CA2484724A1 - Pharmaceutical formulations - Google Patents

Pharmaceutical formulations Download PDF

Info

Publication number
CA2484724A1
CA2484724A1 CA002484724A CA2484724A CA2484724A1 CA 2484724 A1 CA2484724 A1 CA 2484724A1 CA 002484724 A CA002484724 A CA 002484724A CA 2484724 A CA2484724 A CA 2484724A CA 2484724 A1 CA2484724 A1 CA 2484724A1
Authority
CA
Canada
Prior art keywords
desmopressin
carrier material
dosage form
pharmaceutical formulations
pne
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.)
Granted
Application number
CA002484724A
Other languages
French (fr)
Other versions
CA2484724C (en
Inventor
Anders Nilsson
Hans Lindner
Jorgen 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
Individual
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
Application filed by Individual filed Critical Individual
Publication of CA2484724A1 publication Critical patent/CA2484724A1/en
Application granted granted Critical
Publication of CA2484724C publication Critical patent/CA2484724C/en
Anticipated expiration legal-status Critical
Expired - Lifetime 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)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Epidemiology (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 wat er- soluble or water-dispersible carrier material. Desmopressin formulated in th is 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.
CA002484724A 2002-05-07 2003-05-07 Pharmaceutical formulations Expired - Lifetime CA2484724C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
GB0210397.6 2002-05-07
GBGB0210397.6A GB0210397D0 (en) 2002-05-07 2002-05-07 Pharmaceutical formulations
PCT/IB2002/004036 WO2003094885A1 (en) 2002-05-07 2002-09-20 Sublingual pharmaceutical formulation of desmopressin
IBPCT/IB02/04036 2002-09-20
PCT/IB2003/002368 WO2003094886A2 (en) 2002-05-07 2003-05-07 Desmopressin in an orodispersible dosage form

Publications (2)

Publication Number Publication Date
CA2484724A1 true CA2484724A1 (en) 2003-11-20
CA2484724C CA2484724C (en) 2007-01-16

Family

ID=29422105

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002484724A Expired - Lifetime CA2484724C (en) 2002-05-07 2003-05-07 Pharmaceutical formulations

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 (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form

Families Citing this family (41)

* 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
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
PT1500390E (en) 2003-07-25 2005-10-31 Ferring Bv PHARMACEUTICAL COMPOSITION AS A SOLID DOSAGE FORM AND METHOD OF PRODUCTION
EP1689419A4 (en) * 2003-11-10 2009-01-14 Reprise Biopharmaceutics Llc Pharmaceutical compositions including low dosages of desmopressin
EP1530967B1 (en) * 2003-11-13 2006-05-03 Ferring B.V. Blister pack and solid dosage form comprising desmopressin
SI1550439T1 (en) * 2003-12-29 2006-08-31 Ferring Bv Method for preparing a solid dosage form of desmopressin
CA2490601C (en) * 2003-12-29 2006-05-02 Ferring B.V. Method for preparing 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
SE0600482L (en) * 2006-03-02 2006-11-14 Ferring Int Ct Sa Pharmaceutical composition comprising desmopressin, silica and starch
CA2584456C (en) * 2006-03-02 2008-07-22 Ferring International Center S.A. Composition comprising desmopressin
CN101861311A (en) 2007-07-21 2010-10-13 阿尔巴尼分子研究公司 The indazole that the 5-pyridone replaces
WO2009021007A1 (en) * 2007-08-06 2009-02-12 Serenity Pharmaceuticals Corporation Methods and devices for desmopressin drug delivery
CA2722611A1 (en) 2007-11-21 2009-05-28 Decode Genetics Ehf Biaryl pde4 inhibitors for treating pulmonary and cardiovascular disorders
EP2476680B1 (en) 2008-01-11 2014-08-27 Albany Molecular Research, Inc. (1-Azinone)-Substituted Pyridoindoles
US20100286045A1 (en) 2008-05-21 2010-11-11 Bjarke Mirner Klein Methods comprising desmopressin
US11963995B2 (en) 2008-05-21 2024-04-23 Ferring B.V. Methods comprising desmopressin
NO2296686T3 (en) * 2008-05-21 2014-07-12
WO2010059836A1 (en) 2008-11-20 2010-05-27 Decode Genetics Ehf Substituted aza-bridged bicyclics for cardiovascular and cns disease
KR101675174B1 (en) 2009-01-26 2016-11-10 이스라엘 인스티튜트 포 바이올로지컬 리서치 Bicyclic heterocyclic spiro compounds
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
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
PT2442821T (en) 2009-06-18 2017-09-29 Allergan Inc Safe desmopressin administration
CA2767233A1 (en) 2009-07-14 2011-01-20 Albany Molecular Research, Inc. 5-ht3 receptor modulators, methods of making, and use thereof
NZ706991A (en) * 2010-03-29 2016-08-26 Ferring Bv A fast dissolving pharmaceutical composition
JO3112B1 (en) 2010-03-29 2017-09-20 Ferring Bv A fast dissolving pharmaceutical composition
EP3095441B1 (en) * 2010-10-08 2020-12-02 R.P. Scherer Technologies, LLC Oral vaccine fast-dissolving dosage form using starch
JP2011116764A (en) * 2011-02-08 2011-06-16 Fine Seymour H Medical composition containing low dose desmopressin
MX345674B (en) 2011-09-16 2017-02-10 Ferring Bv A 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
CN110049757A (en) 2017-01-11 2019-07-23 辉凌公司 Quickly disintegrated pharmaceutical composition
DE102017104472A1 (en) * 2017-03-03 2018-09-06 Nordmark Arzneimittel Gmbh & Co. Kg Orodispersible tablet containing burlulipase and pharmaceutical composition prepared therefrom
EP3768267A4 (en) 2018-03-20 2022-04-20 Icahn School of Medicine at Mount Sinai Kinase inhibitor compounds and compositions and methods of use
EP3906233B1 (en) 2018-12-31 2024-01-31 Icahn School of Medicine at Mount Sinai Kinase inhibitor compounds and compositions and methods of use

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AU653026B2 (en) * 1991-06-07 1994-09-15 Teikoku Seiyaku Kabushiki Kaisha Physiologically active polypeptide-containing pharmaceutical composition
JP3253127B2 (en) * 1991-06-07 2002-02-04 帝國製薬株式会社 Preparation containing bioactive polypeptide
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
GB9901819D0 (en) * 1999-01-27 1999-03-17 Scherer Corp R P Pharmaceutical compositions
EP1146800A1 (en) * 1999-01-27 2001-10-24 Spenco Medical Corporation Therapeutic magnetic insoles
US6210699B1 (en) * 1999-04-01 2001-04-03 Watson Pharmaceuticals, Inc. Oral transmucosal delivery of drugs or any other ingredients via the inner buccal cavity
GB9908014D0 (en) * 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10548839B2 (en) 2010-03-16 2020-02-04 Wei Tian Process of manufacturing a lyophilized fast dissolving, multi-phasic dosage form

Also Published As

Publication number Publication date
AU2003233118B8 (en) 2009-07-30
PT1501534E (en) 2006-09-29
HRP20041152A2 (en) 2005-04-30
NO20045345L (en) 2005-02-07
WO2003094886A2 (en) 2003-11-20
CA2484724C (en) 2007-01-16
JP2006502972A (en) 2006-01-26
DE60307082D1 (en) 2006-09-07
DE60307082T2 (en) 2007-01-18
AU2003233118A1 (en) 2003-11-11
BR0309819A (en) 2005-03-01
AU2003233118B2 (en) 2006-10-26
NO335167B1 (en) 2014-10-06
DE60307082T4 (en) 2015-04-30
HRP20041152B1 (en) 2008-01-31
WO2003094886A3 (en) 2004-07-22
NZ535861A (en) 2006-11-30

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EEER Examination request
MKEX Expiry

Effective date: 20230508