Finished Fibrous Structures and Methods of Their Use and Preparation

Abstract

The disclosure is directed to fibrous structures finished with active pharmaceutical ingredients, as well as methods of their manufacturer and use.

What is claimed: 
     
         1 . A mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure comprising natural fibers, manmade fibers, synthetic fibers, or a mixture thereof,
 wherein the fibrous structure has been finished with a finishing composition that is a homogeneous dispersion comprising an active pharmaceutical ingredient or a pharmaceutically acceptable salt thereof, a solvent and a surfactant;   wherein the fibrous structure is finished by being caused to interact with the homogeneous dispersion by at least one of diffusion of the homogeneous dispersion into the fibrous structure's fibers, deposition of the homogeneous dispersion onto the surfaces of the fibrous structure's fibers, and deposition of the homogeneous dispersion onto the interstices between the fibrous structure's fibers; and   wherein the dry weight of the mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure is increased at least about 20% Add-on, as compared to the dry weight of the fibrous structure absent the finishing treatment.   
     
     
         2 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein following application to the intact skin of a subject, the mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure provides locally, systemically or both locally and systemically, therapeutically effective amounts of the active ingredient to the subject. 
     
     
         3 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the finishing composition comprises the surfactant in an amount of from about 0.1% (w/w) to about 5% (w/w). 
     
     
         4 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the surfactant is a nonionic surfactant. 
     
     
         5 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the surfactant is a fatty acid ester of glycerol, a fatty acid ester of sorbitol, an ethoxylated amine, a fatty acid amide, a terminally blocked ethoxylate, or a combination thereof. 
     
     
         6 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the surfactant is a fatty acid ester of sorbitol, for example, polysorbate 20, polysorbate 40, polysorbate 60, or polysorbate 80, or a combination thereof, preferably polysorbate 80. 
     
     
         7 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the finishing composition further comprises a humectant in an amount of from about 5% (w/w) to about 25% (w/w). 
     
     
         8 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 7 , wherein the humectant is a polyalkene glycol, a polymeric polyols, a sugar alcohol, or a combination thereof. 
     
     
         9 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the finishing composition further comprises a permeation enhancer in an amount of from about 5% (w/w) to about 15% (w/w). 
     
     
         10 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 9 , wherein the permeation enhancer is a monomeric glycol, a monomeric polyol, a monomeric alcohol, a pyrrolidone, a medium chain glyceride, a laurate salt, a bile salt or bile salt derivative, a fatty acid, a fatty acid derivative, a chelating agent, a sulfoxide, a urea or urea derivative, a terpene, a terpenoid, a phospholipid, dimethyl acetamide, dimethylformamide, or a combination thereof. 
     
     
         11 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the finishing composition comprises from about 0.1% (w/w) to about 25% (w/w) of the active pharmaceutical ingredient or the pharmaceutically acceptable salt thereof. 
     
     
         12 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the active pharmaceutical ingredient is a lipophilic active pharmaceutical ingredient. 
     
     
         13 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the active pharmaceutical ingredient is lidocaine, prilocaine, bupivacaine, mepivacaine, ropivacaine, articaine, tetracaine, capsaicin, diclofenac, menthol, methyl salicylate, salicylic acid, scopolamine, nitroglycerin, clonidine, estradiol, estradiol/norethidrone, ethinyl estradiol/norelgestromin, estradiol/levonorgestrel fentanyl, nicotine, testosterone, oxybutynin, prilocaine, methylphenidate, betamethasone, buprenorphine, triclocarban, acyclovir, adapalene, allantoin, benzocaine, bexarotene, brimonidine, calcipotriene, calcitriol, ciclopirox, clindamycin, clobetasol, dapsone, diphenhydramine, doxepin, econazole, fluocinolone, fluticasone, halobetasol, hydrocortisone, imiquimod, ingenol, ivermectin, ketoconazole, loteprednol, luliconazole, mafenide, methyl salicylate, metronidazole, miconazole, minoxidil, mometasone, mupirocin, neomycin, nystatin, penciclovir, phenylephedrine, pimecrolimus, pramoxine, selenium, sulconazole, sulfacetamide, tacrolimus, tavaborole, tetracycline, tioconazole, tretinoin, triamcinolone, triclosan, selegiline, rotigotine, rivastigmine, terbinafine, clotrimazole, detomidine, medetomidine, dexmedetomidine, or a combination thereof. 
     
     
         14 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the active pharmaceutical ingredient is distributed substantially homogenously throughout the fibrous structure and the finish is a level finish. 
     
     
         15 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 14 , wherein the quantitative distribution of the active pharmaceutical ingredient, the thickness distribution of the active pharmaceutical ingredient, the crystallinity of the active pharmaceutical ingredient, the adherence of the active pharmaceutical ingredient, or a combination thereof, is level throughout the fibrous structure. 
     
     
         16 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the dry weight of the finished fibrous structure is increased from between about 20% to about 300% Add-on, as compared to the dry weight of the fibrous structure absent the finishing treatment. 
     
     
         17 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the Add-on weight is present in an amount of about 1 g/m 2  to about 1200 g/m 2 . 
     
     
         18 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , in the form of loose fibers, yarn, or fabric. 
     
     
         19 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , in the form of a garment. 
     
     
         20 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 19 , wherein the garment is a sock, a t-shirt, glove, or a band. 
     
     
         21 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the structure is non-adhesive to skin. 
     
     
         22 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the structure is non-irritant. 
     
     
         23 . The mechanically dewatered, finished, non-occlusive, pharmaceutical fibrous structure of  claim 1 , wherein the structure is hypoallergenic.