Transdermal electrotransport delivery device including an antimicrobial compatible reservoir composition
First Claim
1. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of (i) a drug or an electrolyte salt or a mixture thereof;
- (ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
2 Assignments
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Accused Products
Abstract
A transdermal electrotransport drug delivery device having an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode. At least one of the anode and the cathode includes an electrode and a reservoir comprised of a housing composed of a polymeric material and an aqueous medium in contact with the housing. The aqueous medium includes (i) a drug or an electrolyte salt or a mixture thereof, (ii) propylene glycol, and (iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium. The propylene glycol prevents the antimicrobial agent from being adsorbed by other materials used in the construction of the delivery device. A process for preparing a transdermal electrotransport drug delivery device is also provided.
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Citations
44 Claims
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1. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
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2. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and ea reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium having a pH in the range of about 4.0 to about 9.0 , said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
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3. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium having a pH in the range of about 5.0 to about 8.0 , said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
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4. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a buffer; -
(ii) a drug or an electrolyte salt or a mixture thereof;
(iii) propylene glycol; and
(iv) an antimicrobial agent in a mount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
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5. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to an anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device, and wherein the polymeric housing material is selected from the group consisting of polyethylene terephthalate, polyethylene terephthalate modified with cyclohexane dimethylol, polypropylene, polyethylene, polyethylene copolymers, and mixtures thereof.
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6. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said cathodic reservoir contains an aqueous medium of an electrolyte salt and is substantially drug free;
- said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof;
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
- said aqueous medium comprised of
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7. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrial power electrically connected to the anode and the cathode;
- at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said anode includes an anodic electrode and an anodic reservoir, said anodic reservoir containing a drug, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof;
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
- at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said anode includes an anodic electrode and an anodic reservoir, said anodic reservoir containing a drug, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
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8. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode;
- at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said anode includes an anodic electrode and an anodic reservoir, said anodic reservoir containing fentanyl in a form that can be delivered when the current flows from the source of electric power;
a drug, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of(i) a drug or an electrolyte salt or a mixture thereof;
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
- at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said anode includes an anodic electrode and an anodic reservoir, said anodic reservoir containing fentanyl in a form that can be delivered when the current flows from the source of electric power;
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9. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device; and
wherein the antimicrobial agent is selected from the group consisting of methylparaben, ethylparaben and propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine and triclosan.
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10. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) a paraben in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device.
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11. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent present in a concentration at least about 0.005% by weight, which is an amount sufficient to inhibit microbial growth in the aqueous medium and is an amount which renders the antimicrobial agent compatible with the device.
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12. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device; and
wherein the aqueous medium contains from about 0.005% by weight to about 2% by weight of the antimicrobial agent.
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13. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device; and
wherein the aqueous medium contains from about 0.01% by weight to about 1% by weight of the antimicrobial agent.
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14. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device; and
wherein the propylene glycol is present in a range of about 5% by weight to about 50% by weight.
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15. A transdermal electrotransport drug delivery or body analyte sampling device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt or a mixture thereof; -
(ii) propylene glycol; and
(iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium wherein the propylene glycol is present in an amount which renders the antimicrobial agent compatible with the device; and
wherein the propylene glycol is present in a range of about 5% by weight to about 30% by weight.
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16. A process for transdermally delivering a drug to or sampling a body analyte from a patient by electrotransport from an electrotransport device comprised of an anode, a cathode and a source of electrical power electrically connected to said anode and said cathode, at least one of said anode and said cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with said housing, said aqueous medium comprised of (i) a drug or an electrolyte salt, (ii) propylene glycol, and iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in said aqueous medium, wherein said propylene renders said antimicrobial agent compatible with said device, said process comprising:
providing electric current from said source of electrical power so that said drug is transdermally delivered to or said body analyte sampled from said patient by electrotransport from or to one of said reservoirs. - View Dependent Claims (17, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30)
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23. A process for transdermally delivering a drug to or sampling a body analyte from a patient by electrotransport from an electrotransport device comprised of an anode, a cathode and a source of electrical power electrically connected to the anode and the cathode, at least one of the anode and the cathode including an electrode and a reservoir comprised of a housing, said housing comprised of a polymeric material and an aqueous medium in contact with the housing, said aqueous medium comprised of
(i) a drug or an electrolyte salt, (ii) propylene glycol, and iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in the aqueous medium, wherein said propylene renders the antimicrobial agent compatible with the device, said process comprising: providing electric current from the source of electrical power so that the drug is transdermally delivered to or the body analyte sampled from the patient by electrotransport from or to one of the reservoirs.
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31. An aqueous medium for use in a transdermal electrotransport delivery or sampling device reservoir, said reservoir contained in a polymeric reservoir housing, said aqueous medium comprised of. (i) a drug or an electrolyte salt or a mixture thereof, (ii) propylene glycol, and (iii) an antimicrobial agent in an amount sufficient to inhibit microbial growth in said aqueous medium;
- wherein said propylene glycol is present in an amount which renders said antimicrobial agent compatible with said device.
- View Dependent Claims (32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43)
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44-52. -52.
Specification