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United States Patent (19) 11 Patent Number: 6,096,733 Lubkin (45) Date of Patent: Aug

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United States Patent (19) 11 Patent Number: 6,096,733 Lubkin (45) Date of Patent: Aug US006096733A United States Patent (19) 11 Patent Number: 6,096,733 Lubkin (45) Date of Patent: Aug. 1, 2000 54) DRUGS FOR TOPICAL APPLICATION OF Olige Estradio-Hemihydrat-Augentropfen 0.025 Prozent; SEX STEROIDS IN THE TREATMENT OF Fischer, H and Reimann H., Neues Rezeptur-Formularium DRY EYE SYNDROME, AND METHODS OF (NRF) Pharmazeutisches Laboratorium, Pharmazeutische PREPARATION AND APPLICATION Zeitung (Pharm. Ztg.) Jan. 14, 1999 144/2 (38-40). 75 Inventor: Virginia Lubkin, One Blackstone Pl., Benitez del Castillo, J.M.E., et al., “ffects of Estrogen Use on Bronx, N.Y. 10471 Lens Transmittance in Postmenopausal Women,” Ophthal 73 Assignee: Virginia Lubkin, Brnx, N.Y. mology 1997: 104:970–973. Sator, M.O., et al., “Treatment of menopausal keratocon 21 Appl. No.: 09/208,423 junctivitis sicca with topical oestradiol, Br. J. Obstet. Gyn. 1998; 105:100-102. 22 Filed: Dec. 10, 1998 (51) Int. Cl." ..................................................... A61K 31/56 52 U.S. Cl. .......................... 514/182; 514/169; 514/177; Primary Examiner Zohreh Fay 514/178; 514/912; 514/914 Attorney, Agent, or Firm Shanks & Herbert 58 Field of Search ..................................... 514/182, 169, 57 ABSTRACT 514/177, 178,912, 914 A topical drug application for the alleviation of kerato 56) References Cited conjunctivitis Sicca (dry eye syndrome) is comprised of a U.S. PATENT DOCUMENTS solution of 17-B-estradiol suspended or dissolved in a vehicle, and the method of preparation and application of the 4,642,305 2/1987 Johansson et al. Same. In the preferred embodiments, 17-B-estradiol is in a 4,774.236 9/1988 Cook et al.. lipid vehicle or 17-f-estradiol 3-phosphate disodium dis 4,861,763 8/1989 Cook et al.. 4.866,049 9/1989 Maumenee et al.. Solved in an aqueous vehicle having a pH of between about 5,041,434 8/1991 Lubkin .................................... 514/182 6 to about 8. This invention may also be useful in treating other conditions where KCS may occur, Such as post OTHER PUBLICATIONS operative corneal transplant patients and patients who can Ostrogen-Therapie in Keratokonjunktivitis Sicca, Dr. J. not receive replacement estrogen therapy. Akramian et al., Spektrum der Augenheilkunde (Spektrum Augenheilkd.) Nov. 5, 1997 (195–97). 32 Claims, 5 Drawing Sheets U.S. Patent Sheet 2 of 5 6,096,733 U.S. Patent Aug. 1, 2000 Sheet 3 of 5 6,096,733 E5DNVHONV/EWNHO-,T\/S)NEE-ESOHEHOOS LEHd-LSELLSOd)(LSE 00°9 BONBHEBHIG]~ U.S. Patent Aug. 1, 2000 Sheet 4 of 5 6,096,733 NV/EWNEÐNVHOHOHHVE_LCH?-XIV/EHEEWNIL LEHd-1SELLSOd)(LSB U.S. Patent Aug. 1, 2000 Sheet 5 of 5 6,096,733 NV/EWNONEHE|-|-||C]X_LIH\/TOWNSONIE LEHd-LSELLSOd)(LSB 6,096,733 1 2 DRUGS FOR TOPCAL APPLICATION OF dose of 0.25 mg per day, or that even near homeopathic SEX STEROIDS IN THE TREATMENT OF concentrations of 17-B-estradiol (0.00025%) in drops DRY EYE SYNDROME, AND METHODS OF applied every 6 hours (in women already taking 2 mg estriol PREPARATION AND APPLICATION Valerate daily by mouth) gave varying or marginal improve ment in corneal lens transmittance and autofluorescence TECHNICAL FIELD AND INDUSTRIAL (Benitez de Castillo, et al., Ophthalmol. 1997 104:970-973). APPLICABILITY While it has been shown in the U.S. Pat. No. Re. 34,578 patent that eye drops with concentrations of 17-B-estradiol This invention relates to the topical application of SeX in Solution of at least 0.1% or greater are effective in treating Steroids in the treatment of human dry eye syndrome (also the Symptoms of KCS in post-menopausal women even in known as keratoconjunctivitis Sicca (KCS)) and, more the absence of concomitant oral estrogen there is currently Specifically, to the preparation and application of 17-B- no available treatment for KCS which uses 17-B-estradiol in estradiol and its derivatives in lipid, liposomes, polymers, or Solution at concentrations below 0.1%. The invention dis aqueous or non-aqueous vehicles for the topical treatment of closes that Such a concentration is extremely useful medi the ocular Surface tissues. This invention may also be useful cally. The present invention shows that the effective con in treating other conditions where KCS may occur, Such as 15 centration of 17-3-estradiol in Solution can be as low as at post-operative corneal transplant patients. least 0.05% to about 0.1% and continue to be effective regardless of the presence or absence of concomitant oral BACKGROUND estrogen therapy in post-menopausal women. This lower dose range is especially useful in providing eye drops that The high incidence of keratoconjunctivitis Sicca in the will contain a concentration of 17-f-estradiol that is low population of postmenopausal women is attended by Symp enough to be both safe and effective (the medical aspect) yet toms ranging from mild foreign body Sensation to frank pain has the potential to be approved by the FDA for use in and Visual loSS due to ocular Surface abnormalities. non-prescription (OTC) based formulations (the commercial The standard treatment with artificial lubricants, which aspect). One can also significantly decrease any potential provides temporary Symptomatic relief in most cases does 25 Systemic absorption of estrogen from the present invention not, however, address the cause of the dry eyes. While there by combining the use of the drops with a punctal plug. A has been described treatment of post menopausal females punctal plug is a Small device which fits inside the punctum with dry eye Syndrome using oral Premarin therapy, the oral lacrimale of the eye and prevents tears from draining into the or parenteral administration of estrogen can frequently pro nasophayngeal cavity through the lacrimal canaliculi. The duce Side effects Such as vaginal bleeding, breast tenderneSS result of using Such a plug is that the tears do not drain away and other undesired effects and the therapeutic effects from the corneal Surface allowing a greater buildup of derived from oral therapy are minimal. This result is now lacrimal fluid around the eye. Use of Such a plug can either understood as a result of studies showing that there are very be temporary or permanent and has been used to alleviate few estrogen receptors in the conjunctiva relative to other eye dryneSS in patients. tissues of the body (Gans, L. A., et al., Am. J. Ophthalmol. 35 Furthermore, dry-eye Syndrome also manifests itself in 109(4):474–477 (1990)). Further, such oral or parenteral pre-menopausal women who have hormonal abnormalities administration implicates the entire body Structure in an including insufficient estrogen production. Typically, these indeterminate effort to Secure an effect in a localized area patients often present complaints to their ophthalmologists (the eye), in the absence of any data relating the level of about the inability to wear contact lenses because of their estrogen introduced into the blood Stream to the level, if any, 40 extreme discomfort. Only upon further examination is the resulting in the tear fluid (it is known generally, that estrogen hormonal imbalance identified. The present invention is concentrations in the eye to be in the range of about 10% of useful in treating the physical conditions described, but its Serum levels). Conservative medicine would indicate the use should not be considered to be limited to only those desirability of limiting the specific effect of the hormone to listed above. the recipient Site if possible. One possible method of accom 45 plishing this is through the use of topically applied Steroids, SUMMARY OF THE INVENTION in drop form. One early reference (Bohigian, G. Handbook Accordingly, it is a principal object of this invention to of External Diseases of the Eye (Alcon, Inc.) 1980, p. 79) provide treatment by topical application of 17-B-estradiol did refer to the use of “special drops” for treating KCS Suspended or dissolved in a Suitable vehicle to the conjunc which in fact, contained conjugated estrogens, however, in 50 tival Surface of the eye to alleviate dry-eye syndrome or a declaration during prosecution of U.S. Pat. No. 5,041,434 KCS. The illustrative vehicle comprises a lipid (oil based) issued to Lubkin (reissued as U.S. Pat. No. Re. 34.578) and Suspension or an aqueous Solution having a pH within the hereby incorporated by reference, Dr. Bohigian Stated that range of 4-8, preferably pH 6-8. It is contemplated that this the concentration of estrone in the drops was 0.0066% by invention can also utilize a liposomal vehicle as well. It is weight and that it was not effective in alleviating any 55 further contemplated that this invention can be comprised of symptoms. In contrast, the U.S. Pat. No. Re. 34,578 patent a biologically compatible polymeric composition which can of Lubkin showed that treatment of dry eye syndrome or release a controlled amount of Steroid over a much longer KCS was shown to be effective using a form of estrogen in period of time than presently possible with a drop. More solution at concentrations of at least 0.1 mg/mL or 0.1% particularly, the object of the invention is to provide Specific (w/v). 60 drug products applicable to these purposes, and the methods Further studies since about 1990 have shown that estrogen of preparation and application of the same. Even more is a component of human tears and that it may play a role in particularly, the present invention can be used to treat ophthalmic changes in ocular tissue (Kramer, P. et al., Symptoms of dry eye syndrome in post-menopausal women, Ophthalmol. 1990 97:303-307; Metka, M. et al., Maturi Women who have had oophorectomies or total hysterecto tas 1991 14:3-8).
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