Adhesive patch for lithium controlled release

Details Adhesive patch for lithium controlled release Adhesive patch for lithium controlled release

1998-10-21

2001-03-27

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

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

C424S449000, C424S443000

Reexamination Certificate

active

06207182

ABSTRACT:

The instant invention concerns an adhesive patch for lithium controlled release.
In particular the invention refers to an adhesive patch for lithium or salts thereof controlled release to be adsorbed transcutaneously, for psychiatric therapy.
Since the XX century the lithium carbonate was used for psychiatric studies; during the last forty years it has widely used in the therapy of psychiatric disorders.
The action mechanism of lithium as mood stabilizer is not completely known. Certainly its activity at level of cell membrane and of the synaptic transmission is of great relevance.
The lithium carbonate is normally taken through oral route by means of tablets or capsules at 0.150 g, two or three times/day, to a total of 1.0-2.0 g per day. Such way of administration has some disadvantages. Firstly, the reoccurrence of administrations is not appreciated by patients. Moreover, drug concentration in the plasma is not steady, due to a discontinuous adsorption thereof. Finally, due to the drug metabolism in the gastrointestinal tract and in the liver, it is necessary to administrate an overdose to get satisfying effects, with poisoning risks and high costs of therapy.
Therefore there is the need of a formulation which lowers lithium dosages, which may be used in a more acceptable way to patients and with more powerful and prolonged pharmacological effects.
The author of the instant invention has set up an adhesive patch for lithium or salts thereof controlled release; exemplificative sales are lithium carbonate, sulphate, acetate, for transcutaneous adsorption, which overcomes the disadvantages of known formulations. In fact, the patch of the intention allows to greatly lower lithium dosages.
The formulated drug is preferably used as mood stabilizer during psychiatric therapies.
It is an object of the invention an adhesive patch for lithium or salts thereof controlled release for a transcutaneous adsorption comprising:
a thin, flexible, inert support having an inner side and an outer side;
an adhesive which is layered onto the support inner side;
at least one of lithium salts which is layered onto the support inner side;
wherein the support is made of a no-repellent is material for the adhesive.
The support is preferably made of polyurethanes.
The adhesive comprises preferably acrylic compounds.
The lithium is preferably present as salts thereof, more preferably carbonate, sulphate and acetate salts, most preferably carbonate salts.
According to a preferred embodiment the lithium salts are mixed with one or more excipients.
Lithium salts are present in amounts comprised between appr. 30 mg/cm
2
and appr. 120 mg/cm
2
of support surface.
The amount of lithium salts is comprised between appr. 150 mg and appr. 1000 mg/patch.
According to a preferred embodiment the adhesive patch further comprises an inner side protective, removable component, having substantially the same size of the support, preferably with a central pre-cutted rima, more preferably consisting of a paper layer.
It is a further object of the invention the use of at least one of lithium salts as carbonate, sulphate or acetate, for preparing an adhesive patch for lithium or salts thereof controlled release to be adsorbed transcutaneously, for psychiatric therapy.


REFERENCES:
patent: 4801458 (1989-01-01), Hidaka et al.
patent: 5260066 (1993-11-01), Wood
patent: 5614212 (1997-03-01), D'Angelo
patent: 849491 (1970-08-01), None
patent: 4242040 (1994-06-01), None
patent: 0602543 (1993-12-01), None
patent: 0528777 (1996-05-01), None
J. Clinical Pharmacology, vol. 31; 1991; pp. 401-418, XP000602912 by Vasant V. Rande: “Drug Delivery Systems. 6. Transdermal Drug Delivery” (See Abstract, Fig. 3).
Database WPI; Week 9050, Derwent Publications Ltd., London; AN 90-372979, XP002040107 and JP 02 270 818 A (Sekisui Chem. Ind. Co., Ltd.) Nov. 5, 1990; (See Abstract).

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