FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
(See section l0 and rule 13]
1. Title of the invention: "Pharmaceutical formulation of Donepezil"
2. Macleods Pharmaceuticals Ltd., an Indian Company, having its Registered Office at 304 - Atlanta Arcade, Opp. Leela Hotel, Marol Church Road, Andheri (East), Mumbai - 400 059, Maharashta, India.
3. The following specification describes the invention.

341 MUM 2009
17 FEB 2009

PHARMACEUTICAL FORMULATION OF DONEPEZIL
Technical Field:
The present invention relates to oral formulation of Donepezil hydrochloride and more specifically to a taste masked orally disintegrating formulations and a method of preparation thereof
Brief description of the Invention:
Donepezil hydrochloride has an unpleasant bitter taste and one of the primary requirements of orally disintegrating tablets is that the bitter taste of drug should be masked.
There have been identified and used various types of taste masking agents and technologies in state of the art, still there is desire for a simpler and economical technique which efficiently masks the bitter taste of drug by using conventional excipients.
According to one of preferred embodiments, the present invention provides a stable, taste masked and a simple orally disintegration formulation comprising Donepezil hydrochloride, a taste-masking agent and one or more pharmaceutical ly acceptable excipients wherein the taste masking, stability, disintegration and hardness of orally disintegrating formulation is achieved while using conventional excipients.
1

According to one of featured aspect of the invention, sodium chloride is used as taste masking agent.
According to one of another aspect of the invention, the Donepezil hydrochloride used in present invention is preferably its polymorphic form I.
The one or more pharmaceutical excipients used in present invention can be fillers, disintegrants, artificial sweeteners and lubricants.
The orally disintegrating formulation of the present invention is preferably a solid oral dosage forms including tablets, granules, capsules, pellets, powders and a like.
According to one of other preferred embodiment, the present invention provides a method of preparation of said formulation, comprising the steps of:
1) Cosifting the sodium chloride and sucrolose through mesh,
2) Cosifting geometrically the mixture of step (1), Donepezil hydrochloride, mannitol and crospovidone through mesh,
3) Mixing the above sifted material of step (2) in the octagonal blender at low speed,
4) Sifting magnesium stearate through mesh, adding the same with prelubricated blend of step (3) for mixing therewith, and
5) Compressing the lubricated blend of step (4) on suitable compression machine for desired strength and hardness of said formulation.
2

The present invention can be illustrated by the following example:

S.No. Ingredients Category Mg/Tab
I. Donepezil HC1 Active ingredients 10
2. Sodium chloride Taste masking agent 10
3. Mannitol Filler 224
4. Crospovidone XL Disintegrant 30
5. Sucralose Artificial sweetener 2
6. Magnesium stearate Lubricant 4
Weight of Tablet 280
FIG 1: - Quantitative Formula of Donepezil ODT tablets l0mg and 5mg

iih
Dated this 12tn day of February, 2009


Signature:
Name: Dr. Rajendra Agarwal

To
The Controller of Patents The patent Office, At Mumbai

3