AU2018236225B2 - Methods and compositions for delivering mycophenolic acid active agents to non-human mammals - Google Patents

Methods and compositions for delivering mycophenolic acid active agents to non-human mammals Download PDF

Info

Publication number
AU2018236225B2
AU2018236225B2 AU2018236225A AU2018236225A AU2018236225B2 AU 2018236225 B2 AU2018236225 B2 AU 2018236225B2 AU 2018236225 A AU2018236225 A AU 2018236225A AU 2018236225 A AU2018236225 A AU 2018236225A AU 2018236225 B2 AU2018236225 B2 AU 2018236225B2
Authority
AU
Australia
Prior art keywords
mpa
release
modified
composition
veterinary
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.)
Ceased
Application number
AU2018236225A
Other languages
English (en)
Other versions
AU2018236225A1 (en
Inventor
Wayne H. Anderson
Michael KLOTSMAN
Gayatri Sathyan
Padmaja Shivanand
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Okava Pharmaceuticals Inc
Original Assignee
Okava Pharmaceuticals Inc
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 Okava Pharmaceuticals Inc filed Critical Okava Pharmaceuticals Inc
Publication of AU2018236225A1 publication Critical patent/AU2018236225A1/en
Application granted granted Critical
Publication of AU2018236225B2 publication Critical patent/AU2018236225B2/en
Ceased 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5073—Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5138—Organic macromolecular compounds; Dendrimers obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/51—Nanocapsules; Nanoparticles
    • A61K9/5107—Excipients; Inactive ingredients
    • A61K9/513—Organic macromolecular compounds; Dendrimers
    • A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Transplantation (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Nanotechnology (AREA)
  • Optics & Photonics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2018236225A 2017-03-13 2018-03-13 Methods and compositions for delivering mycophenolic acid active agents to non-human mammals Ceased AU2018236225B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762470806P 2017-03-13 2017-03-13
US62/470,806 2017-03-13
US201762503270P 2017-05-08 2017-05-08
US62/503,270 2017-05-08
PCT/US2018/022266 WO2018170022A2 (en) 2017-03-13 2018-03-13 Methods and compositions for delivering mycophenolic acid active agents to non-human mammals

Publications (2)

Publication Number Publication Date
AU2018236225A1 AU2018236225A1 (en) 2019-09-19
AU2018236225B2 true AU2018236225B2 (en) 2023-11-30

Family

ID=61911669

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018236225A Ceased AU2018236225B2 (en) 2017-03-13 2018-03-13 Methods and compositions for delivering mycophenolic acid active agents to non-human mammals

Country Status (10)

Country Link
US (4) US11633378B2 (https=)
EP (1) EP3595639A2 (https=)
JP (1) JP7385474B2 (https=)
KR (1) KR20190131036A (https=)
CN (1) CN110662533A (https=)
AU (1) AU2018236225B2 (https=)
BR (1) BR112019019003A2 (https=)
CA (1) CA3054817A1 (https=)
MX (1) MX2019010829A (https=)
WO (1) WO2018170022A2 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11633378B2 (en) 2017-03-13 2023-04-25 Okava Pharmaceuticals, Inc. Methods and compositions for delivering mycophenolic acid active agents to non-human mammals
JP2022506007A (ja) * 2018-09-07 2022-01-17 オカヴァ ファーマシューティカルズ， インコーポレイテッド ミコフェノール酸活性剤を非ヒト哺乳動物に送達するための方法および組成物

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1203328A (en) * 1968-06-04 1970-08-26 Ici Ltd Pharmaceutical compositions
US6306900B1 (en) * 1996-04-12 2001-10-23 Novartis Ag Enteric coated pharmaceutical compositions
US20070036857A1 (en) * 2003-10-03 2007-02-15 Dieter Becker Pharmaceutical multiparticulate composition comprising mycophenolic acid or mycophenolate sodium and combination with rapamycin
US20080206322A1 (en) * 2004-08-31 2008-08-28 Novartis Ag Pharmaceutical Multiparticulate Composit Ion Comprising Mycophenolic Acid or Myco Phenolate Sodium and Combination Compositions with Rapamycin
US20110008426A1 (en) * 2008-03-05 2011-01-13 Rajesh Jain Modified release pharmaceutical compositions comprising mycophenolate and processes thereof
US20110086102A1 (en) * 2009-10-13 2011-04-14 Teva Pharmaceutical Industries Ltd. Delayed release compositions
KR20110091252A (ko) * 2010-02-05 2011-08-11 서울대학교산학협력단 미코페놀레이트 모페틸을 함유한 서방성 면역 억제제
US20110223249A1 (en) * 2007-08-13 2011-09-15 Panacea Biotec Ltd. Extended release compositions comprising mycophenolate sodium and processes thereof
CN102793658A (zh) * 2012-08-23 2012-11-28 无锡福祈制药有限公司 一种含有麦考酚酸或麦考酚酸盐的骨架型制剂及其包衣片
CN103845323A (zh) * 2012-11-30 2014-06-11 重庆华邦制药有限公司 麦考酚酸及其盐肠溶制剂和制备方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4808413A (en) 1987-04-28 1989-02-28 E. R. Squibb & Sons, Inc. Pharmaceutical compositions in the form of beadlets and method
US5049394A (en) 1987-09-11 1991-09-17 E. R. Squibb & Sons, Inc. Pharmaceutical composition containing high drug load and method for preparing same
GB0124953D0 (en) * 2001-10-17 2001-12-05 Novartis Ag Organic Compounds
US20040127403A1 (en) * 2002-09-06 2004-07-01 Francesco Parenti Methods for treating and preventing Gram-positive bacteremias
CN1994295A (zh) 2006-01-06 2007-07-11 华北制药集团新药研究开发有限责任公司 霉酚酸盐的包有肠溶衣的药物组合物
WO2008090569A1 (en) * 2007-01-25 2008-07-31 Panacea Biotec Ltd Modified release pharmaceutical composition and a process of making the same
US11633378B2 (en) 2017-03-13 2023-04-25 Okava Pharmaceuticals, Inc. Methods and compositions for delivering mycophenolic acid active agents to non-human mammals

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1203328A (en) * 1968-06-04 1970-08-26 Ici Ltd Pharmaceutical compositions
US6306900B1 (en) * 1996-04-12 2001-10-23 Novartis Ag Enteric coated pharmaceutical compositions
US20070036857A1 (en) * 2003-10-03 2007-02-15 Dieter Becker Pharmaceutical multiparticulate composition comprising mycophenolic acid or mycophenolate sodium and combination with rapamycin
US20080206322A1 (en) * 2004-08-31 2008-08-28 Novartis Ag Pharmaceutical Multiparticulate Composit Ion Comprising Mycophenolic Acid or Myco Phenolate Sodium and Combination Compositions with Rapamycin
US20110223249A1 (en) * 2007-08-13 2011-09-15 Panacea Biotec Ltd. Extended release compositions comprising mycophenolate sodium and processes thereof
US20110008426A1 (en) * 2008-03-05 2011-01-13 Rajesh Jain Modified release pharmaceutical compositions comprising mycophenolate and processes thereof
US20110086102A1 (en) * 2009-10-13 2011-04-14 Teva Pharmaceutical Industries Ltd. Delayed release compositions
KR20110091252A (ko) * 2010-02-05 2011-08-11 서울대학교산학협력단 미코페놀레이트 모페틸을 함유한 서방성 면역 억제제
CN102793658A (zh) * 2012-08-23 2012-11-28 无锡福祈制药有限公司 一种含有麦考酚酸或麦考酚酸盐的骨架型制剂及其包衣片
CN103845323A (zh) * 2012-11-30 2014-06-11 重庆华邦制药有限公司 麦考酚酸及其盐肠溶制剂和制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CHANDA ET AL "Comparative gastrointestinal effects of mycophenolate mofetil capsules and enteric-coated tablets of sodium-mycophenolic acid in beagle dogs", TRANSPLANT PROC. 2002 DEC. *

Also Published As

Publication number Publication date
KR20190131036A (ko) 2019-11-25
BR112019019003A2 (pt) 2020-04-14
US20240299343A1 (en) 2024-09-12
WO2018170022A3 (en) 2018-11-08
MX2019010829A (es) 2020-02-05
US20250049753A1 (en) 2025-02-13
CN110662533A (zh) 2020-01-07
CA3054817A1 (en) 2018-09-20
US20190201375A1 (en) 2019-07-04
JP7385474B2 (ja) 2023-11-22
EP3595639A2 (en) 2020-01-22
JP2020510691A (ja) 2020-04-09
AU2018236225A1 (en) 2019-09-19
WO2018170022A2 (en) 2018-09-20
US20200030285A1 (en) 2020-01-30
US11633378B2 (en) 2023-04-25
US11786505B2 (en) 2023-10-17

Similar Documents

Publication Publication Date Title
KR101205633B1 (ko) 심혈관계 질환 치료용 약제학적 제제
KR101809305B1 (ko) 다중미립자 l-멘톨 제제 및 관련 방법
RS77904A (sr) Oblik za oralnu primenu teško rastvornih baznih delotvornih supstanci
JP2022033758A (ja) 生理活性の強い、ｕｒａｔ１のインヒビターを含む医薬組成物
US20080305165A1 (en) Sustained release oral formulation and process for the preparation thereof
US20240299343A1 (en) Methods and compositions for delivering mycophenolic acid active agents to non-human mammals
JP2003514019A (ja) カルベジロールメタンスルホン酸塩
KR20070083956A (ko) 양성자 펌프 억제제를 위한 신규 변형 방출 정제 제형
JP2005521682A (ja) 結腸放出組成物
US9114085B2 (en) Modified release pharmaceutical compositions of dexlansoprazole
WO2011051967A2 (en) Pharmaceutical compositions comprising mycophenolate and processes for preparing thereof
HU227490B1 (en) Sustained release pharmaceutical preparation containing carvedilol
EP3290023B1 (en) Rivastigmine-containing sustained-release pharmaceutical composition
EP3307276A1 (en) Extended release capecitabine capsules
CA3111908A1 (en) Methods and compositions for delivering mycophenolic acid active agents to non-human mammals
Singh et al. Development of biphasic pulsatile release mini-tablets system of poorly water soluble carvedilol phosphate
HK1029752A (en) Process for the preparation of pellets with a content of up to 90 wt.% of a pharmaceutical active ingredient
AU2016374382A1 (en) Pulsatile release pharmaceutical composition comprising naftazone or one of its salts

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired