certain compositions that contain active pharmaceutical agents (APAs) are known to be particularly photosensitive. In particular, certain APA compositions may experience lessened efficacy, or even a complete loss of efficacy, after exposure to ultraviolet rays from light. In some cases, even a very brief exposure to such ultraviolet rays can result in a decreased efficacy of the APA. Thus, it is important for some APAs to be housed in a container that shields the APA from exposure to light. 
     At the same time, however, the user of the APA often desires to see the contents of the container; so that the user may be aware of how much APA is left, and whether there is enough of the APA to administer a dosage of the APA. Generally, photosensitive APAs are housed in either colored glass bottles, glass bottles that have been treated with a UV-protectant, or in opaque plastic bottles. When the APA is contained in the colored or UV-treated glass bottle, the user may view the contents therein, however, with some difficulty. However, opaque bottles do not offer the ability to see the contents held within. Further, light-protecting materials, including colorants such as carbon black and UV-protectants, which are typically used on glass bottles cannot be used on plastic bottles, since these additives have a tendency to leach from the plastic material and contact the APA contained therein. Many APAs become contaminated when exposed to these additives, rendering the APA useless and potentially harmful to the user. 
     It is desirable to provide a container which allows the user to view the contents of photosensitive APAs contained therein, and that avoids the problem of APA contamination while simultaneously protecting the photosensitive APAs from exposure to light. 
     SUMMARY OF THE INVENTION 
     In several embodiments, the invention provides a container for housing a photosensitive compound therein, the container including an outer casing, an inner casing disposed within the interior of the outer casing, the inner easing configured to house the photosensitive compound therein, and a viewing window formed through the outer casing to permit viewing of the inner casing from the outside of the outer casing, the viewing window terminating outside of the inner casing, the viewing window being spaced from, and out of contact with, the photosensitive composition, and the viewing window including a light-protecting material. 
     Other embodiments provide a container for housing at least one photosensitive active pharmaceutical agent therein, the container comprising an outer casing; an inner casing disposed within the interior of the outer casing, the inner casing configured to house the at least one photosensitive active pharmaceutical agent therein; and a viewing window formed through the outer casing to permit viewing of the inner casing from the outside of the outer casing, the viewing window terminating outside of the inner casing, the viewing window being spaced from, and out of contact with, the at least one photosensitive active pharmaceutical agent, and the viewing window comprising a light-protecting material. The outer or inner casing may be a glass or plastic material and may be opaque. The outer casing can include titanium. The outer or inner casing may be comprised of at least one material selected from the group consisting of high density polyethylene, polypropylene, polyester, cyclic olefin copolymer and combinations thereof. The inner casing comprises a plastic material. In certain embodiments the inner easing is substantially transparent. 
     Suitable materials for the window include polypropylene, cyclic olefin copolymer and combinations thereof The light-protecting material may include a colorant, a UV-protectant and combinations thereof. The container may include a spraying mechanism. The inner and outer casings may be formed of different materials. The container may include, at least one additional layer between the outer and inner casings. The container may include a middle layer comprising a contrast enhancing agent and the agent may be a dark colorant. 
     Further embodiments provide for a device for dispensing doses of at least one photosensitive active pharmaceutical agent into a nasal cavity of a user, the device comprising a container and a dispenser in communication with the interior of the container, the dispenser configured to urge doses of the at least one photosensitive active pharmaceutical agent from the interior and into the nasal cavity of the user. 
     Still further embodiments provide for a drug product comprising a container and a photosensitive active pharmaceutical agent therein; wherein the container comprises an outer casing; an inner casing disposed within the interior of the outer casing, the inner easing configured to house the at least one photosensitive active pharmaceutical agent therein; and a viewing window formed through the outer casing to permit viewing of the inner easing from the outside of the outer casing, the viewing window terminating outside of the inner casing, the viewing window being spaced from, and out of contact with, the at least one photosensitive active pharmaceutical agent, and the viewing window comprising a light-protecting material. The drug product may contain at least one photosensitive active pharmaceutical agent selected from the group consisting of mometasone furoate monohydrate, azelastine, oxymetazoline, fluticasone furoate, fluticasone propionate and combinations thereof. The composition may include at least one active pharmaceutical agent, such as mornetasone furoate, such as mometasone furoate monohydrate or mometasone furoate anhydrous, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. 
     Still other embodiments provide for a drug product comprising a container and at least one active pharmaceutical agent therein; wherein the container comprises an outer easing; an inner casing disposed within the interior of the outer casing, the inner casing configured to house the at least one photosensitive active pharmaceutical agent therein; and a viewing window formed through the outer easing to permit viewing of the inner casing from the outside of the outer easing, the viewing window terminating outside of the inner casing, the viewing window being spaced from, and out of contact with, the at least one active pharmaceutical agent, and the viewing window comprising a light-protecting material. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of a first embodiment of the subject invention incorporating a view window. 
         FIG. 2  is a schematic view of the first embodiment of the subject invention incorporating a view window. 
         FIG. 3A  depicts an embodiment of the subject invention incorporating a viewing window. 
         FIG. 3B  is a cross-sectional view of the container wall including the viewing window therein. 
         FIG. 4A  is a cross-sectional view multi-layered container wall formed in accordance with the subject invention. 
         FIG. 4B  is a cross-sectional view of a multi-layered container wall formed in accordance with the subject invention including a viewing window therein. 
         FIG. 5  is a side view of a container formed in accordance with another embodiment of the subject invention. 
         FIG. 6  is a cross-sectional view of a container of  FIG. 5 . 
     
    
    
     DETAILED DESCRIPTION 
     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 compounds (e.g., pharmaceutically-active compounds). Any APA-containing compound or composition may be housed in the container, and in particular, the APA-containing compound may include photosensitive APAs. 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 degrade into undesirable degradants, only slightly react and/or lose effectiveness after exposure to light. 
     Non-limiting examples of photosensitive compounds include light sensitive APAs, such as mometasone furoate monohydrate, which is sold under the trademark NASONEX® and is sold by Schering Corporation of Kenilworth, N.J. Another example of a nasal spray photosensitive compound is oxymetazoline, which is sold under the trademark AFRIN® by Schering Corporation of Kenilworth, N.J. Another example of a nasal spray photosensitive compound is fluticasone furoate, which is sold under the trademark VERAMYST® by GlaxoSmithKline. Suitable at least one photosensitive active pharmaceutical agent may include mometasone furoate, such as mometasone furoate monohydrate or mornetasone furoate anhydrous, montelukast, oxymetazoline, azelastine, fluticasone furoate, fluticasone propionate and combinations or pharmaceutically acceptable salts thereof. 
       FIG. 1  depicts a first embodiment of a container  10 . The container  10  may be used to simply store the photosensitive compound, or it may be used in conjunction with a delivery system. Such delivery systems include droppers, sprayers, injectors, and the like. The container  10  described herein is particularly well-suited to be used conjunction with a nasal dispensing device, however it will be understood that the container  10  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 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. 
     The container  10  is a dual-container device having an outer casing  12  and an inner casing  18 . The outer easing  12  may be made of any material desired, such as a light-protecting material. As used herein, the term “light-protecting material” refers to any material that may be used to shield from exposure to light. For example, light-protecting materials may include opaque materials, through which light may not enter. Light-protecting materials may include colorants or UV-protectants, which allow the user to see through the material, but block light and/or UV rays from passing through the material. For example, the outer casing  12  is opaque, through which transmission of light is inhibited. In one embodiment, the outer casing  12  includes at least one light-protecting material, either attached to one or more surfaces of the outer casing  12  or formed integrally as a part of the outer casing  12 . The outer casing  12  may be made from plastic, but it may be made from any desired materials, including glass or other polymeric materials. Suitable materials for the outer casing  12  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 harrier, while maintaining acceptable clarity levels and is not brittle. As will be described in more detail below, the outer easing  12  does not physically come into contact with any photosensitive composition  16  contained in the container  10 . Thus, there is no potential for contamination of the photosensitive composition  16  through use of light-protecting materials on the outer casing  12 . 
     The outer casing  12  may include indicia or other markings identifying the materials contained therein if desired. In several embodiments, the outer casing  12  may be of an opaque material. A viewing window  14  may be formed through the outer easing  12 . The viewing window  14  may either be formed with the outer casing  12  or may be a separate piece and fitted into the outer casing  12 . The viewing window  14  may be made of any material suitable for viewing, and in one embodiment the viewing window  14  is made of plastic. For example, the viewing window  14  may be made from similar materials as the outer easing  12 , but may be made of the same or of different materials. For example, the viewing window  14  may be made from monolayer or multi-layered cyclic olefin copolymer (COC), HDPE, COC, polypropylene, or combinations thereof In one embodiment, the viewing window  14  is a multi-layered configuration, which includes more than one layer of material. In other embodiments, the view window may be made from COC with an over-molded PET layer. The lag window  14  is sufficiently transparent to allow viewing therethrough, and desirably includes a light-protecting material for protecting the contents of the outer casing  12  from exposure to light and/or UV rays. The viewing window  14  may be substantially transparent, and the light-protecting material may be a colorant or a UV-protectant. 
     In one particular embodiment, the container  10  may include an outer casing made from three layers of HDPE and a viewing window  14  made from COC. In this embodiment, the materials used may be bonded together naturally. In another embodiment, the container  10  may include a clear outer casing  12  which is covered by an opaque label, the label having an open portion forming the viewing window  14 . In other embodiments, the container  10  may include an outer casing  12  having a plurality of layers of HDPE with a clarified polypropylene stripe forming the viewing window  14 . 
     The light-protecting material may be in the viewing window  14  or it may be applied to one or more outer surfaces  13 ,  15  of the viewing window  14 . For example, the light-protecting material may be formed integrally with the viewing window  14  during formation, or the light-protecting material may be in the form of a sticker, a coating, or the like, which is then applied to one or more of the surfaces  13 ,  15  of the viewing window  14 . The viewing window  14  may be disposed on any desired surface of the outer casing  12 . In some embodiments, more than one of the viewing windows  14  may be formed through the outer casing  12 . 
     As will be understood, the outer surface  13  of the viewing window  14  is exposed to the outside of the container  10 , while the inner surface  15  of the viewing window  14  is exposed to an interior  17  of the outer casing  12 . With the viewing window  14  being sufficiently transparent, the user is capable of seeing through at least a portion of the outer casing  12  into the interior  17  thereof. The viewing window  14  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  14 . Desirably, the viewing window  14  is located at a position close to the bottom  19  of the container  10 , so that the user will be able to view low levels of any contents contained in the container  10 . 
     With reference to  FIG. 2 , the inner casing  18  may be completely contained in the interior  17  of the outer casing  12 , although portions of the inner casing  18  may extend beyond the interior  17  of the outer casing  12  if desired. In various embodiments, the inner casing  18  is wholly shielded from exposure to light and/or UV rays by the outer easing  12 . 
     As explained above, the outer casing  12  is made of opaque and/or light-protecting material (including but not limited to colorants and UV-protectants). In addition, the viewing window  14  includes light-protecting materials. As such, the materials contained within the interior  17  of the outer casing  12  will be generally protected from light exposure. The inner casing  18  may thus be made from any desired material, which need not necessarily be light-protected. In some embodiments, the inner casing  18  may be made from plastic or glass. The inner casing  18  may be made from the same material or different material as the outer casing  12 , 
     In several embodiments, the inner casing  18  is at least substantially transparent, manufactured from a non-light protecting material, and may be completely transparent. The inner casing  18  has an interior  21 , which houses the photosensitive composition  16 . As such, it is preferred that the inner casing  18  be compatible with the photosensitive composition  16  and not include any materials that may contaminate the photosensitive composition  16 , including but not limited to colorants and UV-protectant materials. The outer casing  12  and the inner casing  18  may be formed of different materials. With the inner casing  12  and the outer casing  18  being of different materials, the casings  12 ,  18  may be formed to suit different purposes. The outer casing  12 , for example, may be provided with light-protecting materials, while the inner easing  18  may be formed to be compatible with the photosensitive composition  16 . In several embodiments, the viewing window  14  terminates at a location outside of the inner casing  18 , such that the viewing window  14  is spaced from, and out of contact with, the photosensitive, composition  16  contained in the inner casing  18 . Issues of leaching associated with typical light-protecting materials may thus be avoided with the subject invention. 
     The inner casing  18  may include an access opening  25 , which provides access into the interior  21  of the inner casing  18 . The access opening  25  is normally covered, such that the photosensitive composition  16  cannot be removed unless the user physically manipulates the container  10  to remove the photosensitive composition.  16 . In one embodiment, a dispensing (e.g., nasal dispenser) or dropping mechanism as explained above may be fixed to the container  10  so as to have access to the interior  21  via the access opening  25 . In this configuration, there may be a nasal dispenser  28  in communication with the interior  21  of the inner casing  18 . The nasal dispenser  28  may be configured to urge doses of the photosensitive compound  16  from the interior  21  and into the nasal cavity of the user. The nasal dispenser  28  and the container  10  collectively define a device for dispensing doses of liquid into a user&#39;s nasal cavity. In other embodiments, the inner casing  18  and/or outer casing  12  may include a lid or other mechanism to allow the user to seal off the interior  21  (e.g., seal off the access opening  25 ) of the inner casing  18 . 
     With the subject invention, the photosensitive composition  16  is contained within the interior  21  of the inner casing  18 , and is thus protected from contamination by colorants or UV-protectant materials contained in the outer casing  12  and/or the viewing window  14 . The inner casing  18  is contained within the interior  17  of the light-protecting outer casing  12 . As such, the photosensitive composition  16  is protected from exposure to light. 
     The viewing window  14  may extend upwardly from the bottom  19  of the container  10 . The viewing window  14  may have sufficient length to allow the top surface  23  of the photosensitive composition  16  to be viewed during normal use. With the ability to view the top surface  23  of the photosensitive composition  16 , the amount of the photosensitive composition  16  may be evaluated. Since the outer casing  12  includes the light-protecting viewing window  14 , the user may view the contents of the inner casing  18  without having to open the container  10  and expose the photosensitive composition  16  to light. The photosensitive composition  16  is also protected during storage and between uses from light. As such, the photosensitive composition  16  is protected from not only the harmful exposure to light but also from potential contamination from light-protecting materials, such as colorants and UV-protectants. 
     The interior  21  may be formed to extend below the viewing window  14 . In this manner, the photosensitive composition  16  may be contained in the interior  17  at such a low level as to not be viewable through the viewing window  14 . This arrangement allows for a slight excess amount of the photosensitive composition  16  to be provided to ensure proper and complete full dosing. With a user believing that there has been full depletion of the photosensitive compound  16 . The excess amount allows for variation in dosing and/or assists in maintaining performance of any dispenser and/or assists in allowing for full dosages to be delivered through any dispenser intake (such as a drop tube). 
     With reference to  FIG. 3A , the container  10  is depicted, with an outer casing  12  having a view window  14  that extends from the very bottom region  50  of the container  10  to the upper region  40  of the container  10 .  FIG. 3B  shows a cross-sectional view of the, outer casing  12 , including the viewing window  14  therein. As can be seen, the outer casing  12  includes an inner surface  25  and an outer surface  26 . Likewise, the viewing window  14  includes an inner surface  15  and an outer surface  13 . In the dual-casing embodiment described herein, the inner casing  18  will be disposed in the interior  60  of the outer casing  12 . In this fashion, the inner surface  15  of the viewing window  14  and/or the inner surface  25  of the outer casing  12  may include one or more colorants or UV protectant materials without potential for harm of the composition  16  housed in the container  10 . 
     The inner casing  12  and/or the outer casing  18  may be of a multi-layered design. As seen in  FIGS. 4A and 4B , the casing  110  (which may be the inner casing  12  and/or the outer casing  18 ) may include multiple layers. The casing  110  may include, for example, a first layer  112 , a second layer  114 , and optionally a third layer  116 . More than three layers may be incorporated if desired. The inner surface  112  includes an inner layer  111  and an outer layer  113 . Similarly, 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 . As seen in  FIG. 4B , the multi-walled design may include a viewing window  120  disposed therein. 
     In the multi-layered wall design, the second layer  114  (or any other layers disposed on the outer surface  117  thereof) includes a colorant, UV protectant, or other light-protecting material therein, in this fashion, the colorant, UV protectant or other light-protecting material is further removed from an interior region  118  of the container  110 . This further serves to reduce the likelihood that the drug-containing composition housed therein will be exposed to the potentially harmful light-protecting materials incorporated into the container  110 . 
     In another embodiment, there may be provided an interior container having a tapered bottom portion to reduce the amount of drug overage. As depicted in  FIGS. 5 and 6 , there is provided a container  200 , having an interior  215 , designed for housing a composition containing at least one APA  240 . In several embodiments, the composition  240  is 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 composition  240  housed therein. In several embodiments, the main body portion  210  and the base portion  230  are 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 opaque. As with the containers described above, the container  200  may include indicia on its body indicating the contents housed therein. 
     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 composition  240  housed therein. 
     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 . In a several embodiments, the viewing window  220  is 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 windows  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 , white 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. 
     In one particular embodiment, as can be seen in  FIG. 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 be positioned to extend approximately to the area where the base portion  230  and the main body portion  210  are joined. The 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 . 
     The tapered bottom  235  of the base portion  230  is useful in reducing the amount of overage of 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. 
     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 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 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. 
     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 limit the invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching.