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United States Patent (19) 11 Patent Number: 5,908,824 Yanagawa (45) Date of Patent: Jun

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United States Patent (19) 11 Patent Number: 5,908,824 Yanagawa (45) Date of Patent: Jun USOO.5908824A United States Patent (19) 11 Patent Number: 5,908,824 Yanagawa (45) Date of Patent: Jun. 1, 1999 54) NASALLY ADMINISTRABLE O457223 11/1991 European Pat. Off.. COMPOSITIONS CONTAINING O 635 270 1/1995 European Pat. Off.. PHYSIOLOGICALLY ACTIVE PEPTIDES O 681 833 11/1995 European Pat. Off.. O5331071 12/1993 Japan . 89/05645 6/1989 WIPO. 75 Inventor: Akira Yanagawa, Yokohama, Japan 91/04034 4/1991 WIPO. 94/20085 9/1994 WIPO. 73 Assignee: Dott Research Laboratory, Yokohama, 94/28020 12/1994 WIPO. Japan WO 95.03818 2/1995 WIPO. 21 Appl. No.: 08/733,065 OTHER PUBLICATIONS 22 Filed: Oct. 16, 1996 Patent Abstracts of Japan, vol. 15, No. 317, Pub. No. 30 Foreign Application Priority Data JP3120229, Ab. Date Aug. (1991). Chemical Abstracts, vol. 117, No. 16, Ab. No. 157517, Oct. Nov. 1, 1995 JP Japan .................................... 7-3064.06 Jan. 17, 1996 JP Japan .... 8-022959 (1992). May 28, 1996 JP Japan .................................... 8-154773 M. Mishima et al., “Promotion of Nasal Absorption of Insulin by Glycyrrhetinic Acid Derivatives”, J. Pharmaco 51 Int. Cl. ............................ A61K 9/50; A61K 38/03; bio-Dyn., vol. 12, (1989), pp. 31-36. A61K 38/16 Budavariet al., “The Merck Index”, Merck & Co., (1989). 52 U.S. Cl. ..................................... 514/2; 514/3; 514/12; 514/15; 514/53; 514/314; 514/327: 514/510; Primary Examiner-Cecilia J. Tsang 514/532; 514/554; 514/675; 530/303; 530/307; ASSistant Examiner Anism Gupta 530/313; 530/399; 424/499 Attorney, Agent, or Firm-Foley & Lardner 58 Field of Search ............................... 514/12, 2, 3, 15, 514/16, 53, 314, 327, 506, 510, 532,554, 57 ABSTRACT 675; 530/303, 307, 313, 399; 424/499 A nasally administrable composition having a physiologi 56) References Cited cally active peptide dispersed homogeneously in and adsorbed homogeneously onto a unique carrier. The com U.S. PATENT DOCUMENTS position contains an effective amount of physiologically active peptide dispersed homogeneously in and adsorbed 4,613,500 9/1986 Suzuki et al. ............................. 429/85 homogeneously onto a mucosa protecting and/or tissue 5,236,700 8/1993 Koslo et al. .. ... 424/66 5,578,324 11/1996 Dohi et al. ....... 424/499 repairing agent, e.g., gefarnate, aceglutamide aluminum, 5,578,567 11/1996 Cardinaux et al. ....................... 514/12 Sucralfate, L-glutamine, Sofalcone, teprenone, plaunotol, rebamipide, aldioxa, cetraxate or troXipide. FOREIGN PATENT DOCUMENTS O 457 223 11/1991 European Pat. Off.. 9 Claims, No Drawings 5,908,824 1 2 NASALLY ADMINISTRABLE ologically active peptides Such as insulin, calcitonin, par COMPOSITIONS CONTAINING athyroid hormone (PTH), human growth hormone (HGH), PHYSIOLOGICALLY ACTIVE PEPTIDES gonadotropin-releasing hormone (GnRH) and So on, and has BACKGROUND OF THE INVENTION proposed nasally administrable compositions using a poly 1. Field of the Invention Valence metal compound Such as hydroxyapatite and cal cium carbonate as the carrier, finding that water-insoluble The present invention relates to a nasally administrable Substances which are Soluble under acidic condition, other composition containing a physiologically active peptide, than high molecular weight compounds Such as polysaccha and, more particularly, to a nasally administrable composi ride celluloses So far Studied, can be an desirable carrier for tion containing a physiologically active peptide Such as use in nasally administrable physiologically active peptide peptide hormone, physiologically active protein, enzymatic compositions. protein and So on with a unique carrier, which is highly absorbable into the body via nasal route. SUMMARY OF THE INVENTION 2. Description of the Prior Art 15 Physiologically active peptides Such as calcitonin, insulin, The present invention has the object to provide a nasally parathyroid hormone (PTH), human growth hormone administrable composition that can nasally administer Such (HGH), gonadotropin-releasing hormone (GnRH) and a physiologically active peptide as unlikely to be adminis derivatives thereof are polymers which are extensively tered orally, with higher bioavailability and less irritability employed in clinical practice for various medical usage than the preparations So far proposed. owing to their specific physiological activity. Through extensive Studies and researches, the inventor of The physiologically active peptides, however, can little be the present invention found that mucosa protecting and/or absorbed intact from the mucous membrane of the intestine tissue repairing agents, which had never been used as a because of either being likely to be decomposed with 25 carrier for nasally administrable compositions, would be proteases existing in the digestive System or being high in useful as the carrier to administer physiologically active molecular weight and polarity. Hence, the administration peptides nasally. For example, gastric mucosa protecting method has been limited to injection. However, injection and/or tissue repairing agents are Soluble under acidic cannot be said to be preferable because it causes pain in condition, and can promote mucus Secretion and alkali patients. In particular, when injection is to be repeated at Secretion, enhance mucous glycoproteins and glycolipids, constant intervals, the patients have to Suffer from the pain increase mucous bloodstream and prostaglandin, promote every time, which may often become too Severe to endure. mucous tissular respiration and metabolism, thereby acti Under the circumstances, there has been Strong demand for vating the tissues. Also, since these agents are highly adhe more Simple and convenient means for administering physi 35 Sive to the mucosa and persist there for a long time, they can ologically active peptides, that is, administration via a provide a long-lasting absorption characteristic. non-injection route to enable patients to administer the drug Accordingly, these agents, when administered nasally, are by themselves. expected to activate the venous plexus of the lamina propria AS one example of preparations for Such non-injection mucosae of the nasal cavity, and therefore, physiologically administration, an aerosol in the form of a Suspension has 40 active peptides, dispersed homogeneously onto the agents as been developed for nasal inhalation of calcitonin, in which the carrier, are expected to be highly absorbable into the a fluorinated hydrocarbon is used as a Spouting agent. AS circulatory System of the body through the mucous mem another means for nasal administration, a spray has been brane of the nasal cavity. proposed as a nasally administrable liquid preparation, 45 The inventor of the present invention actually prepared which is a preparation in which calcitonin is formulated with nasally administrable compositions using a mucosa protect a Surface-active agent as an absorption promoter. ing and/or tissue repairing agent, e.g., a gastric mucosa Furthermore, recently, there have been proposed Some protecting and/or tissue repairing agent as the carrier, nasally administrable powdery preparations with improved wherein the physiologically active peptide is dispersed absorbability, which are prepared by adsorbing calcitonin 50 homogeneously in and adsorbed homogeneously onto the onto a polysaccharide Such as celluloses. These various carrier, and found that the compositions would be highly techniques for nasal administration, which have recently useful for clinical treatment of patients. been actively developed, are Said to be in principle Superior In more detail, the present inventor found that a nasally as a means for administering Such physiologically active 55 administrable composition having a physiologically active peptides as unlikely to be administered orally. Since venous peptide Such as calcitonin, insulin, parathyroid hormone plexus develops at the lamina propria mucosae of the nasal (PTH), human growth hormone (HGH) and gonadotropin cavity, physiologically active peptides, when administered releasing hormone (GnRH) dispersed homogeneously in and nasally, can be absorbed through the mucous membrane of adsorbed homogeneously onto the unique carrier, i.e., a the nasal cavity into the circulatory System of the body; 60 mucosa protecting and/or tissue repairing agent, can attain however, nasally administrable preparations So far proposed equal or higher bioavailability as compared with that cannot be sufficient because of poor absorbability of physi attained by injection. ologically active peptides or local irritability, So that they are Furthermore, the present inventor found that the mucosa not commercially available yet. 65 protecting and/or tissue repairing agent, e.g., a gastric The inventor of the present invention has actively been mucosa protecting and/or tissue repairing agent, as the Studying about carriers for nasal administration of physi carrier for the nasally administrable composition mentioned 5,908,824 3 4 above, is also useful for Stabilizing the active ingredient of Examples of calcitonin include Salmon calcitonin, human the composition, i.e., a physiologically active peptide. calcitonin, Salmon/human chimera calcitonin, hog The present invention has been completed on the basis of calcitonin, chicken calcitonin, cattle calcitonin, eel these findings. calcitonin, and So on. These calcitonins are naturally Accordingly, the present invention provides a nasally occurring, extractable ones that are commercially available. administrable composition wherein an effective amount of a It can be noted herein
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