OVERMOLDING TECHNIQUES AND RELATED ARTICLES PRODUCED FROM THEM

Abstract

Techniques for overmolding a composition onto a substrate are described. More specifically, but not exclusively, techniques for overmolding a therapeutic composition onto a substrate configured for delivery of the composition to teeth and / or oral tissue are described. Overmolding techniques may include injection molding of the therapeutic composition onto the substrate, and the therapeutic composition may include one or more therapeutic agents effective for treating one or more oral conditions.

Description

OVERMOLDING TECHNIQUES AND RELATED ARTICLES PRODUCED FROM THEM Background of the Invention Overmolding is a process in which a single part can be created using two or more different materials in combination. Typically, the first material, sometimes referred to as the substrate, is partially or completely covered by the subsequent materials during the manufacturing process. The most common problems encountered in overmolding are poor adhesion between the substrate and subsequent materials (which can be referred to as overmolding), incomplete molding of the substrate or overmolding, surface irregularities, non-uniformities, and material degradation. Other problems that can arise during the overmolding process include warped parts, which can be caused by temperature differences, inadequate cooling time, and insufficient substrate thickness. Additional problems that can occur during overmolding include voids or openings in the substrate or overmolding, delamination, and inadequate ventilation during the manufacturing process. Brief Description of the Invention Therefore, there is a need to overmold a 77! Lnn / Zznz / E / YILI I laughed. 331456 material on a substrate that can eliminate one or more of the disadvantages or problems described above. It will be appreciated that other disadvantages or problems can be addressed, and the various exemplary modalities do not have to address any particular disadvantage or problem. This description generally refers to techniques for overmolding a composition onto a substrate, and more specifically, but not exclusively, to techniques for overmolding a therapeutic composition onto a substrate configured for delivery of the composition to the teeth and / or oral tissue. Overmolding techniques may include injection molding of the therapeutic composition onto the substrate, and the therapeutic composition may include one or more therapeutic agents effective for treating one or more oral conditions. For example, in one exemplary form, the therapeutic composition may be a tooth-whitening gel and / or a desensitizing gel. Various substrate materials can be used to deliver the composition to a desired location for application or release. By way of non-limiting example, dental and oral treatment devices, such as treatment trays and strips, can be used to deliver dental and oral treatment compositions, such as tooth-whitening compositions, desensitizing compositions, and periodontal medications, to the 77! Lnn / Zznz / E / YILI teeth and / or gums of a user. Dental trays are generally designed to fit over some or all of the user's teeth and may be filled with the oral treatment composition, while dental or oral treatment strips generally include a treatment composition disposed on one side or embedded within a barrier layer. The oral treatment composition may be formulated with a viscosity low enough to allow it to flow so that it can be easily dispensed by a user or during manufacturing. In addition, the oral treatment composition may be formulated with thickeners and / or adhesive agents to adhere the dental treatment device and / or to a user's teeth to facilitate placement and minimize slippage of the device.In addition, to provide a long shelf life, oral treatment compositions can be formulated to maintain a viscous, sticky, and / or fluid consistency over time. The properties of oral treatment compositions, such as viscosity and adhesiveness, can limit the types of processes that can be used to manufacture dispensing trays and strips containing such compositions. Furthermore, it can be difficult to control the deposition of the compositions using current processes, which limits manufacturing efficiency and consistency. Additionally, the 77! Lnn / Zznz / E / YILI compositions for dental applications may deform or bleed out of the dental tray or treatment strip over time, which may reduce the product's lifespan. Furthermore, the composition may be unintentionally released during handling of the dental tray or treatment strip by the user, before the tray or treatment strip is correctly positioned for effective oral treatment. In light of the above, there may be a need for further contributions in this area of ​​technology. The subject matter of the claimed interest is not limited to modalities that resolve any disadvantages or that operate solely in environments such as those described above. Rather, this information is provided only to illustrate examples of where the present description may be used. In one exemplary embodiment, a method may include positioning a mold relative to a substrate and injecting a composition that includes a hydrophilic polymer between the mold and the substrate, and overmolding the composition onto a surface of the substrate in an overmolded configuration corresponding to a configuration defined by the mold. The method may further include separating the mold from the substrate while substantially retaining the composition in the overmolded configuration. In another exemplary modality, a method may include 77! Lnn / Zznz / E / YILI The positioning of an overmolding mold in relation to a dental tray including a tray defined by inner and outer side walls, and the overmolding of an oral treatment composition onto at least a portion of one or both of the inner and outer side walls of the dental tray. The oral treatment composition may include at least one therapeutic agent effective for treating an oral condition. In another exemplary embodiment, an oral treatment system may include a dental tray comprising a basin defined by inner and outer side walls, and an oral treatment composition may be overmolded onto at least a portion of one or both of the inner and outer side walls of the dental tray. The oral treatment composition may include at least one therapeutic agent effective for treating an oral condition. One aspect is a method comprising positioning a mold relative to a substrate, injecting a composition including a hydrophilic polymer between the mold and the substrate, overmolding the composition onto a surface of the substrate in an overmolded configuration corresponding to a configuration defined by the mold, and separating the mold from the substrate while substantially retaining the composition in the overmolded configuration. The substrate may comprise a dental tray. 77! Lnn / Zznz / E / YILI substantially arc-shaped, including a tray defined by inner and outer side walls, and the composition may be overmolded onto at least a portion of one or both of the inner and outer side walls. The method may include molding the dental tray with at least one thermoplastic polymer. The composition may include at least one therapeutic agent effective for treating an oral condition. At least one therapeutic agent may be hydrogen peroxide. The composition may be in the form of a deformable gel exhibiting effective properties for selectively maintaining the composition in the overmolded configuration until the dental tray is used in oral treatment. The composition may include hydrogen peroxide, and injection of the composition may be carried out at a temperature below approximately 25°C.The composition may include at least one therapeutic agent effective for the treatment of an oral condition and at least one hydrophobic agent. Another aspect is a method comprising positioning an overmolding mold relative to a dental tray that includes a basin defined by inner and outer side walls, and overmolding an oral treatment composition onto at least a portion of one or both of the inner and outer side walls of the dental tray. The oral treatment composition may include at least one agent 77! Lnn / Zznz / E / YILI is an effective therapeutic agent for treating an oral condition. The oral treatment composition may be in gel form and may include at least one hydrophilic polymer. The dental tray may have a substantially arched shape. The method may include positioning a first mold relative to a second mold, the first and second molds defining a cavity with a configuration corresponding to the dental tray; injecting a thermoplastic polymer between the first and second molds to form the dental tray; and separating the first mold from the second mold while retaining the dental tray in contact with 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 dental bleaching agents, dental whitening agents, desensitizing agents, remineralizing agents, anesthetics, antiplaque agents, antitartar agents, antimicrobials, antibiotics, disinfectants, antiseptics, antioxidants, healing agents, polishing agents, and combinations thereof. Overmolding may be performed at a temperature below approximately 25°C. Overmolding may include injecting the oral treatment composition between the overmolding mold and the dental tray. Another aspect is an oral treatment system that may comprise a dental tray that includes a tray 77! Lnn / Zznz / E / YILI defined by inner and outer side walls, and an oral treatment composition overmolded onto at least a portion of one or both of the inner and outer side walls of the dental tray. The oral treatment composition may include at least one therapeutic agent effective for treating an oral condition. The therapeutic agent may be hydrogen peroxide. The oral treatment composition may comprise a gel, a liquid, a suspension, a paste, a putty, or a foam. The oral treatment composition may include at least one hydrophilic polymer. The oral treatment composition may comprise a gel exhibiting effective properties for resisting deformation until oral use of the dental tray. Another aspect is an oral treatment system that can be used to treat a user's teeth and / or oral cavity. The oral treatment system may comprise a substrate sized and configured to be placed, at least partially, in a user's mouth, and a therapeutic composition overmolded onto a surface of the substrate. The therapeutic composition may include at least one therapeutic agent effective for treating an oral condition. In one exemplary modality, the substrate may be an oral treatment strip, and the therapeutic composition may be overmolded onto at least a portion of a surface. 77! Lnn / Zznz / E / YILI interior of the oral treatment strip. In another exemplary embodiment, the substrate may be a substantially arch-shaped dental tray and the therapeutic composition may be overmolded onto at least a portion of an interior surface of the substantially arch-shaped dental tray. Another additional aspect is a method that may include providing a mold, and the mold may include a recessed portion; disposing of a substrate in the mold, and the substrate may be sized and configured to be at least partially placed in a user's mouth; injecting a therapeutic composition between the mold and the substrate; overmolding the therapeutic composition onto a surface of the substrate, and the therapeutic composition may include at least one therapeutic agent effective for treating an oral condition; and releasing the substrate from the mold while substantially retaining the therapeutic composition on the substrate. The substrate may be an oral treatment strip, and the therapeutic composition may be overmolded onto at least a portion of an inner surface of the oral treatment strip.The substrate may be a substantially arch-shaped dental tray and the therapeutic composition may be overmolded onto at least a portion of an inner surface of the substantially arch-shaped dental tray. These and other aspects, features, and advantages of the invention will become more evident from the following 77! Lnn / Zznz / E / YILI brief description of the figures, the detailed description of the preferred embodiments and the attached claims. Brief Description of the Figures The accompanying figures contain exemplary embodiments to further illustrate and clarify the foregoing aspects, advantages, and features of the present invention. It will be appreciated that these figures represent only exemplary embodiments of the invention and are not intended to limit its scope. Furthermore, it will be appreciated that although the figures may illustrate preferred sizes, scales, ratios, and configurations of the invention, they are not intended to limit the scope of the claimed invention. The invention will be described and explained more specifically and in greater detail by use of the accompanying figures, in which: Figure 1 is a perspective view of an exemplary oral treatment strip with an overmolded therapeutic composition; Figure 2A is a side view of the oral treatment strip illustrated in Figure 1; Figure 2B is a top view of the oral treatment strip illustrated in Figure 1; Figure 3 is a cross-sectional view of the oral treatment strip illustrated in Figure 1 taken along sight line 3-3 of Figure 2A; Figure 4 is a perspective view of another exemplary modality of an oral treatment strip; Figure 5 is a perspective view of an exemplary oral treatment tray with an overmolded therapeutic composition; Figure 6 is a perspective view of an exemplary mold that can be used to overmold a therapeutic composition into an oral treatment tray, as shown in Figure 5; Figure 7 is a perspective view of a portion of the mold shown in Figure 6, illustrating the mold positioned in relation to the oral treatment tray shown in Figure 5; Figure 8 is another perspective view of a portion of the mold shown in Figure 6, illustrating the mold with the oral treatment tray removed to illustrate the configuration of the overmolded therapeutic composition provided by the mold; and Figure 9 is a perspective view of an exemplary mold used for the preparation of an oral treatment tray, such as the oral treatment tray shown in Figure 5. Detailed Description of the Invention For the purpose of promoting understanding of the present description, reference will now be made to the following exemplary modalities and specific language will be used to 77! Lnn / Zznz / E / YILI describe them. However, it will be understood that it is not intended to limit the scope of the description, since such alterations and additional modifications to the subject matter described, as well as additional applications of the principles described as described herein, are contemplated, as would normally occur to a person skilled in the art to which the description relates. The terms and words used in the following description and claims are not limited to their bibliographic meanings but are used simply to allow for a clear and consistent understanding of the description. It should be understood that the singular forms a, one, an, and the include plural referents unless the context clearly dictates otherwise. Thus, for example, a reference to a surface of the component includes a reference to one or more such surfaces. The term substantially means that the mentioned characteristic, parameter, or value need not be achieved exactly, but deviations or variations, including, for example, tolerances, measurement errors, limitations of measurement precision, and other factors known to those skilled in the art, may occur in amounts that do not impede the effect that the characteristic was intended to provide. The term therapeutic agent, as used herein, means and includes any agent, compound, composition of matter or mixture thereof that provides any cosmetic, therapeutic, prophylactic or hygienic benefit within the oral cavity, either by direct application to the teeth or oral tissue, or by administration elsewhere by absorption through the oral tissue. The term treatment, as used herein, means and includes the process of applying a therapeutic agent or a substance containing a therapeutic agent to the teeth or oral tissue to achieve a cosmetic, therapeutic, prophylactic, or hygienic benefit and / or to treat or benefit one or more oral conditions, such as whitening, desensitizing, and / or remineralizing the teeth. This description refers generally to techniques for overmolding a composition onto a substrate, and more specifically, but not exclusively, to techniques for overmolding a therapeutic composition onto a substrate configured for the delivery of the composition to human or animal teeth and / or oral tissue. In one example, the therapeutic composition may be an oral treatment composition, which is a polymeric composition that includes at least one therapeutic agent effective for treating one or more oral conditions and can be overmolded onto the substrate. 77! Lnn / Zznz / E / YILI using injection molding. However, the principles described herein are not limited to oral and / or dental care applications. Rather, it shall be understood that, in light of this description, the overmolding techniques described herein may be successfully used in other applications. Referring now to Figures 1-3 in general, an oral treatment strip 10 may include a substrate 12 onto which a therapeutic composition 14 is overmolded. The substrate 12 may provide support and flexibility, and the therapeutic composition 14 may, for example, be in the form of a gel, suspension, liquid, paste, putty, foam, or similar. Although the substrate 12 of the oral treatment strip 10 may have a generally rectangular configuration in the illustrated form, it should be appreciated that other shapes and variations thereof are possible. Furthermore, in the illustrated form, the therapeutic composition 14 is overmolded in a shape generally corresponding to the substrate 12. However, in other forms, the therapeutic composition 14 may be overmolded in a shape generally different from that of the underlying substrate 12, which will be discussed in more detail below.Further details regarding the materials that substrate 12 and therapeutic composition 14 may be made of are also provided below. In general, the therapeutic composition 14 can be overmolded onto the substrate 12 by placing 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, for example, be achieved by using a second mold that was used (in combination with a different third mold) to form the substrate 12. The first mold can define a profile that corresponds to the desired final shape and configuration of the therapeutic composition 14 once it is overmolded onto the substrate 12. In this way, when the first mold is conveniently 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 separated from substrate 12, leaving the therapeutic composition 14 in substrate 12 in a configuration corresponding to the cavity. Since the shape and configuration of the therapeutic composition 14 on the substrate 12 can correspond to the profile defined, at least partially, by the first mold, it should be appreciated that the structural characteristics of the therapeutic composition 14 on the substrate 12 can be predetermined and / or can be altered by changing the profile defined, at least partially, by the 77! Lnn / Zznz / E / YILI first mold which, in turn, can change the cavity into which the therapeutic composition 14 is injected. For example, as illustrated in Figures 2B and 3, the therapeutic composition 14 overmolded onto the substrate 12 can include a width W, a length L, and a thickness T, any of which can be varied along all or part of the substrate 12 to change the configuration of the therapeutic composition 14. By way of non-limiting example, one or both of the width W and the thickness T can be varied along the length L, and / or the thickness T can be varied along the width W and along the length L or at discrete locations along the length L. In the manner illustrated, the therapeutic composition 14 can have a continuous configuration on the substrate 12.However, it should be understood that the profile of the first mold can be changed 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 can be the same as or different from one or more of the other portions. Furthermore, in forms where the therapeutic composition 14 includes two or more discrete portions on the substrate 12, it is envisaged that the therapeutic composition 14 could be the same in each discrete portion, or it could be different in each or some of the discrete portions. For example, the therapeutic agent present in the therapeutic composition 14 could be the same in each portion. 77! Lnn / Zznz / E / YILI discrete, or it could be different in each or some of the discrete portions. Therapeutic composition 14 may be overmolded with one or more positioning indicators to facilitate alignment of the therapeutic composition 14 on the teeth. By way of example, but not limitation, such positioning indicators may be formed as three-dimensional lines, markings, 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 therapeutic composition 14 may be placed. In the context of the oral treatment strip 10, it should be noted that variations in the therapeutic composition 14, as overmolded onto the substrate 12, can be pursued to facilitate the treatment of a particular area or areas, and / or the type of treatment applied to a single area, a particular area, or particular areas. For example, the therapeutic composition 14 may have two or more discrete portions which, when sufficiently spaced, can be used for the treatment of non-contiguous teeth and / or oral tissues. Furthermore, or alternatively, when the therapeutic composition 14 includes two or more discrete portions on the substrate 12, different or similar therapeutic agents can be placed in one or more of the discrete portions, which may allow for the treatment of different conditions. 77! Lnn / Zznz / E / YILI conditions in contiguous or non-contiguous teeth and / or in oral tissue. Figure 4 illustrates an exemplary alternative embodiment of an oral treatment strip 20. The oral treatment strip 20 may include a substrate 22 and a cavity 24 that may be recessed relative to the surface 26 and may be surrounded by a side wall 28. The substrate 22 may provide support and flexibility to the oral treatment strip 20. In general, the cavity 24 may provide a recess into which a therapeutic composition (not shown) may be overmolded. The therapeutic composition may, for example, be in the form of a gel, suspension, liquid, paste, putty, foam, or the like, and may be the same as or similar to the therapeutic compositions 14, 114 described herein.Although the substrate 22 of the oral treatment strip 20 may include a generally rectangular configuration and may have one or more notches 30, 32 in the illustrated form, it should be appreciated that other shapes and variations thereof are possible. The therapeutic composition can be overmolded into cavity 24 such that the therapeutic composition, as overmolded onto substrate 22, has a shape that at least partially, substantially, or at least substantially corresponds to the shape of cavity 24. It will be appreciated, after reviewing this description, that other variations are also possible. For example, the therapeutic composition could extend beyond cavity 24 and partially or completely cover surface 26 around all or part of cavity 24. The therapeutic composition can be overmolded onto substrate 22 by placing a first mold relative to substrate 22. The relative positioning of the mold and substrate 22 can be maintained by any suitable means.In forms where the desired final shape and configuration of the therapeutic composition, as overmolded onto substrate 22, corresponds to cavity 24, and the therapeutic composition is flush with surface 26, then the first mold can generally be flat in configuration, such that cavity 24 defines the final shape and configuration of the therapeutic composition. It will be appreciated, after reviewing this description, that in other forms, including those where the therapeutic composition extends above surface 26 and / or partially covers surface 26, then the first mold can define a profile that corresponds to the desired final shape and configuration of the therapeutic composition once it is overmolded onto substrate 22.When the first mold is conveniently 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 separated from substrate 22, leaving the therapeutic composition in substrate 22. After reviewing this description, it should be noted that the structural characteristics of the therapeutic composition, as overmolded onto substrate 22, can be predetermined and / or altered by changing the profile defined by cavity 24 and / or any additional cavities that may be defined by the first mold. Similarly, forms in which the therapeutic composition includes two or more discrete portions on substrate 22 are also considered. In these forms, the therapeutic composition could be the same in each discrete portion, or it could be different in each or some of the discrete portions. For example, the therapeutic agent present in the therapeutic composition could be the same in each discrete portion, or it could be different in each or some of the discrete portions. In the context of the oral treatment strip 20, it should be appreciated after reviewing this description that variations in the overmolded therapeutic composition on substrate 22 may be pursued to facilitate the treatment of a particular area or areas, and / or the type of treatment applied to a single area. For example, the therapeutic composition having two or more discrete portions 77! Lnn / Zznz / E / YILI, when sufficiently separated, can be used for the treatment of non-contiguous teeth and / or oral tissue. Furthermore, or alternatively, when the therapeutic composition includes two or more discrete portions in substrate 22, different or similar therapeutic agents can be disposed of in one or more of the portions, which may allow for the treatment of different conditions in contiguous or non-contiguous teeth and / or oral tissue. Although cavity 24 has been illustrated and described in relation to oral treatment strip 20, it should be appreciated after reviewing this description that the other modalities described herein, including the oral treatment strip 10 discussed above and the oral treatment tray 110 discussed below, could be provided with one or more cavities into which a therapeutic composition could be disposed or injected. Returning to Figure 5, an exemplary oral treatment system 100 is illustrated, which may include an oral treatment tray 110 and a therapeutic composition 114 that may be overmolded onto a substrate 112 of the tray 110. The substrate 112 may provide support and flexibility, and the therapeutic composition 114 may, for example, be in the form of a gel, suspension, liquid, paste, putty, foam, and the like. The tray 110 may have any desired size, shape, configuration, pattern, and / or arrangement, depending on 77! Lnn / Zznz / E / YILI, for example, of the intended use. In some embodiments, the tray 110 may have an elongated, curved shape that imitates or substantially approximates at least a portion of an upper or lower dental arch. For example, the tray 110 may have a square, ovoid, arched, or conical shape. In the illustrated embodiment, the tray 110 generally has an arched shape and may include an outer wall 116, an inner wall 118, and a surface 120 that may be at least partially interposed between at least a portion of the outer wall 116 and the inner wall 118. Between the outer wall 116, the inner wall 118, and the surface 120, a tray 122 may be defined, at least partially.In this arrangement, the tray 110 can be configured to be placed on a dental arch such that the outer wall 116 can be oriented over the labial / buccal surfaces of the teeth, the inner wall 118 can be oriented over the lingual surfaces of the teeth, and the surface 120 can be oriented over the superior or inferior surfaces of the teeth. Although the tray 110 can be described as having the outer wall 116, the inner wall 118, and the surface 120, after reviewing this description, it should be understood that the tray 110 can have a unibody, one-piece structure, wherein the outer wall 116, the inner wall 118, and / or the surface 120 are one or more parts of a dental tray. 77! Lnn / Zznz / E / YILI integrated, which may be a one-piece, integral dental tray. In some forms, the width of surface 120 at an anterior end 124 of the tray 110 and at a transition point between the anterior end 124 and the posterior ends 126a and 126b of the tray 110 may be less than the width of surface 120 in a region near the posterior ends 126a and 126b. The change in width may be a gradual reduction or a more abrupt reduction, such as that shown in Figure 5. In some embodiments, the inner wall 118 may have a reduced width or may terminate at or before the transition between the anterior end 124 and the posterior ends 126a and 126b.Although not previously mentioned, it should also be understood that tray 110 may include the outer wall 116, the inner wall 118, and / or the surface 120 that are substantially devoid of structures corresponding to the size and shape of a person's unique dentition, may be formed to approximate human dentition, and / or may be molded for a person's unique dentition. In the illustrated form, the therapeutic composition 114 can be overmolded into a shape generally corresponding to the substrate 112. After reviewing this description, it will be appreciated that in other forms the therapeutic composition 114 can be overmolded into a shape that is generally different from the underlying substrate 112, further details of which will be provided below. For example, in some modalities, the therapeutic composition 114 can be molded over the entire inner surface of the tray 110 (i.e., over the entire surface of the outer wall 116, the inner wall 118, and the surface 120). In other modalities, the therapeutic composition 114 can be molded over only a portion of the inner surface of the tray 110, as depicted in Figure 5. Further details relating to the materials from which the substrate 112 and the therapeutic composition 114 can be formed are provided below. In general, the therapeutic composition 114 can be overmolded onto the substrate 112 by placing a first mold relative to the substrate 112 of the tray 110. The relative positioning of the mold and the substrate 112 of the tray 110 can be maintained by any suitable means and can, for example, be achieved by using a second mold, which can be used (in combination with a different third mold, if desired) to form the substrate 112 into the shape of the tray 110. The first mold can define a profile that corresponds to the desired final shape and configuration of the therapeutic composition 114 once it is overmolded onto the substrate 112. In this way, when the first mold is conveniently positioned, the profile of the first mold 77! Lnn / Zznz / E / YILI can define a cavity between it and substrate 112, and therapeutic composition 114 can be injected between the first mold and substrate 112 to fill the cavity. The cavity of the first mold can further include a space corresponding to the shape and configuration of tray 110 to facilitate the placement of tray 110 in the first mold. Once the cavity is filled, the first mold can be separated from substrate 112, which can leave therapeutic composition 114 in substrate 112 in a configuration corresponding to the configuration of the cavity. Since the shape and configuration of the therapeutic composition 114 on the substrate 112 can correspond to the profile defined by the first mold, after reviewing the present description, it should be appreciated that the structural characteristics of the therapeutic composition 114 that is overmolded onto the substrate 112 can be predetermined and / or altered, for example, by changing the profile defined by the first mold, which, in turn, can change the cavity into which the therapeutic composition 114 is injected. For example, as discussed earlier in relation to the therapeutic composition 14, one or more of the thickness, height, width, length, etc., of the therapeutic composition 114 overmolded onto the substrate 112 can be varied along all or part of the substrate 112, which can change the configuration of the therapeutic composition. 77! Lnn / Zznz / E / YILI 114. Furthermore, while the therapeutic composition 114 may have a continuous configuration on the substrate 112 as illustrated, it should be appreciated after reviewing this description that the profile of the first mold can be changed to provide the therapeutic composition 114 on the substrate 112 in discrete portions where the thickness, height, width, length, etc., of each discrete portion may be the same as or different from the other portions. Moreover, in forms where the therapeutic composition 114 includes two or more discrete portions on the substrate 112, it is envisaged that the therapeutic composition 114 could be the same in each discrete portion, or it could be different in each or some of the discrete portions. For example, a different therapeutic agent could be provided in each of the discrete portions or in some of them. In the context of tray 110, it should be appreciated that variations in the overmolded therapeutic composition 114 on substrate 112 may be desired to facilitate the treatment of a particular area or areas, and / or the type of treatment applied to a single area or multiple areas. For example, the therapeutic composition 114 may have two or more discrete portions, when sufficiently separated, which can be used for the treatment of non-contiguous teeth and / or oral tissues. Furthermore, or alternatively, when the therapeutic composition 114 includes two or more 77! Lnn / Zznz / E / YILI discrete portions on substrate 112, different or similar therapeutic agents can be placed in one or more of the discrete portions, which may allow the treatment of different conditions in contiguous or non-contiguous teeth and / or in oral tissue to be considered. By way of non-limiting example, the substrates 12 and 112 from which the strip 10 and tray 110, respectively, may be at least partially formed, may be at least substantially impermeable or semipermeable to liquids such as water and saliva, so that the strip 10 and tray 110 can form a moisture-resistant barrier around the teeth, gums, and / or other oral tissues. The substrates 12 and 112 may be flexible and / or conformable and may exhibit plastic and / or elastic deformation, which may allow the strip 10 and / or tray 110 to conform at least substantially to a dental arch. In one example, the strip 10 and tray 110 may be formed using a molding process, such as injection molding, compression molding, blow molding, or thermoforming.In addition, substrates 12, 112 of strip 10 and / or tray 110 may be made up of one or more polymers (including thermoset polymers, thermoplastic polymers and thermoplastic elastomeric polymers), silicones, waxes, resins or combinations thereof, such as. 77! Lnn / Zznz / E / YILI will be described in more detail below. 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 that can exhibit elastic deformation. As non-limiting examples, 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 copolymer, ethylene-vinyl alcohol copolymer, acetates (e.g., ethyl vinyl acetate (EVA) and polyvinyl acetate (PVA)), polyvinyl alcohol (PVOH), polyesters (such as polyethylene terephthalate, or PETE), polycarbonates, methacrylates, acrylates, polyamides (e.g., nylon), polyurethanes, polyvinyl chloride (PVC), synthetic rubber, and phenol resin. 77! Lnn / Zznz / E / YILI formaldehyde (bakelite), neoprene, polystyrene, polyacrylonitrile, polyvinyl butyral (PVB), silicone elastomers, thermoplastic elastomers and natural polymers. As used herein, thermoplastic elastomer or TPE means and includes polymers or combinations of polymers that have both thermoplastic and elastomeric properties. Such thermoplastic elastomers can soften upon heating to exhibit fluidity and can set upon cooling to exhibit elastic deformation. Examples of thermoplastic elastomers (TPEs) that can be used to form substrates 12, 112 may include, but are not limited to, diffin-based, styrene-based, polyester-based, polyurethane-based, polyvinyl chloride-based, polyamide-based, polyisoprene-based, polybutadiene-based, polybutene-based, siloxane-based, polycarbonate-based, ethylene-vinyl acetate-based, ethylene methacrylate-based, polyacrylonitrile-based, polyacrylic ester-based, acrylic-based and / or copolymers or mixtures thereof. The natural polymers that can be used to form substrates 12, 112 may include, but are not limited to, shellac, natural rubber, polysaccharides, cellulosic ethers, cellulose acetate, and proteins. In some modalities, the substrates 12, 112 used 77! Lnn / Zznz / E / YILI to form strip 10 and / or tray 110 may be flexible and include at least one wax and at least one polymer, such as a thermoplastic elastomer. The wax(es) and thermoplastic elastomer(s) can be combined and molded to form the flexible substrate of strip 10 and / or tray 110. In some embodiments, the flexible substrate can 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 corresponding to the configuration of strip 10 or tray 110. In other embodiments, as a person skilled in the art would recognize, strip 10 and / or tray 110 can be constructed from various suitable materials and processes, such as compression molding, rotational molding, blow molding, thermoforming, extrusion, and the like. In some applications using a flexible substrate, the substrate can be thermally stable and exhibit both elastic and / or plastic deformable properties. For example, the flexible substrate may exhibit both plastic and elastic deformability, depending on the amount of deformation applied and the temperature at which it is deformed. For instance, the flexible substrate may exhibit plastic deformation until it is subjected to tension to a certain point, at which point it will begin to exhibit elastic deformation. 77! Lnn / Zznz / E / YILI elastic deformation. The forms that include at least one wax and at least one polymer such as a thermoplastic elastomer can be plastically deformable at room temperature (i.e., between approximately 20 and approximately 25 °C) and thermally stable up to a temperature of at least 40 °C. In these and other embodiments, the flexible substrate can be deformed over an individual's teeth when strip 10 and / or tray 110 are placed over the individual's teeth. For forms in which a flexible substrate includes at least one wax and at least one polymer such as a thermoplastic elastomer, the flexible substrate may include one or more waxes in an amount by weight, based on the total weight of the composition forming the substrate, in the range of approximately 40% to approximately 95%, in the range of approximately 50% to approximately 93%, in the range of approximately 60% to approximately 90%, or in the range of approximately 70% to approximately 85%. 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 paraffins, intermediate waxes, microcrystalline waxes, distilled waxes, and petrolatum. By way of non-limiting example, paraffin wax, intermediate wax, and / or microcrystalline wax may 77! Lnn / Zznz / E / YILI can be mixed to provide a desired level of plastic deformation at room temperature and dimensional stability at higher temperatures. Additional details regarding compositions that include at least one wax and that can be used to form a flexible substrate are found in U.S. Patent Application No. 15 / 027,636, the contents of which are incorporated herein by reference. The flexible substrates described herein may include one or more polymers in an amount by weight, based on the total weight of the substrate composition, in the range of approximately 5% to approximately 60%, approximately 7% to approximately 50%, approximately 10% to approximately 40%, or approximately 15% to approximately 30%. The flexible substrate may also include one or more auxiliary components, such as plasticizers, flow modifiers, and / or fillers. When included, these components may be present in an amount by weight, based on the total weight of the substrate composition, in the range of approximately 0.01% to approximately 5%, approximately 0.1% to approximately 4%, or approximately 1% to approximately 3%. Therapeutic compositions 14, 114 may include at least one therapeutic agent effective for treating a condition, 77! Lnn / Zznz / E / YILI such as an oral condition. Therapeutic compositions 14, 114 may also include at least one polymeric material and / or at least one solvent or carrier. In addition, therapeutic compositions 14, 114 may include at least one hydrophobic agent and / or at least one rheology modifier. The polymer, the therapeutic agent, the hydrophobic agent, and / or the rheology modifier may, for example, be mixed, distributed, dispersed, or dissolved in the solvent or carrier. In an exemplary form, therapeutic compositions 14, 114 include a polymeric material that exhibits polarity and / or that exhibits solubility in polar solvents, such as water or alcohols (i.e., the polymeric material includes one or more hydrophilic polymers). Such hydrophilic polymers may be any monomer, oligomer, or non-crosslinked or crosslinked polymer and may, in some modalities, act as tissue adhesion agents, adhesive agents, and / or thickening agents in therapeutic compositions 14, 114. By way of non-limiting example, therapeutic compositions 14, 114 may include one or more of the pyrrolidone-based polymers (e.g., polyvinylpyrrolidone (PVP)), PVP copolymers (e.g., PVP / vinyl acetate copolymers), acrylic acid-based polymers (e.g., carboxypolymethylene or a carbomer such as Carbopol® and Pemulen™, which are commercially available from Lubrizol). Advanced Materials, Inc.), oxazoline-based polymers (e.g., polyethyleneoxazoline and other poly(2-oxazolines)), polyethylene oxide, also known as polyethylene glycol (e.g., Polyox™, commercially available from Dow Chemical Company), polyacrylates, polyacrylamides, polyacrylic acid-polyacrylamide copolymers, cellulose-based polymers (e.g., hydroxypropyl methylcellulose, carboxymethylcellulose, carboxypropylcellulose and cellulose ethers), polysaccharide gums, proteins and their derivatives. Other non-limiting examples of pyrrolidone-based polymers that could be used include one or more grades of Kollidon® PVP polymers (commercially available from BASF) such as Kollidon® 30, which has an average molecular weight (Mw) of between approximately 44,000 and approximately 54,000, Kollidon® VA 64, which has an Mw of between approximately 45,000 and 70,000, and Kollidon® 90 F, which has an Mw of between approximately 1 million and 1.5 million. Therapeutic compositions 14, 114 may include the polymeric material in an amount by weight, based on the total weight of the composition, in the range of about 1% to about 50%, in the range of about 3% to about 30%, or in the range of about 5% to about 20%, to provide only a few non-limiting examples. As previously mentioned, the compositions Therapeutic compositions 14, 114 may include one or more solvents or carriers in which the polymeric material, and any other component of the composition, may be combined, mixed, dissolved, distributed, or dispersed. In some embodiments, the polymeric material, and any other component of the composition, may be substantially homogeneously distributed in the solvent and / or carrier material. In one example, such solvents and carriers may be in liquid or gel form. By way of 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 methyl, ethyl, and isopropyl alcohol, diols and polyols such as ethylene and propylene glycol compounds (e.g., polyethylene glycol (PEG) and polypropylene glycol (PPG), hexylene glycol, butylene glycol, ethoxydiglycol, glycerin, sorbitol, mannitol, maltitol, and other sugar alcohols), and diols (1,3-propanediol). When the solvent and / or carrier is included in therapeutic compositions 14, 114, the solvent and / or carrier may be present in an amount by weight, based on the total weight of the composition, in the range of approximately 0.5% to approximately 50%, in the range of approximately 10% to approximately 40%, or in the range of approximately 20% to approximately 30%, to provide only a few non-limiting examples.When determining the exact amount of solvent and / or carrier to include in the composition, consideration should be given to providing 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 equipment. As stated above, therapeutic compositions 14, 114 may include at least one therapeutic agent effective for treating a condition. By way of non-limiting example, the therapeutic agents that may be included in therapeutic compositions 14, 114 may include any substance that has cosmetic, personal care, diagnostic, or therapeutic activity, and may or may not have pharmacological activity. For example, the therapeutic agent may be effective for the treatment of an oral condition and may include, but is not limited to, dental bleaching and / or whitening agents, desensitizing and / or remineralizing agents, anesthetics, antiplaque agents, antitartar agents, antimicrobials, antibiotics, disinfectants and / or antiseptics, antioxidants, healing agents for oral soft tissues, such as gingival soothing agents, and brightening agents.Non-limiting examples of teeth whitening and / or bleaching agents include one or more peroxides and / or oxygen-generating or oxygen-releasing compounds, active oxygen, or hydrogen peroxide, such as peroxides (e.g., inorganic or metallic peroxides, such as hydrogen peroxide), glycerol peroxide, hydrogen peroxide urea adducts (e.g., carbamide peroxide), hydrogen peroxide complexes and / or adducts (e.g., hydrogen peroxide-PVP complexes, such as the Peroxydone™ complexes available from Ashland), 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. Non-limiting examples of desensitizing 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 phosphates), magnesium salts (e.g., magnesium sulfate), hydroxyapatite, amorphous calcium phosphate (AGP), casein phosphopeptide (CPP), ACP-CPP, and strontium salts (e.g., strontium chloride and strontium acetate). 77! Lnn / Zznz / E / YILI These desensitizing and / or remineralizing agents may be present in sufficient quantity to desensitize and / or remineralize the teeth. For example, desensitizing and / or remineralizing agents may be present in a weight-based quantity, based on the total weight of the composition, ranging from approximately 0.1% to approximately 10%. It should be noted that, in one example, remineralizing agents may also function as brightening agents, restoring shine to the enamel. 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, tetracycline, phenols, cetylpyridinium chloride, benzoic acid, and quaternary ammonium compounds (e.g., benzalkonium chloride).Non-limiting examples of anti-plaque or anti-tartar agents include pyrophosphate salts. 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 noted above, remineralizing agents can act as brightening agents. When the therapeutic agent included in the 77! Lnn / Zznz / E / YILI therapeutic compositions 14, 114 is a dental bleaching and / or whitening agent, which may be included in any desired concentration, such as, for example, in an amount by weight, based on the total weight of the composition, in the range of approximately 1% to approximately 90%, in the range of approximately 1% to approximately 60%, in the range of approximately 3% to approximately 40%, or in the range of approximately 5% to approximately 30%. It should be appreciated that the amount of the dental bleaching and / or whitening agent may be adjusted, for example, depending on the treatment time planned for each bleaching session. In the forms in which the therapeutic compositions 14, 114 include a peroxide bleaching or lightening agent, such as hydrogen peroxide or carbamide peroxide, the therapeutic compositions 14, 114 may also include one or more peroxide stabilizers or pH buffering agents, such as phosphate salts, ammonium hydroxide, sodium hydroxide, potassium hydroxide, sodium phosphate, potassium phosphate aminopolycarboxylic acid (e.g., ethylenediaminetetraacetic acid (EDTA) or its salts), triethanolamine, TRIS, urea, polyphosphates, pyrophosphates (e.g., sodium pyrophosphate), hydroxypyridones or their salts, a stannic acid salt (e.g., sodium stannate), citric acid, phosphoric acid, nitrates (e.g., sodium nitrate), 77! Lnn / Zznz / E / YILI organophosphonate salts, aminocarboxylic acid salts, and combinations thereof. For clarity, the term salt means and includes the base addition salt of a compound with an alkali metal salt (i.e., lithium, sodium, or potassium), an alkaline earth metal salt (e.g., calcium or magnesium), or an ammonium salt. Such stabilizers may be included in a sufficient amount to stabilize hydrogen peroxide. By way of non-limiting example, the stabilizer(s) may be present in an amount by weight, based on the total weight of the composition, in the range of approximately 0.1% to approximately 10%. By way of non-limiting example, the pH buffer(s) may be present in an amount by weight, based on the total weight of the composition, in the range of approximately 0.1% to approximately 30%. The therapeutic compositions 14, 114 may optionally include one or more hydrophobic agents which, when present, may aid or enable the release of the therapeutic compositions 14, 114 from a mold. For example, the presence of the hydrophobic agent(s) may result in preferential adhesion of the therapeutic compositions 14, 114 to the substrate 12, 112 rather than to the surface of a mold used in the overmolding process. The hydrophobic agent(s) may be added to the therapeutic compositions 14, 114 in a sufficient quantity. 77! Lnn / Zznz / E / YILI to aid the release of the therapeutic compositions 14, 114 from a surface of a mold used in the overmolding process. Although it is not desired to be limited by any particular theory, it is believed that the hydrophobic agent(s) (such as an oil and / or pyrogenic silica) can aid the release of the therapeutic compositions 14, 114 from the mold over a range of temperatures independent of the viscosity and adhesiveness of the therapeutic compositions 14, 114. Consequently, the therapeutic compositions 14, 114 can be formulated with high viscosity and high adhesiveness while readily releasing from the mold used in the overmolding process and, in some modalities, selectively adhering to the substrate 12, 112 on the mold used in the overmolding process. Non-limiting examples of hydrophobic agents that may be included in therapeutic compositions 14, 114 include oils, waxes, hydrophobic fillers, silicone-based compounds, hydrophobic cellulose-based polymers, menthols, and hydrophobic surfactants. More specific examples of hydrophobic agents include, but are not limited to, mint oils (e.g., peppermint oil, spearmint oil, and wintergreen oil), citrus oils (e.g., orange oil), cinnamon oil, camphor oil, basil oil, and amaranth oil. 77! Lnn / Zznz / E / YILI lavender oil, limonene, siloxanes (e.g., dimethicone), silanes, silicones, non-ionic surfactants (e.g., polyglycerol alkyl ethers, glucosyl dialkyl ethers, crown ethers, ester-linked surfactants and polyoxyethylene alkyl ethers) and anionic surfactants (e.g., sodium lauryl sulfate, alkyl sulfates, acyl glycinates and stearate salts), pyrogenic silica and combinations thereof. When included in therapeutic compositions 14, 114, the hydrophobic agent may be present in an amount by weight, based on the total weight of the composition, in the range of approximately 0.5% to approximately 25%, in the range of approximately 1% to approximately 15%, or in the range of approximately 2% to approximately 12%. In a particular but not limiting form, therapeutic compositions 14, 114 may contain one or more oils and hydrophobic silica. In this exemplary form, one or more oils may be present in an amount by weight, based on the total weight of the composition, in the range of approximately 0.01% to approximately 5%, in the range of approximately 0.05% to approximately 2%, or in the range of approximately 0.3% to approximately 0.8%, and hydrophobic silica may be present in an amount by weight, based on the total weight of the composition, in the range of 0% to approximately 20%. 77! Lnn / Zznz / E / YILI 1% to approximately 15%, or in the range of approximately 2% to approximately 11%. Therapeutic compositions 14, 114 may also optionally include one or more rheology modifiers, fillers, colorants, flavorings, sweeteners, and the like. By way of non-limiting example, sucralose or another suitable sweetener may be included in therapeutic compositions 14, 114 in an amount by weight, based on the total weight of the composition, of less than or equal to approximately 5%. In an exemplary form, therapeutic compositions 14, 114 may be a tooth-whitening composition that includes at least one polymeric material, at least one solvent, at least one therapeutic agent, and optionally, a hydrophobic agent. In a more particular but non-limiting form, therapeutic compositions 14, 114 may include polyvinylpyrrolidone and / or polyethyleneoxazoline, water and / or ethanol, and a peroxide.In another particular but not limiting form, therapeutic compositions 14, 114 may include polyvinylpyrrolidone and / or polyethyleneoxazoline, water and / or ethanol, a therapeutic agent, peppermint oil, and / or pyrogenic hydrophobic silica. In another particular but not limiting form, therapeutic compositions 14, 114 may include hydrogen peroxide, other bleaching agents, other medications, and / or one or more rheology modifiers. In this and other forms, therapeutic compositions 14, 114 may be a gel. 77! Lnn / Zznz / E / YILI viscous sticky at room temperature and molding temperature. In some modalities, one or more components of the therapeutic compositions 14, 114 may be temperature sensitive and the therapeutic compositions 14, 114 may overmold at room temperature (approximately 25 °C) or lower temperatures. In some embodiments, the therapeutic compositions 14, 114 may be configured as a sticky and / or adhesive gel or paste with sufficient viscosity to allow them to remain substantially in place during manufacturing, distribution, storage, promotion, and use. For example, the viscosity could prevent the therapeutic composition from flowing out of a tray or strip. In some forms where a cavity similar to cavity 24 is used, the therapeutic composition may have a lower viscosity and be held in place by the cavity and / or a cover, such as a plastic film, which may be placed over the therapeutic composition after the molding process. In other embodiments, the therapeutic compositions 14, 114 may be configured as substantially dry to the touch, becoming increasingly sticky and / or viscous upon contact with a particular liquid, such as water or saliva.Furthermore, the gel or paste form could have properties similar to those of a liquid, a rubbery composition, or even one. 77! Lnn / Zznz / Ε / ΥΙΛΙ harder and drier composition to the touch. Referring now in general terms to Figures 69, further details will be provided regarding the overmolding of the therapeutic composition 114 onto the substrate 112 of the tray 110. After reviewing this description, it should be appreciated that the following details may also be applicable to the overmolding process of the therapeutic composition 14 onto the substrate 12 of the strip 10. The exemplary mold 200 shown in Figure 6 may be used to overmolde the therapeutic composition 114 onto the substrate 112 of the tray 110. The mold 200 may include one or more projections, such as projections 206a-c, and a projection portion 202 that may generally correspond to the configuration of the tray 110, except that the projection portion 202 may include a recessed portion 203 that may be at least partially defined by one or more surfaces 204.When tray 110 is positioned relative to mold 200, the recessed portion 203 can define at least a portion of a cavity into which the therapeutic composition 114 is injected. Therefore, after this description, it should be appreciated that the recessed portion 203 can define the configuration of the therapeutic composition 114 as overmolded in the substrate 112. For example, Figure 7 illustrates mold 200 positioned relative to tray 110 with the recessed portion 203 shown in ghost lines. 77! Lnn / Zznz / Ε / ΥΙΛΙ discontinuous. 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 can leave the therapeutic composition 114 in an overmolded shape having a desired configuration that may correspond to the recessed portion 203. The resulting exemplary configuration of the recessed portion 203 is best seen, for example, in Figure 8, where the tray 110 has been removed to show the shape of the therapeutic composition 114 after injection between the tray 110 and the mold 200. It should be appreciated that Figure 8 is for illustrative purposes and that, in practice, the therapeutic composition 114 would adhere to the substrate 112 of the tray 110 in such a way that it would be carried along with the tray 110 when the tray 110 is displaced from the mold 200. During the overmolding of the therapeutic composition 114 onto the substrate 112 of the tray 110, the positioning of the tray 110 relative to the mold 200 may be secured in any suitable manner. For example, one or more clamps, an additional mold or molds, and / or a vacuum source could be used. In one exemplary form where another mold is used, it may have the configuration of a mold 300 as illustrated in Figure 9. The mold 300 may generally include one or more recesses or hollows, such as recesses 306a-c and a cavity 304 that 77! Lnn / Zznz / E / YILI may have a corresponding but opposite configuration to that of a tray mold (not shown) that can be used in combination with mold 300 to form tray 110. The tray mold may be similar to mold 200 except, for example, for the absence of the recessed portion 203, such that when the tray mold and mold 300 are positioned relative to each other, a cavity can be defined between them that corresponds to the configuration of tray 110 without the overmolded therapeutic composition 114. After reviewing this description, it should be appreciated that mold 300 can be used during the formation of tray 110, as indicated above. Similarly, in an exemplary form, mold 300 can be used first with the tray mold (not shown) during an injection molding process to form tray 110.After the injection of the substrate material 110 between the tray mold and mold 300, the tray mold and mold 300 can be displaced or separated from each other, with the resulting tray 110 retained in mold 300. For example, a vacuum force could be applied to mold 300 to retain tray 110 in mold 300 while the molds separate. Once the tray mold has been removed, mold 200 can be positioned relative to mold 300, and tray 110 can be retained by mold 300 with the protrusions 206a-c fitting into the recesses 306a. c. The therapeutic composition 114 can then be injected between mold 200 and tray 110 to overmold the therapeutic composition 114 onto the substrate 112 of tray 110. After injection of the therapeutic composition 114, molds 200 and 300 can be displaced or separated from each other, with the therapeutic composition 114 adhering to the substrate 112 of tray 110 and carried by tray 110. To the extent that tray 110 remains in contact with mold 200 and / or mold 300 before or after separation, additional force can be applied to remove tray 110 from the corresponding mold. For example, mechanical force can be applied to tray 110, or air can be injected into the corresponding mold. Alternatively, the mold or tray 110 can be cooled to facilitate separation of tray 110 from it. In formulations where therapeutic composition 14, 114 includes a peroxide, the therapeutic composition 14, 114 may be overmolded onto strip 10 or tray 110 at reduced temperatures to minimize or eliminate the decomposition of the peroxide into oxygen and water during the overmolding process. For example, in some formulations, therapeutic composition 14, 114 may be overmolded onto strip 10 or tray 110 at a temperature of 25°C or less, 20°C or less, or 15°C or less. Although not previously mentioned, it should 77! Lnn / Zznz / E / YILI It can be appreciated that one or more of the molds discussed herein may be coated with a fluorocarbon coating, such as a polytetrafluoroethylene coating, a silicone elastomer coating, a polypropylene coating, a chlorotrifluoroethylene coating, or a different low-adhesion or non-adherent coating to help facilitate the separation of the molds from the tray 110 and / or the therapeutic composition 114. In one example, the mold 200 may be coated with a polytetrafluoroethylene coating or a different low-adhesion or non-adherent coating that can reduce the clamping force used in the injection molding process and, additionally or alternatively, can counteract any stickiness of the therapeutic composition 114. As a result, this can help release the therapeutic composition 114 from the mold 200.It is also contemplated that the mold 200 can be kept at a lower temperature than the therapeutic material 114 as injected, which can help the therapeutic material 114 to solidify and take the shape of the cavity defined or arranged, at least partially, between the mold 200 and the tray 110. Although the subject matter has been described here in the context of oral treatment devices and related compositions, it should be appreciated that they are possible 77! Lnn / Zznz / E / YILI other applications. Furthermore, the application of the overmolding techniques described herein is not limited solely to the application of therapeutic compositions that include at least one therapeutic agent. Rather, the overmolding techniques described herein are also applicable to the overmolding of compositions that include one or more hydrophilic polymers. An expert in the field will appreciate that, for this and other processes, operations, and methods described herein, the functions and / or operations performed may be implemented in a different order. Furthermore, the functions and operations described are provided only as examples, and some of them may be optional, combined into fewer functions and operations, or expanded to include additional functions and operations without altering the essence of the described methods. The description of the prior invention should not be construed as limiting the invention to the described embodiments, since those skilled in the art to which the invention relates may devise other equivalent forms within the scope of the invention. Variations and changes that are obvious to a person skilled in the art are provided for within the scope and nature of the present invention. Although this invention has been described in terms of certain exemplary embodiments, other evident embodiments 77! Lnn / Zznz / E / YILI for those skilled in the art are also within the scope of this invention. Accordingly, the scope of the invention is intended to be defined only by the following claims. It is hereby stated that, as of this date, the best method known to the applicant for putting the aforementioned invention into practice is the one that is clear from the present description of the invention.

Claims

Having described the invention as above, the following claims are claimed as property:

1. A method, characterized in that it comprises: positioning a mold with respect to a substrate; injecting a composition, which includes a hydrophilic polymer, between the mold and the substrate and overmolding the composition onto a surface of the substrate in an overmolded configuration corresponding to a configuration defined by the mold; and separating the mold from the substrate while substantially retaining the composition in the overmolded configuration.

2. The method according to claim 1, characterized in that the substrate comprises a substantially arch-shaped dental tray, including a basin defined by inner and outer side walls, and the composition is overmolded onto at least a portion of one or both of the inner and outer side walls.

3. The method according to claim 2, characterized in that it further comprises molding the dental tray with at least one thermoplastic polymer. 77! Lnn / Zznz / E / YILI 4. The method according to claim 2, characterized in that the composition includes at least one therapeutic agent effective for treating an oral condition.

5. The method according to claim 4, characterized in that 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 having effective properties for selectively maintaining the composition in the overmolded configuration until the use of the dental tray 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 approximately 25 °C.

8. The method according to claim 1, characterized in that the composition further includes at least one therapeutic agent effective for treating an oral condition and at least one hydrophobic agent.

9. A method, characterized in that it comprises: positioning an overmolding mold in relation to a dental tray including a tray defined by inner and outer side walls; and overmolding an oral treatment composition onto at least a portion of one or both of the inner and outer side walls of the dental tray; wherein the oral treatment composition includes at least one therapeutic agent effective for treating an oral condition.

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

11. The method according to claim 9, characterized in that the dental tray has a substantially dental arch shape.

12. The method according to claim 9, characterized in that it further comprises: positioning a first mold with respect to a second mold, the first and second molds defining a cavity having a configuration corresponding to the dental tray; injecting a thermoplastic polymer between the first and second molds to form the dental tray; and separating the first mold from the second and retaining the dental tray in contact with the first mold.

13. The method according to claim 12, characterized in that the overmolding mold is placed in relation to the dental tray and the first mold.

14. The method according to claim 9, characterized in that at least one therapeutic agent is selected from dental bleaching agents, dental lightening agents, desensitizing agents, remineralizing agents, anesthetics, anti-plaque agents, anti-tartar agents, antimicrobials, antibiotics, disinfectants, antiseptics, antioxidants, healing agents, brightening agents and combinations thereof.

15. The method according to claim 9, characterized in that the overmolding is carried out at a temperature below approximately 25 °C.

16. The method according to claim 9, characterized in that the overmolding includes injecting the oral treatment composition between the overmolding mold and the dental tray.

17. An oral treatment system, characterized in that it comprises: a dental tray including a tray defined by inner and outer side walls; and an oral treatment composition overmolded onto at least a portion of one or both of the inner and outer side walls of the dental tray; wherein the oral treatment composition includes at least one therapeutic agent effective for treating an oral condition.

18. The system according to claim 17, characterized in that the therapeutic agent is hydrogen peroxide.

19. The system according to claim 17, characterized in that the oral treatment composition comprises a gel, a liquid, a suspension, a paste, a putty or a foam.

20. The system according to claim 17, characterized in that the oral treatment composition further includes at least one hydrophilic polymer.

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