Gastro-resistant formulation containing posaconazole
AssigneeAlfred E. Tiefenbacher (GmbH & Co. KG)
InventorsVamshi Ramana Prathap, Venkatasimhadri Naidu Kalamata, Bala Ramesha Chary Rallabandi, Vinay Kumar Katakam, Hendrik Schlehahn
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Abstract
The present invention relates to a gastro-resistant pharmaceutical composition comprising a solid solution prepared by hot-melt extrusion, whereby the solid solution contains posaconazole, an enteric polymer and a non-enteric polymer. The composition is preferably a granulate material that can be filled into a capsule or compressed into a tablet.
Claims30
A gastro-resistant pharmaceutical composition comprising posaconazole, wherein the posaconazole is molecularly dispersed in a mixture containing an enteric polymer and a non-enteric polymer, the mixture is prepared by hot-melt extrusion, wherein the enteric polymer and non-enteric polymer are present in a ratio of 6:1 to 1:1 and the gastro-resistant pharmaceutical composition releases posaconazole in the intestine and releases≤10% of the posaconazole after two hours in 0.01M HCl and releases at least 80% of the posaconazole after the two hours in 0.01 M HCl followed by 45 minutes at pH 6.8.
A gastro-resistant pharmaceutical composition comprising posaconazole, wherein the posaconazole is molecularly dispersed in a mixture containing an enteric polymer and a non-enteric polymer, the mixture is prepared by hot-melt extrusion, wherein the enteric polymer and non-enteric polymer are present in a ratio of 6:1 to 1:1 and the gastro-resistant pharmaceutical composition releases≤10% of the posaconazole in the stomach and at least 80% of the posaconazole is released in stomach and intestine combined.
Dependencies are inferred from the claim text.