Transdermal drug delivery process
AssigneesTakeda Chemical Industries, Ltd., Advance Co., Ltd., Teikoku Hormone Mfg. Co., Ltd.
InventorsKatsumi Iga, Shigeo Yanai, Keiichiro Okabe, Masaki Itoh
Life of this patent
Estimating the term…
Abstract
A calcitonin, its derivative or a salt thereof is transdermally delivered by iontophoresis in which a substantially constant voltage in the range of 3 to 20 V is applied at an electric current of 0.05 to 0.5 mA/cm.sup.2. In this process, the calcitonin can be delivered transdermally with a higher absorptivity by applying a higher voltage for a short period (at a voltage of about 6 to 14 V for about 5 to 15 minutes) in the initial stage of the voltage application, and then applying a lower voltage for a long period (at a voltage of about 3 to 9 V for about 30 to 40 minutes).
Claims26
A transdermal drug delivery process by iontophoresis for a calcitonin, its derivative having similar function or activity to the calcitonin or a salt thereof, which comprises the step of applying a substantially constant voltage within the range of 3 to 20 V at a current density of 0.05 to 0.5 mA/cm.sup.2, wherein the process comprises:
- (1) at least one cycle comprising:
- (1a) a precedent voltage application step of applying a substantially constant voltage for 1 to 30 minutes, and
- (1b) a succeeding voltage application step of applying a substantially constant voltage, which voltage is lower than the applied voltage of the precedent voltage application step (1a), for 15 to 100 minutes, or
- (2) at least one cycle comprising;
- (2a) a voltage application step of applying a substantially constant voltage in the range of 4 to 15 V for 1 to 30 minutes.
- (2b) a step of interrupting the voltage application for 1 to 30 minutes, and
- (2c) a voltage application step of applying a substantially constant voltage, which voltage is substantially the same as the applied voltage of the voltage application step (2a) and in the range of 4 to 15 V, for 1 to 30 minutes.
- where the current density in the voltage application steps (2a) and (2c) is maintained at 0.08 to 0.3 mA/cm.sup.2.
An apparatus for iontophoresis which is provided with:
- (i) an applicator comprising (ia) an electrode applicable with a direct-current voltage and (ib) an interface conductible to the electrode, capable of contacting a skin, possessing a calcitonin, its derivative having similar function or activity to the calcitonin or a salt thereof, transmittablly and capable of being supplied with a liquid for dissolving the calcitonin, its derivative or a salt thereof,
- (ii) an electric power supply for applying a direct-current voltage to the electrode, and
- (iii) a voltage stabilizing means for applying a substantially constant direct-current voltage in the range of 3 to 20 V supplied from the electric power supply to the electrode with maintaining a current density of 0.05 to 0.5 mA/cm.sup.2.
A method of applying a voltage for enhancing transdermal absorption of a calcitonin with the use of an applicator comprising an electrode applicable with a direct-current voltage, and an interface conductible with the electrode, capable of contacting a skin, possessing a calcitonin, its derivative having similar function or activity to the calcitonin or a salt thereof transmittablly and capable of being supplied with a liquid for dissolving the calcitonin, its derivative or a salt thereof, wherein a substantially constant direct-current voltage in the range of 3 to 20 V is applied to the electrode with maintaining a current density at 0.05 to 0.5 mA/cm.sup.2, and wherein said process comprises:
- (1) at least one cycle comprising;
- (1a) a precedent voltage application step of applying a substantially constant voltage for 1 to 30 minutes, and
- (1b) a succeeding voltage application step of applying a substantially constant voltage, which voltage is lower than the applied voltage of the precedent voltage application step (1a), for 15 to 100 minutes, or
- (2) at least one cycle comprising;
- (2a) a voltage application step of applying a substantially constant voltage in the range of 4 to 15 V for 1 to 30 minutes,
- (2b) a step of interrupting the voltage application for 1 to 30 minutes, and
- (2c) a voltage application step of applying a substantially constant voltage, which voltage is substantially the same as the applied voltage of the voltage application step (2a) and in the range of 4 to 15 V, for 1 to 30 minutes,
- where the current density in the voltage application steps (2a) and (2c) is maintained at 0.08 to 0.3 mA/cm.sup.2.
Dependencies are inferred from the claim text.