SYLOID Silicas - Grace

1 SYLOID Silicas Pharmaceutical Excipient Technical Note Multifunctional Excipients for the Pharmaceutical Industry SYLOID FP and SYLOID XDP Silicas are efficient in many pharmaceutical applications due to its unique morphology. It has a highly developed network of meso-pores that provide access to the large surface area that defines it's performance. The result is a product that is : n Easy to incorporate, providing more uniform dispersion of actives and improved content uniformity n High in adsorptive capacity - both for hydrophilic and hydrophobic compounds Applications: n Glidant n Thickening, Gelation and Suspension n Tabletting Aid n Moisture Scavenger n Carrier for Active Ingredients n Disintegrant Aid n Carrier for Liquisolids/SEDDS.

2 SYLOID FP and SYLOID XDP Silicas - Product Specifications*. Property 63FP 72FP 244FP XDP 3050 XDP 3150. SiO2 (dried basis) (%) Avarage particle size (via Malvern) ( m) 50 150. Oil adsorption (lbs/100lbs) 80 220 300 300 300. Bulk density (g/l) 566 112 60 275 275. Average Pore Volume (cc/gm) * These specifications are provided for informational purposes only. Not to be used as sales , product, or in-process specifications. Note: Certificate of Analysis is supplied with each SYLOID FP and SYLOID XDP silica shipment. Excipients SYLOID excipients are micronized synthetic amorphous silica gels of high purity that are widely formulated into many SYLOID silica Excipients Advantages pharmaceutical products.

3 In therapeutic categories, Anti- n Effective desiccant to increase the stability of infectives, Central Nervous System and Cardiovascular, moisture-sensitive APIs they can effectively contribute to the processability, stability n Efficient conditioner for powder formulations and release of active pharmaceutical ingredients (API) and used in suspensions the shelf life of their finished dosage forms. n Capillary wetting agent for better release and Multifunctional disintegration n Contribution to the release of active SYLOID FP and SYLOID XDP silica 's unique combination of pharmaceutical ingredients (API).

4 Adsorptive capacity, meso-porosity, particle size and surface n Low dusting and easy to handle morphology allows it to promote the consistent release of the drug and protect it from degradation. Applications Water Adsorption Capacity Glidant 140. SYLOID 244FP silica . SYLOID 244FP silica as a glidant should be incorporated in 120. Adsorption Capacity, Weight %. SYLOID 63FP silica . your formulation at levels from - to achieve a free 100 Fumed silica Porosity (PS/PV). flowing powder that will resist sticking to the walls of your 80.

5 Transfer system, tabletting and other equipment. Uniform 60. powder flow is critical to achieving a consistent product 40. dosage, whether the product is a capsule, tablet or other 20. solid dosage form. The adsorptive properties of SYLOID FP 0. silica , along with its ease of incorporation, make it a highly 0 10 20 30 40 50 60 70 80 90 100. Relative Humidity, %. effective glidant for pharmaceutical use.*. The moisture adsorption capacities of the different grades of SYLOID . FP Silicas are compared to fumed silica . It can be seen that for any relative humidity, a SYLOID FP silica can be chosen which will give Carrier for Liquids, Oils and Active Ingredients the highest moisture adsorption.

6 The high porosity of SYLOID XDP Silicas enables them to absorb up to 300g of liquid per 100g of silica . Therefore, water in our formulation, SYLOID FP silica can help protect liquid ingredients can be easily turned into free flowing the bulk powder from these effects.*. powders with optimum density. This is an advantage for liquisolids, solid SEDDS, oily API and powders used in oral Coating suspension dosage forms and tablets to be developed for n Improvement of suspension stability higher API potency. n Protection from light and moisture n Taste masking Tabletting n Wetting of tablets by reducing hydrophobicity Good powder flow is required for the successful n Matting agent manufacturing of solid dosage forms.

7 N Modified drug release SYLOID FP silica incorporated in your powder during the granulation process or direct compression means uniform flow through your equipment. This can boost consistency during the tabletting process and provide improvement in Surface the following parameters: Area n Reduced friability and improved hardness n Content uniformity n Structural stability n Quicker tabletting because of unique moisture adsorption n High resistance to capping, lamination and Internal sticking Porosity During the compression cycle of the tabletting process, and liquid ingredients can be forced to the surface or even Surface caused to exude from the tablet.

8 The large internal porosity Area of SYLOID FP and SYLOID XDP silica provides greater capacity for any liquid ingredients that may be included in The internal porosity of SYLOID FP silica gives it greater available surface your formulation, which can prevent the occurrence of the area. above problems. SYLOID FP and SYLOID XDP Silicas Can Bring Moisture Scavenger / Protector n Superior, strong absorptive capacity for both oil SYLOID FP silica can act as an extremely efficient and water dehydrating agent, even at a very low moisture content.

9 N High capability for improving flow and reducing This can help to maximise product shelf life. Trace caking of many APIs during their processing quantities of moisture can affect a formulation in many and in their final dosage forms ways. It can degrade your API, it can cause reactions n Enhanced compactibility for direct compression between your ingredients and can decrease shelf life. By in combination with other excipients adsorbing moisture from the atmosphere or by binding the n Reduced risk of cross-contamination by minimizing dusting problems.

10 Ease of Handling and Dispersion Density Comparison The higher density of SYLOID Silicas , when compared to many fumed (colloidal) Silicas , makes it easier to handle, g/L. 120. results in less dust for a cleaner production environment 100. and eliminates the need for sieving prior to usage. 80. 60. Compliance 40. SYLOID silica grades are manufactured and certified to 20. meet the specific test requirements as published in the 0. latest editions of the United States Pharmacopoeia- Fumed silica SYLOID 244FP silica National Formulary (USP-NF) for Silicon Dioxide, Japanese Pharmaceutical Excipients (JPE) for Hydrated Silicon Dioxide and the European Pharmacopoeia (EP) for silica , Colloidal Hydrated.