Patent Publication Number: US-7708726-B2

Title: Dosage form cap for an applicator

Description:
BACKGROUND 
   Delivery devices and methods of manufacturing delivery devices are used for the application of various therapeutic treatments or other non-medicinal preparations into the vaginal or other cavity. 
   Many disease states and physiological conditions may occur in a woman, including symptoms associated with premenstrual syndrome, menstruation, and menopause. These symptoms may include dysmenorrhea (menstrual cramping), irritability, water retention, moodiness, depression, anxiety, skin changes, headaches, breast tenderness, tension, weight gain, cravings, fatigue, hot flashes, itching and other associated sensory maladies. 
   Many of these symptoms are due to changes in hormonal levels throughout the menstrual cycle. One example that affects a large number of post-pubescent women is dysmenorrhea, which is the occurrence of painful uterine cramps during menstruation. Menstrual cramping is associated with increased levels of prostaglandin F2α, prostaglandin E2, and, in some cases, leukotrienes in the endometrium and menstrual fluid. These eicosinoids lead to restricted blood flow to the uterus and increased uterine contractions, causing pain. 
   Various analgesics may be effective in limiting the pain from dysmenorrhea; however, some orally-delivered analgesics can cause nausea and vomiting or other untoward side effects. As a result, alternative routes of analgesic delivery are of interest. 
   Attempts have been made to deliver analgesics in the vicinity of the cervix and the vaginal mucosa using various vaginally-inserted devices and methods. Because many of these symptoms typically occur in conjunction with menstruation, some have tried to combine an analgesic with a tampon by coating the tampon, dipping the tampon, or by combining the analgesic with the tampon materials. 
   For example, in a method appropriate for a laboratory setting, a formulation of a fatty compound excipient and an analgesic are heated to a liquid state. Constant mixing of the heated formulation is required to produce a homogeneous formulation. The formulation is then poured onto the tip of a tampon held in a form to contain the liquid. As the formulation cools, the ingredients solidify into a solid waxy substance that has adhered to the absorbent material of the tampon and is thereby securely fastened to the tip of the tampon. 
   SUMMARY 
   Several problems are inherent in a process that attempts to introduce a formulation including a therapeutic agent into or onto a tampon by coating, dipping, solidifying, or the like. Processes such as these may work in a laboratory setting but may not be feasible within an automated tampon manufacturing process. Because of dosing requirements, the formulation including a therapeutic agent must be maintained in a solution that is both homogeneous and of the proper purity to ensure consistent concentration of the therapeutic agent. These requirements are difficult to accomplish during production operation of an automated tampon manufacturing process, and are significantly more difficult to maintain when the automated tampon manufacturing process stops. In addition, different styles and sizes of tampons may have different densities and will absorb an applied liquid formulation including a therapeutic agent differently, resulting in variability in the abilities of the tampons to release the therapeutic agent. 
   Specifically, the need to provide constant agitation or mixing of the formulation including a therapeutic agent poses challenges as to how to keep a therapeutic agent homogeneously suspended in a solution when the automated tampon manufacturing process stops. The use of inline mixers and recirculation of the heated liquid formulation during machine stops may provide a method to keep the formulation moving and. mixed. However, because a machine could be stopped for several hours, the stability of some formulation mixtures may be compromised by long durations at elevated temperatures, or by mechanical shear forces due to the continuous pumping of the recirculating liquid. 
   In addition, environmental conditions, especially during shipping and/or storage, may cause some formulations including a therapeutic agent to melt and absorb into the tampon and/or onto the packaging material prior to use, thus making the therapeutic agent less available for use. 
   This disclosure solves these problems by coupling a cover assembly including a dosage form cap to an applicator to form a medicated applicator assembly. The dosage form cap including a therapeutic agent is solid or semi-solid at room temperature, and is sufficiently stable so that it may be manufactured separately in a controlled facility, whereby the therapeutic agent is easily controlled through controls on homogeneity, concentration, and purity. 
   The advantages of using a pre-manufactured cover assembly over an in-line process where the medicated ingredients are applied to the tampon coincident with the tampon manufacturing process are numerous. The cover assembly including a dosage form cap may be produced at a pharmaceutical manufacturer whose manufacturing facility meets current regulatory and quality requirements for drugs and/or devices as appropriate. This could ensure that a therapeutic agent with the correct dose and purity is homogeneously dispersed within the dosage form cap. The use of a cover assembly including a dosage form cap simplifies the modifications to an existing tampon manufacturing process. The use of dosage form caps allows multiple types of therapeutic agents to be applied with the tampon. The chemical and physical stabilities of the dosage form cap are not compromised by the assembly process with the tampon. The manufacturing process is less dependent on the physical characteristics of the absorbent structure of the tampon because the dosage form cap is not required to bond with the tampon. 
   This disclosure relates to cover assemblies for use with applicator assemblies that may be integral with or associated with feminine care products. The therapeutic agent delivery system including the therapeutic agent and excipients may include any therapeutic agent that will be absorbed into the body through the vaginal or other epithelium, or deposited topically on the vaginal or other epithelium, for the purposes of treating a physiological disease, state, or condition. 
   Objects and advantages will become apparent to those skilled in the art in view of the following description and the accompanying drawings. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is an exploded perspective view of a medicated applicator assembly of the present invention. 
       FIG. 2  is an exploded partially cutaway perspective view of a cover assembly with a barrier seal to be used in conjunction with the medicated applicator assembly of  FIG. 1 . 
       FIG. 3  is an exploded perspective view of a medicated applicator assembly including a medicated tampon of the present invention. 
       FIG. 4  is an exploded partially cutaway perspective view of a cover assembly with a barrier seal to be used in conjunction with the medicated applicator assembly of  FIG. 3 . 
       FIG. 5  is an exploded perspective view of a cover assembly with a barrier to be used in conjunction with the medicated applicator assembly of  FIG. 3 . 
       FIG. 6  is a partial perspective view of an engagement mechanism for the cover assembly and the applicator assembly of  FIG. 3 . 
       FIG. 7  is a partial perspective view of another aspect of an engagement mechanism for the cover assembly and the applicator assembly of  FIG. 3 . 
   

   DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
   The embodiments as described herein will be described for exemplary purposes using a tampon as an example of a feminine care product. The embodiments, however, apply equally to other forms of products, including tampon-like devices and vaginally- and anally-inserted devices, and should not be limited to the example described herein. In addition, although the example described includes a tampon with absorbent material, a product without absorbent material, such as a tampon applicator or other similar applicator, is also contemplated within the invention. Also contemplated is the use in conjunction with non-catamenial feminine products such as incontinence products, including female incontinence inserts. 
   The term “surface” and its plural generally refer herein to the outer or the topmost boundary of an object. 
   The term “dosage form cap” is used herein as a generic term for a unit form of a formulation that includes a therapeutic agent. The dosage form cap includes a discrete and consistent quantity of the therapeutic agent to allow for consistent dosing of one receiving the dosage form cap. The dosage form cap may be any suitable shape dictated by the needs of the application of the dosage form cap. The dosage form cap may have convex, concave, planar, arcuate, or any other suitable surfaces as dictated by the needs of the application of the dosage form cap. 
     FIG. 1  illustrates a delivery device in the form of a medicated applicator assembly  10 , in this case including a tampon assembly  40  and a dosage form cap  45 . The tampon assembly  40  includes a tampon applicator  12  and a catamenial tampon  20 . The tampon applicator  12  includes a first member or outer tube  14  and a second member or inner tube  18 , where the tampon applicator  12  is designed to house the catamenial tampon  20  and provide a comfortable means of inserting the tampon  20  into a woman&#39;s vagina. The dosage form cap  45  is designed to couple to the first member  14 , as is described in more detail below. In another aspect of the present invention, the tampon assembly  40  or the tampon applicator  12  may be referred to simply as an applicator, particularly if the tampon assembly  40  does not include a tampon  20 , or if the tampon applicator  12  is not associated with a tampon  20   
   The first member  14  may be in the form of a spirally wound, convolutely wound or longitudinally seamed hollow tube which is formed from paper, paperboard, cardboard, plastic, other suitable material, or a combination of such materials. Any plastic in the first member  14  is preferably polyethylene, but may be polypropylene or other suitable plastic. The first member  14 , also commonly referred to as an outer tube, may be of any suitable dimensions necessary to house a particular size of tampon  20 . The first member  14  has an outside or exterior surface  24 . 
   The first member  14  is sized and configured to house the absorbent tampon  20 , should one be present, and should have a substantially smooth exterior surface  24  which will facilitate insertion of the first member  14  into a woman&#39;s vagina. When the exterior surface  24  is smooth and/or slippery, the first member  14  will easily slide into a woman&#39;s vagina without subjecting the internal tissues of the vagina to abrasion. The first member  14  may be coated to give it a high slip characteristic. Wax, polyethylene, a combination of wax and polyethylene, cellophane, and clay are representative coatings that may be applied to the first member  14  to facilitate comfortable insertion. The first member  14  itself may be formulated to give it a high slip characteristic, including the addition of additives to the resin from which the first member is made, or by an alteration in physical structure of the exterior surface  24 , such as adding pebbling or other bumps, to decrease the amount of surface area in contact with the vaginal or other epithelium. 
   Referring to  FIG. 1 , the first member  14  has an insertion end  26  and a receiving end  30 . The insertion end  26  is shown without petals, such that it simply has an opening of a diameter approximately equal to the diameter of the first member  14 . In other aspects of the present invention, the diameter of the opening at the insertion end  26  may be larger or smaller than the diameter of the first member  14 . 
   In another aspect of the present invention that is not shown, the insertion end  26  may be configured to have a plurality of pleats or petals that may radially open such that the insertion end  26  has a diameter approximately equal to the diameter of the first member  14 . The petals may be either even or odd in number and may be equally spaced apart or non-uniformly arranged. 
   As stated above, the medicated applicator assembly  10  includes a second member  18 , also commonly referred to as an inner tube. The second member  18 , like the first member  14 , may be a spirally wound, a convolutely wound or a longitudinally seamed hollow tube constructed from paper, paperboard, cardboard, plastic, other suitable material, or a combination thereof. The second member  18  may be constructed of the same material as the first member  14  or it may be made out of a different material. The second member  18  may also be a solid stick or use some other unique shape. It is also possible to form a finger flange  32  on the free end  31  of the second member  18  to provide an enlarged surface onto which the user&#39;s forefinger may rest. The finger flange  32  thereby functions as a seat for the forefinger and facilitates movement of the second member  18  into the first member  14 . The first member  14  may have a fingergrip ring  28  located proximate the receiving end  30 . The fingergrip ring  28  provides an enlarged surface onto which one or more fingers of the user may rest. In use, the user may position one or more fingers on the fingergrip ring  28  and one or more fingers on the finger flange  32 . The user then holds the fingergrip ring  28  and pushes the finger flange  32  to move the second member  18  toward and into the first member  14 . 
   A tampon  20 , should one be present, is an absorbent member primarily designed to be worn by a woman during her menstrual period to absorb menses and other body fluids. The tampon  20  includes a tampon body  34  and a withdrawal string (not shown). The tampon body  34  is normally compressed into the form of a cylinder and may have a blunt, rounded or shaped forward end. The tampon body  34  has a forward or distal end  38  that is closer to the cervix when the tampon  20  is in use. The tampon body  34  also has a proximal end  39  that is closer to the vaginal opening when the tampon  20  is in use. The tampon  20  commonly has a withdrawal string fastened to the tampon body  34  and extending from the proximal end  39 . The withdrawal string serves as a means for withdrawing the tampon  20  from the woman&#39;s vagina. Catamenial tampons suitable for use in the present invention include any absorbent material as is known in the art. The distal end  38  of the tampon body  34  or the tampon body  34  itself may be formed into specific shapes such as various cup shapes to enhance the contact area with the cervix, anterior fornix, posterior fornix, lateral fornices, vaginal epithelium areas, or conformance to other anatomical areas within the vaginal or other cavity. 
   A medicated applicator assembly  10 , which may include the tampon  20 , includes a therapeutic agent included in a dosage form cap  45 , which is typically located within a cover assembly  50 . The cover assembly  50  includes a dosage form cap  45  and a cover  80  enclosing the dosage form cap  45 . As shown in  FIG. 2 , a barrier seal  110  may also be employed to seal the dosage form cap  45  within the cover  80 . 
   Referring to  FIG. 2 , the dosage form cap  45  has a cap attachment end  46  and a cap tapered end  47 . The dosage form cap  45  also includes a cap outer surface  48  and, if the dosage form cap  45  is concave (shown in  FIG. 5 ), a cap inner surface  49 , where the cap inner surface  49  defines and at least partially encloses a cap cavity  51 . 
   The cap attachment end  46  of the dosage form cap  45  includes a portion  54  of a cap engagement mechanism  52  (see  FIG. 1 ) that allows the dosage form cap  45  to be attached to the first member  14  (which includes another portion of the cap engagement mechanism  52 ) with minimal force. The attachment provided by the cap engagement mechanism  52  is preferably two-way or reversible in use. 
   The cap engagement mechanism  52  between the dosage form cap  45  and the first member  14  is shown in  FIG. 1  as having a snap-on engagement profile. Such a profile is convenient to manufacture and may be assembled with minimal force. The cap engagement mechanism  52  may be any other suitable mechanism. 
   In another aspect of the present invention, the cap engagement mechanism  52  may be a biologically-compatible adhesive or any other material suitable for at least temporarily adhering the dosage form cap  45  to the first member  14 . In this case, the bio-adhesive may be applied to the cap inner surface  49  only adjacent the cap attachment end  46 , allowing the dosage form cap  45  to be affixed to the first member  14  by the bio-adhesive. 
   Referring to  FIG. 2 , the cover assembly  50  may also include a cover  80  provided to enclose and protect the dosage form cap  45 . The cover  80  is shown as being generally cylindrical, but the shape is not essential to the invention described herein and any suitable shape may be used. In alternate aspects, the cover  80  may be generally triangular or square or have a flattened side to inhibit the medicated applicator assembly  10  from rolling on a hard surface such as a countertop. The cover  80  includes a cover open end  82 , a cover open end surface  84 , and a cover inner surface  86  that defines and at least partially encloses a cover cavity  88 . The cover cavity  88  projects inwardly from the cover open end  82 . The cover  80  may be manufactured from polyethylene, rubber, or other similar materials that will not adversely interact with the dosage form cap  45  if contact is made therewith. 
   The cover cavity  88  is sized and shaped such that the dosage form cap  45  fits entirely within the cover cavity  88 , preferably with the cover inner surface  86  reflecting the shape of the cap outer surface  48  of the dosage form cap  45  such that the cap outer surface  48  of the dosage form cap  45  maintains general contact with the cover inner surface  86 . The cover  80  is removable and is necessarily removed prior to use of the medicated applicator assembly  10  by a consumer. 
   The dosage form cap  45  may be formed directly within the cover cavity  88  by depositing a formulation including a therapeutic agent directly into the cover cavity  88 . Alternatively, the dosage form cap  45  may also be pre-manufactured in the same or separate facility and then placed within the cover cavity  88  during manufacture of the cover assembly  50 . Further detail concerning the manufacture of a dosage form, in this case a dosage form cap  45 , is disclosed in co-pending U.S. patent application Ser. No. 10,335,816 filed on Dec. 31, 2002 and titled “Medicated Tampon”. 
   In one aspect of the present invention, the dosage form cap  45  may be produced in any suitable form including, but not limited to, suppositories, gels, films, coatings, and other forms. In an alternate aspect of the present invention, the dosage form cap  45  may be produced in encapsulated form. 
   In another aspect of the present invention, the dosage form cap  45  may be designed to melt at approximately body temperature, or to dissolve or otherwise disperse in the presence of a sufficient aqueous or other liquid trigger, or appropriate chemistry, such as a suitable pH. 
   In an additional aspect of the present invention, the dosage form cap  45  may be formed in any shape to promote contact with anatomical structures such as the vaginal epithelium, the anterior fornix, the posterior fornix, the cervix, or other structures. 
   The dosage form cap  45  may include any therapeutic agent, along with any excipients, compounds, or other ingredients that are desirable to introduce into the vaginal or other cavity to promote the functionality of that therapeutic agent. The excipients may assist the release of the therapeutic agent, or assist in the absorbency of the therapeutic agent into the vaginal or other epithelium. The use of excipients to facilitate the formulation, delivery, stability, and aesthetic properties of a therapeutic agent delivery system is well known to those familiar with the art. Examples of ingredients that may accompany the therapeutic agent in the dosage form cap  45  include excipients, biologically-compatible adhesives, surfactants, and penetration enhancers. An example of a suitable excipient is SUPPOCIRE suppository base, available from Gattefossé Corp. SUPPOCIRE suppository base is a semi-synthetic glyceride. An example of a suitable biologically-compatible adhesive is hydroxypropyl methylcellulose (HPMC), available as METHOCEL*K15M from The Dow Chemical Company. An example of a suitable surfactant is polysorbate 80, available from Spectrum Chemical Manufacturing Corp. An example of a suitable penetration enhancer is LABRAFIL M 1944 C nonionic amphiphilic excipient, available from Gattefossé Corp. 
   For the purposes of this invention, any therapeutic agent that will treat the vaginal or other cavity, other mucosal tissue, or will be absorbed into a user&#39;s body through the vaginal or other epithelium for the purposes of treating diseases or conditions, promoting the growth of normal vaginal bacterial flora, or promoting vaginal health may be used. Examples of therapeutic agents include but are not limited to vitamins, minerals, hormones, moisturizers, antifungal agents, antibacterial agents, pro-biotics, botanicals, analgesics, prostaglandin inhibitors, prostaglandin synthetase inhibitors, leukotriene receptor antagonists, essential fatty acids, sterols, anti-inflammatory agents, vasodilators, chemotherapeutic agents, and agents to treat infertility. 
   Some therapeutic agents for use in this invention are absorbable through the vaginal epithelium and travel to the uterus by a unique portal of veins and arteries that are known to exist between the vagina, the cervix, and the uterus. This anastomosis eliminates first-pass metabolism by the liver, effectively delivering higher concentrations of the therapeutic agent to the uterus than would otherwise be available via oral dosing. Those of skill in the art know the efficacy of various therapeutic agents when introduced at a particular anatomical location. For example, when the therapeutic agent is selected to treat dysmenorrhea, it preferably is selected from the following group: nonsteroidal anti-inflammatory drugs (NSAIDs), prostaglandin inhibitors, COX-2 inhibitors, local anesthetics, calcium channel blockers, potassium channel blockers, β-adrenergic agonists, leukotriene blocking agents, smooth muscle inhibitors, and drugs capable of inhibiting dyskinetic muscle contraction. Alternatively therapeutic agents modify the vaginal or other environment to enhance the wellness of this anatomical region. The benefits may be rather simple, for example increasing comfort by providing moisturization and/or lubricity. These benefits may also be more complex, for example modulating epithelial cell function to address vaginal atrophy. The beneficial therapeutic agents may reduce negative sensations such as stinging, burning, itching, etc, or introduce positive sensations to improve comfort. 
   Referring to  FIG. 2 , the cover assembly  50  may also include a removable insert  90 . The insert  90  has an insert surface  92  that is shaped to generally conform to the cap inner surface  49  of the dosage form cap  45 . The insert  90  may be formed from any suitable material that will not adversely interact with the dosage form cap  45 . The primary purpose of the insert  90  is to help maintain the shape of the dosage form cap  45  during shipping and handling. 
   The cover assembly  50  may also include a removable barrier seal  110  to seal the dosage form cap  45  within the cover cavity  88 . The barrier seal  110  may be disposed at the cover open end  82  of the cover  80  such that the barrier seal  110  extends radially beyond the cover cavity  88  to contact the cover open end surface  84 . The barrier seal  110  may project into the cover cavity  88  to improve the seal between the barrier seal  110  and the cover  80 . The barrier seal  110  is affixed to the cover  80  at the cover open end surface  84  using any suitable adhesive or affixing means, including the use of hot-melt, water-based, solvent-based, or pressure-sensitive adhesives, mucilage, a thermal seal, ultrasonic bonding, pressure, friction, electrostatics, cling-like poly wraps, or surface energy effects. The barrier seal  110  remains affixed during shipping and handling, but may be removed by a manufacturer or a consumer to reveal the contents of the cover  80 . The barrier seal  110  may be formed from any suitable material, including foil, poly, film, film laminates, nonwovens, nonwoven laminates, protective materials such as TYVEK protective material, and any suitable elastomeric substance including rubber, or by a combination of these materials as long as the material of the barrier seal  110  will not adversely interact with the dosage form cap  45  or any bio-adhesive that may be present on the dosage form cap  45 . 
   In another aspect of the present invention shown in  FIGS. 3-5 , the cover assembly  50  includes a tip  60  in addition to the dosage form cap  45 , with the tip  60  positioned within the dosage form cap  45 . As shown in  FIG. 4 , a barrier seal  110  may also be employed to seal the dosage form cap  45  and the tip  60  within the cover  80 . 
   Referring to  FIGS. 3-5 , the cover assembly  50  includes a tip  60  with a tip attachment end  62  and a tip second end  64 . The tip  60  has a plurality of petals  66  at the tip second end  64  that may radially open such that the tip  60  has a diameter approximately equal to or greater than the diameter of the first member  14 . The petals  66  may be either even or odd in number and may be equally spaced apart or non-uniformly arranged. Between any two petals  66  is a gap  68  that provides additional flexibility to the petals  66 . In another aspect of the present invention that is not shown, the gaps  68  may be filled by a frangible portion such that the tip second end  64  is closed by petals  66  and frangible portions until force applied by the dosage form  45 , the tampon  20 , or the second member  18  causes the frangible portions to break, allowing the petals  66  to open. 
   The tip  60  also includes a tip outer surface  70  and a tip inner surface  72 , where the tip inner surface  72  defines and at least partially encloses a tip cavity  74 . The tip  60  is preferably manufactured from material similar to that of the first member  14 , but any suitable material that will not adversely interact with the dosage form may be used. 
   Within the cover assembly  50 , the tip  60  is positioned in the cap cavity  51 . The tip outer surface  70  generally conforms in shape to the cap inner surface  49 . The dosage form cap  45  is affixed to the tip  60  using an adhesive, a bio-adhesive, or by any other suitable means such that the dosage form cap  45  remains affixed to the tip  60  during handling and shipping, but detaches from the tip  60  inside the vaginal or other cavity upon insertion of the dosage form cap  45 . 
   The attachment end  62  of the tip  60  includes an engagement mechanism  76  (shown in  FIG. 5 ) that allows the tip  60  to be attached to the first member  14  with minimal force. The attachment provided by the engagement mechanism  76  is preferably one-way or permanent. for the improved structural integrity of the tip  60  with the first member  14  in use. In most types of engagement mechanisms suitably applied in such an application, the engagement mechanism  76  typically includes a first portion  77  and a second portion  78 , where the first portion  77  engages with the second portion  78  to complete the engagement mechanism  76 . The first portion  77  is positioned on one of the tip  60  or the first member  14 , and the second member  78  is positioned on the other of the tip  60  or the first member  14 . 
   In an example of a screw-type engagement mechanism  176  illustrated in  FIG. 6 , the tip  60  includes a first portion  177  including helically-positioned projections  179 , and the first member  14  includes a second portion  178  including helically-positioned projection-receiving spaces  181 . The tip  60  is moved toward and twisted onto the first member  14  such that the helically-positioned projections  179  engage or interlock with the projection-receiving spaces  181 . In another aspect of this example (not shown), the first portion  177  including helically-positioned projections  179  is positioned on the first member  14 , and the second portion  178  including helically-positioned projection-receiving spaces  181  is positioned on the tip  60 . 
   In an example of a quarter-turn-type engagement mechanism  276  illustrated in  FIG. 7 , the tip  60  includes a first portion  277  including a helically-positioned projection  279 , and the first member  14  includes a second portion  278  including a helically-positioned projection-receiving space  281 . The tip  60  is moved toward and twisted onto the first member  14  such that the helically-positioned projection  279  engages or interlocks with the projection-receiving space  281 . In another aspect of this example (not shown), the first portion  277  including a helically-positioned projection  279  is positioned on the first member  14 , and the second portion  278  including a helically-positioned projection-receiving space  281  is positioned on the tip  60 . 
   The engagement mechanism  76  between the tip  60  and the first member  14  is shown in  FIG. 5  as having a snap-on engagement profile. Such a profile is convenient to manufacture, may be assembled with minimal force, and creates the one-way attachment preferred for the structural integrity of this product. The engagement mechanism  76  may be any other suitable mechanism, including, but not limited, to a snap ring, conventional screw threads, quarter-turn threads, a mechanical latch, and an escapement-type mechanism. 
   In the aspect shown in  FIGS. 3-5 , the cover assembly  50  may also include a removable insert (not shown). The insert has an insert surface that is shaped to generally conform to the tip inner surface  72  of the tip  60  with the primary purpose of sealing the gaps  68  to help maintain the shape of the dosage form cap  45  during shipping and handling. The insert may be formed from any suitable material that will not adversely interact with the dosage form cap  45 . In another aspect, the barrier seal  110  may be shaped to conform to the tip inner surface  72 . 
   Returning to  FIG. 1 , the dosage form cap  45  and the tampon assembly  40  are combined to form the medicated applicator assembly  10 . A cover assembly  50  including a dosage form cap  45  is axially aligned with a tampon assembly  40 . The cover assembly  50  and the tampon assembly  40  are moved toward each other using minimal force to cause the engagement mechanism of the dosage form cap  45  and the first member  14  to engage, resulting in the dosage form cap  45  becoming removably attached to the first member  14 . The medicated applicator assembly  10  may then be packaged and shipped. Alternatively, the tampon assembly  40  and the cover assembly  50  with dosage form cap  45  may be packaged separately and shipped together or separately. These may later be combined by an assembler or a consumer. 
   Turning to  FIG. 3 , the dosage form cap  45 , the tip  60 , and the tampon assembly  40  are combined to form the medicated applicator assembly  10 . A cover assembly  50  including a dosage form cap  45  and a tip  60  is axially aligned with a tampon assembly  40 . The cover assembly  50  and the tampon assembly  40  are moved toward each other using minimal force to cause the engagement mechanism of the tip  60  and the first member  14  to engage, resulting in the tip  60  becoming removably attached to the first member  14 . The medicated applicator assembly  10  may then be packaged and shipped. Alternatively, the tampon assembly  40  and the cover assembly  50  with the dosage form cap  45  and the tip  60  may be packaged separately and shipped together or separately. These may later be combined by an assembler or a consumer. 
   More specifically, the various components of the medicated applicator assembly  10  may be manufactured and assembled in a variety of ways, but generally focus on three subassemblies: the tampon assembly  40 , the cover assembly  50 , and the dosage form cap  45 . 
   The dosage form cap  45  may be produced by the same manufacturer as the manufacturer of the tampon assembly  40 . The dosage form cap  45  may also be produced by a separate manufacturer and provided to the tampon manufacturer in any suitable manner. As an example, a dosage form manufacturer with a facility specifically designed for pharmaceutical manufacturing that meets current regulatory and quality requirements for drugs and/or devices, as appropriate, may produce the dosage form caps  45  under conditions such that homogeneity, concentration, and purity of the dosage form cap  45  are closely controlled, and such that production Is In accordance with applicable regulations. The dosage form cap  45  may then be sealed and shipped to the manufacturer of either the tampon assembly  40  or the cover assembly  50 . In this manner, the dosage form cap  45  is produced by a manufacturer with appropriate experience, and the tampon manufacturer may be relieved of establishing a pharmaceutical-production facility. This process is described in more detail in co-pending U.S. patent application Ser. No. 10/335,816 filed on Dec. 31, 2002 and titled “Medicated Tampon”. 
   Likewise, the cover assembly  50  including a dosage form cap  45  may be produced by the same manufacturer as the manufacturer of the tampon assembly  40 . The cover assembly  50  including a dosage form cap  45  may also be produced by a separate manufacturer and provided to the tampon manufacturer in any suitable manner. As an example, a pharmaceutical manufacturer with a facility specifically designed for pharmaceutical manufacturing that meets current regulatory and quality requirements for drugs and/or devices, as appropriate, may produce cover assemblies  50  including dosage form caps  45  under conditions such that homogeneity, concentration, and purity of the dosage form cap  45  are closely controlled, and such that production is in accordance with applicable regulations. The cover assembly  50  including the dosage form cap  45  may then be sealed and shipped to the tampon manufacturer. The tampon manufacturer may then apply the cover assembly  50  including a dosage form cap  45  to a tampon assembly  40  under appropriately-controlled conditions. In this manner, the cover assembly  50  with a dosage form cap  45  is produced by a manufacturer with appropriate experience, and the tampon manufacturer is relieved of establishing a pharmaceutical-production facility. 
   In another aspect of the present invention, the tampon assembly  40  may be produced by a manufacturer different from the manufacturer of the cover assembly  50  and both assemblies ( 40 ,  50 ) may be shipped to the manufacturer of the dosage form cap  45  for manufacture of the medicated tampon assembly  10 . In another aspect of the present invention, the medicated tampon assembly  10  is produced by a manufacturer different from the manufacturer of the dosage form cap  45 , the manufacturer of the tampon assembly  40 , and the manufacturer of the cover assembly  50 . 
   In any case, the dosage form cap  45 , the cover assembly  50 , and the tampon assembly  40  are each manufactured. The dosage form cap  45  and cover assembly  50  are combined and sealed if appropriate, and then the cover assembly  50  (with dosage form cap  45 ) is combined with a tampon assembly  40 , by either a manufacturer or by a consumer. 
   In another aspect of the present invention, the dosage form cap  45  may be combined by a manufacturer with a tampon assembly  40  without the use of a cover assembly  50 . The dosage form cap  45  is attached to the first member  14 , and the combination is sealed, packaged, and shipped. 
   In a different aspect of the present invention, the tampon assembly  40  and the cover assembly  50  with dosage form cap  45  may be packaged separately. Both may then be provided to a consumer, either separately or in one package or kit. The consumer may also obtain the cover assembly  50  and the tampon assembly  40  from separate manufacturers. In either case, either assembly may include instructions for use of a medicated applicator assembly  10 . Such instructions may include information regarding when a medicated applicator assembly  10  is appropriate to use, standard pharmaceutical information regarding the dosage form cap  45  and therapeutic agent(s) contained therein, and directions regarding the method for properly combining the dosage form cap  45  and the tampon assembly  40 . The consumer will be instructed to remove both a tampon assembly  40  and a cover assembly  50  from their packaging. The consumer will then remove the barrier seal  110  from the cover assembly  50 . The consumer will also remove the insert  90  if one is present. The consumer will then be instructed to attach the dosage form cap  45  or the tip  60 , as appropriate, to the tampon assembly  40  by whatever method is appropriate for the type of engagement mechanism  76  is present such that the dosage form cap  45  or the tip  60 , as appropriate, becomes engaged with the tampon assembly  40 . Finally, the consumer will be instructed to remove the cover  80  from the medicated applicator assembly  10  and use the medicated applicator assembly  10  as one would use a standard tampon. 
   In a different aspect of the present invention, a consumer may be provided with a cover assembly  50  including a dosage form cap  45 , along with a tampon assembly  40  that does not include a tampon  20 . The assembly and use in this case will be similar to that of the complete medicated applicator assembly  10 , but the consumer will be using the dosage form cap  45  alone without the tampon  20 . 
   In use, and referring to  FIG. 1 , the medicated applicator assembly  10  functions because the second member  18  is telescopically movable relative to the first member  14 . As the second member  18  is pushed into the first member  14 , the tampon  20  is forced forward against the first member petals if the first member  14  includes petals, or against the petals  66  if the tip  60  is present. The contact by the tampon  20  causes the petals  66  to radially open to a diameter that is sufficient to allow the tampon  20  to be expelled from the first member  14 . As the tampon  20  passes through the petals  66 , the tampon  20  and/or the petals  66  are forced against the dosage form cap  45 , causing it to release from the first member  14 . With the dosage form cap  45  and the tampon  20  properly positioned in the vaginal or other cavity, the tampon applicator  12  is withdrawn and properly discarded. 
   Once the tampon  20  is properly positioned in the vaginal or other cavity, the tampon body  34  absorbs menses and other bodily fluids, and the dosage form cap  45  delivers the therapeutic agent to the vaginal or other epithelium. From there, the therapeutic agent may be transferred to the uterus by normal bodily functions to relieve the uterine condition to be treated. 
   For use in the situation in which the medicated applicator assembly  10  does not include a tampon  20 , the second member  18  is pushed into the first member  14  and the second member  18  is forced forward against the first member petals if the first member  14  includes petals, or against the petals  66  if the tip  60  is present. The contact by the second member  18  causes the petals  66  to radially open to a diameter that is sufficient to allow the second member  18  to pass through the petals  66 . The second member  18  and/or the petals  66  are forced against the dosage form cap  45 , causing it to release from the first member  14 . With the dosage form cap  45  properly positioned in the vaginal or other cavity, the tampon applicator  12  is withdrawn and properly discarded. 
   Once the dosage form cap  45  is properly positioned in the vaginal or other cavity, the dosage form cap  45  delivers the therapeutic agent to the vaginal or other epithelium. From there, the therapeutic agent may be transferred to the uterus by normal bodily functions to relieve the uterine condition to be treated. 
   The invention has been described with reference to various specific and illustrative aspects and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the invention. 
   Accordingly, this invention is intended to embrace all such alternatives, modifications and variations that fall within the spirit and scope of the appended claims.