SG11201805810PA - Extended, delayed and immediate release formulation method of manufacturing and use thereof - Google Patents

Extended, delayed and immediate release formulation method of manufacturing and use thereof

Info

Publication number
SG11201805810PA
SG11201805810PA SG11201805810PA SG11201805810PA SG11201805810PA SG 11201805810P A SG11201805810P A SG 11201805810PA SG 11201805810P A SG11201805810P A SG 11201805810PA SG 11201805810P A SG11201805810P A SG 11201805810PA SG 11201805810P A SG11201805810P A SG 11201805810PA
Authority
SG
Singapore
Prior art keywords
delayed
extended
manufacturing
immediate release
release formulation
Prior art date
Application number
SG11201805810PA
Inventor
David Dill
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 US14/842,509 external-priority patent/US10105330B2/en
Application filed by Wellesley Pharmaceuticals Llc filed Critical Wellesley Pharmaceuticals Llc
Publication of SG11201805810PA publication Critical patent/SG11201805810PA/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • A61K31/4025Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • A61K31/403Heterocyclic 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
    • A61K31/404Indoles, e.g. pindolol
    • A61K31/405Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, ***e
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/472Non-condensed isoquinolines, e.g. papaverine
    • A61K31/4725Non-condensed isoquinolines, e.g. papaverine containing further heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/60Salicylic acid; Derivatives thereof
    • A61K31/612Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
SG11201805810PA 2015-09-01 2016-07-07 Extended, delayed and immediate release formulation method of manufacturing and use thereof SG11201805810PA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/842,509 US10105330B2 (en) 2012-01-04 2015-09-01 Extended, delayed and immediate release formulation method of manufacturing and use thereof
PCT/US2016/041352 WO2017039832A1 (en) 2015-09-01 2016-07-07 Extended, delayed and immediate release formulation method of manufacturing and use thereof

Publications (1)

Publication Number Publication Date
SG11201805810PA true SG11201805810PA (en) 2018-08-30

Family

ID=58188714

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201805810PA SG11201805810PA (en) 2015-09-01 2016-07-07 Extended, delayed and immediate release formulation method of manufacturing and use thereof

Country Status (11)

Country Link
US (2) US20170319521A1 (en)
EP (1) EP3344240A4 (en)
JP (1) JP2018526441A (en)
KR (1) KR20180054655A (en)
CN (1) CN108135870A (en)
AU (1) AU2016317092A1 (en)
HK (1) HK1256098A1 (en)
MX (1) MX2018002450A (en)
RU (1) RU2018111400A (en)
SG (1) SG11201805810PA (en)
WO (1) WO2017039832A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114177155B (en) * 2020-09-08 2023-10-03 越洋医药开发(广州)有限公司 Ibuprofen controlled release tablet and preparation method thereof

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US5609884A (en) * 1992-08-31 1997-03-11 G. D. Searle & Co. Controlled release naproxen sodium plus naproxen combination tablet
US5773031A (en) * 1996-02-27 1998-06-30 L. Perrigo Company Acetaminophen sustained-release formulation
US6126967A (en) * 1998-09-03 2000-10-03 Ascent Pediatrics Extended release acetaminophen particles
US20060240105A1 (en) * 1998-11-02 2006-10-26 Elan Corporation, Plc Multiparticulate modified release composition
US20100172983A1 (en) * 2001-06-01 2010-07-08 Plachetka John R Pharmaceutical Compositions for the Coordinated Delivery of Naproxen and Esomeprazole
US20040132826A1 (en) * 2002-10-25 2004-07-08 Collegium Pharmaceutical, Inc. Modified release compositions of milnacipran
US20050136112A1 (en) * 2003-12-19 2005-06-23 Pediamed Pharmaceuticals, Inc. Oral medicament delivery system
EP1789022A2 (en) * 2004-08-31 2007-05-30 Pfizer Products Incorporated Controlled release dosage forms combining immediate release and sustained release of low-solubility drug
CN101132769A (en) * 2005-02-10 2008-02-27 奥瑞克索股份公司 New pharmaceutical compositions useful in the transmucosal administration of drugs
US20070212417A1 (en) * 2006-03-07 2007-09-13 Cherukuri S R Compressible resilient granules and formulations prepared therefrom
JP2010522135A (en) * 2006-10-09 2010-07-01 チャールストン ラボラトリーズ,インコーポレイテッド Pharmaceutical composition
BRPI0718171A2 (en) * 2006-10-20 2013-11-26 Mcneil Ppc Inc Acetaminophen / IBUPROPHEN COMBINATIONS AND METHOD FOR USE
US20080026054A1 (en) * 2007-04-27 2008-01-31 Nectid Inc. Novel anelgesic combination
US20080286343A1 (en) * 2007-05-16 2008-11-20 Dzenana Cengic Solid form
RU2010153904A (en) * 2008-06-02 2012-07-20 Др. Редди'С Лабораторис Лтд. (In) Niacin-containing Compositions with Modified Release
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WO2010138441A1 (en) * 2009-05-28 2010-12-02 Aptapharma, Inc. Multilayer oral tablets containing a non-steroidal anti-inflammatory drug and/or acetaminophen
US9415048B2 (en) * 2010-07-08 2016-08-16 Wellesley Pharmaceuticals, Llc Pharmaceutical formulation for reducing frequency of urination and method of use thereof
US20150010599A1 (en) * 2010-07-08 2015-01-08 WELLESLEY PHARMACELJTlCALS, LLC Pharmaceutical formulation for reducing bladder spasms and method of use thereof
ES2717178T3 (en) * 2011-03-21 2019-06-19 Broda Tech Co Ltd Hydrogel compositions reversely thermoreversible
MX2014008283A (en) * 2012-01-04 2015-03-03 Wellesley Pharmaceutical Llc Extended-release formulation for reducing the frequency of urination and method of use thereof.
CN103191430A (en) * 2012-01-04 2013-07-10 韦尔斯利医药有限公司 Sustained release preparation for relieving frequent micturition and application method thereof
WO2013103389A1 (en) * 2012-01-04 2013-07-11 Wellesley Pharmaceuticals, Llc Delayed-release formulation for reducing the frequency of urination and method of use thereof
EP2841058A1 (en) * 2012-04-23 2015-03-04 Cadila Healthcare Limited Delazed release pharmaceutical compositions of salsalate
WO2014018223A1 (en) * 2012-07-27 2014-01-30 Wellesley Pharmaceuticals, Llc Pharmaceutical formulation for bedwetting and method of use thereof
TW201422254A (en) * 2012-11-21 2014-06-16 Ferring Bv Composition for immediate and extended release
RU2704613C2 (en) * 2014-11-11 2019-10-30 Д-Р Редди'С Лабораторис Лимитед Pharmaceutical preparations with fixed combination of analgesic and antispasmodic agents doses

Also Published As

Publication number Publication date
HK1256098A1 (en) 2019-09-13
WO2017039832A1 (en) 2017-03-09
US20170319520A1 (en) 2017-11-09
AU2016317092A1 (en) 2018-04-26
EP3344240A4 (en) 2019-09-04
MX2018002450A (en) 2018-08-24
US20170319521A1 (en) 2017-11-09
EP3344240A1 (en) 2018-07-11
CN108135870A (en) 2018-06-08
JP2018526441A (en) 2018-09-13
KR20180054655A (en) 2018-05-24
RU2018111400A (en) 2019-10-03

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