DONEPEZIL FORM

Pharmaceutical Composition Containing Donepezil Hydrochloride, Tablets Produced Therefrom and Methods for Producing the Same - Patent A pharmaceutical composition is provided according to the invention which is suited for the production of tablets by direct compression and which contains donepezil hydrochloride of polymorphic form I. The polymorphic form I of donepezil hydrochloride in the directly compressed tablet is also stable during long storage.The present invention relates to a pharmaceutical composition which contains crystalline donepezil hydrochloride of polymorphic form I and can be directly compressed into tablets as well as to tablets obtained from this composition by direct compression. In particular, the present invention relates to tablets where the donepezil hydrochloride is stable even during storage and is neither converted into other polymorphic forms nor becomes amorphous. One or more compounds which supply part of the material serving for achieving the necessary and desired total tablet composition can be used as fillers. Inter alia microcrystalline cellulose is usable in different particle sizes, in particular with a mean particle size ranging from 20 ?m to 200 ?m, in particular ranging from 50 ?m to 150 ?m, such as about 100 ?m, such as the known Avicel products, e.g. Avicel PH-102. Further suitable fillers are e.g. lactose, cellactose (a mixture of cellulose and lactose), calcium phosphate, dextrose, mannitol, maltodextrin, isomalt and where appropriate also sorbitol or saccharose. When the fillers are selected, care is to be taken that grades are used which are suited for the direct compression of tablets. This is indicated in the commercial products by the respective manufacturers or can be checked by simple experiments. The most preferred filler is microcrystalline cellulose. Commercial products are Avicel, Vivapur and Emcocel, for example.