BRPI0908539B8 - processo para a preparação de uma forma sólida rápida de dosagem da dispersão, oral de alprazolam - Google Patents

processo para a preparação de uma forma sólida rápida de dosagem da dispersão, oral de alprazolam

Info

Publication number
BRPI0908539B8
BRPI0908539B8 BRPI0908539A BRPI0908539A BRPI0908539B8 BR PI0908539 B8 BRPI0908539 B8 BR PI0908539B8 BR PI0908539 A BRPI0908539 A BR PI0908539A BR PI0908539 A BRPI0908539 A BR PI0908539A BR PI0908539 B8 BRPI0908539 B8 BR PI0908539B8
Authority
BR
Brazil
Prior art keywords
time
molecular weight
forms
polymorphism
crystallize
Prior art date
Application number
BRPI0908539A
Other languages
English (en)
Inventor
Jordan Andrew
Mclaughlin Rosie
A M Howes Simon
Tian Wei
Original Assignee
Scherer Technologies Llc R P
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 Scherer Technologies Llc R P filed Critical Scherer Technologies Llc R P
Publication of BRPI0908539B1 publication Critical patent/BRPI0908539B1/pt
Publication of BRPI0908539B8 publication Critical patent/BRPI0908539B8/pt

Links

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
    • A61K31/33—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/22—Anxiolytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

Abstract

processo para minimizar polimorfismo. a presente invenção refere-se a uma formulação comercial das formas rápidas de dosagem da dispersão (fddf) que requer tempos de manutenção substanciais durante a qual grandes quantidades de substância farmaceuticamente ativa são formadas nas unidades de dosagem individuais. durante este tempo de manutenção, agentes farmacêuticos com uma propensão para o polimorfismo em um ambiente aquoso podem cristalizar em vários, e de vez em quando nas formas imprevisíveis. estas formas cristalinas podem afetar a eficácia do agente farmacêutico. as tentativas prévias de controlar este processo têm incluído tentativas para cristalização direta em uma forma estável. a presente invenção age para suprimir cristalização, por utilizar uma combinação de gelatina de peixe com peso molecular padrão e baixa temperatura de processamento, para suprimir a cristalização de um grau que não é realizado ou pelo uso de gelatina de peixe com peso molecular padrão ou baixas temperaturas de processamento individualmente.
BRPI0908539A 2008-02-28 2009-02-26 processo para a preparação de uma forma sólida rápida de dosagem da dispersão, oral de alprazolam BRPI0908539B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US3229808P 2008-02-28 2008-02-28
US61/032,298 2008-02-28
PCT/US2009/035276 WO2009108775A2 (en) 2008-02-28 2009-02-26 Process to minimize polymorphism

Publications (2)

Publication Number Publication Date
BRPI0908539B1 BRPI0908539B1 (pt) 2020-12-08
BRPI0908539B8 true BRPI0908539B8 (pt) 2021-05-25

Family

ID=41016708

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0908539A BRPI0908539B8 (pt) 2008-02-28 2009-02-26 processo para a preparação de uma forma sólida rápida de dosagem da dispersão, oral de alprazolam

Country Status (19)

Country Link
US (1) US20090226522A1 (pt)
EP (1) EP2247284B1 (pt)
JP (2) JP5547096B2 (pt)
KR (1) KR101473419B1 (pt)
CN (2) CN103751091B (pt)
AR (1) AR072245A1 (pt)
AU (1) AU2009219292B2 (pt)
BR (1) BRPI0908539B8 (pt)
CA (1) CA2716901C (pt)
DK (1) DK2247284T3 (pt)
ES (1) ES2633928T3 (pt)
HK (1) HK1154505A1 (pt)
IL (2) IL207824A (pt)
MX (1) MX2010009493A (pt)
MY (1) MY173867A (pt)
NZ (1) NZ587611A (pt)
RU (1) RU2010139643A (pt)
WO (1) WO2009108775A2 (pt)
ZA (1) ZA201006421B (pt)

Families Citing this family (12)

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RU2639447C2 (ru) * 2010-10-08 2017-12-21 Ар.Пи. ШЕРЕР ТЕКНОЛОДЖИЗ, ЭлЭлСи Быстрорастворяющаяся лекарственная форма пероральной вакцины, в которой используют крахмал
EP3261645B1 (en) 2015-02-27 2021-04-28 Dechra Limited Stimulation of appetite, management of weight loss, and treatment of anorexia in dogs and cats
CN107951893B (zh) * 2016-10-18 2022-04-26 天津金耀集团有限公司 一种糠酸莫米松粉吸入剂组合物
BR112019013503A2 (pt) 2016-12-31 2020-01-07 Bioxcel Therapeutics, Inc. Uso de dexmedetomidina sublingual para o tratamento da agitação
CN114983980A (zh) 2018-06-27 2022-09-02 比奥克斯塞尔医疗股份有限公司 含右美托咪定的膜制剂及其制造方法
CN109010295A (zh) * 2018-08-29 2018-12-18 北京兴源联合医药科技有限公司 一种左甲状腺素钠冻干口腔崩解片
CN109316452B (zh) * 2018-09-07 2021-07-30 北京兴源联合医药科技有限公司 一种硫酸氢氯吡格雷冻干口腔崩解片
EP3927312B1 (en) 2019-02-22 2023-09-13 Catalent U.K. Swindon Zydis Limited Minimizing agglomeration, aeration, and preserving the coating of pharmaceutical compositions comprising ibuprofen
AR118419A1 (es) 2019-02-22 2021-10-06 Catalent Uk Swindon Zydis Ltd Minimización de aglomeración de material de revestimiento de partícula de medicamento durante el almacenaje para estabilizar los tiempos de desintegración de productos farmacéuticos
WO2021016112A2 (en) 2019-07-19 2021-01-28 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens
JP2023535829A (ja) * 2020-07-31 2023-08-21 キャタレント・ユーケー・スウィンドン・ザイディス・リミテッド コーティングされたａｐｉを含む医薬組成物
US11672761B2 (en) 2020-11-16 2023-06-13 Orcosa Inc. Rapidly infusing platform and compositions for therapeutic treatment in humans

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GB1548022A (en) * 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
US4946684A (en) * 1989-06-20 1990-08-07 American Home Products Corporation Fast dissolving dosage forms
DD289468B5 (de) 1989-11-07 1994-02-10 Dresden Arzneimittel Arzneimitteltechnologisches verfahren zur herstellung einer alprazolam-arzneiform
CA2020018A1 (en) * 1990-06-27 1991-12-28 Don L. Simmons Method and composition for treating the migraine complex
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ATE260646T1 (de) * 1996-04-16 2004-03-15 Novartis Consumer Health Sa Schnell zerfallende orale dosierungsform
EP0839526A3 (en) * 1996-10-31 1999-01-07 Takeda Chemical Industries, Ltd. Solid pharmaceutical preparation with fast buccal disintegration or dissolution
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EP1042405B1 (en) * 1997-12-26 2004-12-22 Warner-Lambert Company LLC Gelatine compositions
GB9908014D0 (en) * 1999-04-08 1999-06-02 Scherer Corp R P Pharmaceutical compositions
BR0210520A (pt) * 2001-06-22 2004-06-22 Pfizer Prod Inc Composições farmacêuticas de dispersões de fármacos amorfos misturados com polìmeros
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US7972621B2 (en) * 2004-06-03 2011-07-05 R.P. Scherer Technologies, Llc Process for formulating fast dispersing dosage forms comprising at least one fish gelatin selected on the basis of molecular weight
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Also Published As

Publication number Publication date
AU2009219292B2 (en) 2014-02-27
CA2716901A1 (en) 2009-09-03
US20090226522A1 (en) 2009-09-10
AR072245A1 (es) 2010-08-18
KR20100123740A (ko) 2010-11-24
KR101473419B1 (ko) 2014-12-16
WO2009108775A3 (en) 2009-12-03
ES2633928T3 (es) 2017-09-26
IL207824A0 (en) 2010-12-30
NZ587611A (en) 2012-07-27
JP2011513324A (ja) 2011-04-28
JP2014062119A (ja) 2014-04-10
CN102036655B (zh) 2013-11-20
CN102036655A (zh) 2011-04-27
CN103751091A (zh) 2014-04-30
MY173867A (en) 2020-02-25
JP5547096B2 (ja) 2014-07-09
IL252713A0 (en) 2017-08-31
WO2009108775A2 (en) 2009-09-03
HK1154505A1 (en) 2012-04-27
BRPI0908539B1 (pt) 2020-12-08
EP2247284A4 (en) 2013-10-02
ZA201006421B (en) 2011-05-25
CN103751091B (zh) 2017-08-25
DK2247284T3 (en) 2017-07-31
EP2247284A2 (en) 2010-11-10
CA2716901C (en) 2018-07-03
AU2009219292A1 (en) 2009-09-03
EP2247284B1 (en) 2017-04-19
IL207824A (en) 2017-11-30
RU2010139643A (ru) 2012-04-10
MX2010009493A (es) 2010-12-20

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 08/12/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/02/2009 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF