Composition and manufacture of topical pharmaceutical and...

Drug – bio-affecting and body treating compositions – Live hair or scalp treating compositions – Shaving preparation

Reexamination Certificate

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Reexamination Certificate

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06468516

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a non-pressurized pouch containing a post-foaming gel composition and a process for producing pouches containing such a gel.
2. Description of Related Art
Many individuals prefer wet shaving in order to achieve a close and comfortable shave. Wet shaving involves the use of some sort of soap, shaving cream or gel in combination with water and a razor. Most commonly, the surface to be shaved is wetted, the soap, cream, or gel is applied and then the surface is shaved with the razor. Over the years, many various types of shave creams and gels have been utilized. One category of shaving gels which is particularly favored are post-foaming gels. These gels are favored in that they are often more lubricious than regular shaving creams and consequently often produce a more comfortable shave. Post-foaming gels are currently only available in pressurized aerosol delivery systems which contain a propellant. Such delivery systems comprise a metal can containing a bag which holds the gel. A pressurized gas within the can, but outside of the bag, compresses the bag. The gas compresses the bag further and further as the gel is dispensed. A low boiling hydrocarbon such as isopentane is generally mixed into the gel; the hydrocarbon boils at skin temperature and consequently causes the gel to foam upon contact with the skin.
Major drawbacks of post-foaming gels in aerosol cans include the inability to provide a convenient single use system and the requirement that the material be maintained at a high pressure within the packaging. Attempts to produce single use gel packages have previously failed due to an inability to maintain the gel components in a homogeneous state within the package. It would be advantageous to provide a post-foaming gel delivery system which may be used in a single use form and which does not require the extreme pressurization of an aerosol system. Accordingly, it is an objective of the present invention to provide a post-foaming gel single use delivery system and a process for formulating the gel so that it is suitable for use within the system.
SUMMARY OF THE INVENTION
The present invention is directed to a pouch containing a non-pressurized post-foaming gel. The gel within the pouch is enclosed within an inert atmosphere, such as a nitrogen blanket, which protects the gel and prevents premature foaming and the separation of the gel's components. Upon opening the pouch and discharging the contents, the heat of the user's skin allows a low boiling point hydrocarbon, such as isopentane, to cause the gel to foam. Further, the process to produce a gel which is suitable for use in a single use delivery system involves the steps of containing the gel in a jar, spraying the gel with nitrogen to remove the air from the jar, and then swirling the jar to form a non-aerated gel without weight variation problems.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Reference will now be made to the presently preferred embodiments of the present invention. Shave gels for use during wet shaving have been utilized for many years. These gels are contained within an aerosol system and comprise various elements, including a propellant, a low boiling hydrocarbon, water, soap, perfume and dye. The gel is maintained under pressure within a bag in the aerosol system. The hydrocarbon boils at skin temperature and consequently the gel foams upon release from the aerosol can and contact with skin.
Pouches are convenient and useful for protecting products in a single use package. Pouches are especially useful in that they may be constructed from FDA-approved materials and provide the additional benefit of a large, flat exterior surface upon which advertising may be printed. Generally, pouches consist of three layers: the protective layer, the barrier layer, and the sealant layer. The protective layer, the interior layer, is chosen for and provides the qualities of heat resistance, strength, printability and machineablility. Various materials which are useful for this layer include polyester, PET nylon 6, nylon 6,6, OPP, paper or combinations thereof. The barrier layer protects the contents of the pouch from light, moisture and oxygen penetration. Materials which are useful for the barrier layer include foil, ceramics, metalized films, opaque films, printed films, transparent films, metalized polypropylene, metalized polyester, high density polythylene, clear polyproplyene, polyester, low density polyethylene, nylon, PVA coated polypropylene, polyvinylidene copolymer coated polypropylene, polyvinylidene copolymer coated polyester, polyethylene films, aluminum, or combinations thereof. Finally, the sealant layer, the exterior layer, is chosen for purposes of sealability, bulk and strength. Among the materials which may be utilized for the sealant layer are polyethylene, ethylene vinyl acetate, acid copolymers, ionomeric copolymers, polypropylene, polyvinyl chloride, polyacrylonitriles, polyester, nitrocellulose, waxes, hot melts, polychlorotrifluoroethylene copolymers, cold seals, pressure sensitive adhesives, resin adhesives such as SURLYN®, LLDPE, acrylonitrile copolymers such as BAREXO®, sealant film, EAA, low density polyester or combinations thereof.
Two main methods, adhesive laminations and extrusion laminations, exist for adhering the different layers of pouches together. For adhesive laminations a thermoset polyurethane adhesive is normally used as the bonding media. Among the benefits of the adhesive laminations method is that the process requires only a short set up and preparation time. Extrusion laminates utilize a molten layer of thermoplastic material as a bonding media. Examples of such thermoplastic materials include polethylene, polyethylene copolymer and polyethylene extrusion. The actual sealing process may be performed by heat in combination with pressure, pressure only for cold seals or pressure sensitive adhesives, induction via radio frequency or ultrasonic.
The choices of materials for each of the layers and the sealing process are dependent upon the desired properties of the pouch. In addition, multiple interior layers may be utilized for specialized purposes. For example, to provide a pouch with a high degree of child safety and resistance to puncture, an inner paper layer and an outer sealant layer would be utilized in conjunction with inner layers of polyester and one or more thermoplastic films. While many various combinations of layers may be employed, examples of pouches which are satisfactory for holding shave gel are as follows (each layer is listed): paper 50 grams/aluminum 0.0005/copolymer 30 microns; paper 50 grams/aluminum 0.0005/Surlyn 60; 48 gauge polyester/aluminum 0.0005/48 gauge polyester/LLDPE 75 microns; 48 gauge polyester/aluminum 0.0005/LLDPE 70 microns; 48 gauge polyester/aluminum 0.0005 /copolymer 20/LLDPE 60; 48 gauge polyester/7.5#EAA/0.0003 foil/7.5#EAA/1.75 mil. Barex; 92 gauge polyester/ink/15# whiteEAA/0.00035 foil/adhesive/1 mil proprietary sealant film; 48 gauge polyester/aluminum 0.00035/1 mil Proprietary sealant film; 48 gauge polyester/aluminum 0.0005/LLDPE 100; 48 gauge polyester/adhesive/0.00035 foil/adhesive/3 mil cast polypropylene film; 26# C1S paper/7.2#LDPE/0.00035 foil/29#EAA; 26# C1S paper/7.2#LDPE/0.00035 foil/22.5#LDPE; and 26# C1S paper/7.2#LDPE/0.00035 foil/22.5# 1702 Surlyn. Combinations which are especially preferred for shave gel pouches include 48 g. PET/0.003 foil/10.8# CRC-1; 48 g. PET/3 mil. LLDPE; 100 g. Nylon/2.5 mil. LLDPE; 48 g. PET/0.00035 foil/1.75 mil. Barex, 0.48 mil. PET/INK/WLDPE 0.75 mil.; Al foil 0.3 mil./EAA 0/75 mil./Barex film 3.5 mil./product. For the various combinations, the foil thicknesses may vary.
The substrates that are particularly suitable for this flexible packaging application include papers (machine glazed, machine finished, clay coated, natural kraft, super calendered), films (polypropylene, polyester, nylon, cellophane), and foil (laminated foils). Eac

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