BR112012007110A2 - Composição farmacêutica sólida, comprimido de desintegração oral e composição farmacêutica líquida substancialmente não aquosa - Google Patents
Composição farmacêutica sólida, comprimido de desintegração oral e composição farmacêutica líquida substancialmente não aquosa Download PDFInfo
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Abstract
COMPOSIÇÃO FARMACÊUTICA SÓLIDA,
COMPRIMIDO DE ORAL E COMPOSIÇÃO FARMACÊUTICA LÍQUIDA
SUBSTANCIALMENTE NÃO AQUOSA. Trata-se de composições de corticosteroide
oralmente administradas e métodos para tratar uma condição associada com
a inflamação do trato gastrointestinal em um indivíduo, que compreende
administrar a um indivíduo a dita composição de corticosteroide
oralmente administrada.
Description
REFERÊNCIA CRUZADA EM RELAÇÃO A PEDIDOS 5 RELACIONADOS O presente pedido reivindica prioridade para Pedido Provisório n~ U.S. 61/247.642, depositado no dia 1 de outubro de 2009, em que a descrição do mesmo está incorporada ao presente documento a título de referência em sua totalidade para todas as finalidades.
CAMPO TÉCNICO DAS INVENÇÕES Esta invenção refere-se a composições de corticosteroide oralmente administradas, úteis para o tratamento de condições associadas à inflamação do trato gastrointestinal.
ANTECEDENTES DA INVENÇÃO Não existem, atualmente, medicações anti- inflamatórias topicamente administradas aprovadas para o tratamento de condições associadas à inflamação da porção superior do trato gastrointestinal. Tal condição, esofagite eosinofílica (EE), é uma condição inflamatória do esôfago. A mesma se caracteriza histologicamente através da proliferação de eosinófilos. A doença é dolorosa, leva à dificuldade de deglutição e predispõe os pacientes à impactação alimentar e outras complicações. Os tratamentos experimentais e "fora da indicação terapêutica" para EE incluem direcionar medicações esteroides formuladas e aprovadas para inalação para o fundo da garganta de tal modo que as mesmas não sejam apreciavelmente inaladas, e instruir o paciente a enxaguar sua boca imediatamente após administração e a não engolir alimento ou água durante duas horas após administração. Recomenda-se o enxágue porque o
Claims (30)
1. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, caracterizada em que compreende menos do que ou igual a 20 mg de um corticosteroide, em que a composição não tem atividade 5 glicocorticoide ou mineralocorticoide sistêmica significante após a administração oral, em que a composição farmacêutica sólida se desintegra em 60 segundos em fluido de saliva simulado quando testada com o uso do Teste de Desintegração USP <701>.
2. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a reivindicação 1, caracterizada em que a dita composição farmacêutica sólida se desintegra em 30 segundos.
3. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a reivindicação 1, caracterizada em que o dito corticosteroide é selecionado a partir do grupo que consiste em budesonida, fluticasona, flunisolide, ciclesonida, mometasona, beclometasona, e sais, solvatos e ésteres dos mesmos.
4. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a reivindicação 1, caracterizada em que compreende, ainda, um agente adesivo.
5. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a reivindicação 1, caracterizada em que compreende um desintegrante selecionado a partir do grupo que consiste em crospovidona, glicolato de amido sódico, carboximetilcelulose reticulada, hidroxilpropilcelulose de baixa substituição, mani tol, xilitol, sorbitol, mal tol, maltitol, lactose, sacarose, maltose, e combinações dos mesmos.
6. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a rei vindicação 1, caracterizada em que compreende, ainda, um excipiente selecionado a partir do grupo que consiste em manitol, xilitol, sorbitol, mal tol, maltitol, lactose, sacarose, maltose, ciclodextrina, e combinações dos mesmos.
7. COMPOSIÇÃO FARMACÊUTICA SÓLIDA, de acordo com a reivindicação 1, caracterizada em que é substancialmente livre de lubrificante.
8. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 1' caracterizada em que a composição 5 farmacêutica está sob a forma de um comprimido de desintegração oral (ODT).
9. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 8, caracterizada em que o ODT compreende partículas de fármaco e grânulos de rápida dispersão, em que as partículas de fármaco compreendem o corticosteroide, e os grânulos de rápida dispersão compreendem um desintegrante e um álcool de açúcar e/ou sacarídeo.
10. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 9, caracterizada em que as partículas de fármaco têm um tamanho médio de partícula menor do que cerca de 400 pm, os grânulos de rápida dispersão têm um tamanho médio de partícula menor do que cerca de 300 pm, e o desintegrante e álcool de açúcar e/ou sacarídeo têm um tamanho médio de partícula menor do que cerca de 30 pm.
11. COMPOSIÇÃO FARMACÊUTICA, de acordo com a rei vindicação 9, caracterizada em que o corticosteroide é disposto sobre a superfície de um excipiente, os grânulos de rápida dispersão têm um tamanho médio de partícula menor do que cerca de 300 pm, e o desintegrante e álcool de açúcar e/ou sacarídeo têm um tamanho médio de partícula menor do que cerca de 30 pm.
12. COMPOSIÇÃO FARMACÊUTICA, de acordo com a rei vindicação 4, caracterizada em que o agente adesivo e o corticosteroide estão intimamente associados.
13. COMPOSIÇÃO FARMACÊUTICA, de acordo com a rei vindicação 9, caracterizada em que o ODT compreende uma matriz liofilizada, em que a matriz liofilizada compreende o corticosteroide em combinação com pelo menos um excipiente.
14. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 13, caracterizada em que o excipiente é selecionado a partir do grupo que consiste em manitol, xilitol, sorbitol, maltol, mal ti tol, lactose, sacarose, 5 maltose e combinações dos mesmos.
15. COMPRIMIDO DE DESINTEGRAÇÃO ORAL, caracterizado em que compreende menos do que ou igual a 20 mg de um corticosteroide selecionado a partir do grupo que consiste em fluticasona, budesonida, mometasona, e sais, solvatos e ésteres dos mesmos, em que o comprimido de desintegração oral se desintegra em 60 segundos em fluido de sal i v a simulado quando testado com o uso do Teste de Desintegração USP <701>.
16. COMPRIMIDO DE DESINTEGRAÇÃO ORAL, de acordo com a reivindicação 15, caracterizado em que o comprimido de desintegração oral compreende cerca de 0,05 a O, 3 mg de fluticasona.
17. COMPOSIÇÃO FARMACÊUTICA de acordo com a reivindicação 1, caracterizado por tratar uma condição inflamatória do trato gastrointestinal.
18. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 17, caracterizado em que a dita inflamação do trato gastrointestinal compreende inflamação do esôfago.
19. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 17, caracterizado em que a dita condição é a esofagite eosinofílica.
20. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 17, caracterizado em que a dita inflamação compreende inflamação da glote, epiglote, amígdala ou orofaringe.
21. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA SUBSTANCIALMENTE NÃO AQUOSA, caracterizada em que compreende um corticosteroide e um líquido farmaceuticamente aceitável.
22. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com a reivindicação 21, caracterizada em que o líquido é selecionado a partir do grupo que consiste em álcoois farmaceuticamente aceitáveis, óleos, glicóis, glicóis éteres, pirrolidonas, polietilenos glicóis, N-metil-2-pirrolidona, 2- 5 pirrolidona, glicerol, tetraglicol, glicerol formal, solketal, acetato de etila, lactato de etila, butirato de etila, malonato de dibutila, citrato de tributila, acetilcitrato de tri-n-hexila, succinato de dietila, glutarato de dietila, malonato de dietila, citrato de trietila, triacetina, tributirina, carbonato de dietila, carbonato de propileno, acetona, metil etil cetona, sulfóxido de dimetila, dimetilssulfona, tetrahidrofurano, caprolactama, N,N-dietil-m-toluamida, 1-dodecilazacicloheptan-2-ona, 1,3- dimetil-3,4,5,6-tetrohidro-2(1H)-pirimidinona, e combinações dos mesmos.
23. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com a reivindicação 21, caracterizada em que compreende ainda um agente de mudança de fase dissolvido ou suspenso no di to líquido, em que após a administração a um paciente, a dita composição se submete a uma mudança em propriedades físicas da composição mediante o contato com o trato gastrointestinal do dito paciente, através do qual o contato do corticosteroide com o trato gastrointestinal do paciente é intensificado e/ou prolongado.
24. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com a reivindicação 23, caracterizada em que após a administração a um paciente, a dita composição precipita sobre a mucosa do trato gastrointestinal do paciente, através da qual a deposição do corticosteroide sobre a mucosa do trato gastrointestinal é intensificada e/ou prolongada.
25. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com a reivindicação 23, caracterizada em que após a administração a um paciente, a dita composição forma um gel em contato com a mucosa do trato gastrointestinal do paciente, através do qual a deposição do corticosteroide sobre a mucosa do trato gastrointestinal é intensificada e/ou prolongada.
26. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com 5 a reivindicação 21, caracterizada em que após a administração a um paciente, a dita composição aumenta em viscosidade mediante o contato com a mucosa do trato gastrointestinal do paciente, através do qual o tempo de permanência do corticosteroide na mucosa do trato intestinal é prolongado.
27. COMPOSIÇÃO FARMACÊUTICA LÍQUIDA, de acordo com a reivindicação 23, caracterizada em que o agente de mudança de fase é um polímero selecionado a partir do grupo que consiste em poli(N-isopropilacrilamida), poli(etileno glicol- (DL-ácido lático-co-ácido glicólico)-etileno glicol) e misturas dos mesmos.
28. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 21, caracterizada em que o dito corticosteroide é selecionado a partir do grupo que consiste em budesonida, fluticasona, flunisolide, ciclesonida, mometasona, tixocortol, beclometasona, e sais, solvatos e ésteres dos mesmos.
2 9. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 25, caracterizada em que o dito líquido é miscí vel em água e o di to agente de mudança de fase é um polímero biogeleificante que tem uma baixa solubilidade em água.
30. COMPOSIÇÃO FARMACÊUTICA, de acordo com a reivindicação 23, caracterizada em que o dito agente de mudança de fase aumenta em viscosidade quando em contacto com os fluidos da orofaringe, e em que o dito aumento em viscosidade é de pelo menos 50%.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US24764209P | 2009-10-01 | 2009-10-01 | |
US61/247,642 | 2009-10-01 | ||
PCT/US2010/050860 WO2011041509A1 (en) | 2009-10-01 | 2010-09-30 | Orally administered corticosteroid compositions |
Publications (1)
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