Abstract: A chemical signal-impermeable mask is positioned in the electrolyte flow such that the mask is between a source of chemical signal and a working electrode which senses the chemical signal transported from the source (e.g., by diffusion). The configuration of the mask is such that the mask prevents substantially all chemical signal transport from the chemical signal source having a radial vector component relative to a plane of the mask and the catalytic face of the working electrode, thus allowing primarily only chemical signal transport that is substantially perpendicular to the place of the mask and the catalytic surface of the working electrode. By reducing or eliminating chemical signal radial transport toward the working electrode, the mask thus significantly reduces or eliminates edge effects. By substantially reducing edge effects created by radial transport of chemical signal, it is possible to obtain a more accurate measurement of the amount (e.g.

Abstract: An electrode assembly for sensing an electrochemical signal diffused from a source to a working electrode which is comprised of a plurality of substantially separated working electrode surfaces is disclosed. The electrode of the invention is comprised of 1) a working electrode made up of a plurality of working electrode surfaces or components and 2) a electrically insulating gap defined by adjacent edges of 1) insulating the working electrode surfaces or components from each other. The working electrode components are configured to receive electrochemical signal from two or preferably three dimensions simultaneously. The working electrode components configured over the same surface as a single electrode provide (1) an improved signal to noise ratio as compared to a single electrode by reducing noise, and (2) provide an overall enhanced signal after sensing for a given period of time.

Abstract: A method for sampling of a substance from a subject is provided, which comprises placing one or more sampling chambers on a collection site on a tissue surface on the subject; conducting electric current through the tissue to extract a substance from the subject in a first direction in one or more sampling chambers that functions alternatively as both an anode and cathode during the course of the method; reversing the polarity to cause direct current to flow in second direction opposite the first direction; and analyzing the sampling chamber or chambers for the concentration of a substance or a substance metabolite. There is also provided a device for sampling of a substance from an organism on continuously or intermittently using alternating polarity method based on the application of low intensity electric fields of alternating polarity across the skin (iontophoresis) to enhance the transport of a substance (such as glucose, lactic acid, pyruvic acid, and the like) from body tissues to a sampling chamber.

Abstract: A method for measuring the concentration of glucose diffused from a source to a working electrode which assembly includes a scavenging electrode is disclosed. The electrode of the invention is comprised of 1) a working electrode; 2) a scavenging electrode; 3) an electroosmotic electrode; and 4) a electrically insulating gap defined by adjacent edges of 1) and 2) and electrically isolating 1) and 2). The scavenging electrode substantially reduces or eliminates "edge-effects" or error in signal transported to the working electrode via a path which includes a radial vector component, i.e., eliminates chemical signal other than that which moves to the catalytic surface of the working electrode via a path which is substantially perpendicular to catalytic surface of the working electrode.

Abstract: A two-phase hydrophilic drug-containing matrix for use in transdermal drug delivery patches in which one phase is a continuous hydrophobic polymer phase which optionally includes a hydrophobic solvent that acts as a skin permeation enhancer and the other phase is a dispersed particulate hydrated inorganic silicate in whose absorbed aqueous phase the drug is dissolved.

Abstract: A matrix for containing drugs for transdermal delivery systems is disclosed. The matrix formed of a skin-adhesive acrylate copolymer, attains high rates of drug delivery without the addition of drug delivery rate enhancers. In preferred embodiments the matrix is used to administer steroids, in particular estradiol.

Abstract: Compositions and methods for preventing ovulation in a woman are provided, as well as compositions and methods for female hormone replacement therapy. The compositions can be administered by the use of a transdermal patch. The patch will administer 17-deacetyl norgestimate alone or in combination with an estrogen such as ethinyl estradiol to women.

Abstract: This invention provides monolithic matrix formulations for transdermal administration of molsidomine. The device includes a copolymer of 2-ethylhexyl acrylate, 2-hydroxyethylmethacrylate, and methacrylic acid. The invention also provides transdermal devices having a monolithic matrix made using such a formulation in combination with an active ingredient and a vehicle or vehicle formulation.

Abstract: The present invention provides an electrode assembly for use in a transdermal analyte sensor operating in an alternating polarity mode in which a single electrode element provides both the counter electrode and iontophoretic electrode functions. By combining both the functions of the iontophoretic and counter electrode, the surface area of the electrode with respect to each function may be made larger. In turn this increases the ability of the electrode to deliver the required electrical field over a larger area when operating in the iontophoretic mode as well as increasing the ability of the counter electrode to compensate for the larger sensing electrode facilitated by this new design.

Abstract: The present invention is directed to a stable crystalline form of estradiol suitable for incorporation into pharmaceutical formulations. The invention further provides methods of preparing said crystalline form of estradiol. The invention further provides pharmaceutical formulations comprising said crystalline form of estradiol. The invention further provides a method of treatment of an individual in need of such administration by the transdermal administration of estradiol from a polymeric matrix comprising the crystal structure of estradiol of the present invention.

Abstract: Methods are provided for manufacturing transdermal drug delivery systems containing supersaturated drug reservoirs, such that higher drug fluxes are obtained. The methods involve heating the drug reservoir components to a predetermined temperature. Generally, this temperature is higher than the depressed melting temperature of the polymer-drug admixture which will serve as the drug reservoir. In an alternative embodiment, wherein heat treatment of the reservoir components results in a system having two liquid phases, the predetermined temperature is calculated so as to be higher than the melting temperature of the pure drug. Drug reservoirs and novel transdermal delivery systems prepared using the disclosed techniques are provided as well.

Abstract: High capacity drug reservoirs are provided for incorporation into transdermal drug delivery systems. The drug reservoirs are hydrogels formulated from polyurethanes crosslinked with diisocyanate crosslinking agents or cured with radiation in the presence of a photoinitator. Drug loading as high as 65 to 70 wt. % or higher can be achieved by absorbing drug formulation into the reservoir after hydrogel synthesis. Methods for making and using transdermal systems containing such reservoirs are provided as well.

Abstract: Transdermal administration of olanzapine and pharmaceutically acceptable acid addition salts thereof is described. The method involves treating an individual suffering from or susceptible to psychosis, acute mania or mild anxiety states, particularly those afflicted with schizophrenia or schizophreniform illnesses, by administering olanzapine or a salt thereof through the skin or mucosal tissue, for a time period and at an administration rate effective to alleviate the symptoms of the disease. Pharmaceutical formulations and drug delivery systems for administering olanzapine are provided as well.

Abstract: Solubilization enhancer compositions are provided which facilitate transdermal administration of basic drugs from transdermal systems composed of nonpolar adhesive materials. Preferred solubilization enhancer compositions are comprised of liquid, isomeric acid mixtures such as oleic acid dimer. The invention also relates to novel transdermal systems, drug reservoirs, formulations, and methods of drug administration, in which the disclosed solubilization enhancer compositions are used.

Abstract: Compositions and methods for preventing ovulation in a woman are provided, as well as compositions and methods for female hormone replacement therapy. The compositions can be administered by the use of a transdermal patch. The patch will administer 17-deacetyl norgestimate alone or in combination with an estrogen such as ethinyl estradiol to women via an adhesive matrix of a silicone and/or polyisobutylene.

Abstract: Drug delivery systems for the transdermal administration of tamsulosin are described. The systems are in the form of laminated patches having one or more reservoirs comprised of a polymeric adhesive material containing a tamsulosin formulation. The invention also relates to a method for treating benign prostatic hypertrophy (BPH) and related conditions and diseases, by administering tamsulosin transdermally, to tamsulosin-containing pharmaceutical compositions for transdermal administration of the drug and to a low-temperature method for manufacturing a tamsulosin-containing transdermal delivery system.

Abstract: A two-phase hydrophilic drug-containing matrix for use in transdermal drug delivery patches in which one phase is a continuous hydrophobic polymer phase which optionally includes a hydrophobic solvent that acts as a skin permeation enhancer and the other phase is a dispersed particulate hydrated inorganic silicate in whose absorbed aqueous phase the drug is dissolved.

Abstract: A method for measuring the concentration of a chemical present in a blood stream of a mammalian subject is disclosed. The method involves contacting the subject's skin with a sensor assembly comprised of an ionically conducting material which contacts the skin, a working electrode which is in contact with the ionically conducting material which electrode has a catalytic surface and a mask having an opening therein. The mask is positioned between the skin and the working electrode. When the electrode is activated, chemical is transported through the skin and the ionically conductive material. The mask is positioned so that it blocks the flow into the catalytic surface except for flow which is substantially axially to the catalytic surface. Electrical signal generated at the working electrode is monitored over a period of time and correlated with a concentration of chemical present in the blood stream of the mammalian subject.

Abstract: A transdermal drug delivery device that administers drug in an initial pulse followed by a substantially lower continuous rate comprising a drug reservoir of the drug dissolved in a nonvolatile skin permeation enhancer and a volatile permeation enhancer confined between a backing that is permeable to the volatile permeation enhancer and an underlying substrate layer that is permeable to the drug and both enhancers. When the device is placed on the skin the volatile permeation enhancer is depleted from the reservoir by evaporation through the backing such that the magnitude and duration of the pulse is dependent upon the permeability of the backing layer to the volatile enhancer.

Abstract: Transdermal administration of certain indolone derivatives which are dopamine D.sub.2 agonists is described. The method involves treating an individual afflicted with Parkinson's disease by administering an indolone derivative, e.g., ropinirole base or a pharmaceutically acceptable ropinirole salt, through the skin or mucosal tissue, for a time period and at an administration rate effective to alleviate the symptoms of the disease. Pharmaceutical formulations and drug delivery systems for administering the drugs are provided as well.