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
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
For more information or to request product samples, please visit
orth America North Latin America South Latin America Europe, Middle East and Asia Pacific South Asia All information and any product samples from Lubrizol are provided solely for the Customer’s use in developing and evaluating drug product formulations to be submitted for approval by government regulatory agencies such as the Food and Drug Administration (FDA). It is the Customer’s sole responsibility to determine if there are any issues relating to patent infringement of any component or combination of components relating to the supplied information and any product samples. Lubrizol makes no representation and warranty related to the accuracy and use of the information and/or product samples. Any and all information and product samples are provided on an “AS IS” basis without any warranty, expressed or implied, in particular and without limitation, NO WARRANTY, EXPRESSED OR IMPLIED AS TO THE MERCHANTIBILITY OR FITNESS FOR A PARTICULAR PURPOSE FOR ANY INFORMATION AND/OR SAMPLE PRODUCT THAT IS PROVIDED HEREUNDER. Lubrizol Advanced Materials, Inc. is a wholly owned subsidiary of The Lubrizol Corporation
Noveon is a registered trademark of The Lubrizol Corporation
*Trademark owned by The Lubrizol Corporation
Copyright 2011 Lubrizol Advanced Materials, Inc.
String Too Short to be Saved, Donald Hall, David R. Godine Publisher, 1979, 087923282X, 9780879232825,155 pages. This is a collection of stories diverse in subject, but sutured together by the limitless affection theauthor holds for the land and the people of New England. Donald Hall tells about life on a small farm where,as a boy, he spent summers with his grandparents. Gradually the boy grows
Copyright Ó Blackwell Munksgaard 2004Ephedra alkaloids and brief relapse inEMDR-treated obsessive compulsivedisorderFluvoxamine with no compulsive hand washing and no mooddisturbance. In his review of the adverse eﬀects of some herbal medicines,While there is still debate about the mechanism of action ofErnst (1) draws attention to reports that ma-huang, a herbalEMDR in post-traumatic s