MA30335B1 - Compositions antibiotiques a liberation modifiee et leur procede de production - Google Patents

Compositions antibiotiques a liberation modifiee et leur procede de production

Info

Publication number
MA30335B1
MA30335B1 MA31291A MA31291A MA30335B1 MA 30335 B1 MA30335 B1 MA 30335B1 MA 31291 A MA31291 A MA 31291A MA 31291 A MA31291 A MA 31291A MA 30335 B1 MA30335 B1 MA 30335B1
Authority
MA
Morocco
Prior art keywords
antibiotic
dosage form
release
hours
pharmaceutically acceptable
Prior art date
Application number
MA31291A
Other languages
English (en)
Inventor
Rajesh Jain
Kour Chand Jindal
Munish Talwar
Original Assignee
Panacea Biotec Ltd
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 Panacea Biotec Ltd filed Critical Panacea Biotec Ltd
Publication of MA30335B1 publication Critical patent/MA30335B1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/42Oxazoles
    • A61K31/424Oxazoles condensed with heterocyclic ring systems, e.g. clavulanic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/429Thiazoles condensed with heterocyclic ring systems
    • A61K31/43Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La présente invention concerne des compositions pharmaceutiques à libération modifiée innovantes qui comprennent au moins un antibiotique, de préférence de l'amoxicilline ou ses sels, esters, polymorphes, isomères, promédicaments, solvates, hydrates ou dérivés pharmaceutiquement acceptables, seul ou en combinaison avec un ou des autres antibiotiques en tant que matière active, avec au moins un agent modificateur de la libération destiné à réguler la libération du bêta lactame antibiotique, facultativement avec un ou plusieurs autres excipients pharmaceutiquement acceptables, la forme pharmaceutique assurant une libération ne dépassant pas environ 60 % de l'antibiotique en environ 30 minutes et n'étant pas inférieure à environ 70 % de l'antibiotique après 8 heures dans une étude de dissolution in vitro ou lors d'un essai in vivo. L'invention concerne en outre des compositions qui, lors d'essais sur un groupe d'humains en bonne santé, fournit une concentration plasmatique maximale moyenne (Cmax) au moins environ 0,5 heure après l'administration de la forme pharmaceutique. La présente invention concerne également des procédés de préparation d'une telle forme pharmaceutique et des procédés d'utilisation d'une telle forme pharmaceutique.
MA31291A 2006-03-24 2008-10-15 Compositions antibiotiques a liberation modifiee et leur procede de production MA30335B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN824DE2006 2006-03-24

Publications (1)

Publication Number Publication Date
MA30335B1 true MA30335B1 (fr) 2009-04-01

Family

ID=38540834

Family Applications (1)

Application Number Title Priority Date Filing Date
MA31291A MA30335B1 (fr) 2006-03-24 2008-10-15 Compositions antibiotiques a liberation modifiee et leur procede de production

Country Status (16)

Country Link
US (1) US20090111788A1 (fr)
EP (1) EP2001465A1 (fr)
JP (1) JP2009530367A (fr)
KR (1) KR20090006123A (fr)
CN (1) CN101410109A (fr)
AU (1) AU2007230546A1 (fr)
BR (1) BRPI0709179A2 (fr)
CA (1) CA2644911A1 (fr)
CR (1) CR10388A (fr)
EA (1) EA200870368A1 (fr)
MA (1) MA30335B1 (fr)
MX (1) MX2008012260A (fr)
RS (1) RS20080430A (fr)
TN (1) TNSN08348A1 (fr)
WO (1) WO2007110875A1 (fr)
ZA (1) ZA200807943B (fr)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2214680A4 (fr) * 2007-10-26 2010-12-29 Rexahn Pharmaceuticals Inc Formulation pharmaceutique de l'acide clavulanique
US20090148532A1 (en) * 2007-12-06 2009-06-11 Venkatesh Gopi M Preparation of controlled release skeletal muscle relaxant dosage forms
US20100136110A1 (en) * 2008-09-30 2010-06-03 Astellas Pharma Inc. Granular pharmaceutical composition for oral administration
CA2758029A1 (fr) * 2009-04-29 2011-11-04 Rexahn Pharmaceuticals, Inc. Formulation de clavulanate pour une neuroprotection et un traitement de troubles neurodegeneratifs
WO2011086575A2 (fr) * 2010-01-13 2011-07-21 Toyochem Laboratories Composition pharmaceutique destinée au traitement d'infections du tractus respiratoire
EP2575777A1 (fr) * 2010-06-03 2013-04-10 Mahmut Bilgic Formulation comprenant du cefpodoxime proxétil et de l'acide clavulanique
CN102861015B (zh) * 2011-07-05 2015-07-08 北京乐维生物技术有限公司 一种稳定的阿莫西林克拉维酸钾缓释制剂及其制备工艺
CN104582692A (zh) * 2012-08-28 2015-04-29 中化帝斯曼制药有限公司荷兰公司 包含抗生素和β-内酰胺酶抑制剂的组合物,其中抗生素和β-内酰胺酶抑制剂中的至少一种是迷你片剂的形式
US9254261B2 (en) * 2014-03-03 2016-02-09 Sandoz Ag Stable quick dissolving dosage form comprising amoxicillin and clavulanic acid
EP3125873B1 (fr) 2014-04-04 2020-06-03 Pharmaquest International Center, LLC Comprimés monolithiques à libération modifiée se désintégrant, contenant des granules à libération prolongée quadri-couches
US10335374B2 (en) * 2014-12-04 2019-07-02 University System of Georgia, Valdosta State University Tablet composition for anti-tuberculosis antibiotics
MX369634B (es) * 2015-02-20 2019-11-14 Cytec Ind Inc Composiciones de dialquil sulfosuccinato, metodos para hacerlas y metodos de uso.
JP7370125B2 (ja) * 2018-11-09 2023-10-27 日本化薬株式会社 エルロチニブを有効成分とする医薬錠剤
JP7370124B2 (ja) * 2018-11-09 2023-10-27 日本化薬株式会社 エルロチニブを有効成分とする医薬錠剤
CN113116860B (zh) * 2021-04-22 2022-11-25 海南通用三洋药业有限公司 一种阿莫西林胶囊及其制备方法
CN113398069A (zh) * 2021-07-10 2021-09-17 四川成康动物药业有限公司 兽用阿莫西林与磺胺嘧啶钠混悬注射液及制备方法和装置

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE9201930D0 (sv) * 1992-06-24 1992-06-24 Astra Ab Gastric antibacterial treatment
EP1330236A2 (fr) * 2000-10-12 2003-07-30 Beecham Pharmaceuticals (Pte) Limited Nouvelle formulation
US8101209B2 (en) * 2001-10-09 2012-01-24 Flamel Technologies Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles

Also Published As

Publication number Publication date
WO2007110875A1 (fr) 2007-10-04
CA2644911A1 (fr) 2007-10-04
TNSN08348A1 (en) 2009-12-29
CN101410109A (zh) 2009-04-15
RS20080430A (sr) 2009-05-06
KR20090006123A (ko) 2009-01-14
ZA200807943B (en) 2009-11-25
EP2001465A1 (fr) 2008-12-17
CR10388A (es) 2009-01-19
BRPI0709179A2 (pt) 2011-06-28
MX2008012260A (es) 2008-10-07
AU2007230546A1 (en) 2007-10-04
EA200870368A1 (ru) 2009-04-28
JP2009530367A (ja) 2009-08-27
US20090111788A1 (en) 2009-04-30

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