Silica Excipient for Pharmaceutical Applications

1 Grace Davison Discovery Sciences SYLOID 244 FP Silica Silica Excipient for Pharmaceutical Applications Applications Glidant Tabletting Aid Carrier for Active Ingredients Thickening, Gelation, and Suspension Moisture Scavenger High Efficiency Glidant Tabletting SYLOID 244FP Silica is highly . SYLOID 244FP Silica should be . SYLOID 244FP Silica incorporated efficient in many Pharmaceutical incorporated in your formulation at into your powder during the Applications due to its unique particle levels from to achieve granulation process ensures uniform structure and morphology. It has a a free flowing powder that will not flow through your equipment. highly developed network of pores stick to the walls of your transfer This results in higher consistency that provide access to the ultra system, tabletting and other during the tabletting process and high surface area which defines it's equipment.

2 Uniform powder flow improvement in the following performance. The result is a product is critical to achieving a consistent parameters: which is: product dosage, whether the product Content uniformity Easy to incorporate providing more is a capsule, tablet or other oral Structural stability uniform dispersion of actives and dosage form of Pharmaceutical . The improved content uniformity adsorptive properties of SYLOID Reduced friability and improved 244FP Silica , along with its ease of hardness High in adsorptive capacity both for hydrophilic and hydrophobic incorporation, make it more effective Resistance to capping, lamination compounds than other types of glidants used in and sticking pharmaceuticals.

3 Controlled drug release rate During the compression cycle of the tabletting process, liquid ingredients PROPERTY BENEFIT can be forced to the surface or even High internal porosity and High efficiency for lower costs caused to exude from the tablet. The surface area large internal porosity of SYLOID . High adsorptive capacity Carry higher level of actives/. reduced level of inactives 244FP Silica provides greater Low to moderate density for Cleaner work areas and less chance capacity for any liquid ingredients that lower dust of cross contamination may be included in your formulation, Controlled particle size More uniform blending resulting in which can prevent the occurrence of distribution improved content uniformity the above problems.

4 Continued on back 04/2009 M298. WATER ADSORPTION CAPACITY DENSITY. WATER ADSORPTION CAPACITY DENSITY. 140 120. 120. 100. SYLOID 244 Silica 100. Fumed Silica H2O Adsorption g/100g 80. 80. Density (g/L). 60. 60. 40. 40. 20. 20. 0 0. 0 20 40 60 80 SYLOID 244FP Silica Fumed Silica Relative Humidity, %. Comparison with Fumed Silica * Regulatory SYLOID 244FP Silica provides significantly higher SYLOID 244FP meets the requirements of the moisture adsorption than fumed Silica . *Fumed Silica is monograph for silicon dioxide as stated in the latest identified as colloidal Silica in the USP/NF monograph. USP/NF and Japanese Pharmaceutical excipients (JPE). editions. In addition, we manufacture a version that meets the requirements of the European Pharmacopeia.

5 This Ease of Handling and Dispersion product is identified as SYLOID 244FP-EU Silica . This The use of fumed Silica as an Excipient ingredient for grade also meets the requirements of JPE. Pharmaceutical formulations, particularly in tablets and as a carrier for liquids is well known. However, compared with fumed Silica , SYLOID 244FP Silica is larger in particle size Packaging and has a higher density. This translates into a product SYLOID 244FP Silica is packed in bags and palletized. that is much less dusty than fumed and is easier to handle For more information, please contact your Grace Davison and to incorporate into your formulation. representative. NA Customer Service Phone +1 ALLTECH is a trademark, registered in the United States and/or other countries, of Alltech Associates, Inc.

6 GRACE , GRACE DAVISON , and SYLOID are trademarks, registered in the United States and/or other countries, of W. R. Grace & GRACE. DAVISON DISCOVERY SCIENCES is a trademark of W. R. Grace & This trademark list has been compiled using available published information as of the publication date of this brochure and may not accurately reflect current trademark ownership. Alltech Associates, Inc. is a wholly owned subsidiary of W. R. Grace & Grace Davison Discovery Sciences is a product group of W. R. Grace & , which now includes all product lines formerly sold under the Alltech brand. Copyright 2009. Alltech Associates, Inc. All rights reserved. The information presented herein is derived from our testing and experience.

7 It is offered for your consideration and verification. Since operating conditions vary significantly, and are not under our control, we disclaim all warranties on the results that may be obtained from the use of our products. W. R. Grace & and its subsidiaries can not be held responsible for any damage or injury occurring as a result of improper installation or use of its products. Grace reserves the right to change prices and/or specifications without prior notification. 04/2009 M298. Global Headquarters Regional Offices W. R. Grace & Co. Conn. Discovery Sciences Europe W. R. Grace (Hong Kong) Ltd. Grace Brasil Ltda. Discovery Sciences Australia 7500 Grace Drive Brandstraat 12 Shanghai Rep.

8 Office Rua Albion, 229-10o. 2 Kerr Court Columbia, Maryland 21044 USA B-9160 Lokeren, Belgium 1010 Huai Hai Zhong Road Lapa S o Paulo SP - Brasil Rowville, 3178. TEL +1 TEL +32 (0)9 340 65 65 19th Floor K Wah Centre 05077-130 Victoria, Australia NA TOLL FREE +1 FAX +32 (0)9 340 65 60 Shanghai, 200031, China TEL + TEL +61 3 9237 6100. FAX +1 TEL + FAX + FAX +61 3 9237 6101.