HRP20190687T1 - N-acetilcisteinske tablete za gutanje - Google Patents

N-acetilcisteinske tablete za gutanje Download PDF

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Publication number
HRP20190687T1
HRP20190687T1 HRP20190687TT HRP20190687T HRP20190687T1 HR P20190687 T1 HRP20190687 T1 HR P20190687T1 HR P20190687T T HRP20190687T T HR P20190687TT HR P20190687 T HRP20190687 T HR P20190687T HR P20190687 T1 HRP20190687 T1 HR P20190687T1
Authority
HR
Croatia
Prior art keywords
tablet
group
acetylcysteine
amount
tablet according
Prior art date
Application number
HRP20190687TT
Other languages
English (en)
Inventor
Alessandra De Lazzari
Alberto Moretto
Original Assignee
Zambon S.P.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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48748383&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20190687(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Zambon S.P.A. filed Critical Zambon S.P.A.
Publication of HRP20190687T1 publication Critical patent/HRP20190687T1/hr

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Classifications

    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/12Mucolytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pulmonology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (12)

1. Tableta za gutanje koja obuhvaća N-acetilcistein od najmanje 80% po masi i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo odabrano iz skupine koju čine veziva, razrjeđivači, dezintegratori, maziva i klizna sredstva, naznačena time, da se navedena tableta proizvodi uporabom granulata pripravljenog putem postupka suhe granulacije samog N-acetilcisteina, te time, da navedena tableta obuhvaća granulat od samog N-acetilcisteina, najmanje jedno vezivo u količini od 5% ili više, najmanje jedan razrjeđivač u količini od 5% ili više, najmanje jedan dezintegrator u količini od 5% ili više, najmanje jedno mazivo u količini od 1% ili manje, najmanje jedno klizno sredstvo u količini od 1% ili manje, po masi u odnosu na ukupnu masu tablete.
2. Tableta prema zahtjevu 1, naznačena time, da su navedena veziva odabrana iz skupine koju čine hidroksipropilceluloza (HPC), hidroksipropilmetilceluloza (HPMC), polietilenglikol (PEG), metilceluloza (MC), povidon (PVP), modificirane škrobne tvari i ostalo.
3. Tableta prema zahtjevu 1, naznačena time, da su navedeni dezintegratori odabrani iz skupine koju čine krospovidon, natrij-kroskarmeloza, natrijev škrobni glikolat, djelomično predželatinizirani škrob i ostali.
4. Tableta prema zahtjevu 1, naznačena time, da su navedena maziva odabrana iz skupine koju čine Ca-stearat, Mg-stearat, natrijev stearilfumarat, stearinska kiselina i ostalo.
5. Tableta prema zahtjevu 1, naznačena time, da su navedena klizna sredstva odabrana iz skupine koju čine bezvodni koloidni silicijev dioksid, talk i ostalo.
6. Tableta prema zahtjevu 1, naznačena time, da su navedeni razrjeđivači odabrani iz skupine koju čine mikrokristalna celuloza (MCC), bezvodna laktoza ili monohidrat laktoze, predželatinizirani škrob, manitol, izomaltoza, sorbitol i slični ugljikohidrati, bezvodni dikalcijev fosfat ili dikalcijev fosfat-dihidrat, maltodekstrin i ostali.
7. Tableta prema zahtjevu 1, naznačena time, da navedena tableta obuhvaća najmanje jedno vezivo odabrano iz skupine koju čine hidroksipropilceluloza, hidroksipropilmetilceluloza ili polietilenglikol; najmanje jedan razrjeđivač odabran iz skupine koju čine mikrokristalna celuloza, manitol, izomaltoza ili sorbitol; najmanje jedan dezintegrator odabran iz skupine koju čine krospovidon ili natrij-kroskarmeloza; najmanje jedno mazivo odabrano iz skupine koju čine Ca-stearat, Mg-stearat, natrijev stearilfumarat; te najmanje jedno klizno sredstvo odabrano iz skupine koju čine bezvodni koloidni silicijev dioksid ili talk.
8. Tableta prema bilo kojem od prethodnih zahtjeva, naznačena time, da navedena tableta obuhvaća količinu N-acetilcisteina u iznosu između 400 mg i 600 mg.
9. Tableta prema zahtjevu 8, naznačena time, da navedena tableta obuhvaća količinu od 600 mg N-acetilcisteina.
10. Tableta prema zahtjevu 8 ili 9, naznačena time, da se upotrebljava kod pacijenata koji pate od CB (kronični bronhitis) i/ili COPD (kronična opstrukcijska plućna bolest).
11. Tableta prema zahtjevu 10, naznačena time, da su navedeni pacijenti ženskog spola.
12. Postupak proizvodnje tablete za gutanje prema zahtjevu 1, naznačen time, da navedeni postupak obuhvaća (a) fazu granulacije u kojoj se dobiva granulat N-acetilcisteina putem suhe granulacije samog N-acetilcisteina, (b) fazu miješanja u kojoj se granulat N-acetilcisteina koji je dobiven u fazi (a), miješa s navedenim vezivima, razrjeđivačima, dezintegratorima, mazivima i kliznim sredstvima, i (c) faza stlačivanja u kojoj se dobivena smjesa iz faze (b) stlačuje u kompresoru za tabletiranje.
HRP20190687TT 2013-05-29 2019-04-11 N-acetilcisteinske tablete za gutanje HRP20190687T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT000874A ITMI20130874A1 (it) 2013-05-29 2013-05-29 Compresse deglutibili di n-acetilcisteina
PCT/EP2014/060950 WO2014191410A1 (en) 2013-05-29 2014-05-27 Swallowable n-acetylcysteine tablets
EP14728495.4A EP3003278B1 (en) 2013-05-29 2014-05-27 Swallowable n-acetylcysteine tablets

Publications (1)

Publication Number Publication Date
HRP20190687T1 true HRP20190687T1 (hr) 2019-06-14

Family

ID=48748383

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20190687TT HRP20190687T1 (hr) 2013-05-29 2019-04-11 N-acetilcisteinske tablete za gutanje

Country Status (29)

Country Link
US (1) US9808427B2 (hr)
EP (1) EP3003278B1 (hr)
JP (1) JP6438013B2 (hr)
CN (1) CN105228595B (hr)
AU (1) AU2014273148B2 (hr)
BR (1) BR112015029038B1 (hr)
CA (1) CA2911474C (hr)
CY (1) CY1122114T1 (hr)
DK (1) DK3003278T3 (hr)
EA (1) EA031856B1 (hr)
ES (1) ES2721649T3 (hr)
HR (1) HRP20190687T1 (hr)
HU (1) HUE044880T2 (hr)
IL (1) IL242439B (hr)
IT (1) ITMI20130874A1 (hr)
LT (1) LT3003278T (hr)
MX (1) MX366917B (hr)
MY (1) MY174005A (hr)
PE (1) PE20160184A1 (hr)
PH (1) PH12015502608A1 (hr)
PL (1) PL3003278T3 (hr)
PT (1) PT3003278T (hr)
RS (1) RS58653B1 (hr)
SG (2) SG10201709861YA (hr)
SI (1) SI3003278T1 (hr)
TR (1) TR201906101T4 (hr)
UA (1) UA117829C2 (hr)
WO (1) WO2014191410A1 (hr)
ZA (1) ZA201508411B (hr)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL3554491T3 (pl) * 2016-12-15 2023-07-17 Zambon S.P.A. N-acetylocysteina do stosowania jako środek antybakteryjny
IT201700109080A1 (it) * 2017-09-28 2019-03-28 Neilos S R L Composizione per la prevenzione e/o il trattamento delle affezioni delle vie respiratorie
AU2018357886B2 (en) * 2017-11-02 2024-04-18 Zambon S.P.A. Pharmaceutical compositions comprising safinamide
US10288629B1 (en) * 2017-12-19 2019-05-14 Aeterna Zentaris, Inc. Method of assessing growth hormone deficiency in humans by a macimorelin containing composition
SG11202010322XA (en) * 2018-06-14 2020-11-27 Poxel Film-coated tablet comprising a triazine derivative for use in the treatment of diabetes
IT201800007928A1 (it) * 2018-08-07 2020-02-07 Sofar Spa Composizione contenente un agente mucolitico per il trattamento di ipersecrezione di muco e dispositivo per il suo dosaggio
CN112843008A (zh) * 2021-02-07 2021-05-28 广东赛康制药厂有限公司 一种乙酰半胱氨酸片及其制备方法
CN114886860B (zh) * 2022-06-28 2023-04-25 山东达因海洋生物制药股份有限公司 一种乙酰半胱氨酸药物组合物及其制剂和制备工艺

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2077757T5 (es) * 1990-10-19 2001-06-01 Spirig Ag Pharmazeutische Prap Preparacion farmaceutica solida con disolucion rapida que contiene la n-acetilcisteina.
GB9305058D0 (en) * 1993-03-12 1993-04-28 Penn Pharm Ltd Pharmaceutical compositions
IT1311907B1 (it) * 1999-04-06 2002-03-20 Zambon Spa Compresse deglutibili ad alto contenuto di n-acetilcisteina.
US6623754B2 (en) * 2001-05-21 2003-09-23 Noveon Ip Holdings Corp. Dosage form of N-acetyl cysteine
JP2003155232A (ja) * 2001-09-07 2003-05-27 Takeda Chem Ind Ltd 不快な臭いが低減されたl−システイン配合固形製剤およびその製造方法
US20080139654A1 (en) * 2006-12-09 2008-06-12 Eric Mott Soderling Acetaminophen compositions having minimized side effects including reduced hepatotoxicity
IT1399492B1 (it) * 2010-04-13 2013-04-19 Alpex Pharma Sa Composizioni farmaceutiche effervescenti contenenti n-acetilcisteina.
EP2574333B1 (en) 2011-09-27 2017-01-11 Friulchem SpA N-acetylcysteine effervescent tablet and its therapeutical applications

Also Published As

Publication number Publication date
US9808427B2 (en) 2017-11-07
EP3003278B1 (en) 2019-02-27
EA031856B1 (ru) 2019-03-29
TR201906101T4 (tr) 2019-05-21
AU2014273148B2 (en) 2019-02-28
SG10201709861YA (en) 2018-01-30
BR112015029038B1 (pt) 2022-12-06
CN105228595B (zh) 2019-01-04
JP2016520108A (ja) 2016-07-11
PT3003278T (pt) 2019-05-14
EA201592172A1 (ru) 2016-05-31
UA117829C2 (uk) 2018-10-10
MX2015016130A (es) 2016-08-08
JP6438013B2 (ja) 2018-12-12
PE20160184A1 (es) 2016-04-27
AU2014273148A1 (en) 2015-11-26
ITMI20130874A1 (it) 2014-11-30
PH12015502608B1 (en) 2016-02-29
RS58653B1 (sr) 2019-05-31
SG11201509177VA (en) 2015-12-30
BR112015029038A2 (pt) 2017-07-25
HUE044880T2 (hu) 2019-11-28
MY174005A (en) 2020-03-03
IL242439B (en) 2020-01-30
EP3003278A1 (en) 2016-04-13
LT3003278T (lt) 2019-05-10
DK3003278T3 (da) 2019-05-06
US20160113876A1 (en) 2016-04-28
CA2911474A1 (en) 2014-12-04
ZA201508411B (en) 2022-03-30
PL3003278T3 (pl) 2019-07-31
PH12015502608A1 (en) 2016-02-29
CY1122114T1 (el) 2020-07-31
MX366917B (es) 2019-07-30
CA2911474C (en) 2021-04-13
CN105228595A (zh) 2016-01-06
WO2014191410A1 (en) 2014-12-04
SI3003278T1 (sl) 2019-08-30
ES2721649T3 (es) 2019-08-02

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