Overmolding technology and related products

Abstract

Techniques for overmolding compositions onto a substrate are disclosed. More specifically, but not exclusively, techniques for overmolding therapeutic compositions onto a substrate configured for delivery of the composition to teeth and / or oral tissues are disclosed. The overmolding technique may include injection molding the therapeutic composition onto the substrate, and the therapeutic composition may include one or more therapeutic agents that effectively treat one or more oral conditions.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 62 / 885,060, filed August 9, 2019, entitled Overmolding Technology and Related Articles Therefrom, which is incorporated herein by reference in its entirety.

[0003] background

[0004] Overmolding is a process that uses a combination of two or more different materials to create a single part. Typically, the first material, sometimes called the substrate, is partially or completely covered by subsequent materials during the manufacturing process.

[0005] Common problems encountered in overmolding include poor adhesion between the substrate and the subsequent material (often referred to as the overmolded part), incomplete molding of the substrate or overmolded part, surface irregularities, inhomogeneities, and material degradation. Other problems that may occur during the overmolding process include warped parts, which can be caused by temperature differences, insufficient cooling time, and insufficient substrate thickness. Other issues that may arise during overmolding include voids or openings in the substrate or overmolded part, delamination, and improper ventilation during the manufacturing process. Summary of the Invention

[0006] Therefore, it is necessary to overmold the material onto the substrate, which eliminates one or more of the aforementioned disadvantages or problems. It should be understood that other disadvantages or problems can be solved, and the various exemplary embodiments are not necessarily intended to solve any particular disadvantage or problem.

[0007] This disclosure generally relates to techniques for overmolding compositions onto a substrate, and more specifically, but not exclusively, to techniques for overmolding therapeutic compositions onto a substrate configured for delivery of the composition to teeth and / or oral tissues. Overmolding techniques may include injection molding a therapeutic composition onto a substrate, and the therapeutic composition may include one or more therapeutic agents that effectively treat one or more oral conditions. For example, in one exemplary form, the therapeutic composition may be a teeth whitening gel and / or a desensitizing gel.

[0008] Various base materials can be used to deliver the composition to the desired location for application or release. As non-limiting examples, dental and oral treatment devices, such as treatment trays and strips, can be used to deliver dental and oral treatment compositions (such as teeth whitening compositions, desensitizing compositions, and periodontal medications) to a user's teeth and / or gums. Dental trays are typically designed to fit some or all of a user's teeth and can be filled with oral treatment compositions, while dental or oral treatment strips typically include a treatment composition disposed on one side or embedded within a barrier layer. Oral treatment compositions can be formulated with a sufficiently low viscosity to allow the composition to flow, so that it can be easily dispensed by the user or during manufacturing. Furthermore, oral treatment compositions can be formulated with thickeners and / or tackifiers to adhere dental treatment devices and / or to the user's teeth to facilitate device placement and minimize device slippage. Additionally, to provide a long shelf life, oral treatment compositions can be formulated to maintain a viscous, sticky, and / or flowable consistency over time.

[0009] The properties of oral treatment compositions, such as viscosity and adhesiveness, can limit the types of processes that can be used to manufacture delivery trays and strips containing such compositions. Furthermore, current processes may struggle to control composition deposition, thus limiting manufacturing efficiency and consistency. Additionally, compositions used in dental applications can deform or flow out of the tray or strip over time, shortening the product's shelf life. Similarly, compositions can be unintentionally released during user handling of the tray or strip before it is properly positioned for effective oral treatment.

[0010] In light of the foregoing, further contributions in this technical field may be required. The claimed subject matter is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this information is provided merely as an example illustrating where this disclosure may be used.

[0011] In one exemplary embodiment, a method may include positioning a mold relative to a substrate, injecting a composition comprising a hydrophilic polymer between the mold and the substrate, and overmolding the composition onto a surface of the substrate in an overmolding configuration corresponding to the configuration defined by the mold. The method may further include separating the mold from the substrate while substantially retaining the composition within the overmolded configuration.

[0012] In another exemplary embodiment, a method may include positioning an overmolding mold relative to a dental tray including a groove defined by inner and outer sidewalls, and overmolding an oral treatment composition onto at least a portion of one or both of the inner and outer sidewalls of the dental tray. The oral treatment composition may include at least one therapeutic agent that is effective in treating oral conditions.

[0013] In yet another exemplary embodiment, the oral treatment system may include a dental tray comprising a groove defined by an inner wall and an outer wall, and an oral treatment composition may be overmolded onto at least a portion of one or both of the inner wall and the outer wall of the dental tray. The oral treatment composition may include at least one therapeutic agent effective in treating oral conditions.

[0014] One aspect is a method comprising positioning a mold relative to a substrate, injecting a composition comprising a hydrophilic polymer between the mold and the substrate, overmolding the composition onto a surface of the substrate in an overmolding configuration corresponding to the configuration defined by the mold, and separating the mold from the substrate while substantially retaining the composition within the overmolded configuration. The substrate may comprise a generally arched dental tray comprising a groove defined by inner and outer sidewalls, and the composition may be overmolded onto at least a portion of one or both of the inner and outer sidewalls. The method may include molding the dental tray with at least one thermoplastic polymer. The composition may comprise at least one therapeutic agent effective in treating oral conditions. At least one therapeutic agent may be hydrogen peroxide. The composition may be in the form of a deformable gel exhibiting properties that effectively and selectively retain the composition within the overmolded configuration until the dental tray is used in oral treatment. The composition may comprise hydrogen peroxide and may be injected at a temperature below about 25°C. The composition may comprise at least one therapeutic agent effective in treating oral conditions and at least one hydrophobic agent.

[0015] Another method includes positioning an overmolding mold relative to a dental tray comprising a groove defined by inner and outer sidewalls, and overmolding an oral treatment composition onto at least a portion of one or both of the inner and outer sidewalls of the dental tray. The oral treatment composition may include at least one therapeutic agent effective in treating oral conditions. The oral treatment composition may be in gel form and may include at least one hydrophilic polymer. The dental tray may be generally arched. The method may include positioning a first mold relative to a second mold, and the first and second molds defining cavities having a configuration corresponding to the dental tray; injecting a thermoplastic polymer between the first and second molds to form the dental tray; separating the first mold from the second mold and maintaining contact between the dental tray and the first mold. The overmolding mold may be positioned relative to the dental tray and the first mold. At least one therapeutic agent may be selected from teeth whitening agents, teeth brighteners, desensitizing agents, remineralizing agents, anesthetics, anti-plaque agents, anti-tartar agents, antibacterial agents, antibiotics, disinfectants, preservatives, antioxidants, healing agents, gloss agents, and combinations thereof. Overmolding may be performed at a temperature below about 25°C. Overmolding may include injecting an oral treatment composition between an overmolding mold and a dental tray.

[0016] Another aspect is an oral treatment system that may comprise a dental tray including a groove defined by an inner wall and an outer wall, and an oral treatment composition overmolded on at least a portion of one or both of the inner and outer walls of the dental tray. The oral treatment composition may include at least one therapeutic agent effective in treating oral conditions. The therapeutic agent may be hydrogen peroxide. The oral treatment composition may comprise a gel, liquid, suspension, paste, putty, or foam. The oral treatment composition may include at least one hydrophilic polymer. The oral treatment composition may include a gel that exhibits effective resistance to deformation until the dental tray is used in the oral cavity.

[0017] Another aspect is an oral treatment system for treating a user's teeth and / or oral cavity. This system may include a base sized and constructed to be at least partially disposed within the user's oral cavity, and a treatment composition overmolded onto the surface of the base. The treatment composition may include at least one therapeutic agent effective in treating oral conditions. In one exemplary embodiment, the base may be an oral treatment strip, and the treatment composition may be overmolded onto at least a portion of the inner surface of the oral treatment strip. In another exemplary embodiment, the base may be a substantially arched dental tray, and the treatment composition may be overmolded onto at least a portion of the inner surface of the substantially arched dental tray.

[0018] Another aspect is a method that may include providing a mold, and the mold may include a recessed portion; placing a substrate in the mold, and the size and construction of the substrate may be designed to at least partially occupy the oral cavity of a user; injecting a treatment composition between the mold and the substrate; overmolding the treatment composition onto a surface of the substrate, and the treatment composition may include at least one therapeutic agent effective in treating oral conditions; and releasing the substrate from the mold while substantially retaining the treatment composition on the substrate. The substrate may be an oral treatment strip, and the treatment composition may be overmolded onto at least a portion of the inner surface of the oral treatment strip. The substrate may be a substantially arched dental tray, and the treatment composition may be overmolded onto at least a portion of the inner surface of the substantially arched dental tray.

[0019] These and other aspects, features, and advantages of the invention will become more apparent from the following brief description of the accompanying drawings, the detailed description of the preferred embodiments, and the appended claims.

[0020] Brief description of the attached figures

[0021] The accompanying drawings contain illustrations of exemplary embodiments to further illustrate and clarify the above and other aspects, advantages, and features of the invention. It will be understood that these drawings depict only exemplary embodiments of the invention and are not intended to limit its scope. Furthermore, it will be understood that while the drawings may illustrate preferred dimensions, scales, relationships, and configurations of the invention, they are not intended to limit the scope of the claimed invention. The invention will be described and explained with additional features and details using the accompanying drawings, wherein:

[0022] Figure 1 This is a perspective view of an exemplary oral treatment strip having an overmolded therapeutic composition;

[0023] Figure 2A yes Figure 1 The side view of the oral treatment strip shown;

[0024] Figure 2B yes Figure 1 A top view of the oral treatment strip shown;

[0025] Figure 3 yes Figure 1 The shown dental treatment strip Figure 2A A sectional view taken along centerline 3-3;

[0026] Figure 4 This is a perspective view of another exemplary embodiment of the oral treatment strip;

[0027] Figure 5 This is a perspective view of an exemplary oral treatment tray having an overmolded therapeutic composition;

[0028] Figure 6 This is a perspective view of an exemplary mold that can be used to overlay and mold a therapeutic composition onto an oral treatment tray, such as... Figure 5 As shown;

[0029] Figure 7 yes Figure 6 A perspective view of a portion of the mold shown, illustrating its relationship with... Figure 5 The mold shown is for positioning the oral treatment tray;

[0030] Figure 8 yes Figure 6 Another perspective view of a portion of the mold shown illustrates the mold with the dental treatment tray removed, to illustrate the construction of the overmolded treatment composition provided by the mold; and

[0031] Figure 9 It is used to prepare dental treatment trays (such as...) Figure 5 A perspective view of an exemplary mold of the oral treatment tray shown.

[0032] Detailed description

[0033] To facilitate understanding of this disclosure, reference will now be made to the following exemplary embodiments, which will be described using specific language. However, it should be understood that this is not intended to limit the scope of this disclosure, and such changes and further modifications to the subject matter, as well as further applications of the principles of the disclosure, will commonly occur to those skilled in the art.

[0034] The terms and words used in the following description and claims are not limited to their bibliographical meaning, but are used only to enable this disclosure to be understood clearly and consistently. It should be understood that the singular forms of “a,” “an,” and “the” include the plural of the objects they refer to, unless the context clearly specifies otherwise. Thus, for example, reference to “component surface” includes reference to one or more such surfaces.

[0035] The term “substantially” means that the feature, parameter, or value does not need to be precisely achieved, but rather that deviations or variations, including, for example, tolerances, measurement errors, measurement accuracy limitations, and other factors known to those skilled in the art, may occur in a number that does not hinder the effect that the feature is intended to provide.

[0036] As used herein, the term "therapeutic agent" means and includes any composition or mixture of any agent, compound, substance or the like that provides some cosmetic, therapeutic, preventive or hygienic benefit in the oral cavity by direct application to the teeth or oral tissues or by absorption by the oral tissues to other places.

[0037] As used herein, the term “treatment” means and includes the process of applying a therapeutic agent or substance containing a therapeutic agent to the teeth or oral tissues to achieve cosmetic, therapeutic, preventive or hygienic benefits and / or treat or benefit one or more oral conditions (such as teeth whitening, desensitization and / or remineralization).

[0038] This disclosure generally relates to techniques for overmolding compositions onto a substrate, and more specifically, but not exclusively, to techniques for overmolding therapeutic compositions onto a substrate configured for delivery of the composition to human or animal teeth and / or oral tissues. In one exemplary form, the therapeutic composition may be an oral therapeutic composition, which is a polymer composition comprising at least one therapeutic agent effective for treating one or more oral diseases, and may be overmolded onto a substrate using injection molding. However, the principles disclosed herein are not limited to oral and / or dental care applications. Rather, it should be understood that the overmolding techniques disclosed herein can be successfully used in other applications.

[0039] Current overall reference Figures 1-3The oral treatment strip 10 may include a base 12 on which a treatment composition 14 is overmolded. The base 12 may provide support and flexibility, and the treatment composition 14 may be in the form of, for example, a gel, suspension, liquid, paste, putty, foam, etc. While the base 12 of the oral treatment strip 10 may include a generally rectangular configuration as shown in the illustrated form, it should be understood that other shapes and variations thereof are possible. Furthermore, in the illustrated form, the treatment composition 14 is overmolded to a shape generally corresponding to the base 12. However, in other forms, the treatment composition 14 may be overmolded to a shape generally different from that of the base 12 below, further details of which will be provided below. Further details regarding the materials that may form the base 12 and the treatment composition 14 are also provided below.

[0040] Generally, the therapeutic composition 14 can be overmolded onto the substrate 12 by positioning a first mold relative to the substrate 12. The relative positioning of the mold and the substrate 12 can be maintained by any suitable means, and can be achieved, for example, by using a second mold (in combination with a different third mold) to form the substrate 12. Once the therapeutic composition 14 is overmolded onto the substrate 12, the first mold can define a profile corresponding to the desired final shape and construction of the therapeutic composition 14. In this way, when the first mold is properly positioned, the profile of the first mold can define a cavity, and the therapeutic composition 14 can be injected between the first mold and the substrate 12 to fill the cavity. Once the cavity is filled, the first mold can be detached from the substrate 12, leaving the therapeutic composition 14 on the substrate 12 in a configuration corresponding to the cavity.

[0041] Since the shape and configuration of the therapeutic composition 14 overmolded on the substrate 12 can correspond to a contour at least partially defined by the first mold, it should be understood that the structural features of the therapeutic composition 14 overmolded on the substrate 12 can be predetermined and / or modified by altering the contour at least partially defined by the first mold, which in turn can modify the cavity into which the therapeutic composition 14 is injected. For example, as Figure 2B and Figure 3As shown, the therapeutic composition 14 overmolded on the substrate 12 may include a width W, a length L, and a thickness T, any one or more of which may vary along all or part of the substrate 12 to change the configuration of the therapeutic composition 14. As a non-limiting example, one or both of the width W and thickness T may vary along the length L, and / or the thickness T may extend through the width W and vary along the length L or at discrete locations along the length L. In the illustrated form, the therapeutic composition 14 may have a continuous configuration on the substrate 12. However, it should be understood that the profile of the first mold may be modified to provide the therapeutic composition 14 on the substrate 12 in any desired number of discrete portions, and the width, length, and / or thickness of each discrete portion may be the same or different from one or more other portions. Furthermore, in the form where the therapeutic composition 14 comprises two or more discrete portions on the substrate 12, it is conceivable that the therapeutic composition 14 may be the same in each discrete portion, or may be different in each or some discrete portions. For example, the therapeutic agent present in the therapeutic composition 14 may be the same in each discrete portion, or may be different in each or some discrete portions.

[0042] The treatment composition 14 may be overmolded with one or more positional indicators to facilitate alignment of the treatment composition 14 on the teeth. As a non-limiting example, such positional indicators may be formed as three-dimensional lines, marks, text or other symbols, or as one or more shapes that correspond to or mimic the shape of one or more teeth on which the treatment composition 14 may be placed.

[0043] In the case of oral treatment strip 10, it should be understood that variations of the treatment composition 14 overmolded on the base 12 can be pursued to facilitate treatment of a particular region or multiple regions, and / or the type of treatment applicable to a single region, a specific region, or multiple specific regions. For example, the treatment composition 14 may have two or more discrete portions, which, when sufficiently spaced, can be used to treat non-adjacent teeth and / or oral tissues. Alternatively, when the treatment composition 14 comprises two or more discrete portions on the base 12, different or similar therapeutic agents or multiple therapeutic agents may be disposed in one or more discrete portions, which may allow treatment of different diseases on adjacent or non-adjacent teeth and / or oral tissues to be considered.

[0044] Alternative exemplary embodiments of the oral treatment strip 20 are in Figure 4As shown in the figure. The oral treatment strip 20 may include a base 22 and a cavity 24, the cavity 24 being recessed relative to the surface 26 and surrounded by sidewalls 28. The base 22 provides support and flexibility for the oral treatment strip 20. Generally, the cavity 24 may provide a recess into which a treatment composition (not shown) may be overmolded. For example, the treatment composition may be in the form of a gel, suspension, liquid, paste, putty, foam, etc., and the treatment composition may be the same as or similar to the treatment compositions 14, 114 described herein. While the base 22 of the oral treatment strip 20 may include a generally rectangular construction and may have one or more recesses 30, 32 as illustrated, it should be understood that other shapes and variations thereof are also possible.

[0045] The therapeutic composition can be overmolded into the cavity 24 such that the therapeutic composition overmolded onto the substrate 22 is provided with a shape and form that at least partially, substantially, or substantially corresponds to the shape and form of the cavity 24. It will be understood that other variations are possible upon review of this disclosure. For example, the therapeutic composition can extend beyond the cavity 24 and partially or completely cover all or part of the surface 26 surrounding the cavity 24. The therapeutic composition can be overmolded onto the substrate 22 by positioning a first mold relative to the substrate 22. The relative positioning of the mold and the substrate 22 can be maintained by any suitable means. In the form where the desired final shape and configuration of the therapeutic composition overmolded on the substrate 22 corresponds to the cavity 24, and the therapeutic composition is flush with the surface 26, then the first mold can generally be flat in configuration, so that it is precisely the cavity 24 that defines the final shape and configuration of the therapeutic composition. It will be understood that, upon review of this disclosure, in other forms, including those in which the therapeutic composition extends over and / or partially covers surface 26, once the therapeutic composition is overmolded onto substrate 22, the first mold can define a profile corresponding to the desired final shape and construction of the therapeutic composition. When the first mold is properly positioned, the therapeutic composition can be injected between the first mold and substrate 22 to fill cavity 24, or cavity 24 and any additional cavities that may be defined by the first mold. Once filled, the first mold can be detached from substrate 22, which may leave the therapeutic composition on substrate 22.

[0046] Having reviewed this disclosure, it should be understood that the structural features of the therapeutic composition overmolded on the substrate 22 can be predetermined and / or modified by changing the contour defined by cavity 24 and / or by any additional cavity that may be defined by the first mold. Similarly, it is also conceivable for the therapeutic composition to comprise two or more discrete portions on the substrate 22. In these forms, the therapeutic composition may be identical in each discrete portion, or may be different in each or some discrete portions. For example, the therapeutic agent present in the therapeutic composition may be identical in each discrete portion, or may be different in each or some discrete portions.

[0047] In the context of the oral treatment strip 20, it should be understood upon reading this disclosure that variations of the therapeutic composition overmolded on the substrate 22 can be pursued to facilitate treatment of a particular region or regions and / or the type of treatment applied to a single region. For example, a therapeutic composition having two or more discrete portions when sufficiently spaced apart can be used to treat non-adjacent teeth and / or oral tissues. Alternatively or additionally, when the therapeutic composition comprises two or more discrete portions on the substrate 22, one or more different or similar therapeutic agents can be arranged in one or more of these portions, which can allow for the treatment of different conditions on adjacent or non-adjacent teeth and / or oral tissues. While cavity 24 has been described and illustrated in conjunction with oral treatment strip 20, it should be understood upon reading this disclosure that other embodiments described herein, including the oral treatment strip 10 discussed above and the oral treatment tray 110 discussed below, can be provided with one or more cavities into which the therapeutic composition can be arranged upon injection.

[0048] Turn now Figure 5 An exemplary oral treatment system 100 is illustrated, which may include an oral treatment tray 110 and a treatment composition 114 that can be overmolded onto a base 112 of the tray 110. The base 112 may provide support and flexibility, and the treatment composition 114 may be in the form of, for example, a gel, suspension, liquid, paste, putty, foam, etc. The tray 110 may have any desired size, shape, configuration, pattern, and / or arrangement, depending on the intended use. In some embodiments, the tray 110 may have an elongated, curved shape that substantially mimics or approximates at least a portion of the upper or lower dental arch. For example, the tray 110 may have a square, oval, arched, or conical arch. In the illustrated form, the tray 110 generally has an arch and may include an outer wall 116, an inner wall 118, and a surface 120 may be at least partially disposed between at least a portion of the outer wall 116 and the inner wall 118. A groove 122 may be at least partially defined between the outer wall 116, the inner wall 118, and the surface 120. In this arrangement, tray 110 can be configured to rest on the dental arch such that outer wall 116 can be positioned on the labial / buccal surface of the tooth, inner wall 118 can be positioned on the lingual surface of the tooth, and surface 120 can be positioned on the upper or lower surface of the tooth. While tray 110 may be described as having outer wall 116, inner wall 118, and surface 120, it should be understood upon review of this disclosure that tray 110 can have an integral, one-piece structure, wherein outer wall 116, inner wall 118, and / or surface 120 are one or more parts of an integral dental tray, which can be a completely one-piece dental tray.

[0049] In some configurations, the width of surface 120 at the front end 124 of pallet 110 and at the transition point between the front end 124 and the rear ends 126a and 126b of pallet 110 may be smaller than the width of surface 120 in the region near the rear ends 126a and 126b. The change in width can be gradual or abrupt, such as... Figure 5 As shown. In some embodiments, the inner wall 118 may have a reduced width or may terminate at or before the transition between the front end 124 and the rear ends 126a and 126b. Although not previously mentioned, it should also be understood that the tray 110 may include an outer wall 116, an inner wall 118, and / or a surface 120 (which are substantially not structures corresponding to the size and shape of a human's unique dentition), which may be formed to approximate a human dentition, and / or may be molded to a human's unique dentition.

[0050] In the illustrated form, the treatment composition 114 may be overmolded to a shape generally corresponding to the substrate 112. Upon review of this disclosure, it will be understood that in other forms, the treatment composition 114 may be overmolded to a shape generally different from the substrate 112 below, further details of which will be provided below. For example, in some embodiments, the treatment composition 114 may be molded over the entire inner surface of the tray 110 (i.e., over the entire surface of the outer wall 116, inner wall 118, and surface 120). In other embodiments, the treatment composition 114 may be molded over only a portion of the inner surface of the tray 110, such as... Figure 5 As shown. Further details regarding the materials that can form the substrate 112 and the therapeutic composition 114 are provided below.

[0051] Generally, the therapeutic composition 114 can be overmolded onto the substrate 112 by positioning a first mold relative to the base 112 of the tray 110. The relative positioning of the mold and the base 112 of the tray 110 can be maintained by any suitable means and can be accomplished, for example, by using a second mold, which can be used (in conjunction with a different third mold, if desired) to form the base 112 in the form of the tray 110. Once the therapeutic composition 114 is overmolded onto the base 112, the first mold can define a profile corresponding to the desired final shape and construction of the therapeutic composition 114. In this way, when the first mold is properly positioned, the profile of the first mold can define a cavity between it and the base 112, and the therapeutic composition 114 can be injected between the first mold and the base 112 to fill the cavity. The cavity of the first mold can additionally include spaces corresponding to the shape and construction of the tray 110 to facilitate placement of the tray 110 into the first mold. Once the cavity is filled, the first mold can be separated from the base 112, which allows the therapeutic composition 114 to remain on the base 112 with a construction corresponding to the cavity.

[0052] Since the shape and configuration of the therapeutic composition 114 overmolded on the substrate 112 can correspond to the contour defined by the first mold, it should be understood, upon review of this disclosure, that the structural features of the therapeutic composition 114 overmolded on the substrate 112 can be predetermined and / or changed, for example, by altering the contour defined by the first mold, which in turn can alter the cavity in which the therapeutic composition 114 is injected. For example, as discussed above in connection with the therapeutic composition 114, one or more of the thickness, height, width, length, etc., of the therapeutic composition 114 overmolded on the substrate 112 can vary along all or part of the substrate 112, which can alter the configuration of the therapeutic composition 114. Furthermore, although the therapeutic composition 114 can have a continuous configuration on the substrate 112 in an illustrated manner, it should be understood, upon review of this disclosure, that the contour of the first mold can be altered to provide the therapeutic composition 114 on the substrate 112 in discrete portions, in which the thickness, height, width, length, etc., of each discrete portion can be the same as or different from the other portions. Furthermore, in the form where the therapeutic composition 114 comprises two or more discrete portions on the substrate 112, it is conceivable that the therapeutic composition 114 may be identical in each discrete portion, or may be different in each or some discrete portions. For example, different therapeutic agents may be provided in each or some discrete portions.

[0053] In the context of tray 110, it should be understood that variations of the therapeutic composition 114 overmolded on substrate 112 can be pursued to facilitate treatment of a particular region or regions, and / or the type of treatment applicable to a single region or regions. For example, the therapeutic composition 114 may have two or more discrete portions, which, when sufficiently spaced, may be used to treat non-adjacent teeth and / or oral tissues. Alternatively or additionally, when the therapeutic composition 114 comprises two or more discrete portions on substrate 112, different or similar therapeutic agents or multiple therapeutic agents may be disposed in one or more discrete portions, which may allow treatment of different conditions on adjacent or non-adjacent teeth and / or oral tissues to be considered.

[0054] As a non-limiting example, the substrates 12, 112 that may respectively at least partially form strip 10 and tray 110 may be at least substantially impermeable to liquids or semi-permeable to liquids, such as water and saliva, such that strip 10 and tray 110 may form a moisture barrier around teeth, gums, and / or other oral tissues. Substrates 12, 112 may be flexible and / or malleable and may exhibit plastic and / or elastic deformation, which may enable strip 10 and / or tray 110 to at least substantially conform to the dental arch. In one exemplary form, strip 10 and tray 110 may be formed using molding processes (such as, for example, injection molding, compression molding, blow molding, or thermoforming). Furthermore, the substrates 12, 112 of strip 10 and / or tray 110 may be formed from one or more polymers (including thermosetting polymers, thermoplastic polymers, and thermoplastic elastomer polymers), silicone, waxes, resins, or combinations thereof, as will be described in more detail below.

[0055] Non-limiting examples of polymers that can be used to form substrates 12, 112 may include synthetic and natural polymers. In some embodiments, such polymers may be crosslinked polymers capable of exhibiting elastic deformation. As a non-limiting example, one or more polymers used to form substrates 12, 112 may be selected from polyolefins, polyesters, polyurethanes, copolymers, thermoplastic elastomers, thermosetting elastomers, natural polymers, and mixtures thereof. Examples of polyolefins include polyethylene (including high-density polyethylene (HDPE), low-density polyethylene (LDPE), or ultra-low-density polyethylene (ULDPE)), polypropylene (PP), and polytetrafluoroethylene (PTFE) (e.g., Teflon), thermoplastic polyolefins (e.g., thermoplastic polyethylene, thermoplastic polypropylene, thermoplastic olefins), and propylene-based elastomers. Other synthetic polymers include ethylene-vinyl acetate copolymers, ethylene-vinyl alcohol copolymers, acetates (e.g., ethyl vinyl acetate (EVA) and polyvinyl acetate (PVA)), polyvinyl alcohol (PVOH), polyesters (such as polyethylene terephthalate or PETE), polycarbonate, methacrylates, acrylates, polyamides (e.g., nylon), polyurethane, polyvinyl chloride (PVC), synthetic rubber, phenolic resins (Bakelite), chloroprene rubber, polystyrene, polyacrylonitrile, polyvinyl butyral (PVB), silicone elastomers, thermoplastic elastomers, and natural polymers.

[0056] As used herein, “thermoplastic elastomer” or “TPE” means and includes polymers or combinations of polymers having both thermoplastic and elastomer properties. Such thermoplastic elastomers may soften upon heating to exhibit fluidity and solidify upon cooling to exhibit elastic deformation. Examples of thermoplastic elastomers (“TPE”) that can be used to form substrates 12, 112 include, but are not limited to, olefin-based, styrene-based, polyester-based, polyurethane-based, polyvinyl chloride, polyamide-based, polyisoprene-based, polybutadiene-based, polybutene-based, siloxane-based, polycarbonate-based, ethylene-vinyl acetate-based, ethylene-methacrylate-based, polyacrylonitrile-based, polyacrylate-based, acrylic-based, and / or copolymers or mixtures thereof.

[0057] Natural polymers that can be used to form substrates 12 and 112 may include, but are not limited to, shellac, natural rubber, polysaccharides, cellulose ethers, cellulose acetate, and proteins.

[0058] In some embodiments, the substrates 12, 112 used to form the strip 10 and / or tray 110 may be flexible and comprise at least one wax and at least one polymer, such as a thermoplastic elastomer. The wax and thermoplastic elastomer may be combined and molded to form the flexible substrate of the strip 10 and / or tray 110. In some embodiments, the flexible substrate may be formed by an injection molding process by injecting a mixture of one or more waxes and one or more thermoplastic elastomers into a mold cavity that corresponds to the strip 10 or tray 110. In other embodiments, as those skilled in the art will recognize, the strip 10 and / or tray 110 may be constructed from a variety of suitable materials and processes, such as compression molding, rotational molding, blow molding, thermoforming, extrusion, etc.

[0059] In some embodiments using a flexible substrate, the flexible substrate may be thermally stable and may exhibit elastic and / or plastically deformable properties. For example, depending on the amount of deformation applied and the temperature at which the flexible substrate deforms, the flexible substrate may exhibit both plastic and elastically deformable properties. For example, the flexible substrate may exhibit plastic deformation until a point at which pressure applied to the flexible substrate will begin to exhibit elastic deformation. Forms comprising at least one wax and at least one polymer (such as a thermoplastic elastomer) may be plastically deformable at room temperature (i.e., between about 20 and about 25°C) and thermally stable at temperatures up to at least 40°C. In these and other embodiments, the flexible substrate may deform on the individual's teeth when the strip 10 and / or tray 110 are placed on the individual's teeth.

[0060] For flexible substrates comprising at least one wax and at least one polymer (such as a thermoplastic elastomer), the flexible substrate may comprise one or more waxes by weight, ranging from about 40% to about 95%, from about 50% to about 93%, from about 60% to about 90%, or from about 70% to about 85%, based on the total weight of the composition forming the substrate. Examples of waxes that may be used include, but are not limited to, petroleum waxes, distilled waxes, synthetic waxes, mineral waxes, vegetable waxes, and animal waxes. Examples of petroleum waxes include paraffin wax, intermediate waxes, microcrystalline waxes, distilled waxes, and petrolatum. As a non-limiting example, paraffin wax, intermediate waxes, and / or microcrystalline waxes may be mixed to provide the desired level of plastic deformation at room temperature and dimensional stability at higher temperatures. Further details regarding compositions comprising at least one wax and that may be used to form a flexible substrate can be found in U.S. Patent Application No. 15 / 027,636, the contents of which are incorporated herein by reference in their entirety.

[0061] The flexible substrate described herein may include one or more polymers by weight, ranging from about 5% to about 60%, from about 7% to about 50%, from about 10% to about 40%, or from about 15% to about 30%, based on the total weight of the composition forming the substrate. The flexible substrate may also include one or more auxiliary components, such as plasticizers, flow modifiers, and / or fillers. When included, the presence of these components by weight, based on the total weight of the composition forming the substrate, may range from about 0.01% to about 5%, from about 0.1% to about 4%, or from about 1% to about 3%.

[0062] Therapeutic compositions 14, 114 may include at least one therapeutic agent that is effective in treating a disease (such as an oral disease). Therapeutic compositions 14, 114 may also include at least one polymeric material and / or at least one solvent or carrier. Furthermore, therapeutic compositions 14, 114 may include at least one hydrophobic agent and / or at least one rheology modifier. The polymer, therapeutic agent, hydrophobic agent, and / or rheology modifier may, for example, be mixed, distributed, dispersed, or dissolved in a solvent or carrier.

[0063] In one exemplary form, therapeutic compositions 14, 114 comprise polymeric materials exhibiting polarity and / or solubility in polar solvents (such as water or alcohols) (i.e., the polymeric materials comprise one or more hydrophilic polymers). Such hydrophilic polymers can be any non-crosslinked or crosslinked monomers, oligomers, or polymers, and in some embodiments can act as tissue adhesives, tackifiers, and / or thickeners in therapeutic compositions 14, 114. As a non-limiting example, therapeutic compositions 14, 114 may comprise one or more pyrrolidone-based polymers (e.g., polyvinylpyrrolidone (PVP)), PVP copolymers (e.g., PVP / vinyl acetate copolymers), acrylic acid-based polymers (e.g., carboxylated polymethylene or carbomer, such as...). (Capop) and Pemulen TM (Pemron, which is commercially available from Lubrizol Advanced Materials, Inc.), oxazoline-based polymers (e.g., polyethyloxazoline and other poly(2-oxazoline)), polyethylene oxide, also known as polyethylene glycol (e.g., Polyoxazoline), TM (Pyrrolidone, commercially available from Dow Chemical Company), polyacrylates, polyacrylamide, copolymers of polyacrylic acid and polyacrylamide, cellulose-based polymers (e.g., hydroxypropyl methylcellulose, carboxymethyl cellulose, carboxypropyl cellulose, and cellulose ethers), polysaccharide gums, proteins, and derivatives thereof. Other non-limiting examples of pyrrolidone-based polymers that may be used include one or more grades of (Colidon) PVP polymer (available from BASF), such as 30, having a weight-average molecular weight (Mw) between approximately 44,000 and approximately 54,000. VA 64, with a power consumption between approximately 45,000 and 70,000 MW and 90F, with a power of approximately 1 million to approximately 1.5 million Mw.

[0064] Therapeutic compositions 14, 114 may contain polymeric material by weight, ranging from about 1% to about 50%, from about 3% to about 30%, or from about 5% to about 20% based on the total weight of the composition, with only a few non-limiting examples provided.

[0065] As previously described, therapeutic compositions 14, 114 may include one or more solvents or carriers, in which polymeric materials and any other components in the composition may be bound, mixed, dissolved, distributed, or dispersed. In some embodiments, polymeric materials and any other components in the composition may be substantially uniformly distributed in the solvent and / or carrier materials. In one exemplary form, such solvents and carriers may be in liquid or gel form. As a non-limiting example, polar compounds and polar solvents may be used as solvents or carriers in therapeutic compositions 14, 114. Examples of suitable polar compounds and polar solvents may include, but are not limited to, water, alcohols (such as methanol, ethanol, and isopropanol), glycols and polyols (such as ethylene glycol and propylene glycol compounds (e.g., polyethylene glycol (“PEG”) and polypropylene glycol (“PPG”), hexanediol, butanediol, ethoxydiethylene glycol, glycerol, sorbitol, mannitol, maltitol, and other sugar alcohols)) and glycols (1,3-propanediol). When the solvent and / or carrier are included in the therapeutic compositions 14, 114, the solvent and / or carrier may be present by weight, ranging from about 0.5% to about 50%, from about 10% to about 40%, or from about 20% to about 30% based on the total weight of the composition, with only a few non-limiting examples provided. When determining the exact amount of solvent and / or carrier included in the composition, it may be considered to provide the therapeutic composition with a viscosity that facilitates its use in the molding process. For example, among other things, the viscosity of the therapeutic agent will facilitate its passage through the relevant molding facility.

[0066] As described above, therapeutic compositions 14, 114 may include at least one therapeutic agent that is effective in treating a condition. As a non-limiting example, the therapeutic agent that may be included in therapeutic compositions 14, 114 may include any substance having cosmetic, personal care, diagnostic, or therapeutic activity and may or may not have pharmacological activity. In one exemplary form, the therapeutic agent may be effective in treating oral conditions and may include, but is not limited to, teeth whitening agents and / or brightening agents, desensitizing agents and / or remineralizing agents, anesthetics, anti-plaque agents, anti-tartar agents, antimicrobial agents, antibiotics, disinfectants and / or antiseptics, antioxidants, healing agents for soft oral tissues (such as gingival soothing agents), and gloss agents.

[0067] Non-limiting examples of teeth whitening agents and / or brightening agents include one or more peroxide and / or reactive oxygen species, oxygen or hydrogen peroxide-releasing compounds or generating agents, such as peroxides (e.g., inorganic or metal peroxides, such as hydrogen peroxide), glycerol peroxide, hydrogen peroxide urea adducts (e.g., urea peroxide), hydrogen peroxide complexes and / or adducts (e.g., hydrogen peroxide-PVP complexes, such as Peroxydone available from Ashland). TMComplexes), percarbonates (e.g., sodium percarbonate and potassium percarbonate), perborates (e.g., sodium perborate), persulfates (e.g., sodium persulfate), peroxyhydrates (e.g., sodium peroxyhydrate), oxalates (e.g., sodium oxalate), chlorine dioxide, and combinations thereof.

[0068] Non-limiting examples of desensitizing agents and / or remineralizing agents include potassium salts (e.g., potassium nitrate, potassium chlorate, and potassium oxalate), fluoride salts (e.g., sodium fluoride, stannous fluoride, sodium monofluorophosphate, and calcium fluoride), calcium salts (e.g., calcium hydroxide and calcium phosphate), magnesium salts (e.g., magnesium sulfate), hydroxyapatite, amorphous calcium phosphate (ACP), casein phosphopeptide (CPP), ACP-CPP (fluorinated casein phosphopeptide-calcium phosphate complex), and strontium salts (e.g., strontium chloride and strontium acetate). Such desensitizing agents and / or remineralizing agents may be present in an amount sufficient to desensitize and / or remineralize teeth. For example, the desensitizing agent and / or remineralizing agent is present by weight in the range of about 0.1% to about 10% based on the total weight of the composition. It should be understood that, in one exemplary form, the remineralizing agent may also act as a polishing agent by restoring the luster of tooth enamel.

[0069] Non-limiting examples of anesthetics include local anesthetics such as benzocaine and lidocaine. Non-limiting examples of antimicrobial agents include chlorhexidine, triclosan, sodium benzoate, parabens, tetracyclines, phenol, hexadecylpyridinium chloride, benzoic acid, and quaternary ammonium compounds (e.g., benzalkonium chloride). Non-limiting examples of anti-plaque or anti-tartar agents include pyrophosphates. Non-limiting examples of gingival soothing agents include aloe vera, mild potassium nitrate, and isotonic solution-forming salts. Non-limiting examples of antioxidants include vitamin A, vitamin C, vitamin E, other vitamins, and carotene. As mentioned above, remineralizing agents can be used as polishing agents.

[0070] When the therapeutic agent included in therapeutic compositions 14, 114 is a teeth bleaching agent and / or whitening agent, it may be included at any desired concentration, for example, by weight, based on the total weight of the composition, in the range of about 1% to about 90%, in the range of about 1% to about 60%, in the range of about 3% to about 40%, or in the range of about 5% to about 30%. It should be understood that the amount of teeth bleaching agent and / or whitening agent may be adjusted, for example, according to the expected treatment time for each bleaching period.

[0071] In embodiments where therapeutic compositions 14, 114 include a peroxide brightener or bleaching agent (such as hydrogen peroxide or urea peroxide), therapeutic compositions 14, 114 may further include one or more peroxide stabilizers or pH buffers, such as phosphates, ammonium hydroxide, sodium hydroxide, potassium hydroxide, sodium phonsphate, potassium phosphate, aminopolycarboxylic acids (e.g., ethylenediaminetetraacetic acid (EDTA) or a salt thereof), triethanolamine, TRIS, urea, polyphosphates, pyrophosphates (e.g., sodium pyrophosphate), hydroxypyridinones or salts thereof, stannates (e.g., sodium stannate), citric acid, phosphoric acid, nitrates (e.g., sodium nitrate), organophosphonates, aminocarboxylic acids, and combinations thereof. For clarity, as used herein, the term "salt" refers to and includes alkali addition salts of compounds having an alkali metal salt (i.e., lithium, sodium, or potassium), an alkaline earth metal salt (e.g., calcium or magnesium), or an ammonium salt. The amount of such stabilizer may be sufficient to stabilize hydrogen peroxide. As a non-limiting example, based on the total weight of the composition, the stabilizer may be present by weight in the range of about 0.1% to about 10%. As a non-limiting example, based on the total weight of the composition, the pH buffer may be present by weight in the range of about 0.1% to about 30%.

[0072] Treatment compositions 14, 114 may optionally include one or more hydrophobic agents, which, when present, may aid or facilitate the release of treatment compositions 14, 114 from the mold. For example, the presence of a hydrophobic agent may cause treatment compositions 14, 114 to preferentially adhere to the substrate 12, 112 rather than the surface of the mold used in the overmolding process. The hydrophobic agent may be added to treatment compositions 14, 114 in an amount sufficient to aid the release of treatment compositions 14, 114 from the surface of the mold used in the overmolding process. While not wishing to be bound by any particular theory, it is believed that hydrophobic agents (such as oils and / or fumed silica) may facilitate the release of treatment compositions 14, 114 from the mold within a certain temperature range, regardless of the viscosity and adhesiveness of treatment compositions 14, 114. Therefore, treatment compositions 14, 114 may be formulated to have high viscosity and high adhesiveness while readily releasing from the mold used in the overmolding process, and in some embodiments, selectively adhering to the substrate 12, 112 above the mold used in the overmolding process.

[0073] Non-limiting examples of hydrophobic agents that may be included in therapeutic compositions 14, 114 include oils, waxes, hydrophobic fillers, siloxane compounds, cellulose-based hydrophobic polymers, menthol, and hydrophobic surfactants. More specific examples of hydrophobic agents include, but are not limited to, peppermint oil (e.g., peppermint oil, spearmint oil, and wintergreen oil), citrus oil (e.g., orange oil), cinnamon oil, camphor oil, basil oil, amaranth oil, lavender oil, limonene, siloxanes (e.g., polydimethylsiloxane), silanes, organosilicones, nonionic surfactants (e.g., polyglycerol alkyl ethers, glucosyl dialkyl ethers, crown ethers, ester-bonded surfactants, and polyoxyethylene alkyl ethers), and anionic surfactants (e.g., sodium lauryl sulfate, alkyl sulfates, acyl glycinates, and stearates), fumed silica, and combinations thereof.

[0074] When included in therapeutic compositions 14, 114, the hydrophobic agent may be present by weight in the range of about 0.5% to about 25%, about 1% to about 15%, or about 2% to about 12% based on the total weight of the composition. In a particular but non-limiting form, therapeutic compositions 14, 114 may comprise one or more oils and hydrophobic silica. In this exemplary form, one or more oils may be present by weight in the range of about 0.01% to about 5%, about 0.05% to about 2%, or about 0.3% to about 0.8% based on the total weight of the composition, and hydrophobic silica may be present by weight in the range of 0% to about 20%, about 1% to about 15%, or about 2% to about 11% based on the total weight of the composition.

[0075] Treatment compositions 14, 114 may optionally include one or more rheology modifiers, fillers, colorants, flavoring agents, sweeteners, etc. As a non-limiting example, sucralose or another suitable sweetener may be included in treatment compositions 14, 114 in an amount less than or equal to about 5% by weight based on the weight of the composition. In one exemplary form, treatment compositions 14, 114 may be teeth whitening compositions comprising at least one polymeric material, at least one solvent, at least one therapeutic agent, and, optionally, a hydrophobic agent. In a more specific but non-limiting form, treatment compositions 14, 114 may include polyvinylpyrrolidone and / or polyethyloxazoline, water and / or ethanol, and peroxide. In another specific but non-limiting form, treatment compositions 14, 114 may include polyvinylpyrrolidone and / or polyethyloxazoline, water and / or ethanol, a therapeutic agent, peppermint oil, and / or fumed hydrophobic silica. In yet another specific but non-limiting form, therapeutic compositions 14, 114 may include hydrogen peroxide, other bleaching agents, other pharmaceutical agents, and / or one or more rheology modifiers. In this and other forms, therapeutic compositions 14, 114 may be a viscous gel at room temperature and molding temperature. In some embodiments, one or more components of therapeutic compositions 14, 114 may be temperature-sensitive, and therapeutic compositions 14, 114 may be overmolded at approximately room temperature (approximately 25°C) or at a lower temperature.

[0076] In some embodiments, therapeutic compositions 14, 114 may be configured as viscous and / or sticky gels or pastes with sufficient viscosity to allow them to remain substantially in place during manufacture, dispensing, storage, promotion, and use. For example, viscosity can prevent the therapeutic composition from overflowing from a tray or dispensing strip. In some forms using cavities similar to cavity 24, the therapeutic composition may have a lower viscosity and be held in place by the cavity and / or a covering (such as a plastic film) that can be placed on the therapeutic composition after a molding process. In other embodiments, therapeutic compositions 14, 114 may be configured to feel substantially dry to become increasingly viscous and / or sticky upon contact with a particular liquid (such as water or saliva). Furthermore, gel or paste forms may have properties similar to liquid, rubbery compositions, or even compositions that feel harder and drier to the touch.

[0077] Current overall reference Figures 6-9 Further details regarding the overmolding of the therapeutic composition 114 onto the substrate 112 of the tray 110 will be provided. Upon review of this disclosure, it should be understood that the following details also apply to the process of overmolding the therapeutic composition 14 onto the substrate 12 of the strip 10. Figure 6The exemplary mold 200 shown can be used to overmold a therapeutic composition 114 onto a base 112 of a tray 110. The mold 200 may include one or more protrusions, such as protrusions 206a-206c, and a protruding portion 202 that generally corresponds to the configuration of the tray 110, except that the protruding portion 202 may include a recessed portion 203, which may be at least partially defined by one or more surfaces 204. When the tray 110 is positioned relative to the mold 200, the recessed portion 203 may define at least a portion of a cavity into which the therapeutic composition 114 is injected. Therefore, upon review of this disclosure, it should be understood that the recessed portion 203 can define the configuration of the therapeutic composition 114 as overmolded onto the base 112. For example, Figure 7 A mold 200 positioned relative to a tray 110 is shown, with the recessed portion 203 shown as an imaginary or dashed line. Once the therapeutic composition 114 is injected between the tray 110 and the mold 200, it can fill the cavity defined by the tray 110 and the recessed portion 203, and the therapeutic composition 114 can be left in an overmolded form having a desired configuration that corresponds to the recessed portion 203. Exemplary configurations of the resulting recessed portion 203 are shown in, for example... Figure 8 The clearest example is where tray 110 has been removed to reveal the post-injection treatment composition 114 between tray 110 and mold 200. It should be understood that... Figure 8 For illustrative purposes, and in practice, the therapeutic composition 114 will adhere to the base 112 of the tray 110 such that it will be carried along with the tray 110 when the tray 110 is removed from the mold 200.

[0078] During the overmolding of the therapeutic composition 114 onto the base 112 of the tray 110, the positioning of the tray 110 relative to the mold 200 can be secured by any suitable means. For example, one or more jigs, one or more additional molds, and / or a vacuum source can be used. In an exemplary form using another mold, it can have, for example, Figure 9The configuration of mold 300 is shown. Mold 300 typically includes one or more recesses, such as recesses 306a-306c and cavity 304, which may have a corresponding but opposite configuration to a tray mold (not shown), which can be used in conjunction with mold 300 to form tray 110. The tray mold may be similar to mold 200, except, for example, the absence of recessed portion 203, such that when the tray mold and mold 300 are positioned relative to each other, a cavity corresponding to the configuration of tray 110 can be defined therebetween without overmolded therapeutic composition 114 thereon. Upon review of this disclosure, it should be understood that mold 300 can be used during the formation of tray 110, as described above. Similarly, in an exemplary form, mold 300 may first be used with tray mold (not shown) during an injection molding process to form tray 110. After the material forming substrate 110 is injected between tray mold and mold 300, tray mold and mold 300 may be displaced or separated from each other, while the resulting tray 110 remains in mold 300. For example, a vacuum force can be applied to mold 300 to retain tray 110 within mold 300 during mold separation. Once the tray mold has been removed, mold 200 can be positioned relative to mold 300 and tray 110 can be held by mold 300, wherein protrusions 206a-206c are respectively received in recesses 306a-306c. A treatment composition 114 can then be injected between mold 200 and tray 110 to overmold the treatment composition 114 onto the base 112 of tray 110. After injection of treatment composition 114, molds 200 and 300 can be moved or separated from each other, wherein treatment composition 114 adheres to and is carried by the base 112 of tray 110. Additional force can be applied to remove tray 110 from the respective molds to the extent that tray 110 can remain in contact with mold 200 and / or mold 300 before or after their separation. For example, mechanical force can be applied to tray 110 or air can be injected into the respective molds. Alternatively or additionally, the mold or pallet 110 may be cooled to aid in the separation of the pallet 110 from it.

[0079] In embodiments where therapeutic compositions 14, 114 include peroxides, therapeutic compositions 14, 114 may be overmolded onto strip 10 or tray 110 at reduced temperatures to reduce or eliminate the decomposition of peroxides into oxygen and water during the overmolding process. For example, in some embodiments, therapeutic compositions 14, 114 may be overmolded onto strip 10 or tray 110 at temperatures less than or equal to 25°C, less than or equal to 20°C, or less than or equal to 15°C.

[0080] Although not previously mentioned, it should be understood that one or more molds discussed herein may be coated with fluorocarbon coatings, such as polytetrafluoroethylene coatings, silicone elastomer coatings, polypropylene coatings, trichlorofluoroethylene coatings, or various low-tack or non-stick coatings to facilitate separation of the mold from the tray 110 and / or the therapeutic composition 114. In one exemplary form, the mold 200 may be coated with a polytetrafluoroethylene coating or various low-tack or non-stick coatings, which can reduce the clamping forces used in the injection molding process and, additionally or optionally, can counteract any stickiness of the therapeutic composition 114. This can thus aid in the release of the therapeutic composition 114 from the mold 200. It is also contemplated that the mold 200 may be maintained at a temperature lower than that of the therapeutic material 114 at the time of injection, which can aid in the curing of the therapeutic material 114 and its shape to at least partially define or be disposed between the mold 200 and the tray 110.

[0081] Although the subject matter has been described herein within the context of oral treatment devices and related compositions, it should be understood that other applications are also possible. Furthermore, the application of the overmolding techniques described herein is not limited to therapeutic compositions containing at least one therapeutic agent. Rather, the overmolding techniques disclosed herein are also applicable to the overmolding of compositions containing one or more hydrophilic polymers.

[0082] Those skilled in the art will understand that the functions and / or operations performed in relation to this and other processes, operations, and methods disclosed herein may be implemented in different orders. Furthermore, the functions and operations outlined are provided by way of example only, and some functions and operations may be optional, combined into fewer functions and operations, or extended into additional functions and operations without departing from the essence of the disclosed embodiments.

[0083] The above description of the invention should not be construed as limiting the invention to the disclosed embodiments, as those skilled in the art will be able to devise other equivalent forms within the scope of the invention. Variations and modifications that will be apparent to those skilled in the art are intended to fall within the scope and spirit of the invention.

[0084] Although the present invention has been described with reference to certain exemplary embodiments, other embodiments that will be obvious to those skilled in the art are also within the scope of protection of the present invention. Therefore, the scope of the present invention is defined only by the appended claims.

Claims

1. A method comprising: Relative to the base positioning mold; A composition comprising a hydrophilic polymer is injected between a mold and a substrate, and the composition is overmolded onto the surface of the substrate in an overmolding configuration corresponding to the configuration defined by the mold. The composition, as a therapeutic composition, is overmolded onto the substrate to deliver the composition to teeth and / or oral tissues for the treatment of oral conditions. as well as Separate the mold from the substrate while retaining the composition within the overmolded structure.

2. The method according to claim 1, characterized in that, The base includes an arched dental tray comprising a groove defined by an inner sidewall and an outer sidewall, and the composition is overmolded on at least a portion of one or both of the inner sidewall and the outer sidewall.

3. The method of claim 2, further comprising molding the dental tray with at least one thermoplastic polymer.

4. The method according to claim 2, characterized in that, The composition contains at least one therapeutic agent that is effective in treating oral conditions.

5. The method according to claim 4, characterized in that, The at least one therapeutic agent is hydrogen peroxide.

6. The method according to claim 2, characterized in that, The composition is in the form of a deformable gel, exhibiting the property of effectively and selectively retaining the composition in an overmolded structure until the dental tray is used in oral treatment.

7. The method according to claim 1, characterized in that, The composition includes hydrogen peroxide and the injection of the composition is carried out at a temperature below 25°C.

8. The method according to claim 1, characterized in that, The composition also includes at least one therapeutic agent for effectively treating oral conditions and at least one hydrophobic agent.

9. A method comprising: A tooth tray positioning and overmolding mold that includes a groove defined by an inner sidewall and an outer sidewall; Injecting the oral treatment composition between the overmolding mold and the dental tray; and The oral treatment composition is overmolded onto at least a portion of one or both of the inner and outer walls of the dental tray; The oral treatment composition includes a hydrophilic polymer; and The oral treatment composition includes at least one therapeutic agent that is effective in treating oral diseases.

10. The method according to claim 9, characterized in that, The oral treatment composition is in the form of a gel and also contains at least one hydrophilic polymer.

11. The method according to claim 9, characterized in that, The dental tray is arched.

12. The method according to claim 9, further comprising: The overmolding mold positioned relative to the dental tray is the first mold; The first mold is positioned relative to the second mold, and the first and second molds define cavities having a configuration corresponding to the dental tray; A thermoplastic polymer is injected between the first and second molds to form a dental tray; as well as Separate the first mold from the second mold while keeping the dental tray in contact with the first mold.

13. The method according to claim 9, characterized in that, The at least one therapeutic agent is selected from teeth bleaching agents, teeth whitening agents, desensitizing agents, remineralizing agents, anesthetics, anti-plaque agents, anti-tartar agents, antibacterial agents, antibiotics, disinfectants, preservatives, antioxidants, healing agents, gloss agents, and combinations thereof.

14. The method according to claim 9, characterized in that, The dental treatment composition is overmolded onto the dental tray at a temperature below 25°C.

15. The method according to claim 9, characterized in that, The oral treatment composition includes at least one polymer selected from polyvinylpyrrolidone, polyvinylpyrrolidone copolymers, carboxylated polymethylene, and oxazoline-based polymers.

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