OS-CR KC-3 Metformin Hydrochloride 500 mg Extended Release Tablets This formulation features Metformin Hydrochloride 500 mg tablets developed with Carbopol®* 974P NF polymer and hypromellose as the Tablet Properties
2. Carbopol® 974P NF Polymer
Dissolution/Drug Release** 1 hour: 32 - 35%
5. Hypromellose Substitution Type 2208 USP
** USP Apparatus 1, 100 rpm, 900 ml pH 6.8 buf er
Procedure
Metolose® is a registered trademark of Shin-Etsu Chemical Co., Ltd.
1. Weigh Metformin HCl, Carbopol® 974P NF polymer and hypromellose and pass through a
60 mesh sieve. Add the ingredients to a planetary mixer (or a high shear granulator) and
blend for 5 minutes at slow speed (20 rpm). Granulate with isopropyl alcohol (~330 ml for a
1,000 tablet batch ) added over a period of 2 minutes while mixing at medium speed (50
rpm). Continue mixing for about 3 minutes or until the isopropyl alcohol has been
2. Pass the wet mass through a 3 mm screen. Dry the resulting granules on trays without
heating for about 30 minutes to allow the isopropyl alcohol to evaporate. Continue drying at
65°C to a moisture content of less than 2%.
3. Pass the granules through a 20 mesh sieve and blend them with hypromellose (60 mesh
sieve) for 8 minutes. Add the talc and magnesium stearate (60 mesh sieve) and blend for 2
Punches: 17.10 x 8.20 mm concave, capsule shaped Target weight: 800.0 mg Mechanical strength: 15 kP
Friability: NMT 0.5 % w/w (100 revolutions)
Previous Editions: December 19, 2008 / November 20, 2009
• Precautions should be taken during manufacture to avoid contact with water. Also, the manufacturing
area and equipment must be flame proof as isopropyl alcohol is used for granulation.
• The Metformin HCL grade used in this formulation had a specification of not less than 95% passing
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*Trademark owned by The Lubrizol Corporation
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