Solubilizing a drug for use in a coating

Abstract

A method for the provision of a coating on an implantable medical device results in a medical device having a bio-absorbable coating. The coating includes a bio-absorbable carrier component. In addition to the bio-absorbable carrier component, a dissolved therapeutic agent component can also be provided. The coated medical device is implantable in a patient to effect controlled delivery of the coating, including the dissolved therapeutic agent, to the patient.

Description

RELATED APPLICATIONS [0001] This application claims priority to, and the benefit of, co-pending U.S. Provisional Application No. 60 / 613,745, Sep. 28, 2004, for all subject matter common to both applications. The disclosure of said provisional application is hereby incorporated herein by reference in its entirety. This application also relates to co-pending U.S. patent application Ser. No. 11 / ______ (Attorney Docket No. ATA-426), filed concurrently with this application on Sep. 28, 2005.FIELD OF THE INVENTION [0002] The present invention relates to coatings and preparations of coatings for medical devices for the delivery of one or more biologically active agents, and more particularly, the present invention relates to coatings capable of containing one or more biologically active components. BACKGROUND OF THE INVENTION [0003] Percutaneous transluminal coronary angioplasty (PTCA), also known as balloon angioplasty, is a technique widely used for treating intravascular diseases, such ...

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Benefits of technology

[0039] In accordance with one aspect of the present invention, the method of making a coated medical device further includes providing a pre-treatment between the medical device and the coating. The pre-treatment can improve consistency and conformability and enhance the adhesion of the coating to the medical device. In one embodiment, wherein the pre-treatment is bio-absorbable. Accordingly, the pre-treatment can include at least one of a bio-absorbable carrier component, for example, fish oil. The bio-absorbable carrier component may be modified from its naturally occurring state to one of increased viscosity in the form of a cross-linked gel.

[0041] The coated medical device can include a pre-treatment provided on the medical device having a bio-absorbable carrier component and a coating disposed on top of the pre-treatment. The pre-treatment can improve consistency and conformability and can enhance the adhesion of the coating. In another embodiment, the pre-treatment may comprise plasma, parylene, a hydrophobic polymer, or a hydrophilic polymer. The coating disposed on top of the pre-treatment can further include a second bio-absorbable carrier component, a vitamin E compound and an amount of one or more therapeutic agents. In various embodiments, the bio-absorbable carrier component includes a naturally occurring oil, a fish oil fatty acid, a free fatty acid, a fatty acid ester, a mono-, a di- or a triglyceride, an oxidized triglyceride, a partially hydrolyzed triglyceride or a combination thereof. In various embodiments, the coated medical device is implantable in a subject to effect delivery of one or more therapeutic agents to the subject. In accordance with one aspect of the present invention, the coated medical device further includes a compatabilizer, a preservative or a combination thereof. In accordance with one aspect of the present invention, the coated medical device further includes a solvent. In various embodiments, the solvent is selected based on the therapeutic agent. In various embodiments, the solvent can be a solvent compatible with the coating, therapeutic agent, and intended use. In one embodiment, the solvent can be ethanol, N-methyl-pyrrolidone or a combination thereof.

[0048] In accordance with one aspect of the present invention, the coating is non-polymeric. In accordance with one aspect of the present invention the coating can inhibit restenosis and neointimal growth. In accordance with one aspect of the present invention, the coating can promote endothelialization. In accordance with one aspect of the present invention, the coating is bio-absorbable.

Problems solved by technology

Growth factors and cytokines produced during the inflammatory response activate smooth muscle cell proliferation and migration, which can form an obstructing neointima, which, in turn, leads to decreased blood flow through the artery.

This course of action has been shown to limit early complications after PTCA by approximately 35%; however, serious bleeding complications and other side effects can occur.

Additionally, an orally administered drug may not achieve the desired effect in the area of the body in which it is needed.

While deployment of a stent after PTCA effectively eliminates elastic recoil and counteracts arterial remodeling, in-stent restenosis is still a serious problem due to neointimal hyperplasia.

There are substantial concerns, however, regarding the lack of bio-compatibility of polymer stent coatings.

However, there is no indication in the application as to how a slow controlled release of ozone can be affected.

There is no enablement to a long term controlled release of ozone from the olive oil gel, however, there is mention of use of biocompatible polymers to form the coating that holds and releases the ozone.

At the end of the period, it was observed that the bare stents and polymer coated stents resulted in some minor inflammation of the tissue.

Preferences were discussed for the use of oils rather than waxes or solids, and the operations performed on the fat or oil as described can be detrimental to the therapeutic characteristics of some oils, especially polyunsaturated oils containing omega-3 fatty acids.

However, there is no realization of the difficulty of using an oil having its own therapeutic characteristics for the solubilization and release of a therapeutic agent.

However, the '903 patent always requires the use of a hydrophilic surfactant and does not indicate the use of the pharmaceutical compositions described for medical devices.

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