DESCRIPTION
ARICEPT™ (donepezil hydrochloride) is a reversible
inhibitor of the enzyme acetylcholinesterase, known chemically
as (±)-2,3-dihydro-5,6-dimethoxy-2-[[ l-(phenylmethyl)-4-piperidinyl]
methyl]-lH-inden-l-one hydrochloride. Donepezil hydrochloride
is commonly referred to in the pharmacological literature
as E2020. It has an empirical formula of C24H29NO3 HCl
and a molecular weight of 415.96. Donepezil hydrochloride
is a white crystalline powder and is freely soluble in
chloroform, soluble in water and in glacial acetic acid,
slightly soluble in ethanol and in acetonitrile and practically
insoluble in ethyl acetate and in n-hexane.
ARICEPT™ is available for oral administration in
film-coated tablets containing 5 or 10 mg of donepezil
hydrochloride. Inactive ingredients are lactose monohydrate,
cornstarch, microcrystalline cellulose, hydroxypropyl
cellulose, and magnesium stearate. The film coating contains
talc, polyethylene glycol, hydroxypropyl methylcellulose
and titanium dioxide. Additionally, the 10 mg tablet contains
yellow iron oxide (synthetic) as a coloring agent.
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