Drug delivery device employing wicking release window

Abstract

The present invention provides for a drug delivery device. The device can comprise at least one core with a first active pharmaceutical ingredient (API), coated with a first layer that is permeable or semi-permeable to the API, coated with a second layer that is impermeable to the API, and having a delivery window to allow passage of the API through the device and into body fluids or tissues. The device can also have a wicking material to modify the rate of transport of the API into the body fluid or tissues.

1 .- 25 . (canceled) 
     
     
         26 . A drug delivery device, comprising:
 at least one core comprising a first active pharmaceutical ingredient (“API”);   a first coating layer that is permeable and/or semi-permeable to the API covering at least a portion of the at least one core;   a second coating layer that is impermeable to the API, covering at least a portion of the first coating layer;   a third coating layer between the first coating layer and the second coating layer, the third coating layer covering a portion of the first coating layer; and   a delivery window formed in the second coating layer to provide a passage of the API through the second coating layer.   
     
     
         27 . The drug delivery device of  claim 26 , comprising at least two cores, wherein a first core of the at least two cores comprises the first API, and a second core of the at least two cores comprises a second API. 
     
     
         28 . The drug delivery device of  claim 26 , wherein the at least one core comprises a second API. 
     
     
         29 . The drug delivery device of  claim 26 , wherein the API diffuses through the first coating layer and the third coating layer. 
     
     
         30 . The drug delivery device of  claim 26 , wherein the first coating layer comprises one or more materials selected from polyvinyl alcohol, polyurethane, polylactic acid polymer or combinations thereof. 
     
     
         31 . The drug delivery device of  claim 26 , wherein the second coating layer is selected from the group consisting of silicone, polyethylene (“PE”), ethylene vinyl acetate (“EVA”) and combinations thereof. 
     
     
         32 . The drug delivery device of  claim 26 , wherein the third coating layer comprises one or more crosslinked polymers selected from the group consisting of cross-linked polyvinyl alcohol, cross-linked polyvinyl butyrate, cross-linked gelatins, and cross-linked polyvinylpyrrolidone. 
     
     
         33 . The drug delivery device of  claim 26 , wherein the third coating layer comprises cross-linked polyvinyl alcohol. 
     
     
         34 . The drug delivery device of  claim 26 , wherein a wicking material coats one or more inside walls of the delivery window. 
     
     
         35 . The drug delivery device of  claim 34 , wherein the wicking material comprises a hydrophilic polymer. 
     
     
         36 . The drug delivery device of  claim 34 , wherein the wicking material comprise one or more copolymers selected from the group consisting of carboxymethylcellulose-hydroxyethylcellulose (“CMCHEC”) copolymer, polyvinylalcohol-methacrylate (“PVA-MA”) copolymer, and polyethylene glycol-methacrylate copolymer. 
     
     
         37 . The drug delivery device of  claim 26 , configured as an intravaginal ring, a diaphragm, a pessary, a suppository, or a punctual plug. 
     
     
         38 . The drug delivery device of  claim 26 , wherein the API comprises a drug selected from the group consisting of leuprolide, morphine, buprenorphine, acyclovir, famciclovir, valcyclovir, atazanavir, didanosine, efavirenz, emtricitabine, lamivudine, lopinavir, nevirapine, raltegravir, ritonavir, saquinavir, stavudine, tenofovir, tenofovir disoproxil fumarate, or zidovudine, maraviroc, estradiol, estrogen, progestin, progesterone, a calcineurin inhibitor, a beta-blocker, cyclosporine, prostaglandin, gentamycin, corticosteroid, a fluoroquinolone, cyclosporine, insulin, an antineoplastic drug, an anti-nausea drug, a corticosteroid, an antibiotic or corticosteroid, an antineoplastics, a VEGF inhibitor, and combinations thereof. 
     
     
         39 . The drug delivery device of  claim 26 , wherein the third coating layer is semi-permeable to the API. 
     
     
         40 . A method for treating or reducing a disease condition, comprising:
 providing a drug delivery device of  claim 26 ; and   administering the drug delivery device into a subject in need thereof to deliver the active pharmaceutical ingredient.   
     
     
         41 . The method of  claim 40 , wherein the disease condition is selected from the group consisting of disease conditions in vaginal, uterine, pelvic, rectal, eye, ear, sinus, nasal, prostatic, and bladder diseases. 
     
     
         42 . The method of  claim 40 , wherein the administering is performed using a route of administration selected from the group consisting of: sub-dermal, subcutaneous, systemic, local, epidural, intra-lesional, intra-tumor, intra-punctal and combinations thereof. 
     
     
         43 . The method of  claim 40 , wherein the disease condition is selected from the group consisting of hyperhomocysteinemia, chronic renal failure, end stage renal disease, hemodialysis, peritoneal dialysis, vascular dementia, cardiovascular disease, stroke, cerebrovascular accidents, thrombotic disorder, hypercoagulable states, venous thrombosis, deep vein thrombosis, thrombophlebitis, thromboembolic disease, ischemic stroke, restenosis after percutaneous transluminal coronary angioplasty (PTCA), preeclampsia, vasculitis, digital ischemia, multifocal osteonecrosis, retinal vein occlusion, glaucoma, miscarriage, pregnancy complication, placental abruption, transplantation, diabetic retinopathy, ischemic bowel disease, cerebral vein thrombosis, atherosclerosis, coronary artery disease, penile venous thrombosis, impotence, central venous thrombosis, peripheral artery disease, intermittent claudication, hemorrhagic colitis, radiation enteritis, radiation colitis, visceral ischemia, acute mesenteric ischemia, chronic mesenteric ischemia, hypertension, microangiopathy, macro angiopathy, recurrent leg ulcer, carotid stenosis, occlusive vascular disease, arterial aneurysm, abdominal aortic aneurysm, congestive heart failure, hepatopulmonary syndrome, high flow state associated with chronic liver disease, migraine headache, vascular headache, dizziness, lightheadedness, orthostatic intolerance, postural hypotension, postural hypotension, postural orthostatic tachycardia syndrome, idiopathic pulmonary fibrosis, pulmonary hypertension, angioedema, vaso-vagal faints, neuroleptic malignant syndrome, learning disorder, learning disability, insomnia, dementia, age associated memory impairment, attention deficit/hyperactivity disorder (ADHD), mild cognitive impairment, Alzheimer's disease, Down's syndrome, autism, Parkinson's disease, depression, anxiety or anxiety disorder, Asperger syndrome, glucose intolerance, diabetes, reactive hypoglycemia, metabolic syndrome, low Cortisol, hypothalamuspituitary-adrenal dysfunction, myasthenia gravis syndrome, osteoporosis, autoimmune polyendocrine syndrome, chronic fatigue syndrome (CFS), central sensitivity syndrome, angina, syndrome X, chronic neck pain syndrome, chronic neuromuscular pain, osteoarthritis, muscle tension headache, chronic headache, cluster headache, temporalis tendonitis, sinusitis, atypical facial pain, trigeminal neuralgia, facial and neck pain syndrome, temperomandibular joint syndrome, idiopathic chronic low back pain, endometriosis, painful abdominal adhesions, chronic abdominal pain syndrome, coccydynia, pelvic floor myalgia (levator ani spasm), polymyositis, postherpetic neuralgia, polyradiculoneuropathies, mononeuritis multiplex, reflex sympathetic dystrophy, neuropathic pain, vulvar vestibulitis, vulvodynia, chronic regional pain syndrome, osteoarthritis, fibrositis, chronic visceral pain syndrome, female urethral syndrome, painful diverticular disease, functional dyspepsia, nonulcer dyspepsia, nonerosive esophageal reflux disease, acid-sensitive esophagus, interstitial cystitis, chronic pelvic pain syndrome, chronic urethral syndrome, chronic prostatitis, primary dysmenorrheal, dyspareunia, premenstrual syndrome (PMS), vulvodynia, ovarian remnant syndrome, ovulatory pain, pelvic congestion syndrome, myofasical pain syndrome, fibromyalgia polymyalgia rheumatica, Reiter's syndrome (reactive arthritis), rheumatoid arthritis, spondyloarthropathy, functional somatic syndromes, chronic regional pain syndromes, post-polio syndrome, functional somatic syndrome, rhinitis, colitis, ulcerative proctitis, pouchitis, nonspecific ulcerative colitis, inflammatory bowel disease (IBD), celiac disease, diversion colitis, collagenous colitis, lymphocytic colitis, blind loop syndrome, nonalcoholic steatohepatitis (NASH), fatty liver, chronic liver disease, cirrhosis, spontaneous bacterial peritonitis, postoperative ileus, systemic lupus erythematosis, mixed connective tissue disorder, undifferentiated connective tissue disorder, Raynaud's phenomenon, Kawasaki syndrome, polymyositis, dermatomyositis, myositis, multiple autoimmune syndrome, Sjogren's syndrome, lichen planus, idiopathic uveitis, gingivitis, stomatitis, otitis, necrotizing enterocolitis, intensive care unit (ICU) multiple organ failure, primary biliary cirrhosis, idiopathic myelofibrosis, polyarteritis nodosa, eosinophilic pleural effusion, eosinophilic gastroenteritis, eosinophilic esophagitis, graft vs. host disease, Grave's disease, idiopathic thyroid failure, Hashimoto's thyroiditis, autoimmune hepatitis, pancreatitis, CREST syndrome, autoimmune cholangitis, ankylosing spondylitis, atopic dermatitis, vitiligo, scleroderma, autoimmune ear disease, polyangiitis overlap syndrome, primary sclerosing cholangitis, Gulf War syndrome, myalgic encephalomyelitis, food sensitivity, dysregulation spectrum syndrome, posttraumatic stress disorder (PTSD), benign tumor, malignant tumor, cancer and combinations thereof.