DC Calcium Carbonate Vitasmooth CS 90/CS 90L CM 90 CS 95

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2 DC Calcium Carbonate SPI Pharma s calcium line offers a series of choices to the formulator for the manufacture of both Antacid and Nutritional Calcium Supplementation products. Vitasmooth Vitasmooth is a highly compactable and organoleptically pleasing formulation of Calcium Carbonate specifically designed for incorporation into nutritional supplements. Vitasmooth is ideal for the formulation of both Calcium and Calcium and Vitamin supplements manufactured by direct compression. CS 90/CS 90L A highly compactable, porous calcium carbonate with smooth organoleptics, CS 90/CS 90L is ideal for Antacid formulations and Nutritional Supplements, especially where tablet weight is a concern. CS 90/CS 90L has a high surface area due to its high assay, unique formulation and processing. It is readily compacted by direct compression methodology, omitting the need for wet granulation processes while still maintaining a high assay. This allows decreased overall tablet weights. CM 90 CM 90 is ideal for supplements requiring a high calcium carbonate assay, and high density. Due to its high density and high assay, CM 90 is ideal for targeting lower tablet weights and lower tablet volumes, while still providing the required calcium content. CM 90 can be used in both wet granulation and direct compression systems. CS 95 Due to its high assay of calcium carbonate and relatively high density, CS 95 is ideal for making higher concentration calcium products which have a relatively low tablet weight and tablet volume. Its low compaction makes CS 95 a candidate for wet granulation, especially when low tablet weights and volumes are desired. 1

3 Decision Guide Calcium Formulation Low Dose ( 500mg CaCO3) High Dose ( 500mg CaCO3) Per-Oral Chewable Per-Oral Chewable Low Tablet Volume Highly Compactable High Assay Low Tablet Highly Organoleptics Volume Compactable CS 90 CM 90, CS 95 CS 90 CS 90 Vitasmooth CM 90, CS 95 CS 90 No Starch Labeling CM 90 No Starch Labeling CM 90 Vitasmooth Pages 3-5 CS 90/CS 90L Pages 6-8 CM 90 Pages 9-11 CS 95 Pages

4 DC Calcium Carbonate Vitasmooth Vitasmooth is a highly compactable and organoleptically pleasing formulation of Calcium Carbonate specifically designed for incorporation into nutritional supplements. Vitasmooth is ideal for the formulation of both Calcium and Calcium and Vitamin supplements manufactured by direct compression. Figure 1: Vitasmooth is readily compactable and can be used in DC tableting without adding binders. Figure 2: Vitasmooth is low friable, making it the ideal choice for direct compression. Figure 3: Typical Properties Table MATERIAL BULK DENSITY (g/ml) TAPPED DENSITY (g/ml) ANGLE OF REPOSE ( ) CARR S INDEX Vitasmooth Vitasmooth 3

5 Figure 4: Ingredients Vitasmooth Calcium Carbonate Dextrose Sucrose MCC Maltodextrin Figure 5: Sample Formulation: Children s MVI with Calcium chewable Applications Flowability Comparison Formularies Vitasmooth 4

6 DC Calcium Carbonate Vitasmooth DESCRIPTION White to off-white free flowing powder CRITICAL PROPERTIES: Water Activity Info only PSD on 60 mesh, % NMT 25 PSD on 200 mesh, % NLT 10 KF Water, % NMT 3 Calcium Carbonate, % Aerobic plate count, cfu/g NMT 1000 Yeast and mold counts, cfu/g NMT 200 E. Coli Negative Salmonella Negative STANDARD PACKAGING: 100 kg fiber drums. Product is made using USP/NF ingredients. The information and recommendations in this publication are, to the best of our knowledge, reliable. Suggestions made concerning uses or applications are only the opinion of SPI Pharma and users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, SPI Pharma makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose, other than that the material conform to its applicable current standard specifications. Statements herein, therefore, should not be construed as representations or warranties. The responsibility of SPI Pharma for claims rising out of breach or warranty, negligence, strict liability or otherwise is limited to the purchase price of the material. SPI Pharma shall, in no event, be liable for special, incidental or consequential damages, including loss of profits. Statements concerning the use of products of formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for infringement arising out of such use. Standard Specifications, although current at the time of publication, are subject to change without notice. For latest Standard Specifications contact SPI Pharma. Formulating Success Through Innovation Americas SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE Tel: Ext Fax: Europe/Middle East/Africa SPI Pharma SAS Chemin du Vallon du Maire Septemes-Les Vallons France Tel: Fax: Asia/Pacific SPI Pharma, Inc. India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore Karnataka, India Tel: Fax: Australia Distribution Company Anzchem 1 Braidwood Street Enfield NSW 2136 Australia Tel: Fax: Vitasmooth September 2012 Vitasmooth 5

7 DC Calcium Carbonate CS 90/CS 90L A highly compactable, porous calcium carbonate with smooth organoleptics, CS 90/CS 90L is ideal for Antacid formulations and Nutritional Supplements, especially where tablet weight is a concern. CS 90/CS 90L has a high surface area, unique formulation and processing. It is readily compacted by direct compression methodology, omitting the need for wet granulation processes. This allows decreased overall tablet weights. Figure 1: No need for wet granulation. Readily compacted by direct compression. Maintains high assay. Figure 2: CS 90/CS 90L consistently maintains a uniform particle size. CS 90/CS 90L 6

8 Figure 3: Uniform particle size, highly compactable, porous calcium carbonate creates smooth organoleptics. Figure 4: Ingredients CS 90/CS 90L 90% Calcium Carbonate 10% Starch Figure 5: Typical Properties Table MATERIAL BULK DENSITY (g/ml) TAPPED DENSITY (g/ml) ANGLE OF REPOSE ( ) CARR S INDEX CS 90/CS 90L Applications Flowability Comparison Formularies CS 90/CS 90L 7

9 DC Calcium Carbonate CS 90/CS 90L DESCRIPTION White to Beige free flowing powder CRITICAL PROPERTIES: PSD thru 60 mesh, % NLT 60 PSD thru 230 mesh, % NMT 25 Calcium Carbonate, % Aerobic plate count, cfu/g NMT 1000 Loss on Drying/Moisture, % NMT 2 Tapped Density, g/ml STANDARD PACKAGING: 50 kg fiber drums. Product is made using USP/EP ingredients. The information and recommendations in this publication are, to the best of our knowledge, reliable. Suggestions made concerning uses or applications are only the opinion of SPI Pharma and users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, SPI Pharma makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose, other than that the material conform to its applicable current standard specifications. Statements herein, therefore, should not be construed as representations or warranties. The responsibility of SPI Pharma for claims rising out of breach or warranty, negligence, strict liability or otherwise is limited to the purchase price of the material. SPI Pharma shall, in no event, be liable for special, incidental or consequential damages, including loss of profits. Statements concerning the use of products of formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for infringement arising out of such use. Standard Specifications, although current at the time of publication, are subject to change without notice. For latest Standard Specifications contact SPI Pharma. Formulating Success Through Innovation Americas SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE Tel: Ext Fax: Europe/Middle East/Africa SPI Pharma SAS Chemin du Vallon du Maire Septemes-Les Vallons France Tel: Fax: Asia/Pacific SPI Pharma, Inc. India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore Karnataka, India Tel: Fax: Australia Distribution Company Anzchem 1 Braidwood Street Enfield NSW 2136 Australia Tel: Fax: CS 90/CS 90L September 2012 CS 90/CS 90L 8

10 DC Calcium Carbonate CM 90 CM 90 is ideal for supplements requiring a creamy mouth feel, high calcium carbonate assay, and high density. Due to its high density and high assay, CM 90 is ideal for targeting lower tablet weights and lower tablet volumes, while still providing the required calcium content. CM90 can be used in both wet granulation and direct compression systems. Figure 1: As indicated by the compression graph, CM 90, due to the product s high density, provides for the manufacture of relatively thin tablets for a given weight, leading to an overall reduction in tablet volume. For this reason and CM 90 s high calcium carbonate assay, CM 90 is ideal for the manufacture of high-dose calcium supplements or anti-acids, as the overall tablet size is relatively low for a given calcium carbonate dose. Figure 2: CM 90 generates a minimal amount of friction upon ejection from the tablet die. This reduces the wear and tear on the tableting press and ensures that tablet ejection will not decease tablet robustness. Test Conditions: Press: GP-8 rotary tablet press at 25rpm Tooling: FFBE type D punches Tablet weight: 1700mg Formula: 97.5% Calcium product, 2.5% Lubripharm SSF Pre-compression: no CM 90 9

11 Figure 3: Ingredients CM 90 91% Calcium Carbonate 9% Maltodextrin Figure 4: Typical Properties Table MATERIAL BULK DENSITY (g/ml) TAPPED DENSITY (g/ml) ANGLE OF REPOSE ( ) CARR S INDEX CM Figure 5: Typical particle size for CM90 is centered around 500 microns. Applications Flowability Comparison Formularies CM 90 10

12 DC Calcium Carbonate CM 90 DESCRIPTION White to off-white granular powder CRITICAL PROPERTIES: PSD thru 200 mesh, % NMT 25 Calcium Carbonate, % (dried basis) Aerobic plate count, cfu/g NMT 1000 Yeast and mold counts, cfu/g NMT 100 E. Coli Negative Salmonella Negative Loss on Drying/Moisture, % NMT 1 Tapped Density, g/ml Info only Bulk Density, g/ml Info only STANDARD PACKAGING: 125kg fiber drum. Product is made using USP/EP ingredients. The information and recommendations in this publication are, to the best of our knowledge, reliable. Suggestions made concerning uses or applications are only the opinion of SPI Pharma and users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, SPI Pharma makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose, other than that the material conform to its applicable current standard specifications. Statements herein, therefore, should not be construed as representations or warranties. The responsibility of SPI Pharma for claims rising out of breach or warranty, negligence, strict liability or otherwise is limited to the purchase price of the material. SPI Pharma shall, in no event, be liable for special, incidental or consequential damages, including loss of profits. Statements concerning the use of products of formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for infringement arising out of such use. Standard Specifications, although current at the time of publication, are subject to change without notice. For latest Standard Specifications contact SPI Pharma. Formulating Success Through Innovation Americas SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE Tel: Ext Fax: Europe/Middle East/Africa SPI Pharma SAS Chemin du Vallon du Maire Septemes-Les Vallons France Tel: Fax: Asia/Pacific SPI Pharma, Inc. India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore Karnataka, India Tel: Fax: Australia Distribution Company Anzchem 1 Braidwood Street Enfield NSW 2136 Australia Tel: Fax: CM 90 September 2012 CM 90 11

13 DC Calcium Carbonate CS 95 CS 95 has a high assay of calcium carbonate. It has a relatively high density and makes thin tablets. Due to these attributes, CS 95 is ideal for making higher concentration calcium products which have a relatively low tablet weight and tablet volume. Its low compaction makes it a candidate for wet granulation, especially when low tablet weights and volumes are desired. CS 95 Figure 1: CS 95 is ideal when low volume, low weight and high calcium dose swallow tablets are required. Figure 2: CS 95 consistently maintains a uniform particle size. CS 95 12

14 Figure 3: Ingredients CS 95 95% Calcium Carbonate 5% Starch Figure 4: Typical Properties Table MATERIAL BULK DENSITY (g/ml) TAPPED DENSITY (g/ml) ANGLE OF REPOSE ( ) CARR S INDEX CS Applications Flowability Comparison Formularies About SPI Pharma SPI Pharma is headquartered in Delaware, United States and provides products and services to multi-national and regional pharma companies in over 55 countries. SPI has the backing of a strong parent, Assoiciated British Foods (ABF), a $17 Billion company headquartered in the UK. Our product manufacturing sites follow strict cgmp standards and have been successfully audited by global regulatory authorities. CS 95 13

15 DC Calcium Carbonate CS 95 DESCRIPTION White to off-white and free flowing powder CRITICAL PROPERTIES: Water Activity NMT 0.7 PSD on 60 mesh, % (cumulative) PSD on 200 mesh, % (cumulative) KF Water, % Calcium Carbonate, % Aerobic plate count, cfu/g NMT 2000 Yeast and mold counts, cfu/g NMT 200 E. Coli Negative Salmonella Negative STANDARD PACKAGING: 50 kg fiber drums. Product is made using USP/EP ingredients. The information and recommendations in this publication are, to the best of our knowledge, reliable. Suggestions made concerning uses or applications are only the opinion of SPI Pharma and users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, SPI Pharma makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose, other than that the material conform to its applicable current standard specifications. Statements herein, therefore, should not be construed as representations or warranties. The responsibility of SPI Pharma for claims rising out of breach or warranty, negligence, strict liability or otherwise is limited to the purchase price of the material. SPI Pharma shall, in no event, be liable for special, incidental or consequential damages, including loss of profits. Statements concerning the use of products of formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for infringement arising out of such use. Standard Specifications, although current at the time of publication, are subject to change without notice. For latest Standard Specifications contact SPI Pharma. Formulating Success Through Innovation Americas SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE Tel: Ext Fax: Europe/Middle East/Africa SPI Pharma SAS Chemin du Vallon du Maire Septemes-Les Vallons France Tel: Fax: Asia/Pacific SPI Pharma, Inc. India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore Karnataka, India Tel: Fax: Australia Distribution Company Anzchem 1 Braidwood Street Enfield NSW 2136 Australia Tel: Fax: CS 95 May 2013 CS 95 14

16 The information and recommendations in this publication are, to the best of our knowledge, reliable. Suggestions made concerning uses or applications are only the opinion of SPI Pharma and users should make their own tests to determine the suitability of these products for their own particular purposes. However, because of numerous factors affecting results, SPI Pharma makes no warranty of any kind, express or implied, including those of merchantability and fitness for particular purpose, other than that the material conform to its applicable current standard specifications. Statements herein, therefore, should not be construed as representations or warranties. The responsibility of SPI Pharma for claims rising out of breach or warranty, negligence, strict liability or otherwise is limited to the purchase price of the material. SPI Pharma shall, in no event, be liable for special, incidental or consequential damages, including loss of profits. Statements concerning the use of products of formulations described herein are not to be construed as recommending the infringement of any patent and seller assumes no liability for infringement arising out of such use. Standard Specifications, although current at the time of publication, are subject to change without notice. For latest Standard Specifications contact SPI Pharma. Formulating Success Through Innovation Americas SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE Tel: Ext Fax: Europe/Middle East/Africa SPI Pharma SAS Chemin du Vallon du Maire Septemes-Les Vallons France Tel: Fax: Asia/Pacific SPI Pharma, Inc. India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore Karnataka, India Tel: Fax: Sales: Australia Distribution Company Anzchem 1 Braidwood Street Enfield NSW 2136 Australia Tel: Fax: Calcium Brochure May 2013

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