FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL SPECIFICATION
(See sectionlO and rule 13]
1. Title of the invention: "Paracetamol extended release tablet formulation"

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.

PARACETAMOL EXTENDED RELEASE TABLET FORMULATION
Field of the Invention
The invention relates to extended release formulation of Paracetamol
Brief Description
The instant invention provides monolayer extended release formulation of Paracetamol
which is bioequivaient to the currently marketed bilayered product of innovator. The formulation can be prepared by direct compression or granulation method.
WORKING EXAMPLES;
Example 1:

S.No. Composition Qtty(mg)
1 Paracetamol 665
2 Starch Pregelatinized 7.35
3 MCCPH101 18.33
4 HPMC K4M CR 22
5 Povidone K30 15
6 Purified Water q.s
7 Croscarmellose sodium 20
8 Mg. Stearate 7.35
Tablets weight - Core 755
9 HPMC based aqueous film coating

Process:
1. Mix paracetamol, P.G starch, Avicel PH 101, HPMC K4M CR after sieving through 40# mesh.
2. Dissolve povidone in water and granulate the dry mix of Step No 1
3. Dry & Size the granules to have LOD of 1.5 - 2.5%.
4. Prelubricate the sized granules with croscarmellose sodium and lubricate with magnesium stearate.
5. Compress the lubricated blend on rotary compression machine and coat the core tablets with HPMC based coating system.
Example 2:

S.No Name of the ingredient Mg/Tab Function
Granulation I
1 Paracetamol 532.0 Active
2 MCCPH101 9.3 Filler
3 PG Starch 12.0 Binder
4 HPMC K4M CR 16.0 Rate controlling polymer
5 Povidone K 29/32 30.0 Binder
7 Purified water q.s Binder vehicle.
Granulation II
4 Paracetamol 133.0 Active
5 PG Starch 20.0 Binder
6 Purified water q.s Binder vehicle.
Lubrication
7 Croscarmellose sodium 10.0 Disintegrant
8 Magnesium Stearate 7.7 Lubricant
Total Wt Of the tablet 790.0 mg

Dated this 31st day of December, 2008


To
The Controller of Patents The patent Office, At Mumbai