MX366193B - Composiciones farmaceuticas que comprenden rifaximina y aminoacidos, metodo de preparacion y uso de las mismas. - Google Patents

Composiciones farmaceuticas que comprenden rifaximina y aminoacidos, metodo de preparacion y uso de las mismas.

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Publication number
MX366193B
MX366193B MX2014015799A MX2014015799A MX366193B MX 366193 B MX366193 B MX 366193B MX 2014015799 A MX2014015799 A MX 2014015799A MX 2014015799 A MX2014015799 A MX 2014015799A MX 366193 B MX366193 B MX 366193B
Authority
MX
Mexico
Prior art keywords
rifaximin
amino acids
comprised
compositions
present
Prior art date
Application number
MX2014015799A
Other languages
English (en)
Other versions
MX2014015799A (es
Inventor
Dario Braga
Giuseppe Claudio Viscomi
Laura Chelazzi
Fabrizia Grepioni
Maddalena Kindt
Original Assignee
Alfasigma Spa
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46939741&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX366193(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alfasigma Spa filed Critical Alfasigma Spa
Publication of MX2014015799A publication Critical patent/MX2014015799A/es
Publication of MX366193B publication Critical patent/MX366193B/es

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    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61P1/12—Antidiarrhoeals
    • 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
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D498/00—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms
    • C07D498/22—Heterocyclic compounds containing in the condensed system at least one hetero ring having nitrogen and oxygen atoms as the only ring hetero atoms in which the condensed system contains four or more hetero rings
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Communicable Diseases (AREA)
  • Neurology (AREA)
  • Oncology (AREA)
  • Nutrition Science (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)

Abstract

El objetivo de la presente invención se refiere a composiciones de rifaximina que comprenden aminoácidos, que se caracterizan porque incrementan la solubilidad de la rifaximina en soluciones acuosas; las composiciones de rifaximina que comprenden aminoácidos son útiles en el tratamiento de una enfermedad en donde los aminoácidos y la rifaximina son eficaces; la presente invención se refiere a composiciones farmacéuticas que comprenden rifaximina o una de sus sales farmacéuticamente aceptables y uno o más aminoácido(s), en donde la relación molar entre el(los) aminoácido(s) y rifaximina está comprendida entre 1:1 y 10:1, preferiblemente entre 1:1 y 5:1, junto con excipientes farmacéuticamente aceptables; además, la presente invención se refiere a los cristales de rifaximina caracterizados porque se obtienen por medio de un procedimiento que comprende: a) disolución de las composiciones de rifaximina y aminoácidos, en donde los aminoácidos y la rifaximina están en una relación molar comprendida entre 1:1 y 10:1 de acuerdo con la reivindicación 1, en soluciones formadas por etanol/agua, en una relación volumétrica comprendida entre 1:1 y 1:10 (v/v); b) evaporación de la solución obtenida en el paso a) a temperaturas comprendidas entre la temperatura ambiente y 40°C, en un periodo de tiempo comprendido entre 1 y 10 días; en donde los cristales resultantes tienen un grupo espacial monoclínico P21 y los parámetros celulares comprendidos en las escalas: a: 13.7(1)-13.8(1) Å; b: 19.7(1)-19.9 (1)Å; c: 16.4(6)-16.6(6) Å; ß: en donde dichos cristales tienen el grupo espacial monoclínico P21 y los parámetros celulares comprendidos en las escalas a: 14.2(1)-14.5(1) Å; b:19.7(1)-20.1(1) Å; c: 16.1(1)-16.2(1) Å; ß: 108.7(1)-111.4(1) grados.
MX2014015799A 2012-07-06 2013-07-03 Composiciones farmaceuticas que comprenden rifaximina y aminoacidos, metodo de preparacion y uso de las mismas. MX366193B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT000368A ITBO20120368A1 (it) 2012-07-06 2012-07-06 Composizioni comprendenti rifaximina e amminoacidi, cristalli di rifaximina derivanti da tali composizioni e loro uso.
PCT/IB2013/055448 WO2014006576A1 (en) 2012-07-06 2013-07-03 Pharmaceutical compositions comprising rifaximin and amino acids, preparation method and use thereof

Publications (2)

Publication Number Publication Date
MX2014015799A MX2014015799A (es) 2015-03-05
MX366193B true MX366193B (es) 2019-07-01

Family

ID=46939741

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2014015799A MX366193B (es) 2012-07-06 2013-07-03 Composiciones farmaceuticas que comprenden rifaximina y aminoacidos, metodo de preparacion y uso de las mismas.

Country Status (24)

Country Link
US (2) US9452157B2 (es)
EP (2) EP2870163B1 (es)
JP (1) JP6150888B2 (es)
KR (1) KR101880255B1 (es)
CN (1) CN104395322B (es)
AU (1) AU2013285085B2 (es)
BR (1) BR112015000088B1 (es)
CA (1) CA2874815C (es)
CL (1) CL2015000019A1 (es)
DK (1) DK2870163T3 (es)
EA (1) EA028769B1 (es)
ES (1) ES2691971T3 (es)
IL (1) IL235992B (es)
IN (1) IN2014DN11207A (es)
IT (1) ITBO20120368A1 (es)
MX (1) MX366193B (es)
NZ (1) NZ703120A (es)
PL (1) PL2870163T3 (es)
PT (1) PT2870163T (es)
SG (1) SG11201408277UA (es)
TN (1) TN2014000530A1 (es)
UA (1) UA114512C2 (es)
WO (1) WO2014006576A1 (es)
ZA (1) ZA201408990B (es)

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JP7026624B2 (ja) * 2016-02-03 2022-02-28 フイルメニツヒ ソシエテ アノニム アミド化合物の溶液及び分散液
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MX387893B (es) * 2018-04-18 2025-03-19 Alparis Sa De Cv Nuevas fases solidas de rifaximina.
WO2020208140A1 (en) * 2019-04-12 2020-10-15 Sandoz Ag Rifaximin-containing granules
KR102154309B1 (ko) 2019-07-05 2020-09-09 주식회사 비오엑스 테이프 없이 포장가능한 포장상자
KR102252978B1 (ko) 2019-12-11 2021-05-18 주식회사 비오엑스 테이프 없이 포장가능한 포장상자
KR102312848B1 (ko) 2019-12-11 2021-10-15 주식회사 비오엑스 테이프 없이 포장가능한 포장상자
KR102182587B1 (ko) 2020-01-22 2020-11-24 주식회사 비오엑스 밀폐구조를 갖는 포장상자
WO2021260211A1 (en) * 2020-06-26 2021-12-30 Bausch Health Ireland Limited Targeted release rifaximin compositions
KR20220151991A (ko) 2021-05-07 2022-11-15 주식회사 비오엑스 테이프 없이 포장 가능한 포장상자
KR102674188B1 (ko) 2022-01-13 2024-06-12 주식회사 비오엑스 테이프 없이 포장 가능한 포장상자
CN117447487A (zh) * 2022-07-19 2024-01-26 重庆圣华曦药业股份有限公司 一种利福昔明的纯化方法及其在利福昔明片剂中的应用
KR102756705B1 (ko) 2024-07-11 2025-01-21 주식회사 비오엑스 테이프 없이 포장가능한 보온, 보냉용 포장상자

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