Electrokinetic delivery of medicaments

Details Electrokinetic delivery of medicaments Electrokinetic delivery of medicaments

2000-05-31

2002-11-05

Walberg, Teresa (Department: 3742)

Surgery

Means for introducing or removing material from body for...

Infrared, visible light, ultraviolet, x-ray or electrical...

C604S022000, C604S501000, C601S001000

Reexamination Certificate

active

06477410

ABSTRACT:

TECHNICAL FIELD
The present invention relates generally to the electrokinetic mass transfer of substances into and/or extracting substances from tissue and particularly to apparatus and methods for extracting, containing and/or delivering substance, e.g., a medicament to a treatment site.
BACKGROUND
Electrokinetic delivery of medicaments for applying medication locally through an individual's skin is known. One type of electrokinetic delivery mechanism is iontophoresis, i.e., the application of an electric field to the skin to enhance the skin's permeability and to deliver various ionic agents, e.g., ions of soluble salts or other drugs. In certain situations, iontophoretic transdermal or transmucocutaneous delivery techniques have obviated the need for hypodermic injection for many medicaments, thereby eliminating the concomitant problem of trauma, pain and risk of infection to the individual. Other types of electrokinetic delivery mechanisms include electroosmosis, electroporation, electromigration, electrophoresis and endosmose, any or all of which are generally known as electrotransport, electromolecular transport or iontophoretic methods. The electrokinetic delivery mechanism may also be accompanied by ultrasonic vibration to further facilitate electrokinetic transport of the substance, e.g., by opening pores in the skin. Ultrasound may be employed in a number of ways such as (i) traditional piezoelectric elements, (ii) Application Specific Integrated Circuits (ASIC) with ultrasound transmitter built in or (iii) by thin foil sheets with incorporated piezoelectric dipole elements.
There are several difficulties with electrokinetic delivery of substances such as medicaments. One is the heretofore need for somewhat cumbersome, bulky and costly equipment which oftentimes requires the presence of an individual at a doctor's office or treatment center and use of medical professionals to administer the medicament. Private, self-administration of medicaments or for diagnostic application by the individual at non-medical or non-professional facilities is highly desirable. Also, an easily transportable apparatus for electrokinetic delivery of medication, for example, a lightweight, compact portable device useful with an applicator packaged as a single or unit dosage applicator, appears ideal as a patient/consumer friendly self-administration system appropriate for many circumstances.
DISCLOSURE OF THE INVENTION
In accordance with a preferred embodiment of the present invention, there is provided a portable, self-contained, hand-held lightweight, compact and wireless electrokinetic device for delivering or removing a substance, e.g., a medicament, and a unit dosage substance applicator for use with the device for the self-administration of a medicament to the skin. By the term substance is meant a medicament as well as natural or homeopathic products that may be outside the definition of medicament, e.g., inks and pigments for tattoos, and more generally includes any substance capable of electrokinetic transport through skin or mucocutaneous membrane, e.g., into a treatment site or from a site, e.g., for diagnostic purposes. The majority of applications using the present invention are for applying medicaments to treatment sites and therefore the term medicament is used in lieu of the term substance throughout this specification. By medicament is meant any chemical or biologic that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal or cosmetic condition or for the relief of pain or to control, diagnose or improve any physiologic or pathologic condition.
Major therapeutic classes include but are not limited to, ACE inhibitors, such as ranitidine, anti-infectives such as antibacterials, antivirals and antimicrobials, vasodilators, including general, coronary, peripheral and cerebral, adrenocortical steroids, alpha-adrenergic agonists, alpha-adrenergic antagonists, selective alpha-two-adrenergic agonists, analgesics, and analgesic combinations, androgens, local and general anesthetics, antiaddictive agents, antiandrogens, antiarrhythmic agents, antiasthmatic agents, anticholinergic agents, anticholinesterase agents, xanthine derivatives, cardiovasculars including calcium channel blockers such as nifedipine, beta agonists such as dobutamine and ritodine, anticoagulants, including heparin, anticonvulsants, antidiabetic agents, antidiarrheal agents, antidiuretic, antiemetic and prokinetic agents, antiepileptic agents, antiestrogens, antihypertensives, such as atenolol, antimigraine agents, antimotionsickness preparations such as scopolamine, ondansetron, meclizine, antinausants, antimuscarinic agents, antiprurtics, antipsychotics, antipyretics, antispasmodics such as gastrointestinal and urinary, antineoplastic agents, antiparasitic agents, anti-Parkinson's agents, antiplatelet agents, antiprogestins, antithyroid agents, antitussives, atypical antidepressants, azaspirodecanediones, barbituates, benzodiazepines, benzothiadiazides, beta blockers, antiarrythmics beta-adrenergic agonists, beta-adrenergic antagonists, selective beta-one-adrenergic antagonists, selective beta-two-adreneric antagonists, bile salts, medicaments affecting volume and composition of body fluids, butyrophenones, agents affecting calcification, catecholamines and sympathomimetics, cholergic agonists, cholinesterase reactivators, dermatological medicaments, diphenylbutylpiperines, diuretics, ergot alkaloids, estrogens, ganglionic blocking agents, ganglionic stimulating agents, hydantoins, agents for control of gastric acidity, and treatment of peptic ulcers, hematopoitic agents, hisamines, histamine antagonists, 5-hydroxytryptamine antagonists, hyperlipoproteinemia medicaments, hypnotics and sedatives, tranquilizers, hormones, including pituitary hormones such as HGH, HMG, HCG, desmopressin acetate and the like; follicle luteolds, &agr;-ANF, growth factor releasing factor (GFRF), &bgr;-MSH, somatostatin, bradykinin, somatotropin, platelet-derived growth factor, asparaginase, bleomycin sulfate, chymopapain, cholecystokinin, chorionic gonadotropin, corticotropin (ACTH), epidermal growth factor, erythropoietin, epoprostenol (platelet aggregation inhibitor), follicle stimulating hormone, glucagons, hirulog, hyaluronidase, insulin like growth factors, m[a]enotropins (urofollitropin (FSH)and LH), oxytocin, streptokinase, tissue plasminogen activator, urokinase, ACTH analogs, ANP, ANP clearance inhibitors, angiotensin II antagonists, antidiuretic hormone agonists, antidiuretic hormone antagonists, bradykinin antagonists, CD4, ceredase, enkephalins, FAB fragments, IgE peptide suppressors, IGF-1, neurotrophic factors, colony stimulating factors, parathyroid hormone agonists, parathyroid hormone antagonists, pentigetide, protein C, protein S, rennin inhibitors, thymosin alpha-1, thrombolytics, TNF, vaccines, alpha-1 antitrypsin (recombinant), and TGF-beta, immunosuppressives, parasympatholytics, parasympathomimetics, psychostimulants, laxatives, methylxanthines, monomine oxidase inhibitors, neuromuscular blocking agents, organic nitrates, opoid analgesics and antagonists, pancreatic enzymes, phenothiazines, progestins, prostaglandins, e.g., alprostadil, agents for treatment of psychiatric disorders, sodium channel blockers, medicaments for spasticity and acute muscle spasms, e.g., muscle relaxants, succinimides, thioxanthines, thrombolytic agents, thyroid agents, tricyclic antidepressants, inhibitors of tubular transport of organic compounds, uterine motility affecting agents, and the like.
Representative medicaments, their analogs and derivatives thereof, included by way of example and not for purposes of limitation, are interferons, e.g., &agr;-2b interferon, amphotericin &bgr;, angiopeptin, baclofen, bepridil, buserelin, buspirone, calcitonin, ciclopirox, olamine, copper, cyclosporin, zinc, tropisetron, vapreotide, vasopressin, vasopressin antagonist analogs, verapamil, warfarin, zacopride, zotasetron, cromolyn sodi

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