Drug – bio-affecting and body treating compositions – Enzyme or coenzyme containing – Hydrolases
Reexamination Certificate
1999-10-25
2002-04-09
Dees, Jose′ G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Enzyme or coenzyme containing
Hydrolases
C424S401000, C424S094100, C424S443000, C424S444000, C424S078030
Reexamination Certificate
active
06368595
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the field of topical application of an enzyme-containing composition.
BACKGROUND OF THE INVENTION
Enzymes are used in a number of consumer products, among which are detergents and cosmetics. A problem associated with enzyme-containing products is that enzymes may induce allergic sensitization upon inhalation of airborne dust or aerosols. For instance, after topical application of an enzyme-containing cream, enzyme-containing dust particles may be released from the site of application when the cream is dried.
One solution to prevent inhalation of enzyme-containing dust particles is to immobilize the enzyme before its actual application (see Japanese patent applications J57073098 and J61268611). However, the activity of an immobilized enzyme towards a solid substrate (the skin) is known to be quite low. For instance, immobilized proteases are not expected to interact with stratum corneum proteins.
It would therefore be desirable to apply a composition containing an enzyme in a non-immobilized form in such a way that release of dust particles from the site of application would not occur.
The present invention provides a convenient solution to the above problems by providing a method for topical application of an enzyme, wherein the release of enzyme-containing dust-particles from the site of application is prevented whereas enzyme activity is guaranteed.
DESCRIPTION OF THE INVENTION
The present invention discloses a method for topical application of an enzyme-containing composition, wherein an enzyme composition is applied which additionally comprises a film-forming agent. Upon topical application of said composition, the film-forming agent allows for the formation of a peelable film incorporating the enzyme, due to evaporation of the solvent(s) used. After evaporation of the solvent and after the enzyme has fulfilled its task, the film incorporating the enzyme is removed from the site of application. In this way, the release of enzyme-containing dust particles, which easily are formed upon drying of an enzyme-containing composition at the site of application, is prevented.
Specifically, the method of the invention comprises the steps of:
preparing a composition which comprises an enzyme and a film-forming agent,
topically applying said composition,
incubating said composition on the site of application for a sufficient time period to enable formation of a film incorporating the enzyme, and
removing said film incorporating the enzyme from the site of application.
In one embodiment of the invention, the composition comprising an enzyme and a film-forming agent is prepared by mixing two separate compositions, i.e. a first composition comprising the enzyme and a second composition comprising the film-forming agent. In this way, the enzyme is not detrimentally influenced by the presence of the dissolved film-forming agent or by the presence of any auxiliary agent.
A preferred option of this embodiment comprises the packaging of the said two individual compositions in a dual component dispensing system. Using a dual component dispensing system, simultaneous delivery of a composition comprising the enzyme and a composition comprising the film-forming agent is possible. Upon delivery, both individual compositions are mixed, either in situ or in the dispensing system. Mixing of both compositions results in a final composition comprising the enzyme and the film-forming agent in a form which is suitable for direct use.
The dispensing system to be used in this embodiment of the invention is not critical. Any system can be used which allows for the separate containment of the enzyme composition and the composition comprising the film-forming agent.
For instance, a dispensing system can be selected from the dual component dispensing systems which have been developed for the packaging and delivery of non-compatible chemical compounds, i.e. chemical compounds which react with each other when brought into contact. For instance, dual component dispensers are known from the field of adhesives.
Apart from adhesives, multicomponent dispensing systems have also been described for the formulation of incompatible compounds in toothpaste. Flexible two-compartment dentrifice tubes are described in U.S. patents U.S. Pat. No. 4,487,757 and U.S. Pat. No. 4,098,435. A two-compartment tube for the storage of a non-aqueous enzyme composition separate from the aqueous toothpaste composition has been described in FR 2,051,922.
In yet another but basically very simple approach, one pair of plastic pouches provides material for single use only. The outlets of the two pouches are close to each other and discharge of the contents can be effectuated by tearing open the end pieces of the pouch (German patent application DE 3 630 849).
Furthermore, German “Gebrauchsmuster” DE, U, 93 07 726 mentions a two-chamber packaging unit in which the two separately packed components can be mixed by applying pressure on one of the chambers. Only after mixing is complete, the package is opened to release the freshly prepared mixture.
The commercially available container shown in
FIG. 1
is also suitable. In this container, the enzyme composition, e.g. in the form of a lyophilized powder, is present in an insert placed on top of a vial. Pushing the cap downwards pierces the membrane separating the enzyme composition and the composition comprising the film-forming agent. Upon shaking, the enzyme composition and the film-forming composition are mixed and subsequently are applied.
Using the containers shown in
FIGS. 2A and B
, the same complete mixing approach is obtained. The container of
FIG. 2A
is a conventional tube comprising the composition with the film-forming agent, additionally containing a small sachet or ampulla containing the enzyme in a stabilized form. The container of
FIG. 2B
is a two-compartment sachet, wherein both compartments are separated by a breakable membrane. Just before use, the sachet or ampulla is opened or broken by bending or pressing in such a way that the stabilized enzyme is released. After thorough mixing of the enzyme with the composition comprising the film-forming agent, the tube or sachet is opened and its contents topically applied.
The enzyme to be used in the method of the invention will depend on the desired application. Suitable enzymes typically are found in the classes of oxidoreductases, transferases, hydrolases and/or isomerases. For example, the enzyme is a glucose oxidase, peroxidase, lipoxygenase, superoxide dismutase, tyrosinase, protease, phosphatase, phytase, glycosidase, glucanase, lysozyme, esterase, lipase, phospholipase, sulfatase, urease, transglutaminase or protein disulfide isomerase. It is also possible to apply a composition comprising a mixture of two or more enzymes.
A preferred enzyme for use in the method of the invention is a protease.
The way in which the enzyme is formulated is not critical for the invention. The enzyme may be formulated as a solid or as a liquid composition. A liquid composition may for instance be an aqueous composition wherein the enzyme is solubilized and, preferably, stabilized, or may be a suspension wherein a solid form of the enzyme is suspended in a liquid. Alternatively, the enzyme may be formulated as an oil-in-water emulsion or as a water-in-oil emulsion. In both emulsion types, the enzyme is present in the aqueous phase, preferably in a stabilized form. Furthermore, the enzyme can be presented as an essentially dry powder, optionally suspended in a non-aqueous liquid. The nature of the enzyme composition may thereby depend on, for instance, the desired application.
In a preferred embodiment of the invention, the enzyme composition is an aqueous composition wherein the enzyme is solubilized. To stably formulate an enzyme in an aqueous composition, the enzyme composition preferably comprises a sufficient amount of a water activity lowering agent. For instance, a polyol may be used for stabilization.
In that regard, the choice of the polyol which is used to stabilize an aqueous e
Edens Luppo
Noordam Bertus
Cosmoferm B.V.
Dees Jose′ G.
George Konata M.
Morrison & Foerster / LLP
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