Chitosan formulation with azelaic acid and other actives for...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C514S859000, C514S165000, C428S401000

Reexamination Certificate

active

06451773

ABSTRACT:

CROSS-REFERENCE TO RELATED APPLICATIONS
Not Applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not Applicable.
BACKGROUND OF THE INVENTION
Acne is a common disease which afflicts the majority of all teenagers, along with a significant number of men and women of adult age. Acne vulgaris occurs most often on oily areas of the skin having high sebaceous gland concentration. These areas include the face, ears, behind the ears, chest, back and occasionally the neck and upper arms.
Acneiform eruptions can occur wherever there is a pilosebaceous unit or sebaceous follicle which does include the entire human skin surface. The basic lesion in acne is the comedo commonly known as the blackhead. The comedo is created by retention of layers of dead skin known as keratin in the lining of the follicles. In addition to hyperkeratosis, which is a thickening or retentative layering of keratin, there is also an accumulation of sebum which is the lipid-laden product of the sebaceous gland. The combination of keratin and sebum causes the follicular canal to become plugged, resulting in the formation of papules due to inflammation around the comedones. Depending on the degree of inflammation, pustules, cysts, nodules, granulomatous reactions, scars and keloids may develop.
Numerous treatments, both topical and systemic, are currently employed for the treatment of acne. Topical and systemic acne treatment compositions typically employ an active ingredient in combination with a carrier component. The active ingredients typically comprise an antibiotic/antibacterial such as tetracycline, erythromycin, clindamycin, and the like. With respect to topical treatment compositions, benzoyl peroxide is often used in combination with the antibiotic and carrier in order to potentiate the effectiveness of the antibiotic.
A disadvantage associated with the use of antibiotics is that upon prolonged usage, the bacteria targeted for elimination become resistant to antibiotic treatment.
Another causative factor for acne is the presence of bacteria in the follicular canal. Within the follicular canal are bacteria which are indigenous to the follicular lining. Among the bacteria flora present are anaerobic, gram positive organisms called Proprionibacterium acnes. It is believed that Propionibacterium acnes live in symbiosis on the keratin lined follicular canal. Propionibacterium acnes ingest sebum produced from the sebocytes of the sebaceous glands. This nascent sebum is largely lipid in composition and also contains DNA, RNA, proteins, and other cellular components that result from the breakdown of sebocytes themselves. The Propionibacterium acnes which are highly lipophilic, feed on the nascent sebum, found in sebaceous rich areas. If the nutrients increase due to an active and large sebaceous system, then colonization and high growth rates of Proprionibacterium acnes will occur. It has been shown that the resident bacterial flora will produce biologically active molecules such as histamine, extracellular enzymes, and peptides which may be responsible for the chemotaxis of the inflammatory infiltrate in acne vulgaris. Since the follicular lining in the pilosebaceous unit is intact, it has been theorized that if colonization of Proprionibacterium acnes occurs in sufficient numbers, they could produce antigenic molecules that promote the initiation of inflammation. Proprionibacterium acnes can produce proteases, lipase, and hyaluronate lyase all of which may serve as the catalysts or initiators of the inflammatory infiltrate which has been shown to be composed of neutrophils and lymphocytes.
Some of the more commonly used active compounds found in topical acne treatment formulations include topical erythromycin, clindamycin, benzoyl peroxide, sulfur, resorcinol, tetracycline derivatives, salicylic acid and the like.
A disadvantage associated with the use of such active compounds is that they cause epidermal irritation when applied onto the skin. The greater the amount of such active used, the higher the incidence of skin irritation.
BRIEF SUMMARY OF THE INVENTION
The present invention is directed to a composition for treating acneiform eruptions containing:
(a) an active ingredient used in treating acne vulgaris;
(b) a chitosan component having a molecular weight ranging from about 500,000 to about 5,000,000 g/mole, and a degree of deacylation greater than 80%; and
(c) water.
The present invention is also directed to a process for treating acneiform eruptions present on human skin involving contacting human skin with the above-identified composition.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
Not Applicable.


REFERENCES:
patent: 4946870 (1990-08-01), Partain et al.
patent: 5019567 (1991-05-01), Philippe et al.
patent: 5023090 (1991-06-01), Levin
patent: 5260292 (1993-11-01), Robinson et al.
patent: 5505949 (1996-04-01), Benitez
patent: 5665364 (1997-09-01), McAtee
patent: 5962663 (1999-10-01), Wachter et al.
Chemical Abstracts 118:87664, “Antiacne preparations containing chitin, chitosan, or the partial degradation products” (1992).

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