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(12) Patent Application Publication (10) Pub. No.: US 2013/0309296A1 Moreno González Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2013/0309296A1 Moreno González Et Al US 2013 0309296A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0309296A1 Moreno González et al. (43) Pub. Date: Nov. 21, 2013 (54) PHARMACEUTICAL COMPOSITION AND Publication Classification DEVICE FOR PREVENTING, TREATING AND CURING ULCERS ON ADABETC FOOT (51) Int. Cl. AND OTHERWOUNDS, WHICH INCLUDES A6IL 5/44 (2006.01) SNAL SLIME FROM THE SPECIES A6IF I3/06 (2006.01) CRYPTOPHALUS ASPERSUS OR HELIX (52) U.S. Cl. ASPERSA MULLER AND CPC ............... A61L 15/44 (2013.01); A61F 13/064 PHARMACEUTICALLY ACCEPTABLE (2013.01) CARRIERS AND/OR ADDITIVES USPC .............................. 424/446; 424/547: 602/48 (57) ABSTRACT (76) Inventors: Elmo Ernesto Moreno González, Santiago (CL); Nieves Galdames Flores, The present invention is related to a pharmaceutical compo Santiago (CL) sition comprising Snail slime of Helix aspersa miller (Cryp tophalus aspersus) (5% to 50%) and marigold extract, pro (21) Appl. No.: 13/980,735 polis and/or almond oil and pharmacologically accepted additives for the prevention additives and/or pharmaceuti (22) PCT Fled: May 20, 2011 cally acceptable excipients to form a formulation of interme diate to high viscosity (200 to 1000 Pa-s). This invention also (86) PCT NO.: PCT/CL11AOOO31 relates to the use of a composition which can be formed as a S371 (c)(1), cream or a gel, is preferably soaked in gauze, and shaped as a (2), (4) Date: Jul.19, 2013 bandage or sock for the treatment and cure of diabetic foot ulcers and other severe wounds, particularly those associated (30) Foreign Application Priority Data with diabetes, gout, Lesch Nyhan syndrome or other condi tions to the skin, including, keratosis, onychomycosis, ring Jan. 21, 2011 (CL) ..................................... 143-2011 worm, among others. Patent Application Publication Nov. 21, 2013 Sheet 1 of 3 US 2013/030929.6 A1 Figura 1 Patent Application Publication Nov. 21, 2013 Sheet 2 of 3 US 2013/030929.6 A1 S(36) M.39) LA2) XL(45) /// Figura 2 Patent Application Publication Nov. 21, 2013 Sheet 3 of 3 US 2013/030929.6 A1 US 2013/030929.6 A1 Nov. 21, 2013 PHARMACEUTICAL COMPOSITION AND DM type 1 estimated prevalence of 0.5% of the diabetic DEVICE FOR PREVENTING, TREATING AND population, is significantly lower than global estimates (4 and CURING ULCERS ON ADABETC FOOT 6%)(Ministry of Health, MINSAL, Chile 2005). AND OTHER WOUNDS, WHICH INCLUDES 0005 According to the results of the Multinational Project SNAL SLIME FROM THE SPECIES of Diabetes in Children (DiaMOND), Santiago of Chile have CRYPTOPHALUS ASPERSUS OR HELIX one of the lowest incidence of type 1 DM in the world, 1.6 per ASPERSA MULLER AND 100,000 in children under 14 years old, between 1990-1992. PHARMACEUTICALLY ACCEPTABLE (Karvonen M, et al., 2000). CARRIERS AND/OR ADDITIVES 0006 Based on the National Register of incidence of DM1 in children under 15 years old, conducted by the MINSAL FIELD OF THE INVENTION between 1995 and 2000, there was an average of 150 cases per 0001. This invention relates to the use of a composition year. To determine the incidence in the entire population, one and device containing Snail slime, marigold extract, propolis should add in the incident cases of patients over age 15 and/or almond oil and pharmacologically accepted additives (estimated at 30 additional cases), which would give a total of for the prevention, treatment and cure of diabetic foot ulcers 180 cases per year in the country. It is estimated that approxi and other severe wounds, especially those associated with mately 75% of these would be beneficiaries of System of diabetes. National Services of Health (SNSS), bringing 135 new cases of DM1 each year (Ministry of Health, Chile 2005.) BRIEF DESCRIPTION OF THE INVENTION 0007 Diabetes mellitus Type 2 is characterized by insulin resistance, which is usually accompanied by a relative defi 0002 The present invention is related to a pharmaceutical ciency of insulin (Ministry of Health, Chile 2005). composition comprising Snail slime of Helix aspersa miller 0008 Diabetes Mellitus Type 2 (DM 2) is frequently (Cryptophalus aspersus) (5% to 50%) and additives and/or asymptomatic, so the diagnosis is made in about 50% of cases pharmaceutically acceptable excipients to form a formulation for laboratory tests ordered for another reason and not by of intermediate to high viscosity (200 to 1000 Pa-s). This clinical Suspicion. The scant classic symptoms determine, composition, which can be formed as a cream or a gel, is with high frequency, a late diagnosis and the presence of preferably soaked in gauze, and shaped as a bandage or sock chronic complications. This type of diabetes increases with to be applied over ulcerous wounds or other skin-like condi age, obesity and physical inactivity and usually is associated tions. The composition contains natural extracts such as mari with other high-risk cardiovascular diseases such as hyper gold extract, propolis and vegetable oils. Further claimed is tension and dyslipidemia, so inquest to DM is indicated in the preparation process of the composition and its use for these individuals (Ministry of Health, MINSAL, Chile 2005). preparing a medicament or device for preventing or treating 0009. By 2000, it was estimated that over 35 million illnesses of ulcers or poor prognosis wounds generated by people would suffer from DM in the South American conti metabolic diseases such as diabetes, gout, Lesch Nyhan Syn nent, with 54% in Latin America and the Caribbean (LAC), drome or other conditions to the skin, including, keratosis, with a projected 64 million people in 2025, rising to 62% in onychomycosis, ringworm, among others. the Latin American region (Barceló A & Rajpathak Set al., 2001). DISCUSSION OF PRIOR ART 0010. The global demonstrated prevalence by the National 0003 Diabetes is a chronic non-communicable disease Health Survey was 4.2% (4.8% in men and 3.8% in women), with high prevalence worldwide (6.1 to 8.1/100,000). It is which is higher in people older than years old and in poorer estimated that 150 million people suffer from some form of women (http://epiminsal.cl/epi/html/invet/ENS/Informe diabetes. It is estimated that by 2025there will be 300 million Final ENS.pdf). To curb the rise in mortality from diabetes cases, most occurring in developing countries, preferably was one of the goals that Chile address as part of the Health affecting individuals in the middle of productive age (45-64 Objectives for the decade 2000-2010, and the main goal was years) (ALAD Guides et al., 2007). Chronic hyperglycemia, to keep the age-standardized rate in 14 per 100,000 inhabit characteristic of diabetes, affects the long term, the develop ants (Ministry of Health, MINSAL, Chile 2002). ment of nephropathy, retinopathy, neuropathy and cardiovas 0011 Diabetes has a number of complications that can be cular complications, which results in high morbidity and initiated individually or combined, especially the acute com mortality of diabetic patients compared to the general popu plications (hyperglycemia and hypoglycemia), ophthalmo lation (Ministry of Health, MINSAL, Chile 2005). logic, renal, neurologic, diabetic foot, hypertension and dys 0004 Diabetes mellitus type 1 (DM1) is characterized by lipidemia (ALAD Guides et al., 2007). destruction of pancreatic B cells, which results in absolute 0012. The Diabetic Foot, as sequel of two most common insulin deficiency and vital dependence on exogenous insu chronic complications of this disease, peripheral neuropathy lin. It occurs at any age, but the highest incidence is observed and vascular insufficiency, is a condition with high morbidity in youngsters under the age of 15 years, most commonly in and therefore it impacts negatively on the quality of life of preschoolers, especially pre-pubertal. Its etiology is 90% patients as a result of the frequent admissions, longer hospital autoimmune, which is determined by the presence of anti stays and amputations. It is estimated that one in ten people in islet (ICA), anti-GAD and anti-insulin antibodies. About 10% the time of diagnosis of diabetes type 2 (mellitus) have risk of cases are idiopathic (Ministry of Health, Chile 2005). The factors for foot lesions (Boulton, 2005). prevalence estimated by the World Health Organization 0013 The magnitude of the problem is evident consider (WHO) for 2000 was 6.5%. (King H. etal, 1998.). Taking into ing that over 25% of hospital admissions of diabetics in the account the number of people with DM1 under control in the U.S., U.K., Spain and Mexico are related to foot problems National Health Services of the Ministry of Health in Chile (Irkovska, 2001; Got, 2001). About 15% to 25% of all dia (MINSAL) of approximately 3,000 (children and adults), the betic patients will develop a foot or leg ulcer during the course US 2013/030929.6 A1 Nov. 21, 2013 of their disease (Boulton 2005, Pinzur Metal., 2005). Among acteristic wounds of diabetic foot, that in a high percentage of the associated risk factors are described, patients with long cases will result in amputation, thereby leading to large Social term Diabetes mellitus (>10 years), age (>50 years), history and economic costs for the patient, his family and the state. of ulcer or amputation, presence of neuropathy, arthropathy Helix aspersa Miller or vascular disease, presence of other diabetes complications, 0020. The common garden snail, Helix aspersa Miller, low Socioeconomic status of the patient and social isolation, also known as Cryptophalus aspersusa, is a gastropod mol poor diet, poor education on foot care and other risk factors lusk of the Pulmonata order, of terrestrial life. It is one of associated with vascular disease (Gallardo et al 2004, Minis various species of Helix, Very similar among them, also called try of Health, Chile 2005). There are few studies on the Snails.
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