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(12) United States Patent (10) Patent No.: US 6,939,559 B1 Nishibe Et Al

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(12) United States Patent (10) Patent No.: US 6,939,559 B1 Nishibe Et Al USOO6939559B1 (12) United States Patent (10) Patent No.: US 6,939,559 B1 Nishibe et al. (45) Date of Patent: Sep. 6, 2005 (54) PHARMACEUTICAL COMPOSITION FOR 5,474,764 A 12/1995 Patel et al. APPLICATION TO MUCOSA 5,474,768 A 12/1995 Robinson 5,733,569 A 3/1998 AZria et al. ................. 424/434 (75) Inventors: Yoshihisa Nishibe, Hino (JP); Wataru 5,869,096 A 2/1999 Barclay et al. ............. 424/468 Kinoshita, Hino (JP); Hiroyuki 5,942.242 A 8/1999 Mizushima et al. Kawabe, Tokyo (JP) 5,976,573 A * 11/1999 Kim FOREIGN PATENT DOCUMENTS (73) Assignee: Teijin Limited, Osaka (JP) CA 2107587 A1 10/1992 (*) Notice: Subject to any disclaimer, the term of this CA 1327314 A1 3/1994 patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days. (Continued) (21) Appl. No.: 09/446,276 OTHER PUBLICATIONS Bauer K.H. et al Pharmazeutische Technologie, George (22) PCT Filed: Apr. 21, 1999 Thieme verlag, Stuttgart, 3, p. 239, 1991.* (86) PCT No.: PCT/JP99/02126 Dictionary of Food Additivies, 1 Edition, (1994), pp. 36-37. S371 (c)(1), Dictionary of Food Additivies, 1 edition, p. 49-50 (1994), (2), (4) Date: Dec. 21, 1999 and partial translation. (87) PCT Pub. No.: WO99/53899 Textbook of Pharmacology, 2" edition, p. 319-320 (1987), and partial translation. PCT Pub. Date: Oct. 28, 1999 (Continued) (30) Foreign Application Priority Data Primary Examiner-Carlos A. Azpuru Apr. 21, 1998 (JP) ........................................... 10-110887 Apr. 21, 1998 (JP) ........................................... 10-110888 (74) Attorney, Agent, or Firm Sughrue Mion, PLLC (51) Int. Cl.................................................. A61F 13/02 (57) ABSTRACT (52) U.S. Cl. ....................................................... 424/434 The present invention provides a pharmaceutical composi (58) Field of Search .......................................... 424/434 tion for application to the mucosa to be used in drug therapy comprising a water-insoluble and/or water-low Soluble (56) References Cited Substance, a medicament, and an aqueous medium, and having an osmotic pressure of less than 290 mOsm. This U.S. PATENT DOCUMENTS composition is Superior over conventional pharmaceutical 4,271,143 A 6/1981 Schoenwald et al. compositions for application to the mucosa, due to efficient 4,613,500 A 9/1986 Suzuki et al. and high permeability to the blood at the mucosa. The 4,615,697 A 10/1986 Robinson present invention further provides a pharmaceutical compo 5,147,654 A 9/1992 Place et al. ................. 424/473 Sition for application to the mucosa comprising a hemostatic 5,179,079 A 1/1993 Hansen et al. ................. 514/4 agent and a medicament. This composition is Superior over 5,188,826 A 2/1993 Chandrasekaran et al. conventional pharmaceutical compositions for application to 5,192,535 A 3/1993 Davis et al. the mucosa, due to permeability and retentivity at the 5,200,195 A 4/1993 Dong et al. ................. 424/473 5,281,580 A 1/1994 Yamamoto et al. ........... 514/12 COS. 5,340,572 A 8/1994 Patel et al. 5,393,773. A 2/1995 Craig et al. 29 Claims, 4 Drawing Sheets Composition 1 Composition 11 Composition 2 12 Composition 12 Composition 3 13 Composition 13 2 Composition 4 14 Composition 14 Composition 5 15 Composition 15 - Composition 6 Composition 7 3 O O 50 1OO 150 2OO 250 300 Osmotic Pressure (mosm) US 6,939,559 B1 Page 2 FOREIGN PATENT DOCUMENTS ABSTRACT "Nasal absorption of propranolo from differ CA 2164624 A1 1/1995 dosage forms by rats and dogs' J Pharm Sci Dec. 1980; CA 226814.0 A1 4/1998 69(12): 1411–3. CA 2278025 A1 7/1998 ABSTRACT "Nasal absorption of testosterone in rats' J EP 496 308 A1 * 1/1991 Pharm SciSep. 1984; 73(9): 1300–1. EP O4963O8 A1 7/1991 EP O781546 A1 12/1996 ABSTRACT “The time of onset of action of Sublingual EP O 781 546 A1 12/1996 ............ A61 K/9/00 nitroglycerin in exercise-induced angina pectoris. A meth HU 209 247 B 4/1994 ......... A61K/31/685 odological study” Eur Hear JJul. 1985; 6(7): 625-30. JP 59-130820 A 7/1984 ABSTRACT “Intranasal delivery of nicardipine in the rat' JP 63-3O3931 * 12/1988 JP 2-262526 10/1990 .......... A61 K/37/30 J Pharm Sci Jan. 1986; 75(1): 44-6. JP 6-172199 A 6/1994 ABSTRACT “Comparison of the metabolism of diltiazem JP 7-188059 7/1995 .......... A61 K/47/32 following percutaneous, Subcutaneous, oral and intravenous JP 8-217678 A 8/1996 administration.” Drug Des Deliv Nov. 1986; 1(2): 151-6. JP 9-25238 1/1997 ABSTRACT “Comparison of bioavailability in man of JP 9-235220 9/1997 tamoxifen after oral and rectal administration' J Pharm JP 9-2S322O 9/1997 ............ A61 K/9/70 JP 63-166832 A 7/1998 Pharmacol Dec. 1986; 38(12): 888–92. JP 88106305 4/1999 ABSTRACT “Absolute bioavailability of hydromorphone RU 112102979 11/1998 after peroral and rectal administration in humans: Saliva/ RU 11829 12/2000 plasma ratio and clinical effects.” J Clin Pharmacol Sep. WO WO 92/14473 9/1992 WO WO 97/O1337 1/1997 1987; 27(9): 647–53. WO WO 97/31626 A1 9/1997 ABSTRACT “Pharmacodynamics of acute intranasal WO WO 98/OO178 A1 1/1998 administration of Verapamil: comparison with i.v. and oral administration.” Biopharm Drug Dispos Oct.-Dec. 1985; OTHER PUBLICATIONS 6(4): 447-54. Machida Minoru, et al. “Effects of Surfactants and Protease ABSTRACT “Pharmacokinetics of hyrdomorphone after Inhibitors on Nasal Absorption of Recombinant Human intravenous, peroral and rectal administration to human Granulocyte Colony-Stimulating Factor (rhG-CSF) in subjects.” Biopharm Drug Dispos Mar.-Apr. 1988; 9(2): Rats" Biol. Pharm. Bull 17(10) 1375–1378 1994. 187-99. Nomura Hideaki, et al. “Effects of a Dosing Solution on the Nasal Absorptionof Non-glycosylated Recombinant Human ABSTRACT “Pharmacokinetics of bioavailability of Granulocyte Colony-Stimulating Factor in Rats' Biol. hydromorphone: effect of various routes of administration.” Pharm. Bull 19(10) 1490–1493 1996. Pharm Res Nov. 1988; 5(11): 718–21. Abstract for JP 7188059, Yasui Tetsushi et al., Jul. 25, 1995. ABSTRACT "Nasal absorption of 17 alpha-ethinyloestra New Zealand Examination Report, Aug. 31, 2001. diol in the rat.” J Pharm Pharmacol Mar. 1989; 41(3): 214-5. New Zealand Examination Report, Oct. 23, 2001. ABSTRACT "Nasal absorption of tetraethylammonium in EPO Search Report, May 6, 2002. rats.” Arch Int Pharmacodyn Ther Nov.-Dec. 1989; 302: ABSTRACT “Pharmacokinetics and bioavailability of 7-17. papaverine HCI after intravenous, intracorporeal and penis ABSTRACT “Pharmacokinetic study of neostigmine after topical administration in beagle dogs.” Methods Find Exp intranasal and intravenous administration in the guinea pig.” Clin Pharmacol Jun. 1992; 14(5): 373-8. Drugs Exp Clin Res 1990; 16(11): 575–9. ABSTRACT “Enhanced absorption of bumetanide from Suppositories containing weak acids in rabbits.” Biol Pharm ABSTRACT "Asthma therapy: present trends and future Bull Mar. 1993; 16(3): 263–7. prospects.” Compr Ther Mar. 1990; 16(3):12–6. ABSTRACT “Studies on the nasal absorbtion of genta ABSTRACT “Transdermal nitroglycerin systems: meth mycin.” Chung Hua Erh Pi Yen Hou Ko Tsa Chih 1994: ods for comparison.” Clin Ther May-Jun. 1991; 13(3): 29(3): 134-6. 361-7. ABSTRACT "Pharmacokinetics and endometrial effects ABSTRACT “Intranasal absorption of physostigmine and of vaginal administration of micronied progesterone in an arecoline.” J Pharm Sci Aug. 1991; 80(8):750–1. oil-based solution to postmenopausal women.” Fertil Steril Apr. ; 1996; 65(4): 860–2. ABSTRACT “A comparative evaluation of two transder ABSTRACT “Colonic mucus, Smoking and ulcerative mal nitroglycerin delivery systems: Nitro-Dur versus Trans colitis.” Ann R Coll Surg Engl Mar.; 1996; 78(2): 85–91. derm-Nitro. The Collaborative Investigation Group.” Clin ABSTRACT “Studies on the response of nitroglycerin Ther Sep.-Oct. 1991; 13(5): 545–9. oral Spray compared with Sublingual tablets for angina ABSTRACT “Pharmacokinetics and bioavailability of pectoris patients with dry mouth. A multicenter trial.” ArZ papaverine HCI following intravenous, peroral, rectal, vagi neimittelforschung Feb.; 1997; 47(2): 128–31. nal, topical and buccal adminisitration in beagle dogs.” ABSTRACT “Oral transmucosal fentanyl citrate: random Biopharm Drug Dispos Oct. 1991, 12(7): 537–46. ized, double-blinded, placebo-controlled trial for treatment International Search Report. of breakthrough pain in cancer patients.' J Natl Cancer Inst Apr. 15, 1998; 90(8): 611-6. * cited by examiner U.S. Patent Sep. 6, 2005 Sheet 1 of 4 US 6,939,559 B1 009 09Z :[:zI :£I :†7I .9I 00Z 09||00|| (uusOu)?unsseldo?ouuSO 09 Bioavailability (%) U.S. Patent Sep. 6, 2005 Sheet 2 of 4 US 6,939,559 B1 l-l 8| 6| |2 22 6I | .LI :8I .6I :IZ ...ZZ 00||Z00'Z0909€009007 eunssejaO??ouusO(uusOu) 8I Z 09 LI IZ 09 09 0#7 OZ 0|| Bioavailability (%) U.S. Patent Sep. 6, 2005 Sheet 3 of 4 US 6,939,559 B1 00?709800809Z00Z||00 (uusOuu)ºunssºudo?ouuSO 09 Bioavailability (%) U.S. Patent Sep. 6, 2005 Sheet 4 of 4 US 6,939,559 B1 C A ) US 6,939,559 B1 1 2 PHARMACEUTICAL COMPOSITION FOR (Japanese Unexamined Patent Publication (Kokai) No. 63 APPLICATION TO MUCOSA (1988)-303931), for example, provides a method of applying to the nasal cavity a growth hormone-releasing factor at the liquid form having an osmotic pressure ratio of 1 (an PHARMACEUTICAL COMPOSITION FOR 5 osmotic pressure of 290 mOsm) or lower as a method for APPLICATION TO MUCOSA enabling quick and efficient absorption of the a growth hormone-releasing factor through the nasal mucosa to the TECHNICAL FIELD blood circulation. Furthermore, Ohwaki et al. (Japanese The present invention relates to a pharmaceutical com Unexamined Patent Publication (Kokai) No.
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