CA2417736A1 - Dispersions solides de citrate de sildenafil ayant une forte solubilite dans l'eau - Google Patents

Dispersions solides de citrate de sildenafil ayant une forte solubilite dans l'eau Download PDF

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Publication number
CA2417736A1
CA2417736A1 CA002417736A CA2417736A CA2417736A1 CA 2417736 A1 CA2417736 A1 CA 2417736A1 CA 002417736 A CA002417736 A CA 002417736A CA 2417736 A CA2417736 A CA 2417736A CA 2417736 A1 CA2417736 A1 CA 2417736A1
Authority
CA
Canada
Prior art keywords
dosage form
sildenafil citrate
water soluble
xylitol
highly water
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.)
Abandoned
Application number
CA002417736A
Other languages
English (en)
Inventor
Li-Lan Chen
Li Tao
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.)
Lavipharm Laboratories Inc
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
Application filed by Individual filed Critical Individual
Publication of CA2417736A1 publication Critical patent/CA2417736A1/fr
Abandoned legal-status Critical Current

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • A61K9/0031—Rectum, anus
    • 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
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • A61K9/0043—Nose
    • 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
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007—Drug-containing films, membranes or sheets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Reproductive Health (AREA)
  • Urology & Nephrology (AREA)
  • Zoology (AREA)
  • Otolaryngology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Cette invention se rapporte à des dispersions solides de citrate de sildénafil et à certains sucres fortement hydrosolubles, ces dispersions solides accroissant considérablement la solubilité dans l'eau du citrate de sildénafil et sa biodisponibilité. Cette invention concerne des procédés pour préparer des dispersions solides de citrate de sildénafil fortement hydrosolubles. Ces dispersions solides facilitent l'incorporation du citrate de sildénafil dans de nouvelles formes posologiques contenant du citrate de sildénafil, ce qui était jusqu'à présent impossible à mettre en pratique. Un procédé pour améliorer et/ou stimuler les réactions sexuelles chez les animaux, en particulier chez l'homme en administrant ces nouvelles formes posologiques contenant du citrate de sildénafil est également décrit.
CA002417736A 2000-07-19 2001-07-18 Dispersions solides de citrate de sildenafil ayant une forte solubilite dans l'eau Abandoned CA2417736A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US61989900A 2000-07-19 2000-07-19
US09/619,899 2000-07-19
PCT/US2001/022538 WO2002005820A1 (fr) 2000-07-19 2001-07-18 Dispersions solides de citrate de sildenafil ayant une forte solubilite dans l'eau

Publications (1)

Publication Number Publication Date
CA2417736A1 true CA2417736A1 (fr) 2002-01-24

Family

ID=24483782

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002417736A Abandoned CA2417736A1 (fr) 2000-07-19 2001-07-18 Dispersions solides de citrate de sildenafil ayant une forte solubilite dans l'eau

Country Status (4)

Country Link
EP (1) EP1301186A1 (fr)
AU (1) AU2001273545A1 (fr)
CA (1) CA2417736A1 (fr)
WO (1) WO2002005820A1 (fr)

Families Citing this family (52)

* Cited by examiner, † Cited by third party
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US20030077229A1 (en) * 1997-10-01 2003-04-24 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing cardiovascular or renal drugs
US11207805B2 (en) 2001-10-12 2021-12-28 Aquestive Therapeutics, Inc. Process for manufacturing a resulting pharmaceutical film
US8603514B2 (en) 2002-04-11 2013-12-10 Monosol Rx, Llc Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
US8765167B2 (en) 2001-10-12 2014-07-01 Monosol Rx, Llc Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US20110033542A1 (en) 2009-08-07 2011-02-10 Monosol Rx, Llc Sublingual and buccal film compositions
US8900498B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for manufacturing a resulting multi-layer pharmaceutical film
US7357891B2 (en) 2001-10-12 2008-04-15 Monosol Rx, Llc Process for making an ingestible film
US20190328679A1 (en) 2001-10-12 2019-10-31 Aquestive Therapeutics, Inc. Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
US20070281003A1 (en) 2001-10-12 2007-12-06 Fuisz Richard C Polymer-Based Films and Drug Delivery Systems Made Therefrom
US8900497B2 (en) 2001-10-12 2014-12-02 Monosol Rx, Llc Process for making a film having a substantially uniform distribution of components
US10285910B2 (en) 2001-10-12 2019-05-14 Aquestive Therapeutics, Inc. Sublingual and buccal film compositions
US20160175199A1 (en) * 2002-04-11 2016-06-23 Monosol Rx, Llc Film and Drug Delivery System Made Therefrom
DE10232113A1 (de) 2002-07-16 2004-01-29 Bayer Ag Vardenafil Hydrochlorid Trihydrat enthaltende Arzneimittel
SE0202365D0 (sv) 2002-08-05 2002-08-05 Pharmacia Ab New formulation and use thereof
US20050042177A1 (en) * 2003-07-23 2005-02-24 Elan Pharma International Ltd. Novel compositions of sildenafil free base
US20060035905A1 (en) * 2004-02-06 2006-02-16 Becton, Dickinson And Company Formulations of phosphodiesterase 5 inhibitors and methods of use
WO2005112939A1 (fr) * 2004-05-14 2005-12-01 Solvay Pharmaceuticals Gmbh Medicaments renfermant des inhibiteurs a action double de l'endopeptidase neutre et de l'endopeptidase humaine soluble et destines au traitement de la dysfonction sexuelle
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US20070020330A1 (en) 2004-11-24 2007-01-25 Medpointe Healthcare Inc. Compositions comprising azelastine and methods of use thereof
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WO2006131806A2 (fr) * 2005-06-07 2006-12-14 Pfizer Products Inc. Formes multiparticulaires comprenant des medicaments a faible solubilite et supports qui entrainent une liberation rapide de medicament
WO2007033239A2 (fr) * 2005-09-13 2007-03-22 Elan Pharma International, Limited Formulations nanoparticulaires de tadalafil
WO2007139661A1 (fr) * 2006-05-23 2007-12-06 Haley Jeffrey T Trochisques à base de xilitol et leurs procédés d'utilisation
CN102933207B (zh) * 2009-10-30 2018-02-02 Ix生物医药有限公司 快速溶解固体剂型
DE102010024866A1 (de) * 2010-06-24 2011-12-29 Pharmatech Gmbh Formulierung zur Geschmacksmaskierung
US9149959B2 (en) 2010-10-22 2015-10-06 Monosol Rx, Llc Manufacturing of small film strips
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JP5941558B2 (ja) * 2012-02-28 2016-06-29 株式会社ソウル製薬Ｓｅｏｕｌ Ｐｈａｒｍａ． Ｃｏ．， Ｌｔｄ． シルデナフィルを有効成分として含有し、且つ、苦味の隠蔽された高含量速溶フィルム
EP2649989B1 (fr) * 2012-04-13 2017-10-18 King Saud University Procédé de préparation d'une dispersion solide, dispersion solide ainsi obtenue et son utilisation
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EP0992240A4 (fr) * 1997-05-29 2003-04-16 Mochida Pharm Co Ltd Agent therapeutique destine a traiter l'anerection

Also Published As

Publication number Publication date
EP1301186A1 (fr) 2003-04-16
AU2001273545A1 (en) 2002-01-30
WO2002005820A1 (fr) 2002-01-24

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Legal Events

Date Code Title Description
FZDE Discontinued