초록

In some aspects of the present invention is a formulation comprising a solid dispersion or intimate mixture of a poorly water soluble drug and an ionic polymer surprisingly exhibiting fast disintegration of tablet.

대표청구항 ▼

1. An orally disintegrating tablet comprising: an amorphous solid dispersion comprising a hot-melt extrudate comprising a poorly water soluble drug and an ionic polymer,wherein the ionic polymer is selected from the group consisting of: a copolymer of methacrylic acid, ethyl acrylate, and methyl met

1. An orally disintegrating tablet comprising: an amorphous solid dispersion comprising a hot-melt extrudate comprising a poorly water soluble drug and an ionic polymer,wherein the ionic polymer is selected from the group consisting of: a copolymer of methacrylic acid, ethyl acrylate, and methyl methacrylate; hypromellose acetate succinate; and a copolymer of dimethylaminoethyl methacrylate, butyl methacrylate, and methyl methacrylate,wherein the ionic polymer is present in an amount of at least 55% by weight of the amorphous solid dispersion,wherein the poorly water soluble drug and the ionic polymer are present in a weight ratio of between 20:80 and 45:55,wherein the poorly water soluble drug in amorphous form is present in the amount of at least 80% by weight of the poorly soluble drug, andwherein the tablet disintegrates in water within 40 seconds or less. 2. The orally disintegrating tablet of claim 1, wherein an amount of the ionic polymer is at least about 65% by weight of said dispersion. 3. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is megestrol or a pharmaceutically acceptable salt thereof. 4. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is ziprasidone or a pharmaceutically acceptable salt thereof. 5. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is eszopiclone or a pharmaceutically acceptable salt thereof. 6. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is prednisolone or a pharmaceutically acceptable salt thereof. 7. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is clarithromycin or a pharmaceutically acceptable salt thereof. 6. The orally disintegrating tablet of claim 1, wherein the poorly water soluble drug is sumatriptan or a pharmaceutically acceptable salt thereof. 7. The orally disintegrating tablet of claim 1, wherein the drug and the ionic polymer are present in a weight ratio of 20:80, and wherein the tablet disintegrates in 40 seconds or less. 8. The orally disintegrating tablet of claim 1, wherein the drug and the ionic polymer are present in a weight ratio of 45:55, and wherein the tablet disintegrates in 30 seconds or less.