EP2906201A4 - Solid dosage form - Google Patents

Solid dosage form

Info

Publication number
EP2906201A4
EP2906201A4 EP13845400.4A EP13845400A EP2906201A4 EP 2906201 A4 EP2906201 A4 EP 2906201A4 EP 13845400 A EP13845400 A EP 13845400A EP 2906201 A4 EP2906201 A4 EP 2906201A4
Authority
EP
European Patent Office
Prior art keywords
dosage form
solid dosage
solid
dosage
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.)
Withdrawn
Application number
EP13845400.4A
Other languages
German (de)
French (fr)
Other versions
EP2906201A1 (en
Inventor
Chin Beng Stephen Lim
Vivian Bruce Sunderland
Yip Hang Eddy Lee
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.)
IX BIOPHARMA Ltd
Original Assignee
IX BIOPHARMA 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
Priority claimed from AU2012238330A external-priority patent/AU2012238330B1/en
Application filed by IX BIOPHARMA Ltd filed Critical IX BIOPHARMA Ltd
Publication of EP2906201A1 publication Critical patent/EP2906201A1/en
Publication of EP2906201A4 publication Critical patent/EP2906201A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/435—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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • 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
    • A61K38/06—Tripeptides
    • A61K38/063—Glutathione
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Emergency Medicine (AREA)
  • Zoology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP13845400.4A 2012-10-11 2013-10-11 Solid dosage form Withdrawn EP2906201A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
AU2012238330A AU2012238330B1 (en) 2010-10-26 2012-10-11 Fast Dissolving Solid Dosage Form
AU2013200682A AU2013200682C1 (en) 2010-10-26 2013-02-08 Fast Dissolving Solid Dosage Form
AU2013200684A AU2013200684B1 (en) 2010-10-26 2013-02-08 Fast Dissolving Solid Dosage Form
PCT/IB2013/002594 WO2014057351A1 (en) 2012-10-11 2013-10-11 Solid dosage form

Publications (2)

Publication Number Publication Date
EP2906201A1 EP2906201A1 (en) 2015-08-19
EP2906201A4 true EP2906201A4 (en) 2016-10-19

Family

ID=50478109

Family Applications (1)

Application Number Title Priority Date Filing Date
EP13845400.4A Withdrawn EP2906201A4 (en) 2012-10-11 2013-10-11 Solid dosage form

Country Status (11)

Country Link
EP (1) EP2906201A4 (en)
JP (1) JP2015533155A (en)
KR (1) KR20150063567A (en)
CN (2) CN107669649A (en)
CA (1) CA2886573C (en)
HK (1) HK1208353A1 (en)
IL (2) IL238104B (en)
MY (1) MY191875A (en)
NZ (1) NZ706302A (en)
SG (1) SG11201502425WA (en)
WO (1) WO2014057351A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6217052B2 (en) * 2016-04-21 2017-10-25 邦赫 小牧 Effervescent tablet for oral cleaning
JP2017193547A (en) * 2017-05-08 2017-10-26 邦赫 小牧 Foaming tablet for oral cleaning
CN111465391A (en) * 2017-09-27 2020-07-28 阿奎斯蒂弗医疗股份有限公司 Compositions of epinephrine and prodrug with enhanced delivery
IT201800003507A1 (en) * 2018-03-13 2019-09-13 Fulton Medicinali S P A SUBLINGUAL TABLET INCLUDING SILDENAFIL CITRATE
MX2021008247A (en) * 2019-01-07 2021-08-16 Antecip Bioventures Ii Llc Combination of dextromethorphan and bupropion for treating depression.
CN109846841B (en) * 2019-01-18 2021-06-01 西安力邦医药科技有限责任公司 Quick-acting clobazam oral freeze-dried preparation and preparation method thereof
US20220062200A1 (en) * 2019-05-07 2022-03-03 Clexio Biosciences Ltd. Abuse-deterrent dosage forms containing esketamine
US11382873B1 (en) * 2021-01-08 2022-07-12 Vitalis Analgesics LLC Oral administration of ketamine

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US7407669B2 (en) * 1998-09-25 2008-08-05 Mcneil-Ppc, Inc. Fast dissolving orally consumable films
US20090246257A1 (en) * 2008-03-27 2009-10-01 Pankaj Modi Wafer formulation
US20100240724A1 (en) * 2007-10-03 2010-09-23 C.L. Pharm Edible Film
US20110009834A1 (en) * 2008-03-15 2011-01-13 Lts Lohmann Therapie-Systeme Ag Gingival wafer
WO2011117313A1 (en) * 2010-03-23 2011-09-29 Bioalliance Pharma Fast dissolving drug delivery systems
CN102438596A (en) * 2008-11-03 2012-05-02 尼克美制药有限公司 Dosage form for insertion into the mouth
FR2967066A1 (en) * 2010-11-04 2012-05-11 Ethypharm Sa Use of an active ingredient in allopathic quantity to prepare medicament for sublingual treatment of a mammal, where the medicament is present in a solid multiparticulate pharmaceutical form constituted of non compressed microgranules

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6552024B1 (en) * 1999-01-21 2003-04-22 Lavipharm Laboratories Inc. Compositions and methods for mucosal delivery
US7118765B2 (en) * 2001-12-17 2006-10-10 Spi Pharma, Inc. Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms
DK1599186T3 (en) * 2003-02-24 2013-07-08 Pharmaceutical Productions Inc TRANSMUKAL MEDICINE ADMINISTRATION SYSTEM
CA2612917A1 (en) * 2005-06-23 2007-01-04 Schering Corporation Rapidly absorbing oral formulations of pde5 inhibitors
WO2009045022A2 (en) * 2007-10-03 2009-04-09 C.L. Pharm Edible film
PL2493457T3 (en) * 2009-10-30 2018-01-31 Ix Biopharma Ltd Fast dissolving solid dosage form
JP5841433B2 (en) * 2012-01-11 2016-01-13 日東電工株式会社 Intraoral film-form base and preparation
GB2516561B (en) * 2013-03-15 2016-03-09 Aerpio Therapeutics Inc Compositions, formulations and methods for treating ocular diseases

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7407669B2 (en) * 1998-09-25 2008-08-05 Mcneil-Ppc, Inc. Fast dissolving orally consumable films
WO2002005820A1 (en) * 2000-07-19 2002-01-24 Lavipharm Laboratories, Inc. Sildenafil citrate solid dispersions having high water solubility
US20100240724A1 (en) * 2007-10-03 2010-09-23 C.L. Pharm Edible Film
US20110009834A1 (en) * 2008-03-15 2011-01-13 Lts Lohmann Therapie-Systeme Ag Gingival wafer
US20090246257A1 (en) * 2008-03-27 2009-10-01 Pankaj Modi Wafer formulation
CN102438596A (en) * 2008-11-03 2012-05-02 尼克美制药有限公司 Dosage form for insertion into the mouth
WO2011117313A1 (en) * 2010-03-23 2011-09-29 Bioalliance Pharma Fast dissolving drug delivery systems
FR2967066A1 (en) * 2010-11-04 2012-05-11 Ethypharm Sa Use of an active ingredient in allopathic quantity to prepare medicament for sublingual treatment of a mammal, where the medicament is present in a solid multiparticulate pharmaceutical form constituted of non compressed microgranules

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
CHONG CHUI ET AL: "Development of a Sublingual/Oral Formulation of Ketamine for Use in Neuropathic Pain Preliminary Findings from a Three-Way Randomized, Crossover Study", CLINICAL DRUG INVESTIGATION, vol. 29, no. 5, 2009, pages 317 - 324, XP009191103, ISSN: 1173-2563 *
DEVECI S ET AL: "SUBLINGUAL SILDENAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION: FASTER ONSET OF ACTION WITH LESS DOSE", INTERNATIONAL JOURNAL OF UROLOGY, CHURCHILL LIVINGSTONE, TOKYO, JP, vol. 11, no. 11, 1 January 2004 (2004-01-01), pages 989 - 992, XP008068622, ISSN: 0919-8172, DOI: 10.1111/J.1442-2042.2004.00933.X *
DIXIT R P ET AL: "Oral strip technology: Overview and future potential", JOURNAL OF CONTROLLED RELEASE, ELSEVIER, AMSTERDAM, NL, vol. 139, no. 2, 15 October 2009 (2009-10-15), pages 94 - 107, XP026601268, ISSN: 0168-3659, [retrieved on 20090624], DOI: 10.1016/J.JCONREL.2009.06.014 *
JOSHUA S BOATENG ET AL: "Characterisation of freeze-dried wafers and solvent evaporated films as potential drug delivery systems to mucosal surfaces", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 389, no. 1, 9 January 2010 (2010-01-09), pages 24 - 31, XP028308317, ISSN: 0378-5173, [retrieved on 20100118], DOI: 10.1016/J.IJPHARM.2010.01.008 *
SANFORD M: "Vardenafil orodispersible tablet", DRUGS, ADIS INTERNATIONAL LTD, NZ, vol. 72, no. 1, 1 January 2012 (2012-01-01), pages 87 - 98, XP009189559, ISSN: 0012-6667, DOI: 10.2165/11208270-000000000-00000 *
SUBASHVIJAYAKUMAR ET AL: "OVERVIEWONFASTDISSOLVINGFILMS", 3 May 2010 (2010-05-03), XP055291076, Retrieved from the Internet <URL:http://www.ijppsjournal.com/Vol2Suppl3/665.pdf> [retrieved on 20160725] *
TOURDOT S ET AL: "The use of a mucoadhesive microparticulate delivery system enables allergen dose reduction with equivalent efficacy in sublingual immunotherapy", ALLERGY, WILEY-BLACKWELL PUBLISHING LTD, UNITED KINGDOM, vol. 66, no. Suppl. 94, 1 June 2011 (2011-06-01), pages 135, XP009189546, ISSN: 0105-4538 *

Also Published As

Publication number Publication date
CA2886573C (en) 2019-04-02
CA2886573A1 (en) 2014-04-17
IL238104B (en) 2020-03-31
SG11201502425WA (en) 2015-05-28
WO2014057351A1 (en) 2014-04-17
EP2906201A1 (en) 2015-08-19
HK1208353A1 (en) 2016-03-04
CN104812378B (en) 2017-12-01
IL238104A0 (en) 2015-05-31
NZ706302A (en) 2017-07-28
MY191875A (en) 2022-07-18
KR20150063567A (en) 2015-06-09
IL273076A (en) 2020-04-30
JP2015533155A (en) 2015-11-19
CN104812378A (en) 2015-07-29
CN107669649A (en) 2018-02-09

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