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US5116603.Pdf ||||||||||||||||||| US0051 16603A United States Patent (19) 11) Patent Number: 5,116,603 Friedman (45) Date of Patent: May 26, 1992 (54) ORAL ANTIFUNGAL PREVENTATIVE, AND 99.0957 5/1965 United Kingdom . METHOD OF USE OTHER PUBLICATIONS 75 Inventor: Michael Friedman, Jerusalem, Israel Friedman, "Plaque Inhibition by Sustained Release of 73) Assignee: Yissum Research Development Chlorhexide', J. Dental Res. Nov. 1985. Company of the Hebrew University of Soskolne, W. A. et al., "New Sustained Release Dosage Jerusalem, Jerusalem, Israel form of Chlorhexidine for Dental Use', J. Periodontal Res. 18:330-336, (1983). (21) Appl. No.: 465,786 Friedman, "New Sustained Release form of Chlorhexi 22 Filed: Jan. 18, 1990 dine for Denteal Use', J. Periodont Res. 17:323-328 (1982). Related U.S. Application Data Kostiala, I. et al., Acta Odontol. Scand. 37:87-101 (1979). Budtz-Jörgensen, E. et al., Community Dent. Oral 63 Continuation-in-part of Ser. No. 304,092, Jan. 31, 1989, Epidemiol. 3:115 (1975). abandoned. Odds, F. C., CRC Crit Rey. Microbiol. 15: 1-5 (1987). (51 int. Cl. ....................... A61K 6/00; A61K 31/74; Lehner, T. in Clin. Aspects of Immunol, P.G.H. Gell A61K 31/745; A61K 31/78 eds. et al., 3rd edition, Blackwell Scientific Public, Ox 52 U.S. Cl. ........................................ 424/53; 424/49; ford, 1975, pp. 1387-1427. 514/900; 514/902 Friedman, M. et al., IADR Prog. and Abstr. 59:905 58) Field of Search ....................... 424/78, 81, 83, 53, (1980), No. 72. 424/49; 514/900, 902,953 Friedman, M. et al., J. Dent. Res. 64:1319-1321 (1985). 56) References Cited Bossche, H. V., CRC Crit. Rey. Microbiol. 15:57-72 (1987). U.S. PATENT DOCUMENTS Kirk-Othmer Encyclopedia of Chemical Technology, 2.972,545 2/1961 Briskin ............................. 514/781 2nd ed. (vol. 2, pp. 632-635). 2.984,639 5/1961 Stamberger et al. .............. 260/32.4 Kanig, J. L. et al., J. Pharm. Sci. 51:77-83 (1962). 3,312,594 4/1967 Cyr et al. .............................. 67/82 Friedman, M. et al., J. Cont. Rel. 1: 157-160 (1984). 3,394.001 1/1976 Watson ................................. 424/83 3,431,208 3/1969 Bailey ....... ... 252/06 Primary Examiner-Jeffrey E. Russel 3,749.769 7/1973 Sugiyama ......... ... 424/6 Attorney, Agent, or Firm-Sterne, Kessler, Goldstein & 3,956,480 5/1976 Dichter et al. ... ...... 424/78 Fox 4,315,779 2/1982 Heyd et al. ........................... O6/35 4,339,430 7/1982 Gaffar ................................... 424/54 57 ABSTRACT 4,374,824 2/1983 Wahmi .................................. 424/49 The invention relates to an oral composition for preven 4,438.0l 1 3/1984. Howes .................................. 134/42 tion of mycotic infections of the oral cavity comprising 4,459,277 7/1984 Kosti ..................................... 424/49 an antifungal compound embedded in a sustained re 4,725.440 2/1988 Ridgway ...... ... 424/49 lease carrier such as a cellulosic polymer or a hydro 4,925,668 5/1990 Khan et al. ... a a a a a 427/2 phobic polymer, and a method for use of said composi 4,952,411 8/1990 Fox, Jr. et al. ..................... 514/635 tion in preventing microfungal infections in the oral FOREIGN PATENT DOCUMENTS cavity. The invention also provides for the supplemen 175355 10/1984 Canada . tation of said oral composition with an adhesive and a 6055397 11/1981 Fed. Rep. of Germany . plasticizer to increase antifungal effectiveness. 59-216822 12/1984 Japan. 8702580 5/1987 PCT Int'l Appl. , 9 Claims, No Drawings 5,116,603 2 thrix schenki, the cause of sporotrichosis; Rhinosporid ORAL ANTIFUNGAL PREVENTATIVE, AND ium seeberi, the cause of rhinosporidoisis; Histoplasma METHOD OF USE capsulatum, the cause of histoplasmosis; Histoplasma duboisii, the cause of African histoplasmosis, Coccidi CROSS-REFERENCE TO RELATED 5 odes immities, the cause of coccidioidomycosis, Tricho APPLICATIONS phyton mentagrophytes, T. rubrum, T. tonsurans and T. This application is a continuation-in-part of U.S. pa violaceum, the causes of dermatophytosis; and, Rhino tent application Ser. No. 07/304,092 (filed on Jan. 31, cladiella or Phialophora, and Cladosporium, the causes of 1989), now abandoned. chronomycosis. O The Candida species is the most virulent of the fungi FIELD OF THE INVENTION which infect the oral mucosa. Pathogenic Candida spe The invention is directed to an antimycotic composi cies are aerobic yeasts that can also grow anaerobically. tion for the prevention of microfungal infections of the C. albicans, the Candida species most often responsible oral cavity and to a method for using said composition for infections of the oral cavity, grows in two morpho in treating mycotic diseases of the oral cavity caused by 15 logical forms: either as a budding yeast, or as a continu microfungi. ously extending hyphae which extends into tissue. In BACKGROUND OF THE INVENTION the oral cavity, Candida may cause a variety of disor ders based on localization of the infection such as pulpi Microfungi can be classified as yeasts and filamentous tis, gingivitis, tonsillitis, cheilitis, glossitis, stomatitis, fungi. Microfungi are capable of causing a variety of 20 pharyngitis, laryngitis and sinusitis. diseases in the oral cavity and the surrounding area. Mycotic diseases may arise as part of a systemic micro Oral candidosis has been classified into different cate fungal infection or may be derived from an independent gories based on the clinical and histopathological mani infection which establishes in the oral cavity. Oral Iny festations of the infection (Lehner, T., in Clinical Aspects coses and their treatment are an important problem in 25 of immunology, P.G.H. Gell, et al., eds., 3rd edition, oral medicine and have been reviewed in Kostiala, I. et Blackwell Scientific Publications, Oxford, 1975, al., Acta Odontol. Scand. 37:87-101 (1987), incorporated pp. 1387–1427). herein by reference. Acute Pseudomembranous candidosis, or thrush, pri Many factors can predispose a patient to an opportu marily affects children or patients with debilitating nistic microfungal infection in the oral cavity. For ex 30 diseases (Crawson, R. A., Dent. Res. 15:361-364 (1965). ample, general debilitation or poor oral hygiene are C. albicans is a major causative agent of thrush in the predisposing factors. Patients who are being treated newborn. with antibiotics, steroids, or cytostatic therapy, patients The clinical signs which usually appear first are with AIDS, diabetes mellitus or other immunodefi creamy-white, soft, nonkeratotic plaques which appear ciency or hormonal diseases, patients with malignant 35 on the mucosa of the tongue, cheeks, gum and pharynx. tumors or a hematogenous disorder are all at a high risk The plaque is easily rubbed off, leaving an inflamed for opportunistic fungal infections. In addition, certain mucosa underneath. There may be no subjective symp age groups such as infants, the elderly, and pregnant toms until the plaque spreads to the pharynx, larynx or women are at a higher risk of oral fungal infections. esophagus, where it may cause dysphaghia, Soreness Mechanical trauma from an ill-fitted prosthesis is also 40 and dryness of the tongue, a sore throat or symptoms of a major cause of oral microfungal infections. One report cheilitis. estimated that Candida was involved in 60% of the Acute atrophic candidosis is a form of thrush which is cases of "denture sore mouth' (denture stomatitis) in consistently painful, and which is thought to arise as a the elderly (Budtz-Jörgensen, E. et al., Community consequence of the shedding of the fungal plaque from Dent. Oral Epidemiol. 3:115 (1975)). Denture stomatitis 45 its site of attachment to the tissue. It can be found on the appears to be a manifestation of a cell-mediated hyper sensitivity reaction to the microfungal infection. dorsun linguae, or associated with angular cheilitis and It is important to treat oral mycotic infections as soon inflammation of cheeks and lips. as possible. Untreated infections may become the foci Chronic atrophic candidosis, or denture stomatitis is for systemic dissemination of the yeast or fungus, with 50 the term given to Candida-based infections of the den potentially fatal results in severely compromised pa ture-bearing tissues. Torulopsis glabrata is also associ tients. For example, disseminated candidosis is the sec ated with some forms of denture stomatitis. ond most common opportunistic infection in patients Chronic mucocutaneous candidosis refers to four with AIDS (Odds, F. C., CRC Crit. Rey. Microbiol. different types of candidosis which are resistant to treat 15:1-5 (1987)). 55 ment and which are associated with patients with a The most important species of microfungi which heterogeneous pattern of immunodeficiencies. These have been implicated as being involved in superficial or types of candidosis include chronic oral hyperplastic deep mycotic infections in the oral cavity include Can candidosis, which predominately affects adult males dida albicans. C. tropicalis, C. stellatoidea, C. pseudotropi between the ages of 30 and 70; chronic localized muco calis. C. parapsilosis, C. guilliermondi, C. krusei, and C. cutaneous candidosis, which starts in childhood as an vixwanathi, all of which have been implicated in can intractable oral Candida infection and later manifects didosis; Torulopsis glabrata which is the cause of torulp itself as lesions in the nails, and skin of the fingers and sidosis; Geotrichum candidum, which is the cause of toes; chronic localized mucocutaneous candidosis with geotrichosis; Rhizopus, Mucor, Absidia, and Basidiobolus granuloma which primarily affects young girls, starting which are the cause of aspergillosis, Cryptococcus neo 65 in the mouth but later manifesting itself as horny masses formans, the cause of cryptococcosis; Blastomyces der of the face, scalp and upper respiratory tract; and, natitidis, the cause of blastomycosis; Paracoccidioides chronic localized mucocutaneous chadidosis with endo brasiliensis, the cause of paracoccidioidomycosis; Sporo crine disorder, also found most frequently in young 5,116,603 3 4.
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