JP6423353B2 - 潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物 - Google Patents

潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物 Download PDF

Info

Publication number
JP6423353B2
JP6423353B2 JP2015541981A JP2015541981A JP6423353B2 JP 6423353 B2 JP6423353 B2 JP 6423353B2 JP 2015541981 A JP2015541981 A JP 2015541981A JP 2015541981 A JP2015541981 A JP 2015541981A JP 6423353 B2 JP6423353 B2 JP 6423353B2
Authority
JP
Japan
Prior art keywords
container
budesonide
long
pharmaceutically acceptable
acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP2015541981A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015536995A (ja
JP2015536995A5 (enExample
Inventor
アール． パレプ，ナゲシュ
アール． パレプ，ナゲシュ
クリストファー バクストン，フィリップ
クリストファー バクストン，フィリップ
Original Assignee
ハズ トゥー，エルエルシー
ハズ トゥー，エルエルシー
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ハズ トゥー，エルエルシー, ハズ トゥー，エルエルシー filed Critical ハズ トゥー，エルエルシー
Publication of JP2015536995A publication Critical patent/JP2015536995A/ja
Publication of JP2015536995A5 publication Critical patent/JP2015536995A5/ja
Application granted granted Critical
Publication of JP6423353B2 publication Critical patent/JP6423353B2/ja
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
    • A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0031—Rectum, anus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
JP2015541981A 2012-11-09 2013-11-11 潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物 Expired - Fee Related JP6423353B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261724678P 2012-11-09 2012-11-09
US61/724,678 2012-11-09
PCT/US2013/069449 WO2014074995A1 (en) 2012-11-09 2013-11-11 Enema composition for treatment of ulcerative colitis having long term stability

Publications (3)

Publication Number Publication Date
JP2015536995A JP2015536995A (ja) 2015-12-24
JP2015536995A5 JP2015536995A5 (enExample) 2016-12-22
JP6423353B2 true JP6423353B2 (ja) 2018-11-14

Family

ID=50682294

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015541981A Expired - Fee Related JP6423353B2 (ja) 2012-11-09 2013-11-11 潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物

Country Status (8)

Country Link
US (2) US8809308B2 (enExample)
EP (2) EP2916818B1 (enExample)
JP (1) JP6423353B2 (enExample)
AU (1) AU2013342069B2 (enExample)
CA (1) CA2891090A1 (enExample)
ES (1) ES2622372T3 (enExample)
MX (1) MX2015005837A (enExample)
WO (1) WO2014074995A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8916546B2 (en) 2003-08-29 2014-12-23 Therapeutic Research Llc Materials and methods for treatment and diagnosis of disorders associated with oxidative stress
EP2916818B1 (en) * 2012-11-09 2017-02-01 Scidose LLC Enema composition for treatment of ulcerative colitis having long term stability
CN107249595A (zh) 2015-01-26 2017-10-13 Ea制药株式会社 灌肠剂
WO2018122086A1 (en) * 2016-12-28 2018-07-05 Dr. Falk Pharma Gmbh Enema for rectal application
EP4233872B1 (en) 2018-10-24 2025-07-02 Ferring B.V. Mucoadhesive pharmaceutical compositions of corticosteroids

Family Cites Families (42)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4211777A (en) 1977-11-25 1980-07-08 Fisons Limited Compositions comprising a compound having sodium cromoglycate activity and aminosalicylic acid
WO1981002671A1 (en) 1980-03-20 1981-10-01 Ferring Farma Lab Pharmaceutical composition and method for the treatment of colitis ulcerosa and crohn's disease by oral administration
US4657900A (en) 1983-09-27 1987-04-14 Rowell Laboratories Pharmaceutical article of manufacture comprising a bisulfite stabilized aqueous solution of 5-aminosalicylic acid and method
EP0382066A3 (de) 1989-02-09 1992-01-08 ASTA Medica Aktiengesellschaft Verwendung von Dihydroliponsäure als Analgetikum, Antiphlogistikum und/oder Zytoprotektivum
GB8909559D0 (en) 1989-04-26 1989-06-14 Smith Kline French Lab Pharmaceutical compositions
US5378470A (en) 1989-07-25 1995-01-03 Henning Berlin Gmbh Rectally administered pharmaceutical preparation
PT95826B (pt) 1989-11-09 1997-11-28 Asta Medica Ag Processo para a preparacao de composicoes farmaceuticas contendo como ingrediente activo acido r-alfa-liponico ou acido s-alfa-liponico
DE4218572A1 (de) 1992-06-05 1993-12-09 Asta Medica Ag Synergistische Kombination von Arzneimitteln enthaltend als Wirkstoff alpha-Liponsäure, Dihydroliponsäure, deren Metaboliten sowie die oxidierten und reduzierten Enantiomere der alpha-Liponsäure wie die R-alpha-Liponsäure oder S-alpha-Liponsäure sowie Metaboliten der alpha-Liponsäure mit den Vitaminen A, B1-6, B12, C und E
US5569670A (en) 1992-06-05 1996-10-29 Asta Medica Aktiengesellschaft Combination medications containing alpha-lipoic acid and related
US20050090553A1 (en) 1992-06-30 2005-04-28 Shapiro Howard K. Compositions and method for treatment of chronic inflammatory diseases
US6444221B1 (en) 1992-06-30 2002-09-03 Howard K. Shapiro Methods of treating chronic inflammatory diseases using carbonyl trapping agents
US8178516B2 (en) 1992-06-30 2012-05-15 Sylvan Labs, LLC Compositions and method for treatment of chronic inflammatory diseases
US5563131A (en) 1994-08-04 1996-10-08 Pherin Corporation Pregnane steroids as neurochemical initiators of change in human hypothalamic function and related pharmaceutical compositions and methods
DE4446891A1 (de) * 1994-12-27 1996-07-04 Falk Pharma Gmbh Stabile wäßrige Budesonid-Lösung
DE19509806A1 (de) 1995-03-21 1996-09-26 Basf Ag Lagerstabile Arzneiformen
US5817630A (en) 1997-03-18 1998-10-06 Austin Nutriceutical Corporation Glutathione antioxidant eye drops
US6197749B1 (en) 1997-10-29 2001-03-06 Ajinomoto Co., Inc. Method of suppressing immune responses by reducing intracellular content of glutathione in macrophages and monocytes
WO1999055326A1 (en) 1998-04-30 1999-11-04 Vit-Immune, L.C. Method of treatment of glutathione deficient mammals
AR042572A1 (es) 1999-04-02 2005-06-29 Sod Conseils Rech Applic Derivados de acido lipoico, procedimiento para su preparacion, medicamentos y composiciones farmaceuticas que los contienen y utilizacion de dichos derivados para la preparacion de los referidos medicamentos
US6664287B2 (en) 2000-03-15 2003-12-16 Bethesda Pharmaceuticals, Inc. Antioxidants
EP1172110A3 (de) 2000-07-07 2003-09-17 Basf Aktiengesellschaft Verwendung von Liponsäure zur Verbesserung der Bioverfügbarkeit von Mineralsalzen
JP2005512946A (ja) 2001-05-09 2005-05-12 ノバルティス アクチエンゲゼルシャフト 選択的免疫調節法
US20030235571A1 (en) 2002-06-19 2003-12-25 Gabriel Gojon-Romanillos Systemic treatment of pathological conditions resulting from oxidative stress and/or redox imbalance
US7195766B2 (en) 2002-09-10 2007-03-27 National Jewish Medical And Research Center Product and process for liquefaction of mucus or sputum
US7157444B2 (en) 2002-12-21 2007-01-02 Deanna Jean Nelson Aminosalicylate derivatives for treatment of inflammatory bowel disease
EP1599184A4 (en) 2003-02-04 2009-06-24 Chrysalis Tech Inc FULLY HALOGENATED FLUOROCARBON HYDROGEN AND HYDROFLUOROCHLOROUS HYDROGEN FUELS AND METHOD FOR THE PRODUCTION AND USE THEREOF
SE0300480D0 (sv) 2003-02-21 2003-02-21 Astrazeneca Ab Novel compounds
US20060264408A1 (en) 2003-03-06 2006-11-23 Haj-Yehia Abdullah I Sod minic multifunctional compounds for treating inflammatory bowel disease
CA2530407A1 (en) 2003-07-23 2005-02-03 The Regents Of The University Of California Penetration enhancer combinations for transdermal delivery
US8916546B2 (en) * 2003-08-29 2014-12-23 Therapeutic Research Llc Materials and methods for treatment and diagnosis of disorders associated with oxidative stress
US20100112088A1 (en) 2003-08-29 2010-05-06 Jay Pravda Materials and methods for treatment of disorders associated with oxidative stress
US7312243B1 (en) 2003-08-29 2007-12-25 Jay Pravda Materials and methods for treatment of gastrointestinal disorders
US8318210B2 (en) 2005-02-28 2012-11-27 Neos Therapeutics, Lp Compositions and methods of making sustained release liquid formulations
EP1888033B1 (en) * 2005-06-09 2014-02-19 Meda AB Method and composition for treating inflammatory disorders
US8067433B2 (en) * 2005-11-09 2011-11-29 Zalicus Inc. Methods, compositions, and kits for the treatment of ophthalmic disorders
WO2008031013A1 (en) 2006-09-08 2008-03-13 Gene Logic Inc. Method for treating inflammatory diseases of the digestive tract
US20080066739A1 (en) 2006-09-20 2008-03-20 Lemahieu Edward Methods and systems of delivering medication via inhalation
EP2392321A1 (en) * 2007-06-13 2011-12-07 Jay Pravda Combined composition for rectal administration for the treatment of inflammatory bowel disease
DK3354276T3 (da) * 2007-11-13 2020-03-30 Meritage Pharma Inc Sammensætninger til behandlingen af gastrointestinal inflammation
US7750027B2 (en) * 2008-01-18 2010-07-06 Oxagen Limited Compounds having CRTH2 antagonist activity
MX2011010673A (es) 2009-04-10 2012-02-21 Abraxis Bioscience Llc Formulaciones de nanoparticulas y usos de las mismas.
EP2916818B1 (en) * 2012-11-09 2017-02-01 Scidose LLC Enema composition for treatment of ulcerative colitis having long term stability

Also Published As

Publication number Publication date
EP2916818B1 (en) 2017-02-01
JP2015536995A (ja) 2015-12-24
US20140135299A1 (en) 2014-05-15
AU2013342069A1 (en) 2015-05-21
US8809308B2 (en) 2014-08-19
US20140323449A1 (en) 2014-10-30
EP3181120A1 (en) 2017-06-21
EP2916818A1 (en) 2015-09-16
US9238037B2 (en) 2016-01-19
WO2014074995A1 (en) 2014-05-15
CA2891090A1 (en) 2014-05-15
MX2015005837A (es) 2015-09-24
ES2622372T3 (es) 2017-07-06
AU2013342069B2 (en) 2018-05-31
EP2916818A4 (en) 2016-04-13

Similar Documents

Publication Publication Date Title
US12138248B2 (en) Formulations of bendamustine
CN1243548C (zh) 滴眼液
JP2015536995A (ja) 潰瘍性大腸炎の治療のための長期安定性を有する浣腸剤組成物
JP2017514924A5 (enExample)
JP2005015368A (ja) プラノプロフェン含有水性液剤の安定化方法
JP2015536995A5 (enExample)
JP2005535644A5 (enExample)
CN105578878A (zh) 用于保护待局部施用以防微生物侵染的组合物的液体浓缩物
ITMI20121782A1 (it) Composizione iniettabile stabile contenente diclofenac e tiocolchicoside
JP2024504980A (ja) 点眼組成物
KR101776274B1 (ko) 동물용 복합 항생제 조성물 및 이의 제조방법
HK1220393B (en) Aqueous composition containing stabilized 2-amino-3-(4-bromobenzoyl)phenylacetic acid

Legal Events

Date Code Title Description
A711 Notification of change in applicant

Free format text: JAPANESE INTERMEDIATE CODE: A711

Effective date: 20151225

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20151225

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20161031

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20161031

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170704

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20170921

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20171227

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20180206

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180426

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20181002

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20181018

R150 Certificate of patent or registration of utility model

Ref document number: 6423353

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

LAPS Cancellation because of no payment of annual fees