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SI21026B - Stabilen, nasalno, oralno ali sublingvalno uporabljiv farmacevtski pripravek - Google Patents

Stabilen, nasalno, oralno ali sublingvalno uporabljiv farmacevtski pripravek Download PDF

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Publication number
SI21026B
SI21026B SI200120009A SI200120009A SI21026B SI 21026 B SI21026 B SI 21026B SI 200120009 A SI200120009 A SI 200120009A SI 200120009 A SI200120009 A SI 200120009A SI 21026 B SI21026 B SI 21026B
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SI
Slovenia
Prior art keywords
preparation
preparation according
desmopressin
available
pharmaceutical composition
Prior art date
Application number
SI200120009A
Other languages
English (en)
Other versions
SI21026A (sl
Inventor
Helmut Scheidl
Gerhard Hantich
Ernst Hesse
Thomas Zapf
Original Assignee
Gebro Pharma Gmbh
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=3669975&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SI21026(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gebro Pharma Gmbh filed Critical Gebro Pharma Gmbh
Publication of SI21026A publication Critical patent/SI21026A/sl
Publication of SI21026B publication Critical patent/SI21026B/sl

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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
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • A61K38/095Oxytocins; Vasopressins; Related peptides
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00General protective or antinoxious agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/12Antidiuretics, e.g. drugs for diabetes insipidus

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nutrition Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Otolaryngology (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Toxicology (AREA)
  • Emergency Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (20)

18 PATENTNI ZAHTEVKI 1. Stabilni, nasalno, oralno ali sublingvalno uporabljiv farmacevtski pripravek za uporabo pri pacientih, v obliki tekoče, zlasti vodne raztopine desmopresina kot učinkovine, pri čemer ta raztopina vsebuje osmotik in pufer, in pri katerem vrednost PH znaša med 4 in 6, prednostno 5, označen s tem, da je pufer za stabiliziranje desmopresina predstavlja jabolčna kislina.
2. Pripravek po zahtevku 1, označen s tem, da je jabolčna kislina na voljo v nizki koncentraciji, prednostno v območju 1 do 5 mM, še zlasti približno 2,5 mM.
3. Pripravek po zahtevku 1 ali 2, označen s tem, da je jabolčna kislina na voljo kot racemat.
4. Pripravek po enem od zahtevkov 1 do 3, označen s tem, da je desmopresin na voljo v nizki koncentraciji, zlasti v območju koncentracij od 0,005 do 2 mg/ml.
5. Pripravek po zahtevku 4, označen s tem, da je pri pripravku, primernem za oralno uporabo, desmopresin na voljo v koncentraciji od 0,005 do 0,04 mg/ml.
6. Pripravek po zahtevku 4, označen s tem, da je pri pripravku, primernem za nasalno uporabo, desmopresin na voljo v koncentraciji od 0,02 do 2,0 mg/ml, prednostno 0,08 do 1,0 mg/ml, zlasti 0,1 mg/ml.
7. Pripravek po zahtevku 4, označen s tem, da je pri pripravku, primernem za sublingualno uporabo, desmopresin na voljo v koncentraciji od 0,4 do 2,0 mg/ml.
8. Pripravek po enem od zahtevkov 1 do 7, označen s tem, daje za uravnavanje osmotskega tlaka uporabljen NaCl. 19
9. Pripravek po enem od zahtevkov 1 do 8, označen s tem, da je poleg jabolčne kisline uporabljen še nadaljnji pufer, npr. acetat/ocetna kislina.
10. Pripravek po enem od zahtevkov 1 do 9, označen s tem, daje brez konservansov.
11. Pripravek po enem od zahtevkov 1 do 9, označen s tem, da pripravek vsebuje 0,05 do 0,20 mg/ml benzalkonijevega klorida.
12. Pripravek po enem od zahtevkov 1 do 9, označen s tem, da pripravek vsebuje 1 do 2,5 mg/ml, zlasti 1 do 2 mg/ml metil-estra p-hidroksi-benzojeve kisline, po potrebi v kombinaciji z do 0,2 mg/ml, prednostno 0,1 do 0,2 mg/ml, zlasti 0,15 do 0,2 mg/ml propil-estra p-hidroksi-benzojeve kisline.
13. Pripravek po enem od zahtevkov 1 do 12, označen s tem, da vsebuje 0,1 mg/ml acetata desmopresina kot tudi DL-jabolčno kislino v koncentraciji 2,5 mM ter NaCl kot osmotik, po potrebi pa tudi 0,10 mg/ml benzalkonijevega klorida kot konservans, pri čemer je vrednost pH pripravka uravnana na približno 5.
14. Pripravek po enem od zahtevkov 1 do 13, označen s tem, da je jabolčna kislina na voljo v obliki soli, npr. natrijeve soli v raztopljenem stanju.
15. Postopek priprave pripravka po enem od zahtevkov 1 do 14, vsebujočega farmacevtski preparat, pri čemer se pripravek polni v steklene posode hidrolitiČnega razreda I ali II.
16. Nasalno uporabljiv farmacevtski preparat, vsebujoč pripravek po enem od zahtevkov 1 do 14.
17. Oralno uporabljiv farmacevtski preparat, vsebujoč pripravek po enem od zahtevkov 1 do 14. 20
18. Sublingvalno uporabljiv farmacevtski preparat, vsebujoč pripravek po enem od zahtevkov 1 do 14.
19. Uporaba farmacevtskega pripravka po enem od zahtevkov 1 do 14 za pripravo zdravila za zdravljenje pacientov z antidiuretičnimi obolenji, zlasti enuresis nocturna ali diabetes insipidus.
20. Uporaba farmacevtskega pripravka po enem od zahtevkov 1 do 14 za pripravo zdravila za zdravljenje pacientov s krvnimi obolenji, zlasti hemofilijo A, Willebrand-Jiirgensovim sindromom ali postoperativnimi krvavitvami.
SI200120009A 2000-02-16 2001-01-10 Stabilen, nasalno, oralno ali sublingvalno uporabljiv farmacevtski pripravek SI21026B (sl)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AT0023300A AT409081B (de) 2000-02-16 2000-02-16 Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung
PCT/AT2001/000007 WO2001060394A1 (de) 2000-02-16 2001-01-10 Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung

Publications (2)

Publication Number Publication Date
SI21026A SI21026A (sl) 2003-04-30
SI21026B true SI21026B (sl) 2004-02-29

Family

ID=3669975

Family Applications (1)

Application Number Title Priority Date Filing Date
SI200120009A SI21026B (sl) 2000-02-16 2001-01-10 Stabilen, nasalno, oralno ali sublingvalno uporabljiv farmacevtski pripravek

Country Status (20)

Country Link
US (1) US20030119728A1 (sl)
EP (1) EP1255557B1 (sl)
JP (1) JP2003529562A (sl)
AT (2) AT409081B (sl)
AU (1) AU771251B2 (sl)
CA (1) CA2399822A1 (sl)
CZ (1) CZ20022686A3 (sl)
DE (1) DE50100958D1 (sl)
DK (1) DK1255557T3 (sl)
ES (1) ES2210121T3 (sl)
HU (1) HU229961B1 (sl)
NO (1) NO20023875L (sl)
NZ (1) NZ520396A (sl)
PL (1) PL357132A1 (sl)
PT (1) PT1255557E (sl)
SI (1) SI21026B (sl)
SK (1) SK285374B6 (sl)
TR (1) TR200400234T4 (sl)
WO (1) WO2001060394A1 (sl)
ZA (1) ZA200205868B (sl)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0210397D0 (en) * 2002-05-07 2002-06-12 Ferring Bv Pharmaceutical formulations
WO2003097080A1 (en) * 2002-05-15 2003-11-27 Sun Pharmaceutical Industries Limited A stable aqueous composition of a peptide
AT413078B (de) * 2002-10-10 2005-11-15 Gebro Pharma Gmbh Verwendung eines puffers auf basis von apfelsäure für die herstellung einer nasal applizierbaren zubereitung
US7094545B2 (en) 2003-04-30 2006-08-22 Ferring Bv Pharmaceutical composition as solid dosage form and method for manufacturing thereof
SI1500390T1 (sl) 2003-07-25 2006-02-28 Ferring Bv Farmacevtski dezmopresinski sestavek kot trdna dozirna oblika in postopek za njegovo pripravo
PT1530967E (pt) * 2003-11-13 2006-09-29 Ferring Bv Embalagem blister e uma forma de dosagem solida que compreende desmopressina.
US7018653B2 (en) 2003-12-29 2006-03-28 Ferring B.V. Method for preparing solid dosage form of desmopressin
JP5079257B2 (ja) * 2005-05-16 2012-11-21 株式会社三和化学研究所 Burkholderiacepaciaに対する保存剤
SE528446C2 (sv) * 2006-03-02 2006-11-14 Ferring Int Ct Sa Farmaceutisk sammansättning innefattande desmopressin, kiseldioxid och stärkelse
ES2319054B1 (es) * 2007-08-06 2010-02-12 Gp Pharm S.A. Composicion farmaceutica oral de desmopresina.
WO2009021007A1 (en) 2007-08-06 2009-02-12 Serenity Pharmaceuticals Corporation Methods and devices for desmopressin drug delivery
US20100286045A1 (en) 2008-05-21 2010-11-11 Bjarke Mirner Klein Methods comprising desmopressin
CA2724653A1 (en) 2008-05-21 2009-11-26 Ferring International Center S.A. Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia
US11963995B2 (en) 2008-05-21 2024-04-23 Ferring B.V. Methods comprising desmopressin
JO3400B1 (ar) 2010-09-30 2019-10-20 Ferring Bv مركب صيدلاني من كاربيتوسين
JP2011116764A (ja) * 2011-02-08 2011-06-16 Fine Seymour H 低用量デスモプレシンを含有する医薬組成物
HUE034209T2 (en) 2013-06-28 2018-02-28 Amgen Inc AMG 416 stable liquid preparation (velcalcetide)
JP6341777B2 (ja) * 2014-06-30 2018-06-13 リプリーズ バイオファーマシューティクス,エルエルシー 低用量デスモプレシンを含有する医薬組成物
CA2967390A1 (en) * 2014-11-20 2016-05-26 Allergan, Inc. Methods and compositions comprising desmopressin in combination with an alpha-adrenergic receptor antagonist
GB201721846D0 (en) * 2017-12-22 2018-02-07 Arecor Ltd Novel composition
WO2020237170A1 (en) 2019-05-22 2020-11-26 Biovie Inc. Formulations of terlipressin
WO2024211393A2 (en) 2023-04-04 2024-10-10 Tulex Pharmaceuticals Inc. Desmopressin oral compositions

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Also Published As

Publication number Publication date
WO2001060394A1 (de) 2001-08-23
NO20023875D0 (no) 2002-08-15
JP2003529562A (ja) 2003-10-07
AU771251B2 (en) 2004-03-18
SI21026A (sl) 2003-04-30
ES2210121T3 (es) 2004-07-01
TR200400234T4 (tr) 2004-03-22
HUP0204550A2 (en) 2003-05-28
US20030119728A1 (en) 2003-06-26
NZ520396A (en) 2004-05-28
AT409081B (de) 2002-05-27
DE50100958D1 (de) 2003-12-18
SK10492002A3 (sk) 2003-02-04
HUP0204550A3 (en) 2004-12-28
ATE253928T1 (de) 2003-11-15
ATA2332000A (de) 2001-10-15
ZA200205868B (en) 2004-02-10
NO20023875L (no) 2002-10-11
EP1255557A1 (de) 2002-11-13
PL357132A1 (en) 2004-07-12
DK1255557T3 (da) 2004-03-22
SK285374B6 (sk) 2006-12-07
PT1255557E (pt) 2004-04-30
EP1255557B1 (de) 2003-11-12
HU229961B1 (hu) 2015-03-30
AU2652001A (en) 2001-08-27
CA2399822A1 (en) 2001-08-23
CZ20022686A3 (cs) 2003-01-15

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