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WO 2007/147133 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date PCT (10) International Publication Number 21 December 2007 (21.12.2007) WO 2007/147133 Al (51) International Patent Classification: (74) Agent: SARUSSI, Steven, J.; Mcdonnel Boehnen HuI- A61K9/20 (2006.01) A61K 31/65 (2006.01) bert & Berghoff LIp, 300 South Wacker Drive, Suite 3200, A61K9/00 (2006.01) A61P 31/00 (2006.01) Chicago, IL 60606 (US). (81) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of national protection available): AE, AG, AL, AM, PCT/US2007/071369 AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, (22) International Filing Date: 15 June 2007 (15.06.2007) ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (25) Filing Language: English LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, (26) Publication Language: English PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW 60/813,925 15 June 2006 (15.06.2006) US 60/814,255 16 June 2006 (16.06.2006) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, SERENEX, INC. [US/US]; 323 Foster Street, Durham, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), NC 27701 (US). European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, PL, (72) Inventors; and PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, (75) Inventors/Applicants (for US only): BETTIS, John GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). [US/US]; 2613 Forest Glen Drive, Greenville, NC 27858 Published: (US). [US/US]; 404 West Haven Road, COBB, Joe — with international search report Greenville, NC 27834 (US). C. STAGNER, William, — before the expiration of the time limit for amending the [US/US]; 4217 Ellinwood Drive, Apex, NC 27539 (US). claims and to be republished in the event of receipt of [US/US] ; 3405 Dunhaven Drive, Greenville, GOLD, Brad amendments NC 27834 (US). HOLMES, Keith [US/US]; 913 Bre merton Drive, Greenville, NC 27858 (US). SMITH, For two-letter codes and other abbreviations, refer to the "G uid Alexander, D. [US/US]; 105 Youngsford Ct., Cary, NC ance Notes on Codes and Abbreviations" appearing at the beg in 27513 (US). ning of each regular issue of the PCT Gazette. (54) Title: STABILIZED TETRACYCLINE COMPOSITIONS (57) Abstract: The invention provides a package that comprises a first rapidly disintegrating dosage form comprising tetracycline, and a second rapidly disintegrating dosage form that comprises a buffer. The invention also provides methods for treating or pre- venting mucositis, comprising mixing the dosage forms of the package in an aqueous medium to form a solution or suspension, and administering the solution or suspension topically to the oral cavity of a patient. The invention further provides an aqueous formu- lation comprising the first and second dosage forms in an aqueous medium. STABILIZED TETRACYCLINE COMPOSITIONS This application claims priority from U.S. Provisional Application No. 60/813925, filed June 15, 2006, and U.S. Provisional Application No. 60/814255, filed June 16, 2006; both of which are incorporated by reference. BACKGROUND OF THE INVENTION Field Of The Invention The invention relates to packages comprising a first rapidly disintegrating solid dosage form containing a tetracycline, and a second rapidly disintegrating a solid dosage form containing a buffer or a base. The two dosage forms can be added to an aqueous medium, where they rapidly dissolve, thereby forming a solution that is useful for treating or preventing mucositis when administered topically to the oral cavity. Description of the Related Art Tetracycline is a broad- spectrum antibiotic from the certain streptomyces species . Tetracycline is typically used to treat bacterial infections, such as infections of the skin, respiratory tract, genital and urinary systems, and stomach. Tetracycline is also used to treat Lyme disease. Tetracycline works by preventing the growth and spread of bacteria. Tetracycline antibiotics degrade rapidly to form epi tetracycline, anhydrotetracycline, epianhydro tetracycline, and other degradation products. Once degraded, tetracycline has no therapeutic value, since the degradation products have no therapeutically useful activity. Tetracycline degradation begins as soon as it is in solution, and continues until reaching equilibrium of tetracycline and epimer concentrations . The equilibrium point is temperature and pH dependent, with more epimer being formed at higher temperatures and lower pH. After equilibrium is established, oxidation and other side reactions cause further degradation. Thus, tetracycline products have a very limited existence in aqueous environments . Consequently, tetracycline cannot be stored in solution for extended periods of time. Therefore, there is a need for tetracycline formulations that remain therapeutically effective during long term storage. SUMMARY OF THE INVENTION In a broad aspect, the invention provides a pharmaceutical composition comprising: (a) a first dosage form comprising a therapeutically effective amount of a tetracycline; and (b) a second dosage form comprising a base or buffer, , the second dosage form being physically separated from the first dosage form. In certain aspects, the first dosage form comprises meclocycline sulfosalicylate, and the second dosage form comprises tromethamine . When simultaneously or nearly simultaneously placed in an aqueous medium, the dosage forms rapidly disintegrate, and the tetracycline rapidly dissolves in the resulting mixture, thereby forming a solution of the tetracycline. The resulting solution may also contain water insoluble particulate or granular material that was released from the tablets upon disintegration. The invention also provides methods for treating and/or preventing mucositis comprising mixing the dosage forms in an aqueous medium to form a solution or suspension, and administering the solution or suspension to a patient's oral cavity. The invention further provides an aqueous formulation comprising (a) a solution phase comprising a tetracycline (such as meclocycline or meclocycline sulfosalicylate) and a buffer dissolved in water, and (b) a solid phase present or suspended in the solution, the solid phase comprising water insoluble material, where the water insoluble material, preferably in a particulate or granular form, comprises tablet binder, carrier, adjuvant, excipient, diluent, disintegrant, glidant, or a combination thereof . Specific preferred embodiments of the invention will become evident from the following more detailed description of certain preferred embodiments and the claims . DETAILED DESCRIPTION OF THE INVENTION In a particular embodiment, the invention provides a package that comprises a rapidly disintegrating dosage form comprising a tetracycline, preferably meclocycline, and most preferably meclocycline sulfosalicylate. The package further comprises a second rapidly disintegrating dosage form comprising a buffer. As used herein, "rapidly" generally means that the dosage form dissolves or disintegrates within a short time, for example within about one to five minutes, preferably about one minute, when placed in an aqueous medium. Preferably, the aqueous medium is water. Shorter dissolution times, e.g., about 15, 30 or 45 seconds, are also within the scope of the invention. Preferred buffers include for use in the second dosage form include tris (hydroxymethyl) aminomethane (tromethamine) ; monobasic phosphate salts such as monobasic sodium phosphate and monobasic potassium phosphate; dibasic phosphate salts such as dibasic sodium phosphate dibasic potassium phosphate, and dibasic sodium/potassium phosphate; tribasic phosphate salts, such as sodium phosphate tribasic, potassium phosphate tribasic, and tribasic sodium/ potassium phosphate; sodium pyrophosphate; lysine; or a combination of at least two of the above. The first dosage form typically further comprises a filler /binder/disintegrant , such as a cellulose derivative, e.g., hydroxymethylcellulose or microcrystalline cellulose; lactose (preferably lactose DT) ; pregelatinized starch; or corn starch; etc. A particularly preferred cellulose derivative is microcrystalline cellulose. Silicified microcrystalline cellulose is still more preferred. The first dosage form generally also comprises a lubricant, such as magnesium stearate, stearic acid, talc, or combinations thereof. Magnesium stearate is preferred. The first dosage form typically further comprises excipients such as microcrystalline cellulose, lactose, povidone, silicon dioxide (such as colloidal silicone dioxide NF), corn starch or pregelatinized starch. Silicon dioxide is preferred. Colloidal silicone dioxide NF is more preferred. The first dosage form typically further comprises a coloring agent . In one embodiment, the invention provides a package where the first dosage form further comprises at least two of silicified microcrystalline cellulose, magnesium stearate, silicone dioxide or a coloring agent. The second dosage form typically further comprises
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