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DRUG-CARRYING HYDROGEL FORMULATION AND METHOD FOR PRODUCING SAME

Foreign code F160008914
File No. (S2015-0921-N0)
Posted date Dec 21, 2016
Country WIPO
International application number 2016JP059515
International publication number WO 2016158707
Date of international filing Mar 24, 2016
Date of international publication Oct 6, 2016
Priority data
  • P2015-073019 (Mar 31, 2015) JP
Title DRUG-CARRYING HYDROGEL FORMULATION AND METHOD FOR PRODUCING SAME
Abstract Provided are a drug-carrying formulation with which it is possible to carry out release with little initial burst, and a method for producing the same. Provided is a method for producing a drug-carrying hydrogel formulation, the method including the following: (a) a step for obtaining a biodegradable polymer gel by crosslinking a biodegradable polymer in an aqueous solution; (b) a step for finely granulating the biodegradable polymer gel; and (c) a step for obtaining a drug-carrying hydrogel by bringing the finely granulated biodegradable polymer gel into contact with a solution that contains a drug.
Outline of related art and contending technology BACKGROUND ART
Peritoneal seeding, advanced gastric cancer and colorectal cancer and the like, cancer cells can be exposed to the serosal surface of the organ, and strewn (seeded) into the abdominal cavity, the peritoneum attached, lesion formation in the disease occurs. And seeding cancer cells into the abdominal cavity once, the total excision of the lesion difficult, often outside the adaptive surgery. Therefore, intravenous administration of the anticancer drug at present, such as oral administration and systemic chemotherapy is a standard of care, satisfactory effect is not obtained.
A peritoneal-seeding porosity may be poor blood flow, as systemic chemotherapy, intravenously, orally administered anticancer agent is difficult to bundle the routine proceeds to a peritoneal-seeding. In addition, systemic chemotherapy is, the more intense side effects associated with high blood levels. Many of the patients with peritoneal seeding already deteriorated general condition, from the viewpoint of QOL is impossible to effect in systemic chemotherapy is not small.
Of the anticancer drug into the blood concentration is associated with side effects since, while suppressing the blood concentration of the anti-cancer, anti-cancer lesions in the appropriate concentration of peritoneal-seeding for exposure, direct administration into the abdominal cavity anti-attempts have been made so far. However, such as gastric cancer and the effect of the water-soluble anticancer agent is cisplatin and the like, absorbs the earlier from the peritoneum, intraperitoneal administration, in order to obtain sufficient results have not yet been accomplished. Therefore, a biodegradable polymer such as gelatin in a state in which the anticancer drug is bound to the, intraperitoneally administered, sustained release anti-cancer therapeutic effect can be promoted, and by maintaining the appropriate blood concentration to reduce the side effects that the treatment method are now under study, animal studies have also been carried out (for example non-patent document 1).
Conventional, agent impregnated with the hydrogel formulation is a biodegradable polymer, referred to as initial burst upon administration and release of the agent, the ratio of the agent impregnated in the free from the split 3 reach about 2. For this reason, there is a loss of the drug, in addition to the cost for the preparation of the formulation, administration of the formulation of the subject person is exposed to high concentrations of medication which is problematic. In addition, a biodegradable polymer hydrogel formulations may be administered to a human for those that are, in their preparation, in many cases, an organic solvent such as acetone or hexane is used, prepared without using an organic solvent is desirable.
Therefore, less of the initial burst of the drug-carrying agent formulation, and, such formulations can be manufactured without using an organic solvent has been needed is a method.
Scope of claims (In Japanese)[請求項1]
以下:
(a)生分解性高分子を水溶液中で架橋反応させて生分解性高分子ゲルを得る工程;
(b)生分解性高分子ゲルを細粒化する工程;及び
(c)細粒化した生分解性高分子ゲルと薬剤を含む溶液とを接触させて薬剤担持ハイドロゲルを得る工程
を含む、薬剤担持ハイドロゲル製剤の製造方法。
[請求項2]
工程(c)の後に、薬剤担持ハイドロゲルを遠心分離し、次いで上清を除去する工程(c’)をさらに含む、請求項1に記載の製造方法。
[請求項3]
工程(c)の後かつ工程(c’)の前に、薬剤担持ハイドロゲルを凍結乾燥する工程(c’’)をさらに含む、請求項2に記載の製造方法。
[請求項4]
工程(b)の後かつ工程(c)の前に、細粒化した生分解性高分子ゲルを分子量及び/又は粒子径により分画する工程(b’)をさらに含む、請求項1~3のいずれか1項に記載の製造方法。
[請求項5]
薬剤が、シスプラチン、カルボプラチン、ネダプラチン及びオキサリプラチンからなる群より選ばれる少なくとも1種である、請求項1~4のいずれか1項に記載の製造方法。
[請求項6]
生分解性高分子がゼラチンである、請求項1~5のいずれか1項に記載の製造方法。
[請求項7]
請求項1~6のいずれか1項に記載の製造方法により得られる、薬剤担持ハイドロゲル製剤。
  • Applicant
  • ※All designated countries except for US in the data before July 2012
  • KYOTO UNIVERSITY
  • Inventor
  • TSUNODA Shigeru
  • SAKAI Yoshiharu
  • TABATA Yasuhiko
  • GUNJI Shutaro
  • YAMASHITA Kota
IPC(International Patent Classification)
Specified countries National States: AE AG AL AM AO AT AU AZ BA BB BG BH BN BR BW BY BZ CA CH CL CN CO CR CU CZ DE DK DM DO DZ EC EE EG ES FI GB GD GE GH GM GT HN HR HU ID IL IN IR IS JP KE KG KN KP KR KZ LA LC LK LR LS LU LY MA MD ME MG MK MN MW MX MY MZ NA NG NI NO NZ OM PA PE PG PH PL PT QA RO RS RU RW SA SC SD SE SG SK SL SM ST SV SY TH TJ TM TN TR TT TZ UA UG US UZ VC VN ZA ZM ZW
ARIPO: BW GH GM KE LR LS MW MZ NA RW SD SL SZ TZ UG ZM ZW
EAPO: AM AZ BY KG KZ RU TJ TM
EPO: AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
OAPI: BF BJ CF CG CI CM GA GN GQ GW KM ML MR NE SN ST TD TG
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