AU2012363789B2 - Extended-release formulation for reducing the frequency of urination and method of use thereof - Google Patents

Extended-release formulation for reducing the frequency of urination and method of use thereof Download PDF

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Publication number
AU2012363789B2
AU2012363789B2 AU2012363789A AU2012363789A AU2012363789B2 AU 2012363789 B2 AU2012363789 B2 AU 2012363789B2 AU 2012363789 A AU2012363789 A AU 2012363789A AU 2012363789 A AU2012363789 A AU 2012363789A AU 2012363789 B2 AU2012363789 B2 AU 2012363789B2
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AU
Australia
Prior art keywords
release
pharmaceutical composition
extended
formulated
component
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
AU2012363789A
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English (en)
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AU2012363789A1 (en
AU2012363789A2 (en
Inventor
David A. Dill
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.)
Wellesley Pharmaceuticals LLC
Original Assignee
Wellesley Pharmaceuticals LLC
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 US13/343,332 external-priority patent/US20120135050A1/en
Priority claimed from US13/424,000 external-priority patent/US8236857B2/en
Priority claimed from US13/487,348 external-priority patent/US20120244221A1/en
Application filed by Wellesley Pharmaceuticals LLC filed Critical Wellesley Pharmaceuticals LLC
Publication of AU2012363789A1 publication Critical patent/AU2012363789A1/en
Publication of AU2012363789A2 publication Critical patent/AU2012363789A2/en
Application granted granted Critical
Publication of AU2012363789B2 publication Critical patent/AU2012363789B2/en
Priority to AU2017203418A priority Critical patent/AU2017203418B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K31/60—Salicylic acid; 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K31/12—Ketones
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/4025—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 not condensed and containing further heterocyclic rings, e.g. cromakalim
    • 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
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/472—Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725—Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/06—Anti-spasmodics
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • Pain & Pain Management (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Power-Operated Mechanisms For Wings (AREA)
  • Guiding Agricultural Machines (AREA)
AU2012363789A 2012-01-04 2012-08-22 Extended-release formulation for reducing the frequency of urination and method of use thereof Ceased AU2012363789B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2017203418A AU2017203418B2 (en) 2012-01-04 2017-05-22 Extended-release formulation for reducing the frequency of urination and method of use thereof

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US13/343,332 2012-01-04
US13/343,332 US20120135050A1 (en) 2010-07-08 2012-01-04 Extended-release formulation for reducing the frequency of urination and method of use thereof
US13/424,000 2012-03-19
US13/424,000 US8236857B2 (en) 2010-07-08 2012-03-19 Extended-release formulation for reducing the frequency of urination and method of use thereof
US13/487,348 US20120244221A1 (en) 2010-07-08 2012-06-04 Extended-release formulation for reducing the frequency of urination and method of use thereof
US13/487,348 2012-06-04
PCT/US2012/051888 WO2013103390A1 (en) 2012-01-04 2012-08-22 Extended-release formulation for reducing the frequency of urination and method of use thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2017203418A Division AU2017203418B2 (en) 2012-01-04 2017-05-22 Extended-release formulation for reducing the frequency of urination and method of use thereof

Publications (3)

Publication Number Publication Date
AU2012363789A1 AU2012363789A1 (en) 2014-07-17
AU2012363789A2 AU2012363789A2 (en) 2014-07-24
AU2012363789B2 true AU2012363789B2 (en) 2017-04-13

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Family Applications (2)

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AU2012363789A Ceased AU2012363789B2 (en) 2012-01-04 2012-08-22 Extended-release formulation for reducing the frequency of urination and method of use thereof
AU2017203418A Ceased AU2017203418B2 (en) 2012-01-04 2017-05-22 Extended-release formulation for reducing the frequency of urination and method of use thereof

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AU2017203418A Ceased AU2017203418B2 (en) 2012-01-04 2017-05-22 Extended-release formulation for reducing the frequency of urination and method of use thereof

Country Status (13)

Country Link
US (3) US8685453B2 (OSRAM)
JP (4) JP2015503583A (OSRAM)
KR (2) KR20140108675A (OSRAM)
AU (2) AU2012363789B2 (OSRAM)
BR (1) BR112014016661A8 (OSRAM)
CA (1) CA2856677A1 (OSRAM)
IL (1) IL232715A0 (OSRAM)
MX (1) MX2014008283A (OSRAM)
MY (1) MY173582A (OSRAM)
RU (1) RU2603471C2 (OSRAM)
SG (1) SG11201500407XA (OSRAM)
WO (1) WO2013103390A1 (OSRAM)
ZA (1) ZA201404606B (OSRAM)

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US9532959B2 (en) 2010-07-08 2017-01-03 Wellesley Pharmaceuticals, Llc Pharmaceutical formulation for reducing frequency of urination and method of use thereof
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WO2013149022A1 (en) * 2012-03-30 2013-10-03 Givaudan S.A. N-acyl proline derivatives as food flavouring compounds
CN106714805A (zh) * 2014-06-06 2017-05-24 韦尔斯利医药有限公司 降低排尿频率的药物制剂及其使用方法
CN107072971A (zh) * 2014-09-24 2017-08-18 韦尔斯利医药有限公司 用于减轻膀胱痉挛的药学制剂及其使用方法
WO2017039832A1 (en) * 2015-09-01 2017-03-09 Wellesley Pharmaceuticals, Llc Extended, delayed and immediate release formulation method of manufacturing and use thereof
HK1259196A1 (zh) * 2015-09-01 2019-11-29 韦尔斯利医药有限公司 延迟释放制剂、其制备方法和用途
WO2017058436A1 (en) * 2015-09-30 2017-04-06 Wellesley Pharmaceuticals, Llc Composition for reducing the frequency of urination, method of making and use thereof
TW201726114A (zh) * 2015-11-23 2017-08-01 魏斯理製藥公司 降低排尿頻率之組成物、其製備方法、及其應用
JP7229012B2 (ja) * 2018-12-25 2023-02-27 小林製薬株式会社 内服用医薬組成物
JP2019069991A (ja) * 2018-12-27 2019-05-09 ウェルズリー ファーマスーティカルズ、エルエルシー 膀胱痙攣を低減するための医薬製剤およびその使用の方法

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US7582651B2 (en) * 2002-07-11 2009-09-01 Takeda Pharmaceutical Company Limited Pyrrolopyridine derivative and use thereof
US20040054008A1 (en) * 2002-09-13 2004-03-18 Tohru Araki Medicament for treatment of nocturia
US20080085314A1 (en) * 2005-07-29 2008-04-10 Shalaby Shalaby W Solid oral formulations for combination therapy

Also Published As

Publication number Publication date
JP2015503583A (ja) 2015-02-02
AU2012363789A1 (en) 2014-07-17
ZA201404606B (en) 2015-11-25
AU2012363789A2 (en) 2014-07-24
BR112014016661A2 (pt) 2017-06-13
WO2013103390A1 (en) 2013-07-11
US20150272968A1 (en) 2015-10-01
US8685453B2 (en) 2014-04-01
AU2017203418B2 (en) 2019-01-17
IL232715A0 (en) 2014-07-31
KR20180025993A (ko) 2018-03-09
MY173582A (en) 2020-02-04
NZ626619A (en) 2017-03-31
NZ732149A (en) 2018-11-30
MX2014008283A (es) 2015-03-03
NZ721818A (en) 2017-07-28
US20130216620A1 (en) 2013-08-22
KR20140108675A (ko) 2014-09-12
US20140154320A1 (en) 2014-06-05
BR112014016661A8 (pt) 2017-07-04
AU2017203418A1 (en) 2017-06-08
JP2017031172A (ja) 2017-02-09
CA2856677A1 (en) 2013-07-11
SG11201500407XA (en) 2015-03-30
RU2603471C2 (ru) 2016-11-27
JP2018087217A (ja) 2018-06-07
RU2014131285A (ru) 2016-02-20
JP2020037575A (ja) 2020-03-12

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