DK200200947A - Hurtig insertionsformulering - Google Patents

Hurtig insertionsformulering Download PDF

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Publication number
DK200200947A
DK200200947A DK200200947A DKPA200200947A DK200200947A DK 200200947 A DK200200947 A DK 200200947A DK 200200947 A DK200200947 A DK 200200947A DK PA200200947 A DKPA200200947 A DK PA200200947A DK 200200947 A DK200200947 A DK 200200947A
Authority
DK
Denmark
Prior art keywords
formulation
pyridoxine hcl
doxylamine succinate
weight
rapid
Prior art date
Application number
DK200200947A
Other languages
English (en)
Inventor
Eric Gervais
Original Assignee
Duchesnay Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42104724&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK200200947(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Duchesnay Inc filed Critical Duchesnay Inc
Publication of DK200200947A publication Critical patent/DK200200947A/da
Application granted granted Critical
Publication of DK176018B1 publication Critical patent/DK176018B1/da

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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
    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • 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
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Hospice & Palliative Care (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Lubricants (AREA)
  • Seal Device For Vehicle (AREA)
  • Memory System Of A Hierarchy Structure (AREA)
  • Power Steering Mechanism (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Description

Krav 1. Entero-coatet pyridoxin HCl og doxylaminsuccinat hurtig insertionsformulering indbefattende et opløsningsmiddel således, at de følgende opløsningsprofiler opfyldes ved måling i 1000 ml phosphatbuffer ved pH 5,8 og 37°C i et type 2 opløsningsapparatur ved 100 rpm: (a) mindst cirka 40% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 30 minutters måling; (b) mindst cirka 7 0% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 60 minutters måling; (c) mindst cirka 80% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 90 minutters måling; (d) mindst cirka 90% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 120 minutters måling. 2. Entero-coatet pyridoxin HCl og doxylaminsuccinat hurtig insertionsformulering ifølge krav 1, hvori de følgende opløsningsegenskaber også opfyldes ved måling i 1000 ml phosphatbuf fer ved pH 6,8 og 37°C i et type 2 opløsningsapparatur ved 100 rpm: (a) mindst cirka 20% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 15 minutters måling; (b) mindst cirka 60% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 45 minutters måling; (c) mindst cirka 80% af de totale mængder af hver af pyridoxin HCl og doxylaminsuccinat opløses efter 75 minutters måling. 3. Hurtig insertionsformulering ifølge krav 1 eller 2, hvori mindst cirka 40% af de totale mængder af hver af pyridoxin HC1 og doxylaminsuccinat opløses inden for 5 minutter ved måling i 1000 ml phosphatbuffer ved pH 6,8 og 37°C i et type 2 opløsningsapparatur ved 100 rpm. 4. Hurtig insertionsformulering ifølge krav 1 eller 2, hvori nævnte formulering indeholder en kerne, som er coatet med mindst én entero-coating, nævnte kerne indbefatter pyridoxyn HC1, doxylaminsuccinat og de følgende ikke-aktive stoffer: et fyldstof eller bindemiddel, et opløsningsmiddel, et smøremiddel, et silicamiddel mod klumpdannelse og en stabilisator. 5. Hurtig insertionsformulering ifølge krav 4, hvori nævnte fyldstof eller bindemiddel består af mikrokrystallinsk cellulose. 6. Hurtig insertionsformulering ifølge krav 4, hvori nævnte opløsningsmiddel består af croscarmellose-natrium. 7. Hurtig insertionsformulering ifølge krav 4, hvori nævnte smøremiddel består af magnesiumstearat. 8. Hurtig insertionsformulering ifølge krav 4, hvori nævnte silicamiddel mod klumpdannelse består af siliciumdioxid. 9. Hurtig insertionsformulering ifølge krav 4, hvori nævnte stabilisator består af magnesiumtrisilicat. 10. Hurtig insertionsformulering ifølge krav 1 eller 2, hvori nævnte kerne indbefatter: (a) cirka 4-10 vægtprocent pyridoxin HC1; (b) cirka 4-10 vægtprocent doxylaminsuccinat; (c) cirka 40-80 vægtprocent mikrokrystallinsk cellulose; (d) cirka 10-30 vægtprocent magnesiumtrisilicat; (e) cirka 0,5-5 vægtprocent siliciumdioxid; (f) cirka 0,5-5 vægtprocent croscarmellose-natrium; og (g) cirka 0,5-5 vægtprocent magnesiumsterat. 11. Hurtig insertionsformulering ifølge krav 10, hvori nævnte kerne indbefatter: (a) cirka 7 vægtprocent pyridoxin HCl; (b) cirka 7 vægtprocent doxylaminsuccinat; (c) cirka 62 vægtprocent mikrokrystallinsk cellulose; (d) cirka 18 vægtprocent magnesiumtrisilicat; (e) cirka 1 vægtprocent siliciumdioxid; (f) cirka 3 vægtprocent croscarmellose-natrium; og (g) cirka 3 vægtprocent magnesiumstearat. 12. Hurtig insertionsformulering ifølge krav 4, hvori nævnte mindst ene entero-coating er vandbaseret. 13. Hurtig insertionsformulering ifølge krav 12, hvori nævnte entero-coating består af en forseglingscoating påført kernen, en entro-coating per se påført forseglingscoatingen og en æstetisk topcoating påført den entero-coating per se. 14. Anvendelse af hurtig insertionsformulering ifølge krav 1 eller 2 til at lindre symptomerne kvalme og opkastning hos pattedyr. 15. Anvendelse af hurtig insertionsformulering ifølge krav 1 eller 2 til at lindre symptomerne kvalme og opkastning under human graviditet. 16. Medikament til dæmpe symptomerne i forbindelse med kvalme og opkastning hovedsageligt bestående af formuleringen ifølge krav 4. 17. Fremgangsmåde til fremstilling af hurtig insertionsformulering ifølge krav 4, nævnte fremgangsmåde indbefatter trinnene: at blande nævnte doxylaminsuccinat og nævnte silicamiddel mod klumpdannelse for at få en forblanding; at blande nævnte forblanding med nævnte pyridoxin HCl for at få nævnte blanding af virksomt stof; at blande nævnte blanding af virksomt stof med nævnte resterende ikke-virksomme bæremidler, nemlig: et fyldstof eller bindemiddel, et opløsningsmiddel, et smøremiddel og en stabilisator for at få en slutblanding; og at tablettere og coate nævnte slutblanding. 18. Fremgangsmåde ifølge krav 17, hvori nævnte sluttablettering og coatingtrin indbefatter komprimering af nævnte slutblanding til tabletform, forseglingscoating af nævnte tabletform, efterfulgt af entero-coating, efterfulgt af farvecoating.
DK200200947A 2000-12-20 2002-06-20 Formulering med pyridoxin, HC1 og doxylaminsuccinat, dets anvendelse og fremgangsmåde til dets fremstilling DK176018B1 (da)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
CA2350195 2000-12-20
CA002350195A CA2350195C (en) 2000-12-20 2000-12-20 Rapid onset formulation of pyridoxine hydrochloride and doxylamine succinate
US09/885,051 US6340695B1 (en) 2000-12-20 2001-06-21 Rapid onset formulation
PCT/CA2001/000951 WO2003000263A1 (en) 2000-12-20 2001-06-21 Rapid onset formulation
US88505101 2001-06-21
CA0100951 2001-06-21

Publications (2)

Publication Number Publication Date
DK200200947A true DK200200947A (da) 2003-01-03
DK176018B1 DK176018B1 (da) 2005-12-05

Family

ID=42104724

Family Applications (2)

Application Number Title Priority Date Filing Date
DK01951259T DK1397133T3 (da) 2000-12-20 2001-06-21 Hurtig insertionsformulering
DK200200947A DK176018B1 (da) 2000-12-20 2002-06-20 Formulering med pyridoxin, HC1 og doxylaminsuccinat, dets anvendelse og fremgangsmåde til dets fremstilling

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK01951259T DK1397133T3 (da) 2000-12-20 2001-06-21 Hurtig insertionsformulering

Country Status (34)

Country Link
US (1) US6340695B1 (da)
EP (1) EP1397133B1 (da)
JP (1) JP4242763B2 (da)
KR (1) KR100527985B1 (da)
CN (1) CN1229112C (da)
AT (1) ATE307582T1 (da)
AU (1) AU2001272243B2 (da)
BE (1) BE1014929A4 (da)
BR (1) BR0107371A (da)
CA (1) CA2350195C (da)
DE (2) DE10196426T1 (da)
DK (2) DK1397133T3 (da)
EG (1) EG24483A (da)
ES (1) ES2251494T3 (da)
FI (1) FI117961B (da)
FR (1) FR2826277B1 (da)
GB (1) GB2383751C (da)
GR (1) GR1004371B (da)
HU (1) HU227003B1 (da)
IL (1) IL150349A0 (da)
IS (1) IS2225B (da)
IT (1) ITTO20020524A1 (da)
LU (1) LU90934B1 (da)
MC (1) MC200059A1 (da)
MX (1) MXPA02006037A (da)
MY (1) MY132786A (da)
NL (1) NL1020895C2 (da)
NO (1) NO332190B1 (da)
PL (1) PL204507B1 (da)
SE (1) SE526307C2 (da)
TR (1) TR200201685T1 (da)
UA (1) UA74807C2 (da)
UY (1) UY27352A1 (da)
WO (1) WO2003000263A1 (da)

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CA2350195C (en) * 2000-12-20 2003-06-10 Duchesnay Inc. Rapid onset formulation of pyridoxine hydrochloride and doxylamine succinate
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CA2392486A1 (en) * 2002-07-05 2002-12-08 Duchesnay Inc. Pharmaceutical dosage form bearing pregnancy-friendly indicia
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WO2013123569A1 (en) * 2012-02-22 2013-08-29 Duchesnay Inc. Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
JP5914701B2 (ja) 2012-02-22 2016-05-11 デュシネイ・インコーポレイテッド ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤
JP5818219B2 (ja) 2012-05-14 2015-11-18 塩野義製薬株式会社 ６，７−不飽和−７−カルバモイルモルヒナン誘導体含有製剤
PL3024466T3 (pl) * 2013-07-22 2018-08-31 Duchesnay Inc. Kompozycja do kontrolowania nudności i wymiotów
CN103432126A (zh) * 2013-08-05 2013-12-11 北京阜康仁生物制药科技有限公司 一种治疗孕吐的药物组合物
SG11201701448XA (en) * 2014-08-29 2017-03-30 Duchesnay Inc Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
US9526703B2 (en) 2014-08-29 2016-12-27 Duchesnay Inc. Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
EP3337480A4 (en) 2015-08-17 2019-05-08 Aequus Pharmaceuticals Inc. TRANSDERMAL ADMINISTRATION OF DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
CN105510512B (zh) * 2016-01-25 2018-06-29 南京济群医药科技股份有限公司 一种琥珀酸多西拉敏有关物质的rt-hplc检测方法
RS61368B1 (sr) * 2018-09-27 2021-02-26 Inibsa Ginecologia S A Postupak za pripremu višejediničnog oralnog doznog oblika sa modifikovanim oslobađanjem doksilamin sukcinata i piridoksin hidrohlorida
CN114099450A (zh) * 2020-08-31 2022-03-01 长春海悦药业股份有限公司 一种比拉斯汀片及其制备方法
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Also Published As

Publication number Publication date
DE60114475D1 (de) 2005-12-01
MY132786A (en) 2007-10-31
NL1020895C2 (nl) 2003-03-13
MXPA02006037A (es) 2005-05-12
AU2001272243B2 (en) 2004-02-05
NO20022982D0 (no) 2002-06-20
IS6412A (is) 2002-12-22
HU227003B1 (en) 2010-04-28
FR2826277A1 (fr) 2002-12-27
DK176018B1 (da) 2005-12-05
BE1014929A4 (fr) 2004-06-01
FI20021708A0 (fi) 2002-09-25
FI117961B (fi) 2007-05-15
SE0202061L (sv) 2003-01-28
IL150349A0 (en) 2003-12-23
GB2383751A (en) 2003-07-09
GB2383751C (en) 2008-08-05
EP1397133B1 (en) 2005-10-26
HUP0301950A3 (en) 2005-06-28
GR20020100280A (el) 2003-03-28
CN1447694A (zh) 2003-10-08
IS2225B (is) 2007-04-15
ATE307582T1 (de) 2005-11-15
ITTO20020524A1 (it) 2003-12-18
KR100527985B1 (ko) 2005-11-09
NO20022982L (no) 2002-10-09
NO332190B1 (no) 2012-07-23
CN1229112C (zh) 2005-11-30
ES2251494T3 (es) 2006-05-01
SE526307C2 (sv) 2005-08-16
TR200201685T1 (tr) 2003-06-23
FI20021708L (fi) 2002-12-22
NL1020895A1 (nl) 2002-12-30
UY27352A1 (es) 2002-09-30
CA2350195A1 (en) 2001-08-11
US6340695B1 (en) 2002-01-22
LU90934B1 (fr) 2002-12-23
KR20030023612A (ko) 2003-03-19
PL362763A1 (en) 2004-11-02
GR1004371B (el) 2003-10-23
DE60114475T2 (de) 2006-07-13
UA74807C2 (en) 2006-02-15
HK1052654A1 (en) 2003-09-26
GB0213990D0 (en) 2002-07-31
DK1397133T3 (da) 2006-02-27
ITTO20020524A0 (it) 2002-06-18
MC200059A1 (fr) 2003-01-30
JP2004521146A (ja) 2004-07-15
PL204507B1 (pl) 2010-01-29
DE10196426T1 (de) 2003-08-21
HUP0301950A2 (hu) 2003-11-28
JP4242763B2 (ja) 2009-03-25
CA2350195C (en) 2003-06-10
EG24483A (en) 2009-08-09
EP1397133A1 (en) 2004-03-17
FR2826277B1 (fr) 2004-07-02
SE0202061D0 (sv) 2002-07-03
WO2003000263A1 (en) 2003-01-03
IE20020488A1 (en) 2003-04-30
GB2383751B (en) 2005-02-09
BR0107371A (pt) 2003-06-10

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