Administration of therapeutic or diagnostic agents using interlabial pad

Abstract

A method is disclosed for administering an agent (for example delivering a drug or diagnostic agent) intravaginally or to the interlabial space by positioning an interlabial device, such as an absorbent pad, between the labia. The pad is retained between the labia for a sufficient period of time to deliver an active agent, or allow a reaction with a diagnostic agent. Alternatively, the pad is applied after medication is administered, for example intravaginally or labially or perilabially, to help reduce discomfort to the subject, or loss of medication. The active agent may be carried by the pad itself, or in an intravaginal extension of the pad, or separately in a suppository or other dosage form. In particular examples, the pad has a smaller minor portion superimposed on a larger major portion, and the smaller minor portion is inserted as a leading edge between the labia of the subject to facilitate interlabial insertion. In another example, the pad is placed interlabially after insertion of an agent (such as a medicated suppository) into the vagina, to inhibit loss of the medication from the vagina. The pad can have a variety of shapes, including major and minor portions that are portions of spheres or ellipsoids, or which are elongated and have cross-sections that are circular or ellipsoid, or pads which are folded.

1 . An interlabial delivery device comprising a delivery material, wherein the device is configured to be retained between labia of a subject, and the device carries a therapeutically or diagnostically effective amount of a diagnostic or therapeutic agent.  
     
     
         2 . The device of  claim 1 , wherein the delivery material is a pad configured to be retained between labia of the subject.  
     
     
         3 . The device of  claim 2 , wherein the pad is a highly absorbent non-swellable material.  
     
     
         4 . The device of  claim 2 , wherein the pad has a uniform cross-section along its entire length or is tapered along its length.  
     
     
         5 . The device of  claim 2 , wherein the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion and wherein the minor portion is tapered to facilitate insertion between the labia and retention in the interlabial space.  
     
     
         6 . The device of  claim 5 , wherein the minor an major portions of the pad have a elliptical cross-section with a major axis, wherein the major axis of the minor portion is less than the major axis of the major portion.  
     
     
         7 . The device of  claim 1 , wherein the delivery material includes an agent for absorbing odors.  
     
     
         8 . The device of  claim 1 , wherein the agent is a diagnostic agent.  
     
     
         9 . The device of  claim 1 , wherein the agent is a therapeutic agent.  
     
     
         10 . The device of  claim 1 , wherein the delivery device comprises an intravaginal portion and an extravaginal portion, and the intravaginal portion carries the agent to be delivered.  
     
     
         11 . The device of  claim 1 , wherein the agent is an antibiotic or anti-fungal agent.  
     
     
         12 . The device of  claim 1 , wherein the agent is a hormone.  
     
     
         13 . The device of  claim 1 , wherein the agent is a transdermal agent.  
     
     
         14 . The device of  claim 1 , wherein the agent is a drug is in a unit dosage form.  
     
     
         15 . A method of treating a disease, comprising: 
 positioning a device configured to be retained between labia of a subject in an interlabial space of a subject in need of the therapeutic agent to treat the disease, wherein the device is a pad which carries a therapeutically or diagnostically effective amount of an active agent, or the agent has already been applied to the labia or administered intravaginally prior to placing the pad in the interlabial space.    
     
     
         16 . The method of  claim 15 , wherein the device is placed substantially completely external to a vaginal orifice.  
     
     
         17 . The method of  claim 15 , wherein the pad has a tapered leading edge, and the method further comprises inserting the pad into an interlabial space to push the labia apart as the leading edge of the pad is inserted between the labia.  
     
     
         18 . The method of  claim 17 , wherein the tapered leading edge is positioned against the vaginal orifice, and a remainder of the pad has a width which is wider than a normal anatomic interlabial space, such that the remainder of the pad is frictionally engaged and retained by opposing labia.  
     
     
         19 . The method of  claim 17 , wherein the pad is elongated.  
     
     
         20 . The method of  claim 15 , wherein the method is a method of locally delivering the agent to the perilabial area.  
     
     
         21 . The method of  claim 20 , wherein the method is a method of systemically delivering the agent.  
     
     
         22 . A method for administering a drug, comprising inserting a pad impregnated with the drug into the subject's interlabial space, positioning the pad adjacent to the subject's external vaginal orifice, wherein the pad is devoid of corners and flat surfaces intermediate its ends, and the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion, wherein both the minor and the major portion are curvilinear in cross-section, and wherein the minor portion facilitates insertion between the subject's labia and retention in the interlabial space.  
     
     
         23 . The method of  claim 22 , wherein the pad is elongated and has a uniform cross-section along its entire length, or is tapered along its length.  
     
     
         24 . The method of  claim 22 , wherein the pad is elongated, and when placed in the interlabial space, extends external to the vaginal orifice.  
     
     
         25 . The method of  claim 22 , wherein the pad carries a therapeutically effective amount of a medicinal agent, and positioning the pad comprises administering the medicinal agent to the subject.  
     
     
         26 . The method of  claim 22 , wherein the medicinal agent is an antifungal agent or a hormone.  
     
     
         27 . The method of  claim 26 , wherein the hormone is estrogen or testosterone.  
     
     
         28 . A method for treating a symptom of a subject, comprising positioning an interlabial elongated absorbent pad such that the pad is retained between the labia external to the subject's vaginal orifice, wherein the pad comprises a longitudinally extending major portion and a longitudinally extending minor portion integrated with the posterior portion, wherein the minor portion has a smaller transverse section diameter relative to the larger transverse section diameter of the major portion, wherein the minor portion is designed for insertion of the pad between the subject's labia in the anatomic interlabial space adjacent to the vaginal opening, and the major portion is attached to the anterior portion such that is retained between the labia, wherein insertion and retention of the pad adjacent to the vaginal opening reduces the symptom.  
     
     
         29 . The method of  claim 28 , wherein the minor and major portions of the pad have a length greater than their width, and the shape of the pad substantially conforms to the interlabial space in which the pad is retained.  
     
     
         30 . The method of  claim 29 , wherein the pad is held between the labia without adhesive or attachment to a supporting garment.  
     
     
         31 . The method of  claim 28 , wherein the major portion of the pad has longitudinally extending, opposed, substantially parallel face portions.  
     
     
         32 . The method of  claim 28 , wherein the minor portion of the pad has longitudinally extending, opposed substantially parallel face portions.  
     
     
         33 . The method of  claim 32 , wherein the opposed flat face portions of the pad are substantially parallel.  
     
     
         34 . The method of  claim 32 , wherein the opposed flat face portions of the pad are substantially convergent.  
     
     
         35 . The method of  claim 31 , wherein the minor portion of the pad has longitudinally extending, opposed substantially parallel face portions.  
     
     
         36 . The method of  claim 35 , wherein the opposed flat face portions of the pad are substantially parallel.  
     
     
         37 . The method of  claim 36 , wherein the opposed flat face portions of the pad are substantially convergent.  
     
     
         38 . The method of  claim 28 , wherein the minor and major portions of the pad have a shoulder shaped junction.  
     
     
         39 . The method of  claim 28 , wherein the pad carries a therapeutically effective amount of a medicinal agent, and positioning the pad comprises administering the medicinal agent to the subject to relieve the symptom.  
     
     
         40 . The method of  claim 39 , wherein the medicinal agent is an anti-microbial or a hormone.  
     
     
         41 . The method of  claim 28 , wherein the pad includes a cavity in which a medicinal agent is placed prior to positioning the pad.  
     
     
         42 . The method of  claim 41 , wherein the cavity is compressed between the labia when the pad is positioned.  
     
     
         43 . The method of  claim 42 , wherein the cavity communicates with an exterior surface of the pad.  
     
     
         44 . The method of  claim 43 , wherein the cavity is a recess in an exterior surface of the pad.  
     
     
         45 . The method of  claim 44 , wherein the pad is elongated, and the cavity extends longitudinally along the pad.  
     
     
         46 . The method of  claim 28 , wherein the method further comprises applying medication intravaginally or perilabially prior to or simultaneously with positioning the pad.