The present invention relates generally to asymmetrical film packaging systems and unit assemblies and processes to make same. Specifically, the present invention relates to packaging systems of multiple individual film strips, each film strip having an active within a polymer matrix, where the film strips are packaged within a unit assembly in an asymmetrical order to be readily distributable in single dose form to a user.
Pharmaceuticals, biologicals, nutraceuticals, and therapeutic substances in general are typically required to be ingested in relatively precise amounts. Ingestible film strip technology allows for precise pharmaceutical amounts to be incorporated on or into a digestible film strip. Thus, a user requiring a dosage of a material would place an ingestible film strip in their mouth, to be consumed.
Ingestible film strips may be packaged individually, to prevent accidental ingestion of more than one film strip by a user. That is, a user may accidentally take more than one film strip together from a cassette style package, as the strips are very thin and the user may be unaware that they have removed multiple films at one time. However, individual packaging of each film strip has inefficiencies associated with it, as it significantly increases manufacturing costs. As the user has to unwrap each individual film strip package, there is a lead time associated with administering dosages and each film strip is susceptible to tearing and/or contamination by the user as the user attempts to open the film strip package. Additionally, certain users may find opening individual packages difficult, especially the elderly or those with arthritis or other such conditions.
An aspect of the present invention provides a unit assembly including: a plurality of individual film strips, each film strip having an active within a polymer matrix, the film strips having respective perimetrical edges, the plurality of individual film strips being alternatingly positioned next to one another such that a film strip perimetrical edge is at least partially offset from a subsequent film strip perimetrical edge, wherein the respective perimetrical edges of the film strips are directly adjacent to each other.
Another aspect of the present invention provides a method for making a unit assembly, the method including: providing at least two individual polymeric film strips, the film strips having respective perimetrical edges; and alternatingly overlaying the film strips onto one another such that the respective perimetrical edges of a first film strip is at least partially offset from the perimetrical edges of the each of the other film strips which are directly adjacent to a first film strip.
Still another aspect of the present invention provides a method for making a unit assembly, the method including: providing a sheet of an ingestible film, the film including a polymeric matrix having an active therein; cutting the sheet with at least a first cutter and a second cutter, the first cutter having a first orientation generally parallel to a longitudinal axis of the sheet, the second cutter having a second orientation generally perpendicular to the longitudinal axis of the sheet, wherein the first and second cutters create a plurality of individual film strips having substantially the same shape and size from the sheet; overlaying the individual film strips into a unit assembly such that each film strip does not completely overlay the perimeter of its adjacent film strips.
Still another aspect of the present invention provides an apparatus for making a unit assembly including: a mandrel on which a sheet of film is supported, the film including an active within a polymer matrix; at least two blades, a first blade having a first position relative to a sheet position and a second blade having an adjustable position relative to the sheet position wherein the second blade is rotatable.
Yet another aspect of the present invention provides a method of dosage retrieval, including: providing a unit assembly including a plurality of individual film strips packaged therein, each film strip having an active within a polymer matrix; removing a individual film strip from the unit assembly; and inspecting the individual film strip for a cue that the individual film is a single dosage.
These and other features of the invention will be more fully understood from the following description of specific embodiments of the invention taken together with the accompanying drawings.
The embodiments of the present invention are directed to a unit assembly for dispensing individual ingestible films, an apparatus for making the individual film dosages, and methods of making and using the film dosages. The film dosages may be used to effectively and efficiently administer one or more agents to an individual in need thereof, for example various therapeutic agents including but not limited to pharmaceuticals, bioeffecting agents, medicaments, nutraceuticals, and/or cosmetic products. The individual film dosages may be desirably configured into an orientation with respect to one another so that an individual may remove a single film dosage from the unit assembly for dosing purposes. Further, the individual film strips may be desirably configured to correspond to the buccal (inner cheek) area (trapezoid or triangle), or to the sublingual area beneath the tongue of a user (e.g., trapezoid or triangle), or generally to lie along the tongue with a larger portion of the film positioned towards the front or back of the mouth (e.g., L-shape).
The unit assembly includes individual film dosages that are visually identifiable and distinguishable from one another, for example, through the use of one or more visual cues. The films may be similarly shaped for efficiency in manufacturing and to ensure consistent dosages per film strip. However, in the packaging of the unit doses, the film strips may be rotated from one another so that the film dosages do not completely overlap one another. This may be accomplished through the use of one or more shapes or designs that are not perfectly symmetrical and/or when overlaid on each other do not perfectly overlap. Such shapes may include, for example, trapezoids, L-shaped polygons, triangles, and the like, as may be desired.
The unit assembly thus includes a plurality of individual film strips, each film strip with a dosage of one or more desired agents for administration to an individual. For dosing purposes, the individual films may be configured to be recognizable and distinguishable from one another to aid a user in removing the proper dosage from the unit assembly for ingestion and administration. Thus, the unit assembly, apparatus, and methods of the present invention are advantageous in that the embodiments promote effective and efficient dosing from a multi-pack unit assembly. A major drawback of traditional multi-pack assemblies has been that the film strips of identical shape and orientation within the casing may stick together to resemble a single dosage, even to the most careful of user. Thus, double dosages or more could be accidentally ingested repeatedly by users.
The embodiments of the present invention may employ various additional cues to a user, in addition to differing perimeter profiles, to provide additional guidance to a user and to promote ease of use. In addition to using various shapes, colors, transparency/opaqueness, writing, and shapes or lines may be imprinted, indented or embossed onto the face or surface of each individual film strip.
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As previously noted, various other indicia, such as color, texture, design imprints or embossing may be used in combination with film shapes and juxtapositions. Such combinations apply to all embodiments discussed in this invention.
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Various shapes and designs of the film strips may be employed, as may be desired. Shapes of film strips to be used with the embodiments of the present invention may include one or more desirable and/or advantageous characteristic. Specifically, it may be desirable for the film strips to be of the same shape in order to ensure that each film strip has an identical amount of active therein to correspond to a consistent dosage. It is also be desirable for the film strips to be of a shape which may be rotated and overlaid upon another film strip to create a portion of overlap, or shared perimeter and a portion of non-overlap in order to provide a shape for individual strips that is different and distinct from the profile or perimeter of a plurality of strips. One way of achieving this characteristic may be through the use of shapes that are asymmetrical, but have mirror symmetry. It may also be desirable for the film shape to use as much surface area as possible from a sheet of film in order to promote cost effectiveness and efficiency in manufacturing and prevent wasted film bi-product. It may further be desirable to use a shape that may be repeated along the length and width of a sheet of film that has at least one common cut line, as shown in
Each of the plurality of film strips 22 further may desirably include an active within a polymer matrix. The active may include a pharmaceutical, a nutraceutical, and/or other agents, as may be desired. The polymer matrix may desirably be ingestible and/or rapidly solubilizable. Controlled release, rapid release, sequential release, pulse release and sustained release compositions, among others, may be employed to give the desired release profile. Thus, the individual film strip may contain a dosage of a medicament or an agent which is to be administered and dissolved in a user's orifice, including the mouth, e.g., cheek, or under or on the tongue; mucosal membrane area such as the vagina, anus, eyes; or on a wound, or on the skin, e.g., via a transdermal application.
The unit assembly 20 may be stored in a cassette 34 or in an encasing member, as shown in
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The sheet 48 may be cut into a plurality of triangle film strips, trapezoid film strips, L-shaped film strips, and the like, as shown in
At least one of the blades may be rotatable. For example, if the second blade 38 is rotatable, then a zigzag blade may be replaced with a straight, conventional cutting edge on the second blade 38. Thus, a first pass may be from the first blade to cut the sheet into long lengths, while the second pass may be from a rotatable second blade 38. The blade may rotate from about 10 degrees up to about 60 degrees. Preferably, the blade is rotatable from about 30 degrees to about 45 degrees back and forth in order to cut the smaller sheets 48 into the individual film strips. To rotate the second blade, the apparatus 50 may further include a tool 54 to hold and rotate the blade 38. The alternating inclinations of the cutting edge of the blade 46 may be provided by a mechanical or electromechanical device which reorients the blade 46 between successive cuts of the sheet 48a by the cutting edge. Alternately, the blades 36, 38 may remain in a non-rotatable position. Rather, the sheet 58 may be rotated and/or configured so that the blades 36/38 may make the appropriate cuts to reduce the sheet 48 to a plurality of individual film strips 22.
The tool 54 supports the first and second blades 36, 38, and may be movable relative to the mandrel 52 such that, when the sheet 48 is supported on the mandrel 52, the tool 54 forces the cutting edges of the first and second blades 36, 38 through the sheet 48. The respective first and second blades 36, 38 sever alternating parts of the sheet 48 to form the plurality of individual film strips 22.
The sheet 48 may be cut in a variety of different configurations, as may be desired. One such configuration is to first cut the sheet 48 by forcing the cutting edge of the first blade 36 (straight edge) through the sheet 48 to cut a plurality of long sheets, smaller sheets from the large sheet 48. Such a cut will allow for the plurality of long, smaller sheets to continue to be supported by the mandrel and conveyed along the manufacturing line or production line. The first cut by the first blade 36 is depicted in
In addition, it may be desirable to include a static reduced environment in the cutting or stacking of the strips 22 in the unit assembly 20. Thus, the accumulation of electrical charges, which may occur in the conveying and assembly of the strips into packages, will not interfere with the film strip placement into unit assembly cassettes, packages, and the like.
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In an alternative embodiment, the sheet 48 is cut into the ribbons 35 without the formation of the L-shaped sections 34 in the sheet. In this embodiment, the respective blades 36, 38 sever alternating parts of the ribbons 35 to form the L-shaped sections 34, as shown in
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While the invention has been described by reference to certain preferred embodiments, it should be understood that numerous changes could be made within the spirit and scope of the inventive concept described. Accordingly, it is intended that the invention not be limited to the disclosed embodiments, but that it have the full scope permitted by the language of the following claims.
This application claims the benefit of U.S. Provisional Application No. 61/144,222, filed Jan. 13, 2009, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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61144222 | Jan 2009 | US |