HRP20191412T1 - Pripravci s kontroliranim oslobađanjem i postupci njihove upotrebe - Google Patents

Pripravci s kontroliranim oslobađanjem i postupci njihove upotrebe Download PDF

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HRP20191412T1
HRP20191412T1 HRP20191412T HRP20191412T1 HR P20191412 T1 HRP20191412 T1 HR P20191412T1 HR P20191412 T HRP20191412 T HR P20191412T HR P20191412 T1 HRP20191412 T1 HR P20191412T1
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preparation according
oil
surfactant
preparation
colloidal silica
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Alawi Fadil Al
Olaf Bork
Ian George Tucker
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Bayer New Zealand Ltd
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Publication of HRP20191412T1 publication Critical patent/HRP20191412T1/hr

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    • 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
    • A61K31/54Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/545Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine
    • A61K31/546Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • 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
    • A61K31/431Compounds 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 containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
    • 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
    • A61K31/54Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
    • A61K31/542Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0041Mammary glands, e.g. breasts, udder; Intramammary administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/14Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • A61P31/18Antivirals for RNA viruses for HIV
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Rheumatology (AREA)
  • AIDS & HIV (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Pain & Pain Management (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Lubricants (AREA)

Claims (16)

1. Pripravak za intramamarnu primjenu, pripravak sadrži terapeutski učinkovitu količinu najmanje jednog aktivnog sredstva, i bazu konfiguriranu da osigura kontrolirano oslobađanje najmanje jednog aktivnog sastojka, te baza uključuje, količinu hidrofobne koloidne silike; najmanje jedno ulje; i najmanje jedan surfaktant, pri čemu aktivno sredstvo je antibiotik; pri čemu je viskoznost pripravka ispod 1000 mPas pri brzini smicanja od 100 1/s i pri temperaturi od 20°C, i pri čemu su hidrofobna koloidna silika i aktivno sredstvo dispergirani u ulju.
2. Pripravak prema patentnom zahtjevu 1 naznačen time što je antibiotsko aktivno sredstvo a. odabrano iz skupine koja se sastoji od beta-laktama, penicilina, cefalosporina, aminoglikozida, kinolona, sulfonamida, tetraciklina i makrocikličkog antibiotika; i/ili b. odabrano iz skupine koja se sastoji od kloksacilina, tilozina, cefapirina i njihovih kombinacija.
3. Pripravak prema patentnom zahtjevu 1 naznačen time što pripravak sadrži najmanje dva aktivna sredstva, a kombinacija aktivnog sredstva se bira od: - amoksicilina i klavulanske kiseline; - penicilinskog aktivnog sredstva i aminoglikozida; - kloksacilina i tilozina; - antibiotika i nesteroidnog protuupalnog lijeka.
4. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 3 naznačen time što hidrofobna koloidna silika je pirogena koloidna silika.
5. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 4 naznačen time što koncentracija hidrofobne koloidne silike iznosi između 0.1-5% m/m, ili između 1-3% m/m.
6. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 5 naznačen time što surfaktant ima HLB između 0.5 i 30, ili HLB između 4 i 16.
7. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 6 naznačen time što je surfaktant: a. anionski, kationski, amfoterni ili neionski surfaktant; ili b. neionski surfaktant i odabran je iz skupine koju čine sorbitan esteri, polioksietilen sorbitan esteri masnih kiselina, derivati polioksietilen ricinusovog ulja, polioksietilen stearati, polietilen oksid monooleat i njihove kombinacije.
8. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 7 naznačen time što je koncentracija surfaktanta između 0.01 do 10 % m/m.
9. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 8 naznačen time što omjer hidrofobne koloidne silike prema surfaktantu u bazi iznosi između 1:100 i 500:1, ili između 1:5 i 6:1.
10. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 9 naznačen time što baza sadrži više od jednog surfaktanta.
11. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 10 naznačen time što viskoznost ulja iznosi: a. između 1 do 100 mPas pri 20°C; i/ili b. manje od 40 mPas pri 20°C.
12. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 11 naznačen time što je ulje odabrano iz skupine koja se sastoji od triglicerida srednjeg lanca, lakog tekućeg parafina, etil oleata i sezamovog ulja.
13. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 12 naznačen time što je gustoća ulja između 0.80 i 0.99 g/cm3.
14. Pripravak prema bilo kojem od patentnih zahtjeva 1 do 13 naznačen time što pripravak ima viskoznost ispod 300 mPas pri brzini smicanja od 100 1/s i temperaturi od 20°C, ili viskoznost ispod 150 mPas pri brzini smicanja od 100 1/s i temperaturi od 20°C.
15. Postupak za proizvodnju pripravka prema bilo kojem od patentnih zahtjeva 1 do 14 naznačen time što uključuje korake: a) miješanje ulja i surfaktanta u spremniku da se dobije homogena smjesa ulja; b) dispergiranje aktivnog sredstva u smjesi ulja; i c) naknadno dodavanje hidrofobne koloidne silike u smjesu ulja.
16. Uporaba pripravka prema bilo kojem od patentnih zahtjeva 1 do 15 naznačena time što je za proizvodnju lijeka za upotrebu u liječenju ili prevenciji pred kliničkog ili kliničkog mastitisa kod životinje kojoj je to potrebno.
HRP20191412 2012-02-27 2019-08-02 Pripravci s kontroliranim oslobađanjem i postupci njihove upotrebe HRP20191412T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NZ59844312 2012-02-27
PCT/NZ2013/000022 WO2013129944A1 (en) 2012-02-27 2013-02-27 Controlled release compositions and their methods of use
EP13755420.0A EP2819699B2 (en) 2012-02-27 2013-02-27 Controlled release compositions and their methods of use

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HRP20191412T1 true HRP20191412T1 (hr) 2019-11-15

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HRP20191412 HRP20191412T1 (hr) 2012-02-27 2019-08-02 Pripravci s kontroliranim oslobađanjem i postupci njihove upotrebe

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US (1) US10828311B2 (hr)
EP (1) EP2819699B2 (hr)
JP (1) JP6271443B2 (hr)
KR (1) KR102100271B1 (hr)
CN (2) CN104244983A (hr)
AU (1) AU2013201147A1 (hr)
BR (1) BR112014021218A2 (hr)
CA (1) CA2865555C (hr)
CL (1) CL2014002227A1 (hr)
CO (1) CO7061074A2 (hr)
CR (1) CR20140396A (hr)
DK (1) DK2819699T3 (hr)
DO (1) DOP2014000195A (hr)
ES (1) ES2740958T3 (hr)
HR (1) HRP20191412T1 (hr)
HU (1) HUE045495T2 (hr)
MX (1) MX366726B (hr)
NI (1) NI201400096A (hr)
PH (1) PH12014501919A1 (hr)
PL (1) PL2819699T3 (hr)
PT (1) PT2819699T (hr)
RU (1) RU2627429C2 (hr)
SI (1) SI2819699T1 (hr)
SV (1) SV2014004796A (hr)
WO (1) WO2013129944A1 (hr)
ZA (1) ZA201406267B (hr)

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EP2819699A4 (en) 2015-10-28
CL2014002227A1 (es) 2015-01-09
BR112014021218A2 (pt) 2020-10-27
CN110604819A (zh) 2019-12-24
MX2014010274A (es) 2014-09-16
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JP2015508098A (ja) 2015-03-16
WO2013129944A1 (en) 2013-09-06
RU2014135524A (ru) 2016-04-20
CN104244983A (zh) 2014-12-24
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