AU2013213317B2 - In-situ multilayered tablet technology - Google Patents

In-situ multilayered tablet technology Download PDF

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Publication number
AU2013213317B2
AU2013213317B2 AU2013213317A AU2013213317A AU2013213317B2 AU 2013213317 B2 AU2013213317 B2 AU 2013213317B2 AU 2013213317 A AU2013213317 A AU 2013213317A AU 2013213317 A AU2013213317 A AU 2013213317A AU 2013213317 B2 AU2013213317 B2 AU 2013213317B2
Authority
AU
Australia
Prior art keywords
tablet
drug
polymer
layer
capsule
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
AU2013213317A
Other languages
English (en)
Other versions
AU2013213317A1 (en
Inventor
Kanwarpreet Singh Bakshi
Anuj Kumar Fanda
Murali Krishna
Ravish Sharma
Romi Barat Singh
Ajay Kumar Singla
Kumaravel Vivek
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.)
Sun Pharmaceutical Industries Ltd
Original Assignee
Sun Pharmaceutical Industries Ltd
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 Sun Pharmaceutical Industries Ltd filed Critical Sun Pharmaceutical Industries Ltd
Publication of AU2013213317A1 publication Critical patent/AU2013213317A1/en
Assigned to SUN PHARMACEUTICAL INDUSTRIES LIMITED reassignment SUN PHARMACEUTICAL INDUSTRIES LIMITED Amend patent request/document other than specification (104) Assignors: RANBAXY LABORATORIES LIMITED
Application granted granted Critical
Publication of AU2013213317B2 publication Critical patent/AU2013213317B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • 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
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/65Tetracyclines
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • 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
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2013213317A 2012-01-23 2013-01-23 In-situ multilayered tablet technology Ceased AU2013213317B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN193/DEL/2012 2012-01-23
PCT/IB2013/050584 WO2013111070A1 (en) 2012-01-23 2013-01-23 In-situ multilayered tablet technology
IN193DE2012 IN2012DE00193A (enExample) 2012-01-23 2013-01-23

Publications (2)

Publication Number Publication Date
AU2013213317A1 AU2013213317A1 (en) 2014-08-14
AU2013213317B2 true AU2013213317B2 (en) 2016-06-30

Family

ID=47884433

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2013213317A Ceased AU2013213317B2 (en) 2012-01-23 2013-01-23 In-situ multilayered tablet technology

Country Status (7)

Country Link
US (1) US20140377347A1 (enExample)
EP (1) EP2806861A1 (enExample)
AU (1) AU2013213317B2 (enExample)
CA (1) CA2862469A1 (enExample)
IN (1) IN2012DE00193A (enExample)
WO (1) WO2013111070A1 (enExample)
ZA (1) ZA201405499B (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017145146A1 (en) 2016-02-25 2017-08-31 Dexcel Pharma Technologies Ltd. Compositions comprising proton pump inhibitors
US10076494B2 (en) 2016-06-16 2018-09-18 Dexcel Pharma Technologies Ltd. Stable orally disintegrating pharmaceutical compositions
TR201717134A2 (tr) * 2016-12-07 2018-07-23 Imuneks Farma Ilac Sanayi Ve Ticaret Anonim Sirketi Ağrı Ve Enflamasyonun Hızlı Tedavisi İçin Diklofenak Ve H2 Reseptör Antagonistlerinin Çabuk Salımlı Oral Kombinasyonları

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6143327A (en) * 1998-10-30 2000-11-07 Pharma Pass Llc Delayed release coated tablet of bupropion hydrochloride
US20030157166A1 (en) * 2001-03-16 2003-08-21 Chen Chih Ming Controlled release sulfonylurea formulation
US20050089575A1 (en) * 2002-01-16 2005-04-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Bilayer pharmaceutical tablet comprising telmisartan and a diuretic and preparation thereof

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1188212B (it) 1985-12-20 1988-01-07 Paolo Colombo Sistema per il rilascio a velocita' controllata di sostanze attive
US5221278A (en) 1992-03-12 1993-06-22 Alza Corporation Osmotically driven delivery device with expandable orifice for pulsatile delivery effect
IT1256393B (it) 1992-11-17 1995-12-04 Inverni Della Beffa Spa Forme matriciali multistrato per il rilascio controllato di principi attivi
US6183778B1 (en) 1993-09-21 2001-02-06 Jagotec Ag Pharmaceutical tablet capable of liberating one or more drugs at different release rates
IT1265240B1 (it) 1993-11-30 1996-10-31 Ekita Investments Nv Compressa farmaceutica a rilascio controllato, di forma lenticolare
US6103262A (en) * 1994-01-27 2000-08-15 G. D. Searle & Company Modified-release metronidazole compositions and methods for making and using same
US5783212A (en) 1996-02-02 1998-07-21 Temple University--of the Commonwealth System of Higher Education Controlled release drug delivery system
IT1282650B1 (it) 1996-02-19 1998-03-31 Jagotec Ag Compressa farmaceutica,caratterizzata da elevato aumento di volume a contatto con liquidi biologici
US6797283B1 (en) 1998-12-23 2004-09-28 Alza Corporation Gastric retention dosage form having multiple layers
GB0319874D0 (en) * 2003-08-22 2003-09-24 Glaxo Group Ltd Novel formulation
US7387793B2 (en) 2003-11-14 2008-06-17 Eurand, Inc. Modified release dosage forms of skeletal muscle relaxants
US20060003000A1 (en) * 2004-07-01 2006-01-05 Lawrence Solomon Adhesively bonded dosage form
KR101052436B1 (ko) * 2004-08-13 2011-07-29 베링거 인겔하임 인터내셔날 게엠베하 프라미펙솔 또는 약제학적으로 허용되는 이의 염을함유하는 연장 방출형 정제 제형, 이의 제조방법 및 이의용도
US20080311191A1 (en) * 2004-08-27 2008-12-18 Avinash Nangia Multi-Layer Tablets and Bioadhesive Dosage Forms
US8691272B2 (en) * 2005-12-30 2014-04-08 Intelgenx Corp. Multilayer tablet
KR100885029B1 (ko) 2007-02-07 2009-02-23 지엘팜텍 주식회사 경구투여용 서방성 삼중정제

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6143327A (en) * 1998-10-30 2000-11-07 Pharma Pass Llc Delayed release coated tablet of bupropion hydrochloride
US20030157166A1 (en) * 2001-03-16 2003-08-21 Chen Chih Ming Controlled release sulfonylurea formulation
US20050089575A1 (en) * 2002-01-16 2005-04-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Bilayer pharmaceutical tablet comprising telmisartan and a diuretic and preparation thereof

Also Published As

Publication number Publication date
CA2862469A1 (en) 2013-08-01
WO2013111070A1 (en) 2013-08-01
IN2012DE00193A (enExample) 2015-06-12
ZA201405499B (en) 2015-11-25
US20140377347A1 (en) 2014-12-25
AU2013213317A1 (en) 2014-08-14
EP2806861A1 (en) 2014-12-03

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FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired