ECSP10010383A - Polvo para suspension oral de un macrolido inmunosupresor - Google Patents

Polvo para suspension oral de un macrolido inmunosupresor

Info

Publication number
ECSP10010383A
ECSP10010383A ECSP10010383A ECSP10010383A EC SP10010383 A ECSP10010383 A EC SP10010383A EC SP10010383 A ECSP10010383 A EC SP10010383A EC SP10010383 A ECSP10010383 A EC SP10010383A
Authority
EC
Ecuador
Prior art keywords
powder
pharmaceutical compositions
suspension
oral suspension
tacrolimus
Prior art date
Application number
Other languages
English (en)
Inventor
Ramirez Monetta Rodrigo Ivan
Original Assignee
Igloo Zone Chile S A
Gynopharm S A
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 Igloo Zone Chile S A, Gynopharm S A filed Critical Igloo Zone Chile S A
Publication of ECSP10010383A publication Critical patent/ECSP10010383A/es

Links

Classifications

    • 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
    • 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
    • A61K31/436—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 six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K47/46—Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Botany (AREA)
  • Pulmonology (AREA)
  • Dermatology (AREA)
  • Transplantation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invencion describe composiciones farmaceuticas que consisten en un polvo para suspension oral de tacrolimus que presenta gran estabilidad, como polvo para suspension y tambien una vez preparada la suspension extemporanea sin la formacion de aglomerados de tipo torta (cake), de buen sabor y agradable aroma. La invencion tambien describe el metodo de preparacion de las composiciones farmaceuticas, procedimiento en seco que consiste en mezclar durante un tiempo adecuado tacrolimus y los excipientes farmaceuticamente aceptables previamentetamizados, y el uso de las composiciones farmaceuticas para el tratamiento y prevencion del rechazo de transplante de organos y dermatitis atopica.
ECSP10010383 2008-02-05 2010-08-05 Polvo para suspension oral de un macrolido inmunosupresor ECSP10010383A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CL2008000374A CL2008000374A1 (es) 2008-02-05 2008-02-05 Composicion farmaceutica que comprende un polvo para suspension oral de tacrolimus o una de sus sales, hidratos o solvatos y excipientes farmaceuticamente aceptables; procedimiento de preparacion de dicha composicion farmaceutica; y uso para la preve
PCT/IB2009/050455 WO2009098649A1 (es) 2008-02-05 2009-02-05 Polvo para suspensión oral de un macrólido inmunosupresor

Publications (1)

Publication Number Publication Date
ECSP10010383A true ECSP10010383A (es) 2010-11-30

Family

ID=40261181

Family Applications (1)

Application Number Title Priority Date Filing Date
ECSP10010383 ECSP10010383A (es) 2008-02-05 2010-08-05 Polvo para suspension oral de un macrolido inmunosupresor

Country Status (15)

Country Link
US (2) US20110021553A1 (es)
EP (1) EP2248522B1 (es)
JP (1) JP2011511059A (es)
CN (1) CN101977602A (es)
AR (1) AR070323A1 (es)
BR (1) BRPI0908072A2 (es)
CA (1) CA2714237A1 (es)
CL (1) CL2008000374A1 (es)
CO (1) CO6660422A2 (es)
EC (1) ECSP10010383A (es)
ES (1) ES2355884B1 (es)
MX (1) MX349358B (es)
PE (1) PE20091372A1 (es)
PT (1) PT2248522T (es)
WO (1) WO2009098649A1 (es)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IN2014CN02850A (es) 2011-10-31 2015-07-03 Glaxosmithkline Intellectual Property Ltd
CN115804760A (zh) * 2022-11-23 2023-03-17 无锡福祈制药有限公司 一种他克莫司纳米晶体胶囊剂及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8608080D0 (en) * 1986-04-02 1986-05-08 Fujisawa Pharmaceutical Co Solid dispersion composition
KR0177158B1 (ko) 1990-03-01 1999-03-20 후지사와 도모기찌로 면역억제 활성을 갖는 트리사이클릭 화합물 함유 용액 제제
CA2054983A1 (en) * 1990-11-08 1992-05-09 Sotoo Asakura Suspendible composition and process for preparing the same
ATE464900T1 (de) * 1998-03-26 2010-05-15 Astellas Pharma Inc Retardpräparat mit makroliden wie tacrolimus
DE602004028023D1 (de) 2003-08-29 2010-08-19 Lifecycle Pharma As Tacrolimus enthaltende feste dispersionen
ATE531368T1 (de) 2003-08-29 2011-11-15 Veloxis Pharmaceuticals As Tacrolimus enthaltende zusammensetzungen mit modifizierter freisetzung
KR100866728B1 (ko) 2004-11-12 2008-11-03 주식회사종근당 타크로리무스를 함유하는 주사제
EP1817315A1 (en) * 2004-12-01 2007-08-15 Teva Gyógyszergyár Zártköruen Muködo Részvenytarsaság Processes for producing crystalline macrolides
KR100678829B1 (ko) 2004-12-06 2007-02-05 한미약품 주식회사 타크로리무스의 경구용 마이크로에멀젼 조성물
CA2590675A1 (en) 2004-12-15 2006-06-22 Elan Pharma International Ltd. Nanoparticulate tacrolimus formulations
KR100678824B1 (ko) * 2005-02-04 2007-02-05 한미약품 주식회사 용해성이 증가된 무정형 타크로리무스 고체분산체 및 이를포함하는 약제학적 조성물
HUP0600097A3 (en) 2006-02-08 2008-07-28 Richter Gedeon Nyrt Pharmaceutical compositions comprising tacrolimus and process for their preparation
WO2008013416A1 (en) * 2006-07-27 2008-01-31 Amorepacific Corporation Process for preparing powder comprising nanoparticles of sparingly soluble drug
CN100515413C (zh) 2006-09-15 2009-07-22 杭州平和安康医药科技有限公司 他克莫司口服制剂

Also Published As

Publication number Publication date
CN101977602A (zh) 2011-02-16
EP2248522A1 (en) 2010-11-10
EP2248522A4 (en) 2013-01-09
PT2248522T (pt) 2017-07-27
JP2011511059A (ja) 2011-04-07
AR070323A1 (es) 2010-03-31
MX349358B (es) 2015-08-25
ES2355884A1 (es) 2011-04-01
US20140088135A1 (en) 2014-03-27
PE20091372A1 (es) 2009-10-18
MX2010008327A (es) 2010-11-30
CL2008000374A1 (es) 2008-04-04
BRPI0908072A2 (pt) 2015-07-21
US20110021553A1 (en) 2011-01-27
EP2248522B1 (en) 2017-05-03
CA2714237A1 (en) 2009-08-13
CO6660422A2 (es) 2013-04-30
ES2355884B1 (es) 2012-01-24
WO2009098649A1 (es) 2009-08-13

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ECSP10010383A (es) Polvo para suspension oral de un macrolido inmunosupresor