Iontophoretic transdermal drug-delivery interface and skin treat

Details Iontophoretic transdermal drug-delivery interface and skin treat Iontophoretic transdermal drug-delivery interface and skin treat

1996-05-23

1999-04-13

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

604 20, A61F 1300, A61K 970

Patent

active

058940219

DESCRIPTION:

BRIEF SUMMARY
TECHNICAL FIELD

The present invention relates to an iontophoretic interface for electrically permeating of a drug through the skin. More particularly, it relates to an iontophoretic interface suitable for effectively causing absorption into the skin of an ionic bioactive peptide-type drug having a high activity in a minute amount.
The present invention further relates to a skin treatment composition used mainly for pretreatment at the time of iontophoretic transdermal drug delivery and a pretreatment method using the same. More particularly, it relates to a skin treatment agent capable of effectively absorbing, into the skin, an ionic bioactive peptide-type drug having a high activity in a minute amount when using iontophoresis for electrically absorbing a drug into the skin, in particular enhancing the adsorption into the skin of calcitonin and other bioactive peptides having a positive charge and substances similar to the same at a higher efficiency than in the past, and a treatment method using the same.


BACKGROUND ART

In the past, when administering bioactive peptides or bioactive proteins, oral administration resulted in a poor efficiency of absorption of the drug due to its breakdown by the digestive enzymes in the gastrointestinal tract and enzymes of the intestinal walls, breakdown by intestinal bacteria, absorption by food, etc., and therefore, the general practice had been for administration by injection. Administration by injection, however, is painful to patients and cannot, with some exceptions, be performed by themselves and therefore, a specialist had to be relied on. Therefore, development of a method of administration taking the place of injection has been desired. Active research on new drug delivery systems (DDS) is currently underway and energetic studies are being conducted on oral preparations, rectal preparations, nasal preparations, transdermal preparations, etc. in combination with absorption promoters, but nothing satisfactory has yet come out. In particular, development of new technology is being awaited in administration of hormone-like peptides for which time controlled or intermittent administration is required.
These bioactive peptides are difficult to be absorbed and hard to be absorbed in an effective dosage. Further, since they are amphipathic molecules, when present in an aqueous solution, they are adsorbed on various storage containers and, as a result, are hard to recover from the materials, which is extremely disadvantageous in a small amount of preparations. Accordingly, in the past, containers have been treated with silicone, protein with relatively low adsorption activities compared with these bioactive peptides have been made copresent, or surfactants, hydrocarbons, amino acids, etc. have been blended in so as to try to prevent adsorption on the storage containers (for example, see Japanese Laid-Open Patent Application (Kokai) No. 61-221125 and Japanese Laid-Open Patent Application (Kokai) No. 63-57527).
Iontophoresis is a system for promoting transdermal absorption using electricity. This method of treatment has been known since early 1900. Namely, the molecules having a positive charge pass through the skin layer from the anode side and the molecules having a negative charge pass from the cathode side in an electric field generated through the anode and cathode during conductance of power (J. Controlled Release 18, 213-220, 1992), but recently this technology has been reevaluated as a system for administration of bioactive peptides. Iontophoresis is known to improve the transdermal absorption of peptide type drugs. Much research is going on toward practical application. In iontophoresis, the smaller sized molecules of the peptide easily pass through the skin. Further, steps taken in the preparations to suppress association of the molecules raise the efficiency of permeation through the skin.
As an iontophoretic interface capable of serving as such a drug holding member, an interface having a water-soluble layer, for being impregnated with and holding an ionic

REFERENCES:
patent: 5224927 (1993-07-01), Tapper
Journal of Controlled Release 18, (1992) pp. 213-220, S. Kumar et al., "In vivo transdermal iontophoretic delivery of growth hormone releasing factor GRF (1-44) in hairless guines pigs."
J. Controlled Release 18, 213-220, 1992.

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