Administration of vaso-active agent and therapeutic agent

Details Administration of vaso-active agent and therapeutic agent Administration of vaso-active agent and therapeutic agent

1995-12-04

1998-05-12

Phelan, D. Gabrielle

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

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

514944, 514945, 514969, A61F 1300

Patent

active

057501416

DESCRIPTION:

BRIEF SUMMARY
FIELD OF INVENTION

This invention is a 371 of PCT/AU94/00174, filed Apr. 8, 1994.
THIS INVENTION relates to administration of a vaso-active agent in combination with a therapeutic agent which is useful in treatment of tissues of the body which are located below the stratum corneum or the outermost layer of the epidermis. The vaso-active agent may be administered by a local, topical or transdermal route to a particular site and the therapeutic agent may be administered in a similar manner in combination with the vaso-active agent or may be administered separately.


BACKGROUND ART

The transdermal route of administration has been investigated for a wide variety of active agents such as drugs since this route bypasses the gastrointestinal tract as a site of absorption and hence first pass degradation of the drug. Transdermal absorption ensures essentially constant administration of the drug and requires little motivation on the part of the patient. Reference to a variety of transdermal treatment systems is described in U.K. Specification 2192539 which refers to topical pharmaceutical compositions comprising the anti-inflammatory drug diclofenac or a salt thereof which uses as a vehicle a mineral oil. These compositions are described as having excellent skin penetration properties and which therefore can be used in transdermal therapeutic systems as a drug reservoir. The preferred mineral oil referred to in the specification is a liquid paraffin at body temperature which may be mixtures of saturated aliphatic or cycloaliphatic hydrocarbons.
The transdermal systems utilised in this specification included to the skin by a medicinal plaster, covered on one side with a polyester backing layer and on the other with siliconised polyester which is to be removed before use. Transdermal systems are cut from these laminates, and control membrane together with a contact adhesive surface and a peel strip. Transdermal systems are cut from this laminate.
The skin is the major barrier to the entry of foreign solutes from the environment into the body as well to the loss of heat and moisture from the body. Appropriately formulated drugs with desirable physical chemical properties are absorbed through the skin and, indeed, drugs have been applied to the skin for the treatment of local disorders for many centuries. In recent years, a number of commercial products providing a controlled systemic delivery of drugs have been developed for a number of medical conditions (e.g. nitroglycerine, oestrogen and fentanyl patches). Products applied to the skin allow ready application and removal and are often referred to as topical delivery systems. The outermost layer of the epidermis, the stratum corneum, is normally assumed to be the major barrier to drug absorption through the skin. It has also been assumed that the drugs penetrating the epidermis are then removed by the dermal blood supply.
To date, topical drug delivery appears to be particularly useful in the management of local painful conditions with clinical studies being reported for pain arising from musculo-skeletal disorders, acute herpetic and post-herpetic neuralgia. Many of the therapies appear somewhat empirical in their approach to product formulation as reported in Benedittus et. al. (1992) Pain 48 383-390 or controversial as discussed in Levy et al. N Eng J Med 324:776-777 (1991) and Rumsfield et al. (1991) Annals Pharmacother 25 381-387. Little is known about the extent of topical absorption of compounds through intact skin. It is known, however, that drugs will not penetrate into deeper tissues after topical application if the stratum corneum barrier is not overcome. Complete removal of this barrier should yield tissue levels equivalent to those observed after dermal application. Iontophoresis (movement of solutes into the skin using an electrical potential difference) also yields tissue concentrations for lignocaine and salicylic acid in vivo which are similar to those observed after dermal application as discussed in Singh et al. (1993) J Pharm Sci 82 127-131. Tr

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Benedittis et al., Pain. 48:383-390, 1992.
Levy et al., N. Eng. J. Med., 324: 776-777, 1991.
Rumsfield et al., Annals Pharmacother. 25:381-387, 1991.
Singh et al., J. Pharm. Sci., 82:127-131, 1993.
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Masada et al., Int. J. Pharm., 49: 57-62, 1989.
Singh et al., Drug Design and Delivery, 4:1-12, 1989.
Garagiola et al., Clin. Ther. 10:553-558, 1988.
Patent Joernaal, Abstract of ZA 90/6583, Sep. 1991.

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