Sterile compositions for human cosmetic products

Abstract

Because antimicrobial preservatives used in virtually all cosmetics exhibit degrees of adverse human toxicity that have become of increasing concern, a three element system is disclosed that eliminates the need for cosmetic preservatives and their degradation fragments that may exhibit toxicity. Element 1 comprises a cosmetic formulation not containing any preservative components. Element 2 is an individual unit dose of an Element 1 cosmetic formulation in a microbially-impenetrable disposable container. Element 3 comprises the sterilization of the sealed unit dose disposable container, employing heat or, preferably, employing ionizing radiation.

Claims

1. A cosmetic product which comprises: a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package; wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, and wherein the product is sterile.

2. The cosmetic product of claim 1, wherein the formulation contains at least one free radical scavenger.

3. The cosmetic product of claim 1, wherein the package comprises a metal foil or a metal foil plastic laminate.

4. The cosmetic product of claim 2, wherein the package comprises a metal foil or a metal foil plastic laminate.

5. The cosmetic product of claim 4, wherein the package is a blister package that is heat-sealed.

6. The cosmetic product of claim 1, wherein the package comprises a plastic dispenser.

7. The cosmetic product of claim 1, wherein the formulation is expressible from the package by mechanical compression or by manual squeezing after the package is opened.

8. The cosmetic product of claim 1, wherein the package comprises a single dose syringe dispenser contained in a foil or plastic outer package, wherein the syringe comprises one or more barrels or barrel compartments.

9. The cosmetic product of claim 8, wherein the syringe comprises more than one barrel or barrel compartments and a mixing-dispensing component attached to the distal end of the syringe.

10. The cosmetic product of claim 1, wherein the package comprises a removable cap that can be removed to release the formulation.

11. The cosmetic product of claim 1, wherein the package comprises a sealed tubular extension that can be cut off to release the formulation.

12. The cosmetic product of claim 1, wherein the sealed package and formulation contained within the package have been radiation-sterilized using gamma rays from a cobalt 60 source.

13. The cosmetic product of claim 1, wherein the formulation has been sterilized in bulk and aseptically transferred to a presterilized empty package, and the formulation-containing sterile package is then aseptically sealed.

14. The cosmetic product of claim 2, wherein the free radical scavenger comprises a vitamin E ester.

15. The cosmetic product of claim 1, wherein the formulation is in the form of a powder, liquid, cream, soft wax, solution, lotion, salve, paste, emulsion, or putty.

16. The cosmetic product of claim 1, wherein the formulation is selected from the group consisting of a skin moisturizer, skin wrinkle reducer, skin lotion, discolored skin area reducer, skin cleanser, skin exfoliant, skin depilatories, perfume, cologne, a fragrance, a lipstick, a nail polish, an eye make-up preparation, an eye shadow preparation, a make-up remover, a body powder, a foundation, a rouge, a sun block, an artificial (sunless) sun tan preparation, a shampoo, a permanent wave hair formulation, a hair color formulation, a gel, and a deodorant, and combinations thereof.

17. The cosmetic product of claim 1, wherein the cosmetic formulation is impregnated in a porous carrier material prior to package sealing and sterilization, where the porous carrier material serves as an aid to application of the sterile cosmetic.

18. The cosmetic product of claim 1, wherein the product is radiation sterilized.

19. The cosmetic product of claim 1, wherein the product is gamma-radiation or electron beam sterilized.

Description

DETAILED DESCRIPTION OF THE INVENTION

(1) The instant invention is based on a novel combination of three elements. The first element is the elimination of all preservatives from the formulation. The second element requires that the preservative-free cosmetic product of element one be packaged as a single unit dose to be used for one application and any remaining product discarded. The last element requires that the packaged single dose cosmetic product be sterilized in the package, preferably using ionizing radiation.

(2) In one embodiment, the cosmetic product comprises:

(3) a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;

(4) wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, and

(5) wherein the product is gamma-radiation or electron beam sterilized.

(6) In one embodiment, the cosmetic product comprises:

(7) a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;

(8) wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, but does comprise at least one free radical scavenger, and

(9) wherein the product is gamma-radiation or electron beam sterilized.

(10) In one embodiment, the cosmetic product comprises:

(11) a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;

(12) wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive,

(13) wherein the package comprises a metal foil or a metal foil plastic laminate, and

(14) wherein the product is gamma-radiation or electron beam sterilized.

(15) In one embodiment, the cosmetic product comprises:

(16) a sealed, single dose package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;

(17) wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, but does comprise at least one free radical scavenger,

(18) wherein the package comprises a metal foil or a metal foil plastic laminate, and

(19) wherein the product is gamma-radiation or electron beam sterilized.

(20) In one embodiment, the cosmetic product comprises:

(21) a sealed, single dose blister package that is impermeable to microorganisms and air comprising a cosmetic formulation within the package;

(22) wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, but does comprise at least one free radical scavenger,

(23) wherein the package comprises a metal foil or a metal foil plastic laminate, and is heat-sealed, and

(24) wherein the product is gamma-radiation or electron beam sterilized.

(25) In one embodiment, the formulation contains at least one free radical scavenger. In one embodiment, the free radical scavenger comprises a vitamin E ester.

(26) In one embodiment, the package comprises a metal foil or a metal foil plastic laminate. In one embodiment, the package is a blister package that is heat-sealed.

(27) In one embodiment, the formulation is expressible from the package by mechanical compression or by manual squeezing after the package is opened. In one embodiment, the package comprises a plastic dispenser. In one embodiment, the package comprises a removable cap that can be removed to release the formulation. In one embodiment, the package comprises a sealed tubular extension that can be cut off to release the formulation.

(28) In one embodiment, the package comprises a single dose syringe dispenser contained in a foil or plastic outer package, where the syringe comprises one or more barrels or barrel compartments. In one embodiment, the syringe comprises more than one barrel or barrel compartments and a mixing-dispensing component attached to the distal end of the syringe.

(29) In one embodiment, the sealed package and formulation contained within the package have been radiation-sterilized using gamma rays from a cobalt 60 source or by a sterilizing electron beam apparatus. In one embodiment, the sealed package and the formulation contained within the package have been radiation sterilized using x-rays. In one embodiment, the sealed package is gas permeable and the gas permeable sealed package and formulation contained within the package have been sterilized using super critical carbon dioxide. In one embodiment, the gas permeable sealed package and the formulation contained within the package have been sterilized using nitrogen dioxide. In one embodiment, the sealed package and formulation contained within the package have been heat-sterilized using an autoclave, microwave radiation, Pasteurization, or combinations thereof. In one embodiment, the formulation has been sterilized in bulk and aseptically transferred to a presterilized empty package, and the formulation-containing sterile package is then aseptically sealed.

(30) In one embodiment, the formulation is in the form of a powder, liquid, cream, soft wax, solution, lotion, salve, paste, emulsion, or putty. In one embodiment, the formulation is selected from the group consisting of a skin moisturizer, skin wrinkle reducer, skin lotion, discolored skin area reducer, skin cleanser, skin exfoliant, skin depilatories, perfume, cologne, a fragrance, a lipstick, a nail polish, an eye make-up preparation, an eye shadow preparation, a make-up remover, a body powder, a foundation, a rouge, a sun block, an artificial (sunless) sun tan preparation, a shampoo, a permanent wave hair formulation, a hair color formulation, a gel, and a deodorant, and combinations thereof.

(31) In one embodiment, the cosmetic formulation is impregnated in a porous carrier material prior to package sealing and sterilization, where the porous carrier material serves as an aid to application of the sterile cosmetic. In one embodiment, for improved application, the cosmetic products are impregnated into a porous carrier material such as a sponge, woven, knitted, non-woven fabric or a disposable brush comprising fibers or sponge on one end of a supporting member. This embodiment allows application of the sterile cosmetic without the need for employing user's fingers. Such carrier materials also may be packaged and sterilized separately from the cosmetic and combined at the time of use.

(32) In one embodiment of this invention, the sealed product is ionizing radiation-sterilized, e.g., using a validated gamma ray exposure of, e.g., 25 kGy. The product dosage is controlled by sealing a constant amount of product corresponding to an optimum dose, e.g., 2.8 cc. or gm., in a plastic or, preferably, in a foil pouch that can be easily torn, peeled or cut open and the entire contents mechanically or manually expelled and applied to the skin after which the used container with any un-expelled cosmetic content is discarded.

(33) In the orthopedic industry, implants such as artificial joints and allograft bone are commonly sterilized using either ethylene oxide or gamma radiation. Newer methods of sterilization have more recently been developed but are not yet widely used. Such methods are discussed by M. Barbella (worldwideweb.odtmag.com/issues/2015-02-01/view_features/comingclean/) and involve methods employing subcritical carbon dioxide (SCCO.sub.2), nitrogen dioxide (NO.sub.2) or x-ray. Advantages of using SCCO.sub.2 is that while it can provide sterilizing 6-log reduction of microorganisms, it does not degrade radiation-susceptible components, is chemically inert, easily removed from the product and is not toxic. Potential disadvantages of SCCO.sub.2 for cosmetic applications are cost and the need for gas-permeable packaging that may require a gas-impermeable overwrap package. In one embodiment, SCCO.sub.2 is an excellent candidate for terminal cosmetic sterilization.

(34) Nitrogen dioxide sterilization developed by Noxilizer, Inc. involves its RTS 360 Industrial NO.sub.2 Sterilizer, which uses nitrogen dioxide gas which is non-carcinogenic and nonflammable. Possible disadvantages include relatively small production lots for cosmetic applications. However, there is a need to sterilize expensive cosmetics not produced in large lots and, in another embodiment, NO.sub.2 gas is applicable to this need.

(35) X-radiation is an alternative to gamma sterilization. Ion Beam Applications S.A. offers contract x-ray sterilization services for medical products. X-rays will penetrate full pallets of product better than gamma rays which are less concentrated, an advantage for high volume cosmetic production. Synergy Health, plc in Daeniken, Switzerland developed a large scale x-ray sterilization unit based on a 700 kW Rhodotron electron beam accelerator that can process up to 80,000 pallets annually, a useful embodiment for terminally sterilizing large quantities of cosmetics.

(36) In another embodiment, a syringe-like package may be used to contain the product. The syringe may be of a single barrel if one composition is indicated or a multiple barrel or compartmentalized single barrel syringe with an optional mixing-dispensing device attached to the distal end of the syringe if multiple components are to be mixed prior to application. For example, an anhydrous mixture not physically or chemically stable in the presence of water can be contained in one syringe compartment while water or buffer or saline or an aqueous gel can be contained in a second compartment and mixed together while being expelled from the syringe. This arrangement can avoid the separation of water from incompatible oil components during product aging.

(37) In another embodiment, the container may have a cap or uncapped but sealed tubular extension on one end that may be cut or screwed off to release a constant weight or volume of the single dose product.

(38) In one embodiment, preservatives are completely eliminated from the formulation and the sealed single use container containing the product is radiation sterilized which allows a sterile product to be applied each time the product is used. This embodiment also prevents exposure to air which may cause oxidative degradation of susceptible cosmetic components thus shortening shelf-life.

(39) Other embodiments allow the use of other methods of sterilization such as heat [e.g., autoclave (e.g., 15 lbs of steam pressure for 15-20 minutes) if the product contains even small quantities of water], Pasteurization, i.e., rapid heating followed by rapid cooling, microwave radiation of foil or plastic packages containing the cosmetic, less desirable ethylene or propylene oxide exposure and electron beam radiation as alternatives to preferred gamma radiation.

(40) In certain embodiments, if radiation-sterilization is employed, physiologically-safe free radical scavengers, e.g., d,l-tocopheryl acetate (vitamin E acetate), may optionally be added to the formulation.

(41) Among the types of skin products contemplated by this invention are sterile moisturizing, anti-aging, anti-wrinkle, anti-viral (e.g., Shingles) anti-inflammatory, anti-pain (e.g., sunburn, chemical and thermal burns), anti-acne and anti-infectives, anti-neoplastics (e.g., chemotherapeutic drugs), post-natal stretch mark removal and post-operative skin therapies to avoid hypertrophic scars (e.g., keloids), Some of these examples are classified as drugs requiring FDA-approval rather than as cosmetics.

(42) The cosmetic products can include within the formulation any of the ingredients for cosmetic formulations recognized in the art, such as for example, but not limited to, one or more of castor oil, a castor oil derivative, a dye, a pigment, a silicone, a mineral, iron oxide, talc, zinc oxide, a natural oil or fat, and a modified natural oil or fat. The formulation, for example, can be in the form of a powder, liquid, cream, soft wax, solution, lotion, salve, paste, emulsion, putty or aerosol spray.

(43) In an optional embodiment, preservative(s) can be left in the radiation-sterilized product as an extra measure of safety should a package containing the cosmetic be unknowingly damaged or otherwise sterility-compromised.

(44) In one version of any of the embodiments disclosed herein, the cosmetic product comprises a sealed, single dose package that is impermeable to microorganisms and optionally impermeable to air, comprising a cosmetic formulation within the package, wherein the cosmetic formulation does not contain an antimicrobial additive or a molecular fragment of an antimicrobial additive, and wherein the product is gamma-radiation or electron beam sterilized.

(45) All combinations of the various elements described herein are within the scope of the invention unless otherwise indicated herein or otherwise clearly contradicted by context.

(46) The invention also includes methods of making the cosmetic products disclosed herein, as well as methods of using the cosmetic products.

Prophetic Example 1

(47) A commercially available hand cream indicated for helping to heal dry, cracked hands, listed on the jar's label among its ingredients, propylparaben, sodium benzoate and imidazolidinyl urea, all antimicrobial preservatives. This product, is formulated as closely as possible without the three preservatives and samples heat-sealed in foil blister packages and irradiated in a cobalt 60 source at a sterilizing gamma dose of 25 kGy (2.5 mrads). Comparative testing of the sterilized samples according to the label directions, Apply as needed especially after hand washing, does not distinguish any qualitative efficacy differences between the samples containing or without containing the listed preservatives.