Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Aluminum – calcium or magnesium element – or compound containing
Reexamination Certificate
2001-02-09
2001-11-06
Hartley, Michael G. (Department: 1619)
Drug, bio-affecting and body treating compositions
Inorganic active ingredient containing
Aluminum, calcium or magnesium element, or compound containing
C424S430000, C424S401000, C132S076400
Reexamination Certificate
active
06312735
ABSTRACT:
DETAILED DESCRIPTION
Warts are a widespread medical problem that cause pain and discomfort, and may lead to complications if untreated or improperly treated. Warts are benign growths of the skin caused by a virus that involves the epidermis. Five different types of warts are classified by their clinical presentation: (1) Verrucae vulgares are common warts that display hyperkeratosis and may occur anywhere except the genital and mucous membranes and plantar surfaces (soles of the feet); (2) Verrucae planae are flat warts that usually occur on the face, trunk and extremities; (3) Verrucae plantares are warts that occur only on the soles of the feet; (4) Condylomata acuminata are venereal warts that occur on the genitals and mucous membranes; (5) premalignant warts (Epidermoldysplasia verruciformis) usually occur on the hands and feet and are rare in occurrence. Currently, there are no completely successful, treatments for warts. Current treatments of verrucae involve physical destruction of the infected cells. Choice of treatment depends on the location, size, number, and type of wart, age and co-operation of the patient. No single treatment modality is uniformly effective or directly antiviral. Antiwart treatments include cryotherapy with liquid nitrogen, caustics and acids such as salicylic acid, lactic acid and trichloroacetic acid, which destroy and peel off infected skin. Retinoic acid has been used topically to treat flat warts. Cantharidin is an extract of the green blister beetle that leads to blistering and focal destruction of the epidermis. Induction of allergic contact dermatitis with dinitrochlorobenzene (DNCB) produces local inflammation to warts on which this chemical has been applied. Chemotherapeutic agents also employed for venereal warts include topically applied podophyllin resin, which is more effective on mucosal surfaces. It is contraindicated in pregnancy and the potency of podophyllin preparations may be highly variable. Purified podophyllotoxin is available having activity that is reproducible in vitro Application of 5-fluorouracil is sometimes used to treat flat warts and Condylomata acuminata. Intralesional bleomycin has also been used but may cause extensive tissue necrosis. Curettage, electrodesiccation, CO
2
, and lasers are also used to treat warts. These treatment modalities are often painful and may require anesthesia and cause scarring. A new immunomodulator, Imiquimod has recently been used to topically treat genital and perianal warts. Salicylic acid in a topical composition is available for the treatment of warts. In this form, salicylic acid is a keratolytic agent that softens the hyperkeratotic areas by dissolving the intra-cellular matrix and enhancing shedding of scales. This composition is nonspecific, being also used for the treatment of psoriasis and other hyperkeratotic disorders. Unfortunately, application of salicylic acid is not always effective for wart resolution. Many patients with warts become frustrated while using salicylic acid because it is ineffective, forcing those patients to seek medical consultation. This may result in applying physical or surgical agents to alleviate patient distress. Because no effective extemporaneous keratolytic treatment to remove warts without appreciable side effects is yet available, other modalities are needed. In this invention we have used and extemporaneous application of slaked lime and betel leaf stem to instantly remove warts from human skin surface.
Slaked lime contains at least 95% calcium hydroxide (CaH
2
O
2
), prepared commercially by hydration of lime (W. L. Faith et al., Industrial Chemicals. John Wiley & Sons, 3
rd
Ed., 1965, New York, N.Y.). It is crystalline or soft, odorless, granules of powder with slightly bitter alkaline taste. It readily absorbs carbon dioxide from air forming calcium carbonate; upon igniting it loses water forming calcium oxide (CaO). It is slightly soluble in water, soluble in glycerol, sugar or ammonium chloride solutions. The pH of saturated solution is 12.4. LD50 orally in rats is 7.34 g/kg (The Merck Index 12
th
Ed., Merck & Co., Whitehouse Station, N.J.).
Betel leaf (Piper betle L. (Piperaceae) is also called Ju Jiang Ye in Chinese medicine. One of the most popular uses of betel leaf is in the composition called, “betel,” which is a compound of natural substances chewed for its psychostimulating effects. Betel is composed of the nut of the areca palm (Areca catechu), the leaf of the betel pepper (Piper betle), and lime (calcium hydroxide). Approximately 300 million persons chew betel regularly throughout the western Pacific basin and south Asia. Only three drugs (nicotine, ethanol, and caffeine) are consumed more widely than betel. When betel is chewed, it produces mild psychoactive and cholinergic effects. There is copious production of blood-red saliva that can stain oral structures. After years of chewing, the teeth may become red-brown to nearly black. Betel use is associated with oral leukoplakia, submucous fibrosis, and squamous cell carcinoma. Use of betel is discouraged in Western countries because of its alleged carcinogenic and perceived dysesthetic properties; nevertheless, betel is widely available in the West. (Norton S A, Betel: consumption and consequences: J Am Acad Dermatol January;38(1):81-8, 1998). It contains many phenols including anti-nitrosating phenolic compounds (Nagabhushan, M., et al., Hydroxychavicol: a new anti-nitrosating phenolic compound from betel leaf, Mutagenesis, May;4(3):200-4, 1989). The anecdotal use of the prescribed combination of the components of betel exists because of a balance of chemical activity brought about mutually by the components. Betel leaf has antiviral properties and its component appear to be better extracted when combined with slaked lime.
REFERENCES:
patent: 5997549 (1999-12-01), Sauceda et al.
Derwent Abstract 1989-300878 of Liu, CN 8805705, published Nov. 9, 1988.*
Woodruff, John. “Adding the Natural Touch to Cosmetics,” Manufacturing Chemist, Dec. 1998, vol. 69, issue 12, p. 18.*
Martha Tilaar Salon & Spa Bali-Sari Ayu Skin Care Product for Special Treatment, product brochure, 2000.*
Liao et al., “Contact leukomelanosis induced by the leaves of Piper betle L. (Pieraceae): A clinical and histopathologic survey,” Journal of the American Academy of Dermatology, Apr. 1999, vol. 40, issue 4, pp. 583-589.
Niazi Riaz K.
Niazi Sarfaraz K.
Hartley Michael G.
Willis Michael A.
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