HK39094A - Aqueous steroid formulations for nasal administration - Google Patents

Aqueous steroid formulations for nasal administration Download PDF

Info

Publication number
HK39094A
HK39094A HK39094A HK39094A HK39094A HK 39094 A HK39094 A HK 39094A HK 39094 A HK39094 A HK 39094A HK 39094 A HK39094 A HK 39094A HK 39094 A HK39094 A HK 39094A
Authority
HK
Hong Kong
Prior art keywords
amount
formulation
inflammatory steroid
polysorbate
propylene glycol
Prior art date
Application number
HK39094A
Other languages
English (en)
French (fr)
Inventor
Joel Benjamin Eric
Tyabji Anik Shabbir
Tracy Lin Ya-Yin
Original Assignee
Syntex Pharmaceuticals International Limited
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 Syntex Pharmaceuticals International Limited filed Critical Syntex Pharmaceuticals International Limited
Publication of HK39094A publication Critical patent/HK39094A/en

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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
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/16Otologicals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (9)

  1. Verfahren zur Herstellung einer im wesentlichen nicht stechenden, wäßrigen entzündungshemmenden Steroidformulierung, die zur intranasalen Verabreichung geeignet ist, umfassend das Lösen von einem entzündungshemmenden Steroid in einer Menge zwischen 0,01% und 0,05% (Gew/Vol); Propylenglykol in einer Menge zwischen 2% und 10% (Gew/ Vol); PEG 400 in einer Menge zwischen 10% und 25% (Gew/Vol); und Polysorbat 20 in einer Menge zwischen 1% und 4% (Gew/Vol) in Wasser.
  2. Verfahren nach Anspruch 1, umfassend das Lösen von einem entzündungshemmendes Steroid in einer Menge zwischen 0,01% und 0,05% (Gew/Vol); Propylenglykol in einer Menge zwischen 2% und 10% (Gew/ Vol); PEG 400 in einer Menge zwischen 10% und 25% (Gew/Vol); Polysorbat 20 in einer Menge zwischen 1% und 4% (Gew/Vol); einer wirksamen Menge an Konservierungsmittel; einer wirksamen Menge an Antioxidans; einer wirksamen Menge an Stabilisator; und pH-Puffer, ausreichend, um den pH der resultierenden Lösung auf zwischen 3,5 und 7 einzustellen.
  3. Verfahren nach Anspruch 2, umfassend das Lösen von Konservierungsmittel in einer Menge zwischen 0,02% und 0,08% (Gew/Vol); Antioxidans in einer Menge zwischen 0,001% und 0,05% (Gew/Vol); und Stabilisator in einer Menge zwischen 0,005% und 0,05% (Gew/Vol).
  4. Verfahren nach den Ansprüchen 1, 2 oder 3, worin das entzündungshemmende Steroid Flunisolid ist.
  5. Verfahren nach den Ansprüchen 1, 2, 3 oder 4, welches außerdem das Lösen von Sorbit in einer Menge zwischen 0,00%1 und 5% (Gew/ Vol) umfaßt.
  6. Verfahren nach Anspruch 2, umfassend das Lösen von Flunisolid-Hemihydrat in einer Menge von 0,025% (Gew/Vol); Propylenglykol in einer Menge von 5% (Gew/Vol); PEG 400 in einer Menge von 20% (Gew/Vol); Polysorbat 20 in einer Menge von 2,50% (Gew/Vol); Benzalkoniumchlorid in einer Menge von 0,035% (Gew/Vol); Dinatrium-EDTA in einer Menge von 0,01% (Gew/Vol); BHT in einer Menge von 0,01% (Gew/Vol); Citronensäure in einer Menge von 0,005% (Gew/Vol); Natriumcitrat-Dihydrat in einer Menge von 0,00765% (Gew/ Vol); Sorbit in einer Menge von 2,00% (Gew/Vol); worin der pH der resultierenden Lösung auf 5,2 eingestellt wird.
HK39094A 1986-05-22 1994-04-21 Aqueous steroid formulations for nasal administration HK39094A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US06/866,171 US4782047A (en) 1986-05-22 1986-05-22 Aqueous steroid formulations for nasal administration

Publications (1)

Publication Number Publication Date
HK39094A true HK39094A (en) 1994-04-29

Family

ID=25347059

Family Applications (1)

Application Number Title Priority Date Filing Date
HK39094A HK39094A (en) 1986-05-22 1994-04-21 Aqueous steroid formulations for nasal administration

Country Status (19)

Country Link
US (1) US4782047A (de)
EP (1) EP0246652B1 (de)
JP (1) JP2521291B2 (de)
KR (1) KR950008308B1 (de)
AT (1) ATE65183T1 (de)
AU (1) AU609718B2 (de)
CA (1) CA1288048C (de)
DE (1) DE3771389D1 (de)
DK (1) DK175238B1 (de)
ES (1) ES2031467T3 (de)
FI (1) FI88459C (de)
GR (1) GR3002317T3 (de)
HK (1) HK39094A (de)
IE (1) IE60259B1 (de)
IL (1) IL82615A (de)
IT (1) IT1205667B (de)
NO (1) NO173365C (de)
NZ (1) NZ220394A (de)
ZA (1) ZA873663B (de)

Families Citing this family (35)

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US4983595A (en) * 1986-05-22 1991-01-08 Syntex (U.S.A.) Inc. Aqueous steroid formulations for nasal administration
JPH0311016A (ja) * 1989-06-09 1991-01-18 Tokyo Tanabe Co Ltd ピリド[1,2―a]ピリミジン誘導体の水性製剤
GB9103824D0 (en) * 1991-02-23 1991-04-10 Fisons Ag Formulation
US5338732A (en) * 1991-06-18 1994-08-16 Bristol-Myers Squibb Company Megestrol acetate formulation
WO1995011042A1 (en) * 1993-10-21 1995-04-27 Hisamitsu Pharmaceutical Co., Inc. Pernasal composition and pernasal preparation containing the same
US5762917A (en) * 1994-09-27 1998-06-09 Virotex Corporation Method and composition for cleansing wounds with minimal cytotoxicity for minimal scarring
US5976573A (en) * 1996-07-03 1999-11-02 Rorer Pharmaceutical Products Inc. Aqueous-based pharmaceutical composition
US6241969B1 (en) * 1998-06-26 2001-06-05 Elan Corporation Plc Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
US8466134B1 (en) 1998-06-26 2013-06-18 Athena Neurosciences, Inc. Aqueous compositions containing corticosteroids for nasal and pulmonary delivery
GB9918559D0 (en) * 1999-08-07 1999-10-06 Glaxo Wellcome Kk Novel pharmaceutical formulation
US20040115133A1 (en) * 2000-05-10 2004-06-17 Wermeling Daniel P. Intranasal opioid compositions
US6610271B2 (en) * 2000-05-10 2003-08-26 University Of Kentucky Research Foundation System and method for intranasal administration of lorazepam
US20060083691A1 (en) * 2000-05-10 2006-04-20 Wermeling Daniel P Intranasal opioid compositions, delivery devices and methods of using same
AU2001286518A1 (en) 2000-08-15 2002-02-25 University Of Kentucky Research Foundation Programmable multi-dose intranasal drug delivery device
US20040176359A1 (en) * 2001-02-20 2004-09-09 University Of Kentucky Research Foundation Intranasal Benzodiazepine compositions
GB2389530B (en) 2002-06-14 2007-01-10 Cipla Ltd Pharmaceutical compositions
CA2493764C (en) 2002-08-01 2011-05-24 Aesgen, Inc. Improved treatment of cancer with glutamine
US7148211B2 (en) * 2002-09-18 2006-12-12 Genzyme Corporation Formulation for lipophilic agents
US7404489B1 (en) 2003-03-04 2008-07-29 Qol Medical, Llc Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
JP5238779B2 (ja) * 2003-04-25 2013-07-17 ロート製薬株式会社 点鼻剤
JP4632687B2 (ja) * 2003-04-25 2011-02-16 ロート製薬株式会社 点鼻剤
WO2005065185A2 (en) * 2003-12-24 2005-07-21 Collegium Pharmaceuticals, Inc. Temperature-stable formulations, and methods of development thereof
GB0400804D0 (en) 2004-01-14 2004-02-18 Innoscience Technology Bv Pharmaceutical compositions
US20060045850A1 (en) * 2004-08-30 2006-03-02 Qpharma, Llc Nasal delivery of cyclodextrin complexes of anti-inflammatory steroids
JP5607291B2 (ja) 2004-11-24 2014-10-15 メダ ファーマシューティカルズ インコーポレイテッド アゼラスチンを含む組成物およびその使用方法
WO2007022345A2 (en) * 2005-08-17 2007-02-22 Fleming And Company, Pharmaceuticals Vitamin b12 nasal spray and method of use
KR100767976B1 (ko) 2006-08-25 2007-10-18 한국유나이티드제약 주식회사 비내 건조증에 효과적인 약제학적 조성물
CN101678112B (zh) 2007-01-19 2016-08-31 哈南亚有限公司 用于递送治疗剂的方法和组合物
US20080275030A1 (en) 2007-01-19 2008-11-06 Sveinbjorn Gizurarson Methods and Compositions for the Delivery of a Therapeutic Agent
JP2011001317A (ja) * 2009-06-19 2011-01-06 Fumakilla Ltd 鼻用洗浄剤
WO2014145067A1 (en) * 2013-03-15 2014-09-18 Medicis Pharmaceutical Corporation Topical compositions of flunisolide and methods of treatment
US11135155B2 (en) 2014-07-08 2021-10-05 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
JP6097787B2 (ja) * 2015-06-09 2017-03-15 パル ファーマシューティカル, インコーポレーテッド 鼻内送達用シアノコバラミン低粘度水性製剤
US11510859B2 (en) 2015-07-16 2022-11-29 Marinomed Biotech Ag Method for improving aqueous solubility of water-insoluble or slightly water-soluble drugs
EA036233B1 (ru) 2015-07-16 2020-10-16 Мариномед Биотек Аг Способ улучшения растворимости в воде лекарственных средств, нерастворимых или слаборастворимых в воде

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US2989437A (en) * 1955-06-08 1961-06-20 Upjohn Co Anti-inflammatory and anti-bacterial decongestant nasal spray compositions
MX3864E (es) * 1975-05-27 1981-08-26 Syntex Corp Un proceso para prepara el compuesto cristalino 6-fluiro-11b 21-dihiroxi-16 17-isopropilidendioxipregna-1 4-dien-3 20-diona
DE2750090A1 (de) * 1976-11-19 1978-06-01 Sandoz Ag Neue verabreichungsformen fuer organische verbindungen
US4444762A (en) * 1980-04-04 1984-04-24 Nelson Research & Development Company Vehicle composition containing 1-substituted azacyclopentan-2-ones
US4344940A (en) * 1981-11-30 1982-08-17 E. R. Squibb & Sons, Inc. Steroid formulation containing dipotassium EDTA
US4603131A (en) * 1982-04-26 1986-07-29 Bernstein Joel E Method and composition for treating and preventing irritation of the mucous membranes of the nose

Also Published As

Publication number Publication date
GR3002317T3 (en) 1992-12-30
NO872127D0 (no) 1987-05-21
EP0246652A3 (en) 1988-02-03
AU7327387A (en) 1987-11-26
FI872231L (fi) 1987-11-23
EP0246652B1 (de) 1991-07-17
AU609718B2 (en) 1991-05-09
KR950008308B1 (ko) 1995-07-27
CA1288048C (en) 1991-08-27
IL82615A (en) 1991-11-21
NO872127L (no) 1987-11-23
EP0246652A2 (de) 1987-11-25
NO173365B (no) 1993-08-30
NZ220394A (en) 1990-04-26
KR870010862A (ko) 1987-12-18
IT8720621A0 (it) 1987-05-21
ES2031467T3 (es) 1992-12-16
DK258687D0 (da) 1987-05-21
FI872231A0 (fi) 1987-05-21
IE871335L (en) 1987-11-22
NO173365C (no) 1993-12-08
DK258687A (da) 1987-11-23
FI88459C (fi) 1993-05-25
IT1205667B (it) 1989-03-31
IE60259B1 (en) 1994-06-29
US4782047A (en) 1988-11-01
DE3771389D1 (de) 1991-08-22
DK175238B1 (da) 2004-07-19
ZA873663B (en) 1988-12-28
JP2521291B2 (ja) 1996-08-07
ATE65183T1 (de) 1991-08-15
JPS62283927A (ja) 1987-12-09
IL82615A0 (en) 1987-11-30
FI88459B (fi) 1993-02-15

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Legal Events

Date Code Title Description
PF Patent in force
PC Patent ceased (i.e. patent has lapsed due to the failure to pay the renewal fee)

Effective date: 20060521