Metformin Hydrochloride 1000 mg Extended Release Tablets OS-CR KC-4
This formulation features Metformin Hydrochloride 1000 mg tablets developed with Carbopol®* 974P NF polymer as the extended release Tablet Properties Ingredient Name Carbopol® 974P NF Polymer
Dissolution/Drug Release** 1 hour: 38 – 39%
1. Weigh Metformin HCl and Carbopol® 974P NF polymer and pass through a 60 mesh
** USP Apparatus 1, 100 rpm, 900 ml pH 6.8 buffer
sieve. Add both ingredients to a high shear granulator and blend for 6 minutes at 150 rpm.
2. Dissolve stearic acid in ~ 300 ml of isopropyl alcohol for a 1,000 tablet batch (if necessary,
heat the isopropyl alcohol on a water bath).
3. Granulate the powder blend with the solution of stearic acid and isopropyl alcohol, add it
over a period of 2 minutes while mixing the blend at 100 rpm. If necessary, add more
isopropyl alcohol while mixing to achieve the granulation end point.
4. Dry the granules without heating for about 30 minutes to allow the isopropyl alcohol to
evaporate. Pass the granules through a 12 mesh screen and dry them at 45°C to a moisture content of less than 2%.
5. Pass the granules through a 20 mesh sieve and blend them with magnesium stearate and
Punches: 20.15 x 9.70 mm concave, oval shaped Target weight: 1250.0 mg Mechanical strength: 25 kP Friability: NMT 0.5 % w/w (100 revolutions)
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 through a 100 mesh sieve.
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The information contained herein is believed to be reliable, but no representations, guarantees or warranties of any kind are made as to its accuracy, suitability for particular applications or the results to be obtained. The information often is based on laboratory work with small-scale equipment and does not necessarily indicate end product performance or reproducibility. Formulations presented may not have been tested for stability and should be used only as a suggested starting point. Because of the variations in methods, conditions and equipment used commercially in processing these materials, no warranties or guarantees are made as to the suitability of the products for the applications disclosed. Full-scale testing and end product performance are the responsibility of the user. Lubrizol Advanced Materials, Inc. shall not be liable for and the customer assumes all risk and liability for any use or handling of any material beyond Lubrizol Advanced Materials, Inc.’s direct control. The SELLER MAKES NO WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Nothing contained herein is to be considered as permission, recommendation, nor as an inducement to practice any patented invention without permission of the patent owner.
Lubrizol Advanced Materials, Inc. is a wholly owned subsidiary of The Lubrizol Corporation *Trademark owned by The Lubrizol Corporation Copyright 2008 Lubrizol Advanced Materials, Inc.
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