Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2001-08-03
2002-07-09
Lilling, Herbert J. (Department: 1651)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S489000, C424S750000
Reexamination Certificate
active
06416788
ABSTRACT:
BACKGROUND OF THE INVENTION
In one aspect, this invention relates to a position of matter useful for treating skin discomforts as well as maintaining normal skin. In another aspect, this invention relates to a method for treating skin discomforts as well as, maintaining normal skin. In yet another aspect, this invention relates to formulating a reliever of skin discomforts as well as normal skin care maintenance.
Oatmeal has been used throughout history as a topical application for skin, in cosmetic preparations, raw and for the bath. It has been used ground dry as well as cooked. Technology now allows use to extract certain properties from the entire oat, not just the grain. Colloidal Oatmeal, a product processed by grinding of the oat grain, has been consistently recommended for adults, geriatrics as well as infants in lotions, creams, shampoos, conditioners, soaps, ointments and the like as well as in bath and cleansing products, and poultices. Colloidal oatmeal additions to skin have a soothing effect on inflammation and irritation, as well as being an effective cleanser or topical powder. Oat Protein is actively substantive to hair and skin contributing to conditioning.
Several topical agents (creams, ointments, liniments and the like), as well as shampoos, conditioners and bath products have been utilized for the relief of treating skin discomforts as well as maintaining normal skin. Most of these have provided a little, but only temporary, relief to persons suffering treating skin discomforts and maintaining normal skin. Many combinations of varying ointments, creams, aqueous solutions, liniments, shampoos, conditioners, bath products and the like for the treatment of treating skin discomforts as well as maintaining normal skin are known. The most efficacious of these contains as its active ingredient the flour product derived from the grain of the avena sativa plant, commonly known as oats. Oat derived colloidal oatmeal is devised for external application to the affected area of the body by applying directly to the desired area for treating skin discomforts as well as maintaining normal skin. The active ingredient is colloidal oatmeal.
The Federal Register, Volume 54 Number 190, Tuesday, Oct. 3, 1989, Proposed rules states:
Agency's Tentative Conclusions on the Comments (Exerts as follows):
The Panel found colloidal oatmeal at all concentrations to be safe an effective as a bath additive, cleansing bar, and soak for symptomatic relief and treatment of dry skin and the resulting itching.
The comment contended that colloidal falls within the topical analgesic panel's definition of a skin protectant. The comment argued that, due to its physical and chemical properties, colloidal oatmeal isolates exposed skin or mucous membrane surface from harmful or annoying stimuli. (See proposed 347.3 at 43 FR 34628 at 34648; Aug. 4, 1978.) The comment also stated that colloidal oatmeal that is dispersed in water and applied to the skin and leaves behind an occlusive film barrier that is helpful in protecting skin against irritation and in soothing irritated or pruritic skin conditions. The comment added that colloidal oatmeal when added to water control osmotic pressure of water with respect to the skin and permits adequate water to enter into the stratum corneum. The comment stated that oatmeal leaves behind a thin occlusive film on the skin and this serves to hold in the adsorbed water. The result of this coating is that the skin is protected against irritation and hence the ingredient has an antipruritic and generally soothing effect. The comment noted that the topical analgesic panel stated that 43 FR 34830 that “ . . . the fluids from seeping rashes or toxic dermatoses (poison ivy, poison sumac, poison oak, etc.,) are absorbed or adsorbed by many of these drugs. Often itching is ameliorated.” Based on the above comment contended that the following claim for colloidal oatmeal is justified. “For prompt, temporary relief of itchy, sore, sensitive skin due to . . . poison ivy and oak . . . ”.
The topical analgesic panel stated at 43 FR 34630 that well controlled clinical studies have been conducted for most of the skin protectant ingredients. The Panel recommended that the requirement for well controlled studies be waived on the grounds that clinical studies are not necessary to support the use of mechanical barriers such as these ingredients to protect the skin form further injury. The agency agrees with this recommendation regarding skin protectant (physical barrier) type ingredients. In addition, the agency agrees that colloidal oatmeal qualifies as a skin protectant because of its barrier like qualities. Montebovi (Ref 2) identified and evaluated a number of hydrophilic colloids including colloidal oatmeal using the Gold Number is an in vitro physical chemical determination intended to measure the protective ability of hydrophilic colloids.
With initial as well as persistent application, colloidal oatmeal is effective to relieve and treat skin discomforts and maintaining normal skin, such as, diaper rash, prickly heat, poison oak, ivy and sumac, reduces sunburn discomfort, hives and insect bites, eczema and psoriasis, chicken pox, as well as its non detergent or surfactant free cleansing abilities.
Colloidal oatmeal is also effective to relieve the various itching, burn relief, itching and inflammation caused from shingles, itching and inflammation caused by miscellaneous sources such as medication reactions, diaper rash, insect bites, sunburn, adhesive bandage irritation and the like. It is further commonly prescribed to reduce the irritation of eczema and psoriasis, and “phantom itching”, as from medication, or no known source, and the like.
Unfortunately, although colloidal oatmeal is often the most effective agent available, the beneficial ingredients, oat beta glucan, active oat extract and oat protein has been degraded or even lost during the refining and separation process.
The loss of these essential proteins and nutrients through refinement has limited the properties of colloidal oatmeal, and does not use its full potential to help promote healing and to treat skin irritations and other types of skin complaints caused by numerous stimuli, such as melanoma and damage caused by radiation, chemotherapy as well as deep tissue burning, as well as itching caused by medication, and also to maintain normal skin.
A colloidal oatmeal based raw material which contains all the beneficial proteins, active oat extracts, and oat beta glucan, would be extremely desirable and acceptable to patients and people in general who are experiencing the types of skin irritation or discomfort, as well as skin care maintenance for normal skin as outlined above.
OBJECTS OF THE INVENTION
It is an object of this invention to provide a refined colloidal oatmeal base, and recreate the beneficial properties in the natural oat seed, using a technique that uses ultra refined particle size of 44 micron colloidal oatmeal into a readily dispersible product for bath, loose powder and cosmetic formulations with all the therapeutic benefits of the oat as described in Federal register official monograph for category 1 skin protectants.
It is another object of this invention to provide a method for formulating a cosmetic binding and thickening agent with emulsification properties to be able to be used in low or high concentrations, is fully functional, one which provides smoothness and elegance to formulations, dry, liquid, lotion or otherwise.
It is a further object of this invention to provide a method for treating skin discomforts as well as maintaining normal skin, in a dry powder, or cosmetic form such as cream, lotion, liniment, ointment and the like, as well as shampoos, conditioners, soaps and bath preparations, sunscreens and the like.
SUMMARY OF THE INVENTION
In accordance with one aspect of the invention, there is provided a composition comprising a carrier, an encapsulation agent, and a binder.
In accordance with another aspect of the invention, there is provided a method for treating a vict
Barr Teresa Leigh
Buskop Wendy
Buskop Law Group P.C.
Lilling Herbert J.
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