| 摘要 |
<p>The present invention describes in an embodiment a coating composition which contains in a film coating an active pharmaceutical ingredient, which is defined by a low water solubility of about 10 mg/ml or lower as measured in water at 20°C at about pH 7, or which is defined by presenting a dispersed state when placed in water at 20°C at about pH 7, and a co-polymer of polyvinyl alcohol with polyethylene glycol. Preferably the active pharmaceutical ingredient has been applied dispersed in an aqueous coating vehicle onto a core which optionally comprises a same or different active pharmaceutical ingredient. The present invention also describes a process for the preparation of a pharmaceutical single unit dosage form, wherein the process comprised the steps of providing a core of the single unit dosage form, optionally providing one or more subcoating layer(s) on the core, subjecting the core to film coating using a composition comprising an aqueous coating vehicle, a co-polymer of polyvinyl alcohol with polyethylene glycol and at least one active pharmaceutical ingredient dispersed in the aqueous coating vehicle, wherein said co-polymer amounts for at least 7.0 wt.%, preferably at least 9.4 wt. % of said composition and the weight ratio of said co-polymer to said active pharmaceutical ingredient is at least 1:1 to 5:1. Other process embodiments are also described. High drug loads, uniformity of drug load, and fast dissolution rates of active pharmaceutical ingredient from film coatings of pharmaceutical single unit dosage forms can be achieved according to the present invention.</p> |
