USPTO Applicaton #: #20160184436 30/6/2016
Inventors: Jeremy Cottrell, Giacinto Gaetano, Mahmoud El-tamimy, Nicholas Kennedy, Paul David Gavin
The Patent Description & Claims data below is from USPTO Patent Application 20160184436, Transdermal delivery patch.
TECHNICAL FIELD
The present invention relates to a composition suitable for use in a transdermal delivery patch for administration of a biologically active compound, and a transdermal delivery patch comprising the composition, or matrix layer.
BACKGROUND
In this specification where a document, act or item of knowledge is referred to or discussed, this reference or discussion is not an admission that the document, act or item of knowledge or any combination thereof was at the priority date, publicly available, known to the public, part of common general knowledge; or known to be relevant to an attempt to solve any problem with which this specification is concerned.
Drug delivery is the method or process of administering a pharmaceutical compound to achieve a therapeutic effect in humans and animals.
Drug delivery technologies have been developed to improve bioavailability, safety, duration, onset or release, of the pharmaceutical compound.
When developing drug delivery technologies, problems likely to be encountered include compatibility of the drug delivery system and the pharmaceutical compound, maintaining an adequate and effective duration, potential for side effects, and meeting patient convenience and compliance. As a consequence, many drug delivery technologies fall short of desired improvements and requirements.
Accordingly, there is still a need for alternate delivery systems that effectively deliver drugs and other biologically active compounds.
SUMMARY
The present invention relates to a composition suitable for use in a transdermal delivery patch for administration of a biologically active compound, and a transdermal delivery patch comprising the composition, or matrix layer.
Accordingly, a first aspect of the present invention provides a matrix layer for use in a transdermal delivery patch for administration of a biologically active compound, the matrix layer comprising a mixture of a mono-tocopheryl phosphate compound and a di-tocopheryl phosphate compound and a polymer carrier wherein the polymer carrier is present in an amount within the range of about 30% w/w to about 95% w/w.
The present invention also provides use of the composition, or matrix layer, in a transdermal delivery patch for administration of a biologically active compound.
It has surprisingly been found that biologically active compounds can be effectively administered using a transdermal delivery patch.
A second aspect of the present invention provides a transdermal delivery patch for administration of a biologically active compound comprising the composition, or matrix layer. The composition, or matrix layer, may be a solid or semi-solid layer. The transdermal delivery patch may comprise further layers.
A third aspect of the present invention provides a method for preparing a transdermal delivery patch for administration of a biologically active compound comprising the steps of:
(i) combining a polymer carrier and optional inert carrier components with a suitable solvent;
(ii) combining (i) with a dispersion comprising a biologically active compound and a mixture of a mono-tocopheryl phosphate compound and a di-tocopheryl phosphate compound;
(iii) stirring (ii) until complete homogenisation is achieved;
(iv) placing the composition of (iii) in a suitable mould or casting the composition of (iii) on a surface;
(v) drying the composition under heat.
DETAILED DESCRIPTION
The present invention relates to a composition suitable for use in a transdermal delivery patch for administration of a biologically active compound, the composition comprising a phosphate compound of tocopherol and a polymer carrier. The composition, or matrix layer, may form part of a transdermal delivery matrix patch. It has been surprisingly found that a transdermal delivery patch comprising this composition, or matrix layer, can effectively administer biologically active compounds.
Tocopheryl Phosphate Compound
The composition, or matrix layer, comprises a mixture of a mono-tocopheryl phosphate compound and a di-tocopheryl phosphate compound.
Vitamin E exists in eight different forms, namely four tocopherols and four tocotrienols. All feature a chroman ring, with a hydroxyl group that can donate a hydrogen atom to reduce free radicals and a hydrophobic side chain which allows for penetration into biological membranes. Such derivatives of vitamin E may be classified as “hydroxy chromans”. Both tocopherols and tocotrienols occur in alpha, beta, gamma and delta forms, determined by the number and location of methyl groups on the chroman ring. The tocotrienols differ from the analogous tocopherols by the presence of three double bonds in the hydrophobic side chain. The various forms of vitamin E are shown by Formula.
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