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WO2003094886A3 - Desmopressin in an orodispersible dosage form - Google Patents

Desmopressin in an orodispersible dosage form Download PDF

Info

Publication number
WO2003094886A3
WO2003094886A3 PCT/IB2003/002368 IB0302368W WO03094886A3 WO 2003094886 A3 WO2003094886 A3 WO 2003094886A3 IB 0302368 W IB0302368 W IB 0302368W WO 03094886 A3 WO03094886 A3 WO 03094886A3
Authority
WO
WIPO (PCT)
Prior art keywords
desmopressin
dosage form
carrier material
water
orodispersible dosage
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
PCT/IB2003/002368
Other languages
French (fr)
Other versions
WO2003094886A2 (en
Inventor
Lars Anders Ragnar Nilsson
Hans Lindner
Jensen Joergen Wittendorff
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.)
Ferring BV
Original Assignee
Ferring BV
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
Priority claimed from GBGB0210397.6A external-priority patent/GB0210397D0/en
Priority to JP2004502972A priority Critical patent/JP2006502972A/en
Priority to EP03727870A priority patent/EP1501534B1/en
Priority to KR1020047017821A priority patent/KR100632455B1/en
Priority to HK05106142.9A priority patent/HK1074393B/en
Priority to US10/513,437 priority patent/US7560429B2/en
Priority to HR20041152A priority patent/HRP20041152B1/en
Priority to NZ535861A priority patent/NZ535861A/en
Priority to DE2003607082 priority patent/DE60307082T4/en
Priority to CA002484724A priority patent/CA2484724C/en
Priority to DK03727870.2T priority patent/DK1501534T5/en
Priority to DE60307082A priority patent/DE60307082D1/en
Priority to SI200330434T priority patent/SI1501534T1/en
Priority to ES03727870.2T priority patent/ES2266820T4/en
Application filed by Ferring BV filed Critical Ferring BV
Priority to AU2003233118A priority patent/AU2003233118B8/en
Priority to MXPA04010926A priority patent/MXPA04010926A/en
Priority to BR0309819-2A priority patent/BR0309819A/en
Publication of WO2003094886A2 publication Critical patent/WO2003094886A2/en
Publication of WO2003094886A3 publication Critical patent/WO2003094886A3/en
Priority to IL164519A priority patent/IL164519A/en
Anticipated expiration legal-status Critical
Priority to NO20045345A priority patent/NO335167B1/en
Priority to US12/487,116 priority patent/US7947654B2/en
Priority to US13/110,619 priority patent/US8802624B2/en
Priority to US14/326,939 priority patent/US9220747B2/en
Priority to US14/947,261 priority patent/US9504647B2/en
Priority to US15/333,503 priority patent/US9919025B2/en
Priority to US15/881,123 priority patent/US10307459B2/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/10—Drugs for disorders of the urinary system of the bladder
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2063—Proteins, e.g. gelatin
    • 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
    • A61K9/2095—Tabletting 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

Landscapes

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

Abstract

Good bioavailability of desmopressin can be obtained by means of an orodispersible pharmaceutical dosage form which provides for a rapid dispersion of the active substance in the oral cavity. Thereby, desmopressin may be absorbed across the sublingual, buccal and/or gingival mucosa, and/or from the gastrointestinal tract for systemic distribution. Preferred dosage forms comprise desmopressin and an open matrix network which is an inert water-soluble or water-dispersible carrier material. Desmopressin formulated in this way is useful for voiding postponement, or the treatment or prevention of incontinence, primary nocturnal enuresis (PNE), nocturia or central diabetes insipidus. A process for the production of the dosage form by subliming solvent from a composition comprising desmopressin and a solution of carrier material is also provided.
PCT/IB2003/002368 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form Ceased WO2003094886A2 (en)

Priority Applications (24)

Application Number Priority Date Filing Date Title
SI200330434T SI1501534T1 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form
AU2003233118A AU2003233118B8 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form
KR1020047017821A KR100632455B1 (en) 2002-05-07 2003-05-07 Pharmaceutical preparations
HK05106142.9A HK1074393B (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form
US10/513,437 US7560429B2 (en) 2002-05-07 2003-05-07 Orodispersible dosage forms of desmopressin acetate
HR20041152A HRP20041152B1 (en) 2002-05-07 2003-05-07 PHARMACEUTICAL FORMULATIONS
NZ535861A NZ535861A (en) 2002-05-07 2003-05-07 Desmopressin acetate in an orodispersible dosage form that disintegrates in the mouth within 10 seconds
DE2003607082 DE60307082T4 (en) 2002-05-07 2003-05-07 PHARMACEUTICAL COMPOSITION WITH DESMOPRESSIN DISPERSIBLE IN THE MOUTH VALVE
CA002484724A CA2484724C (en) 2002-05-07 2003-05-07 Pharmaceutical formulations
DK03727870.2T DK1501534T5 (en) 2002-05-07 2003-05-07 Desmopressin in orodispersible dosage form
DE60307082A DE60307082D1 (en) 2002-05-07 2003-05-07 PHARMACEUTICAL COMPOSITION WITH DESMOPRESSIN DISPERSIBLE IN THE MOUTH VALVE
EP03727870A EP1501534B1 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form
ES03727870.2T ES2266820T4 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form
JP2004502972A JP2006502972A (en) 2002-05-07 2003-05-07 Orally dispersible pharmaceutical formulation of desmopressin
BR0309819-2A BR0309819A (en) 2002-05-07 2003-05-07 Pharmaceutical Formulations
MXPA04010926A MXPA04010926A (en) 2002-05-07 2003-05-07 Pharmaceutical formulations.
IL164519A IL164519A (en) 2002-05-07 2004-10-12 Orodispersible pharmaceutical dosage form of desmopressin, a process for its preparation and its use
NO20045345A NO335167B1 (en) 2002-05-07 2004-12-06 Pharmaceutical dosage form
US12/487,116 US7947654B2 (en) 2002-05-07 2009-06-18 Pharmaceutical formulations
US13/110,619 US8802624B2 (en) 2002-05-07 2011-05-18 Methods of treatment using orodispersible desmopressin pharmaceutical formulations
US14/326,939 US9220747B2 (en) 2002-05-07 2014-07-09 Methods using desmopressin acetate in orodispersible form
US14/947,261 US9504647B2 (en) 2002-05-07 2015-11-20 Pharmaceutical formulations of desmopressin
US15/333,503 US9919025B2 (en) 2002-05-07 2016-10-25 Pharmaceutical formulations of desmopressin
US15/881,123 US10307459B2 (en) 2002-05-07 2018-01-26 Pharmaceutical formulations of desmopressin

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GBGB0210397.6A GB0210397D0 (en) 2002-05-07 2002-05-07 Pharmaceutical formulations
GB0210397.6 2002-05-07
PCT/IB2002/004036 WO2003094885A1 (en) 2002-05-07 2002-09-20 Sublingual pharmaceutical formulation of desmopressin
IBPCT/IB02/04036 2002-09-20

Related Child Applications (3)

Application Number Title Priority Date Filing Date
US10/513,437 A-371-Of-International US7560429B2 (en) 2002-05-07 2003-05-07 Orodispersible dosage forms of desmopressin acetate
US10513437 A-371-Of-International 2003-05-07
US12/487,116 Continuation US7947654B2 (en) 2002-05-07 2009-06-18 Pharmaceutical formulations

Publications (2)

Publication Number Publication Date
WO2003094886A2 WO2003094886A2 (en) 2003-11-20
WO2003094886A3 true WO2003094886A3 (en) 2004-07-22

Family

ID=29422105

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/002368 Ceased WO2003094886A2 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form

Country Status (10)

Country Link
JP (1) JP2006502972A (en)
AU (1) AU2003233118B8 (en)
BR (1) BR0309819A (en)
CA (1) CA2484724C (en)
DE (2) DE60307082T4 (en)
HR (1) HRP20041152B1 (en)
NO (1) NO335167B1 (en)
NZ (1) NZ535861A (en)
PT (1) PT1501534E (en)
WO (1) WO2003094886A2 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7405203B2 (en) 2002-05-07 2008-07-29 Reprise Biopharmaceutics, Llc Pharmaceutical compositions including low dosages of desmopressin
US9375530B2 (en) 2007-08-06 2016-06-28 Allergan, Inc. Methods and devices for desmopressin drug delivery

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JP4523265B2 (en) * 2002-11-13 2010-08-11 旭化成ファーマ株式会社 Orally disintegrating preparations for the treatment of urination disorders
US7772188B2 (en) 2003-01-28 2010-08-10 Ironwood Pharmaceuticals, Inc. Methods and compositions for the treatment of gastrointestinal disorders
US7094545B2 (en) 2003-04-30 2006-08-22 Ferring Bv Pharmaceutical composition as solid dosage form and method for manufacturing thereof
ES2243840T3 (en) 2003-07-25 2005-12-01 Ferring B.V. PHARMACEUTICAL COMPOSITION OF DESMOPRESIN AS A SOLID PHARMACEUTICAL FORM OF DOSAGE AND METHOD FOR THE MANUFACTURE OF THE SAME.
EP2322198A2 (en) * 2003-11-10 2011-05-18 Reprise Biopharmaceutics, LLC Pharmaceutical compositions including low dosages of desmopressin
DE60305043T2 (en) * 2003-11-13 2006-11-30 Ferring B.V. Blister packaging and solid dosage form containing desmopressin
CA2490601C (en) * 2003-12-29 2006-05-02 Ferring B.V. Method for preparing solid dosage form of desmopressin
SI1550439T1 (en) * 2003-12-29 2006-08-31 Ferring Bv Method for preparing a solid dosage form of desmopressin
US7018653B2 (en) 2003-12-29 2006-03-28 Ferring B.V. Method for preparing solid dosage form of desmopressin
GB0406048D0 (en) * 2004-03-18 2004-04-21 Ardana Bioscience Ltd Drug formulations
US7972621B2 (en) * 2004-06-03 2011-07-05 R.P. Scherer Technologies, Llc Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight
WO2007098945A2 (en) * 2006-03-02 2007-09-07 Ferring International Center S.A. Stable solid dosage form comprising desmopressin
SE528446C2 (en) * 2006-03-02 2006-11-14 Ferring Int Ct Sa Pharmaceutical composition comprising desmopressin, silica and starch
BRPI0814772A2 (en) 2007-07-21 2015-03-03 Albany Molecular Res Inc INDAZOES REPLACED BY 5-PYRIDINONE
US20090136473A1 (en) 2007-11-21 2009-05-28 Decode Genetics Ehf Biaryl pde4 inhibitors for treating pulmonary and cardiovascular disorders
ES2523580T3 (en) 2008-01-11 2014-11-27 Albany Molecular Research, Inc. Pyridoindoles substituted with (1-Azinone)
US20100286045A1 (en) 2008-05-21 2010-11-11 Bjarke Mirner Klein Methods comprising desmopressin
SI3225250T1 (en) * 2008-05-21 2019-11-29 Ferring Bv 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
WO2010059836A1 (en) 2008-11-20 2010-05-27 Decode Genetics Ehf Substituted aza-bridged bicyclics for cardiovascular and cns disease
RU2506266C2 (en) 2009-01-26 2014-02-10 Израэл Инститьют Фо Байолоджикал Рисерч Bicyclic heterocyclic spirocompounds
TWI471127B (en) 2009-04-29 2015-02-01 Intervet Int Bv A process for preparing an orally disintegrating tablet for human use, an orally disintegrating tablet thus obtained and a package containing the orally disintegrating tablet
TWI468157B (en) * 2009-04-29 2015-01-11 Intervet Int Bv Process to form a tablet, system for performing this process and package comprising the tablet
MX343193B (en) 2009-06-18 2016-10-26 Allergan Inc Safe desmopressin administration.
KR20120104512A (en) 2009-07-14 2012-09-21 알바니 몰레큘라 리써치, 인크. 5-ht3 receptor modulators, methods of making, and use thereof
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form
JO3112B1 (en) 2010-03-29 2017-09-20 Ferring Bv A fast dissolving pharmaceutical composition
CA2793485A1 (en) * 2010-03-29 2011-10-06 Ferring B.V. A fast dissolving pharmaceutical composition
DK3095441T3 (en) * 2010-10-08 2021-01-11 Scherer Technologies Llc R P QUICK DISSOLVING DOSAGE FORM OF AN ORAL VACCINE USING STARCH
JP2011116764A (en) * 2011-02-08 2011-06-16 Fine Seymour H Medical composition containing low dose desmopressin
US9731018B2 (en) 2011-09-16 2017-08-15 Ferring B.V. Fast dissolving pharmaceutical composition
JP5928159B2 (en) * 2012-05-28 2016-06-01 ニプロ株式会社 Pharmaceutical composition
TW201422254A (en) * 2012-11-21 2014-06-16 Ferring Bv Composition for immediate and extended release
CN103993061B (en) * 2014-05-20 2018-03-23 海南美合泰生物科技有限公司 A kind of production method of Isin glue collagen
KR20150144209A (en) * 2014-06-16 2015-12-24 훼링 비.브이. Pharmaceutical composition comprising stabilized desmopressin or pharmaceutically acceptable salt thereof
JP6341777B2 (en) * 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 Pharmaceutical composition containing low dose desmopressin
KR20190104322A (en) 2017-01-11 2019-09-09 훼링 비.브이. Fast disintegrating pharmaceutical composition
DE102017104472A1 (en) 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Orodispersible tablet containing burlulipase and pharmaceutical composition prepared therefrom
CA3093340A1 (en) 2018-03-20 2019-09-26 Icahn School Of Medicine At Mount Sinai Kinase inhibitor compounds and compositions and methods of use
JP2022515652A (en) 2018-12-31 2022-02-21 アイカーン スクール オブ メディシン アット マウント サイナイ Kinase inhibitor compounds and compositions and methods of use
EP4603546A1 (en) * 2022-12-28 2025-08-20 Chugai Seiyaku Kabushiki Kaisha Solid dispersion containing substance to be dispersed, pharmaceutical composition containing same, and production methods therefor

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US5298256A (en) * 1992-04-28 1994-03-29 Corint, Ltd. Desmopressin buccal patch composition
US5849322A (en) * 1995-10-23 1998-12-15 Theratech, Inc. Compositions and methods for buccal delivery of pharmaceutical agents
WO2000044351A1 (en) * 1999-01-27 2000-08-03 R.P. Scherer Corporation Fast dispersing dosage forms free of gelatin
WO2000059423A1 (en) * 1999-04-01 2000-10-12 Watson Pharmaceuticals, Inc. Oral transmucosal delivery of drugs or any other ingredients via the inner buccal cavity
WO2000061117A1 (en) * 1999-04-08 2000-10-19 R.P. Scherer Corporation Fast-dispersing dosage forms containing fish gelatin

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EP0517211A1 (en) * 1991-06-07 1992-12-09 Teikoku Seiyaku Kabushiki Kaisha Physiologically active polypeptide containing pharmaceutical composition
US5298256A (en) * 1992-04-28 1994-03-29 Corint, Ltd. Desmopressin buccal patch composition
US5849322A (en) * 1995-10-23 1998-12-15 Theratech, Inc. Compositions and methods for buccal delivery of pharmaceutical agents
WO2000044351A1 (en) * 1999-01-27 2000-08-03 R.P. Scherer Corporation Fast dispersing dosage forms free of gelatin
WO2000059423A1 (en) * 1999-04-01 2000-10-12 Watson Pharmaceuticals, Inc. Oral transmucosal delivery of drugs or any other ingredients via the inner buccal cavity
WO2000061117A1 (en) * 1999-04-08 2000-10-19 R.P. Scherer Corporation Fast-dispersing dosage forms containing fish gelatin

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7405203B2 (en) 2002-05-07 2008-07-29 Reprise Biopharmaceutics, Llc Pharmaceutical compositions including low dosages of desmopressin
US7579321B2 (en) 2002-05-07 2009-08-25 Reprise Biopharmaceutics, Llc Pharmaceutical compositions including low dosages of desmopressin
US7799761B2 (en) 2002-05-07 2010-09-21 Allergan, Inc. Pharmaceutical compositions including low dosages of desmopressin
US9375530B2 (en) 2007-08-06 2016-06-28 Allergan, Inc. Methods and devices for desmopressin drug delivery

Also Published As

Publication number Publication date
BR0309819A (en) 2005-03-01
HRP20041152A2 (en) 2005-04-30
CA2484724A1 (en) 2003-11-20
CA2484724C (en) 2007-01-16
PT1501534E (en) 2006-09-29
DE60307082D1 (en) 2006-09-07
AU2003233118B8 (en) 2009-07-30
NZ535861A (en) 2006-11-30
NO20045345L (en) 2005-02-07
AU2003233118A1 (en) 2003-11-11
JP2006502972A (en) 2006-01-26
WO2003094886A2 (en) 2003-11-20
HRP20041152B1 (en) 2008-01-31
AU2003233118B2 (en) 2006-10-26
NO335167B1 (en) 2014-10-06
DE60307082T4 (en) 2015-04-30
DE60307082T2 (en) 2007-01-18

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