JP2010523678A - 凍結乾燥薬学的組成物、及びその製造及び使用方法 - Google Patents

凍結乾燥薬学的組成物、及びその製造及び使用方法 Download PDF

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Publication number
JP2010523678A
JP2010523678A JP2010503077A JP2010503077A JP2010523678A JP 2010523678 A JP2010523678 A JP 2010523678A JP 2010503077 A JP2010503077 A JP 2010503077A JP 2010503077 A JP2010503077 A JP 2010503077A JP 2010523678 A JP2010523678 A JP 2010523678A
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Prior art keywords
lyophilized solid
api
solid formulation
formulation
lyophilized
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Japanese (ja)
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JP2010523678A5 (enExample
Inventor
ドゥルー、クレアー
ダーフィー、スティーブ、エル．
ホール、リチャード、ジェイ．
グエン、タム
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Cephalon France SAS
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    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/23—Calcitonins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/28—Insulins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Inorganic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Nutrition Science (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
JP2010503077A 2007-04-11 2008-04-11 凍結乾燥薬学的組成物、及びその製造及び使用方法 Pending JP2010523678A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07290443A EP1980240A1 (en) 2007-04-11 2007-04-11 Lyophilized pharmaceutical compositions and methods of making and using same
PCT/US2008/004755 WO2008127679A1 (en) 2007-04-11 2008-04-11 Lyophilized pharmaceutical compositions and methods of making and using same

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2014165583A Division JP2015028030A (ja) 2007-04-11 2014-08-15 凍結乾燥薬学的組成物、及びその製造及び使用方法

Publications (2)

Publication Number Publication Date
JP2010523678A true JP2010523678A (ja) 2010-07-15
JP2010523678A5 JP2010523678A5 (enExample) 2012-06-14

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Family Applications (2)

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JP2010503077A Pending JP2010523678A (ja) 2007-04-11 2008-04-11 凍結乾燥薬学的組成物、及びその製造及び使用方法
JP2014165583A Pending JP2015028030A (ja) 2007-04-11 2014-08-15 凍結乾燥薬学的組成物、及びその製造及び使用方法

Family Applications After (1)

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JP2014165583A Pending JP2015028030A (ja) 2007-04-11 2014-08-15 凍結乾燥薬学的組成物、及びその製造及び使用方法

Country Status (5)

Country Link
EP (2) EP1980240A1 (enExample)
JP (2) JP2010523678A (enExample)
CA (1) CA2683603A1 (enExample)
MX (1) MX2009010989A (enExample)
WO (1) WO2008127679A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017535613A (ja) * 2014-11-21 2017-11-30 バイオヘイブン・ファーマシューティカル・ホールディング・カンパニー・リミテッドＢｉｏｈａｖｅｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｈｏｌｄｉｎｇ Ｃｏｍｐａｎｙ Ｌｔｄ． リルゾールの舌下製剤
JP2022533510A (ja) * 2019-03-12 2022-07-25 エデンブリッジ・ファーマシューティカルズ・リミテッド・ライアビリティ・カンパニー グリコピロレートを含む口腔内崩壊錠剤および生物学的利用率を増大させるための方法

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2359812A1 (en) * 2010-01-18 2011-08-24 Cephalon France Oral lyophilised compositions
EP2552407A1 (en) 2010-03-31 2013-02-06 Wockhardt Limited Composition comprising insulin and herbal oil for transdermal or transmucosal administration
GB201007290D0 (en) * 2010-04-30 2010-06-16 R5 Pharmaceuticals Ltd Pharmaceutical powder compositions
CN102440956B (zh) * 2011-12-21 2013-06-05 中国人民解放军第三军医大学 自乳化舒马曲坦及其盐制剂的制备方法
FR2987267B1 (fr) * 2012-02-28 2015-01-16 Debregeas Et Associes Pharma Application du modafinil dans le traitement de substitution des cacainomanes
GR20120100181A (el) * 2012-03-28 2013-10-15 Μαριαννα Αχιλλεα Παπαμιχαηλ Νεες λυοφιλοποιημενες φαρμακοτεχνικες και καλυντικοτεχνικες μορφες λυοφιλοποιημενων γαλακτωματων
EP2895153A1 (en) * 2012-09-11 2015-07-22 University Of The Witwatersrand, Johannesburg Fast dissolving ocular insert
WO2017072774A1 (en) * 2015-10-29 2017-05-04 Solubest Ltd Pharmaceutical compositions for transmucosal delivery
US9650338B1 (en) 2016-07-29 2017-05-16 VDM Biochemicals, Inc. Opioid antagonist compounds and methods of making and using

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5008A (en) * 1847-03-13 Machinery for cleaning
JP2004534839A (ja) * 2001-07-10 2004-11-18 シーマ・ラブス、インコーポレイテッド 連続的薬剤送達システム
WO2005077336A1 (en) * 2004-02-12 2005-08-25 Korea Institute Of Science And Technology Composition and formulation of colloidal system comprising biocompatible aqueous-soluble polymer, and preparation method thereof
JP2005526021A (ja) * 2002-01-31 2005-09-02 ナショナル スターチ アンド ケミカル インベストメント ホールディング コーポレイション 多糖とポリカルボキシル化ポリマーとを含んでなる生物接着性組成物
JP2006512409A (ja) * 2002-10-31 2006-04-13 ユーエムディー， インコーポレイテッド 薬物送達用治療組成物で被覆上皮に対するもの及びそれを介するもの
WO2007034287A2 (en) * 2005-09-19 2007-03-29 University Of The Witwatersrand, Johannesburg Oramucosal pharmaceutical dosage form

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2023401A (en) * 1999-12-01 2001-06-12 Natco Pharma Limited A rapid acting freeze dired oral pharmaceutical composition for treating migraine
WO2006103657A2 (en) * 2005-03-31 2006-10-05 Dexcel Pharma Technologies Ltd. A solid composition for intra-oral delivery of insulin

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5008A (en) * 1847-03-13 Machinery for cleaning
JP2004534839A (ja) * 2001-07-10 2004-11-18 シーマ・ラブス、インコーポレイテッド 連続的薬剤送達システム
JP2005526021A (ja) * 2002-01-31 2005-09-02 ナショナル スターチ アンド ケミカル インベストメント ホールディング コーポレイション 多糖とポリカルボキシル化ポリマーとを含んでなる生物接着性組成物
JP2006512409A (ja) * 2002-10-31 2006-04-13 ユーエムディー， インコーポレイテッド 薬物送達用治療組成物で被覆上皮に対するもの及びそれを介するもの
WO2005077336A1 (en) * 2004-02-12 2005-08-25 Korea Institute Of Science And Technology Composition and formulation of colloidal system comprising biocompatible aqueous-soluble polymer, and preparation method thereof
WO2007034287A2 (en) * 2005-09-19 2007-03-29 University Of The Witwatersrand, Johannesburg Oramucosal pharmaceutical dosage form

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2017535613A (ja) * 2014-11-21 2017-11-30 バイオヘイブン・ファーマシューティカル・ホールディング・カンパニー・リミテッドＢｉｏｈａｖｅｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｈｏｌｄｉｎｇ Ｃｏｍｐａｎｙ Ｌｔｄ． リルゾールの舌下製剤
JP2021001173A (ja) * 2014-11-21 2021-01-07 バイオヘイブン・ファーマシューティカル・ホールディング・カンパニー・リミテッドＢｉｏｈａｖｅｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｈｏｌｄｉｎｇ Ｃｏｍｐａｎｙ Ｌｔｄ． リルゾールの舌下製剤
JP2022533510A (ja) * 2019-03-12 2022-07-25 エデンブリッジ・ファーマシューティカルズ・リミテッド・ライアビリティ・カンパニー グリコピロレートを含む口腔内崩壊錠剤および生物学的利用率を増大させるための方法

Also Published As

Publication number Publication date
MX2009010989A (es) 2009-10-29
EP1980240A1 (en) 2008-10-15
CA2683603A1 (en) 2008-10-23
EP2152234A1 (en) 2010-02-17
WO2008127679A1 (en) 2008-10-23
JP2015028030A (ja) 2015-02-12

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