SG11201802073YA - Pharmaceutical composition containing anionic drug, and preparation method therefor - Google Patents

Pharmaceutical composition containing anionic drug, and preparation method therefor

Info

Publication number
SG11201802073YA
SG11201802073YA SG11201802073YA SG11201802073YA SG11201802073YA SG 11201802073Y A SG11201802073Y A SG 11201802073YA SG 11201802073Y A SG11201802073Y A SG 11201802073YA SG 11201802073Y A SG11201802073Y A SG 11201802073YA SG 11201802073Y A SG11201802073Y A SG 11201802073YA
Authority
SG
Singapore
Prior art keywords
preparation
pharmaceutical composition
composition containing
method therefor
containing anionic
Prior art date
Application number
SG11201802073YA
Inventor
Hye Yeong Nam
Bong-Oh Kim
Min-Hyo Seo
Ji-Yeon Son
Ji-Hye Choi
Sang Hoon Kim
Original Assignee
Samyang Biopharmaceuticals
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 Samyang Biopharmaceuticals filed Critical Samyang Biopharmaceuticals
Priority claimed from PCT/KR2016/010269 external-priority patent/WO2017048018A1/en
Publication of SG11201802073YA publication Critical patent/SG11201802073YA/en

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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/7105—Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7088—Compounds having three or more nucleosides or nucleotides
    • A61K31/711—Natural deoxyribonucleic acids, i.e. containing only 2'-deoxyriboses attached to adenine, guanine, cytosine or thymine and having 3'-5' phosphodiester links
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/541—Organic ions forming an ion pair complex with the pharmacologically or therapeutically active agent
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
    • A61K47/543—Lipids, e.g. triglycerides; Polyamines, e.g. spermine or spermidine
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6905—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion
    • A61K47/6907—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit the form being a colloid or an emulsion the form being a microemulsion, nanoemulsion or micelle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K48/00—Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
SG11201802073YA 2015-09-15 2016-09-12 Pharmaceutical composition containing anionic drug, and preparation method therefor SG11201802073YA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR20150130587 2015-09-15
KR1020160117053A KR101828877B1 (en) 2015-09-15 2016-09-12 Pharmaceutical Composition Containing Anionic Drug and Preparation Method of the Same
PCT/KR2016/010269 WO2017048018A1 (en) 2015-09-15 2016-09-12 Pharmaceutical composition containing anionic drug, and preparation method therefor

Publications (1)

Publication Number Publication Date
SG11201802073YA true SG11201802073YA (en) 2018-04-27

Family

ID=58496160

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201802073YA SG11201802073YA (en) 2015-09-15 2016-09-12 Pharmaceutical composition containing anionic drug, and preparation method therefor

Country Status (16)

Country Link
US (2) US11253598B2 (en)
EP (1) EP3357491B1 (en)
JP (1) JP6638072B2 (en)
KR (2) KR101828877B1 (en)
CN (1) CN108024960B (en)
AU (1) AU2016324450B2 (en)
CA (1) CA2998092C (en)
DK (1) DK3357491T3 (en)
ES (1) ES2883290T3 (en)
HK (1) HK1251464A1 (en)
IL (1) IL257937B (en)
MX (1) MX2018003096A (en)
PT (1) PT3357491T (en)
RU (1) RU2721558C2 (en)
SG (1) SG11201802073YA (en)
ZA (1) ZA201802303B (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3008788C (en) * 2015-12-18 2021-05-25 Samyang Biopharmaceuticals Corporation Method for preparing polymeric micelles containing an anionic drug
KR102175069B1 (en) * 2017-11-10 2020-11-05 주식회사 삼양바이오팜 Composition and process for freeze-drying of lipid nanoparticles for delivering an anionic drug
KR102259513B1 (en) * 2017-11-16 2021-06-02 주식회사 삼양홀딩스 Composition and process for freeze-drying of a pharmaceutical composition containing an anionic drug
KR20190127277A (en) * 2018-05-04 2019-11-13 주식회사 삼양바이오팜 Polymeric nanoparticle composition for delivering mRNA and preparation method thereof
CN109136271B (en) * 2018-09-20 2021-07-20 西北工业大学 Application of cationic polyvinylamine linear polymer as transgenic vector
CA3157437A1 (en) 2019-11-07 2021-05-14 So Jin Lee Polymer nanoparticle composition for inducing immunity and preparation method therefor
CA3159021A1 (en) * 2019-11-22 2021-05-27 So Jin Lee Kit for preparing nanoparticle composition for drug delivery
US20230039124A1 (en) * 2019-12-20 2023-02-09 Samyang Holdings Corporation Kit for preparing nanoparticle composition for drug delivery, comprising polylactic acid salt
EP4331576A1 (en) * 2021-04-30 2024-03-06 Samyang Holdings Corporation Composition for drug delivery comprising nanoparticles not containing amphiphilic polymer
GB202108444D0 (en) * 2021-06-14 2021-07-28 Imperial College Innovations Ltd Sub-micron particle
CN114569577B (en) * 2022-03-07 2023-04-11 晟迪生物医药(苏州)有限公司 Polymer coated nanoparticle and preparation method thereof

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR0180334B1 (en) 1995-09-21 1999-03-20 김윤 Drug messenger using el-2l-2 micelle and method for sealing drug to it
US6458382B1 (en) 1999-11-12 2002-10-01 Mirus Corporation Nucleic acid transfer complexes
ES2336887T5 (en) 2000-03-30 2019-03-06 Whitehead Inst Biomedical Res Mediators of RNA interference specific to RNA sequences
EP1463518A2 (en) 2001-12-28 2004-10-06 Supratek Pharma, Inc. Pharmaceutical compositions comprising polyanionic polymers and amphiphilic block copolymers and methods of use thereof to improve gene expression
AU2003288902A1 (en) 2002-09-06 2004-04-08 Genteric, Inc. Microcapsules and methods of use
KR100829799B1 (en) * 2004-05-06 2008-05-16 주식회사 삼양사 Delivery composition for bioactive agents on the basis of a polymeric drug carrier comprising an amphiphilic block polymer and a polylactic acid
KR100949791B1 (en) 2007-12-18 2010-03-30 이동기 Novel siRNA Structure for Minimizing Off-target Effects and Relaxing Saturation of RNAi Machinery and the Use Thereof
US20090312402A1 (en) * 2008-05-20 2009-12-17 Contag Christopher H Encapsulated nanoparticles for drug delivery
KR20110051214A (en) * 2008-07-30 2011-05-17 닛토덴코 가부시키가이샤 Drug carriers
NZ594245A (en) 2008-12-26 2013-02-22 Samyang Biopharmaceuticals Pharmaceutical composition containing an anionic drug, a cationic lipid and an amphiphilic block copolymer
AU2009331027B2 (en) * 2008-12-26 2012-12-13 Samyang Holdings Corporation Preparation method of polymeric micellar nanoparticles composition containing a poorly water-soluble drug
KR101296326B1 (en) * 2009-12-30 2013-08-14 주식회사 삼양바이오팜 Composition for Delivery of Anionic Drugs Containing Poly-lactic Acid and Preparation Method thereof
US9314529B2 (en) * 2010-07-09 2016-04-19 The University Of Tokyo Nucleic acid delivery composition and carrier composition, pharmaceutical composition using the same, and method for nucleic acid delivery
EP3695850A1 (en) * 2010-12-30 2020-08-19 Samyang Biopharmaceuticals Corporation Carrier for negatively charged drugs comprising a cationic lipid and a preparation method thereof
ES2836279T3 (en) * 2012-04-04 2021-06-24 Samyang Biopharmaceuticals Method of preparing a composition for administering an anionic drug
KR102109188B1 (en) 2013-04-01 2020-05-11 삼성전자주식회사 Temperature sensitive liposome comprising cationic lipid and use thereof
JP2016526011A (en) 2013-04-09 2016-09-01 ユニバーシティ・オブ・ジョージア・リサーチ・ファウンデイション・インコーポレイテッド Combination therapy nanoparticles

Also Published As

Publication number Publication date
RU2018113459A3 (en) 2019-10-18
JP2018527413A (en) 2018-09-20
ES2883290T3 (en) 2021-12-07
CA2998092A1 (en) 2017-03-23
AU2016324450A1 (en) 2018-04-12
ZA201802303B (en) 2019-01-30
US20220125929A1 (en) 2022-04-28
PT3357491T (en) 2021-08-02
CN108024960A (en) 2018-05-11
DK3357491T3 (en) 2021-08-02
KR20180008854A (en) 2018-01-24
EP3357491A1 (en) 2018-08-08
RU2721558C2 (en) 2020-05-20
IL257937B (en) 2020-10-29
EP3357491B1 (en) 2021-06-02
CN108024960B (en) 2020-12-29
US20180250409A1 (en) 2018-09-06
US11253598B2 (en) 2022-02-22
RU2018113459A (en) 2019-10-18
EP3357491A4 (en) 2019-05-08
MX2018003096A (en) 2018-05-11
CA2998092C (en) 2020-08-04
IL257937A (en) 2018-05-31
AU2016324450B2 (en) 2019-04-18
KR20170032858A (en) 2017-03-23
HK1251464A1 (en) 2019-02-01
KR101948839B1 (en) 2019-02-15
JP6638072B2 (en) 2020-01-29
KR101828877B1 (en) 2018-02-14

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