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
Decision Guide
Calcium Formulation Low Dose
High Dose
(≥500mg CaCO3)
(≤500mg CaCO3)
Per-Oral
Chewable
Per-Oral
Chewable
Low Tablet Volume
Highly Compactable
High Assay
Organoleptics
Low Tablet Volume
Highly Compactable
CM 90, CS 95
CS 90
CS 90
Vitasmooth
CM 90, CS 95
CS 90
No Starch Labeling
No Starch Labeling
CM 90
CM 90
Vitasmooth®
CS 90/CS 90L
CM 90
CS 95
Pages 3-5
Pages 6-8
Pages 9-11
Pages 12-14
CS 90
2
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
Vitasmooth • 3
MATERIAL
BULK DENSITY (g/mL)
TAPPED DENSITY (g/mL)
ANGLE OF REPOSE (°)
CARR’S INDEX
Vitasmooth
0.617
0.802
36.8
23.1
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
DC Calcium Carbonate
Vitasmooth®
DESCRIPTION White to off-white free flowing powder CRITICAL PROPERTIES: Water Activity PSD on 60 mesh, % PSD on 200 mesh, % KF Water, % Calcium Carbonate, % Aerobic plate count, cfu/g Yeast and mold counts, cfu/g E. Coli Salmonella
Info only NMT 25 NLT 10 NMT 3 54-60 NMT 1000 NMT 200 Negative 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
Europe/Middle East/Africa
Asia/Pacific
Australia Distribution Company
SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE 19809
SPI Pharma SAS Chemin du Vallon du Maire 13240 Septemes-Les Vallons France
SPI Pharma, Inc. – India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore – 560100 Karnataka, India
Anzchem 1 Braidwood Street Enfield NSW 2136 Australia
Tel: 302-576-8600 800-789-9755 Ext. 8600
Tel: 33 4 9196 3600
Tel: 91 80 3027 0005
Tel: 61 2 9475 2200
Fax: 33 4 9196 3633
Fax: 91 80 3027 0050
Fax: 61 2 9475 2211
Fax: 302-576-8567
Vitasmooth • 5
www.spipharma.com
Vitasmooth September 2012
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. #$ +&
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CS 90/CS 90L • 6
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
0.805
0.87
36.6
18.2
Applications • Flowability Comparison • Formularies
CS 90/CS 90L • 7
DC Calcium Carbonate CS 90/CS 90L
DESCRIPTION White to Beige free flowing powder CRITICAL PROPERTIES: PSD thru 60 mesh, % PSD thru 230 mesh, % Calcium Carbonate, % Aerobic plate count, cfu/g Loss on Drying/Moisture, % Tapped Density, g/mL
NLT 60 NMT 25 85.5-95.5 NMT 1000 NMT 2 0.75-0.95
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
Europe/Middle East/Africa
Asia/Pacific
Australia Distribution Company
SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE 19809
SPI Pharma SAS Chemin du Vallon du Maire 13240 Septemes-Les Vallons France
SPI Pharma, Inc. – India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore – 560100 Karnataka, India
Anzchem 1 Braidwood Street Enfield NSW 2136 Australia
Tel: 302-576-8600 800-789-9755 Ext. 8600
Tel: 33 4 9196 3600
Tel: 91 80 3027 0005
Tel: 61 2 9475 2200
Fax: 33 4 9196 3633
Fax: 91 80 3027 0050
Fax: 61 2 9475 2211
www.spipharma.com
CS 90/CS 90L September 2012
Fax: 302-576-8567
CS 90/CS 90L • 8
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: 0.625” FFBE type “D” punches Tablet weight: 1700mg Formula: 97.5% Calcium product, 2.5% Lubripharm SSF Pre-compression: no
CM 90 • 9
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 90
1.212
1.462
42.2
17.1
Figure 5: Typical particle size for CM90 is centered around 500 microns. #$ -&
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Applications • Flowability Comparison • Formularies
CM 90 • 10
DC Calcium Carbonate CM 90
DESCRIPTION White to off-white granular powder CRITICAL PROPERTIES: PSD thru 200 mesh, % Calcium Carbonate, % (dried basis) Aerobic plate count, cfu/g Yeast and mold counts, cfu/g E. Coli Salmonella Loss on Drying/Moisture, % Tapped Density, g/mL Bulk Density, g/mL
NMT 25 88-93 NMT 1000 NMT 100 Negative Negative NMT 1 Info only 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
Europe/Middle East/Africa
Asia/Pacific
Australia Distribution Company
SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE 19809
SPI Pharma SAS Chemin du Vallon du Maire 13240 Septemes-Les Vallons France
SPI Pharma, Inc. – India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore – 560100 Karnataka, India
Anzchem 1 Braidwood Street Enfield NSW 2136 Australia
Tel: 302-576-8600 800-789-9755 Ext. 8600
Tel: 33 4 9196 3600
Tel: 91 80 3027 0005
Tel: 61 2 9475 2200
Fax: 33 4 9196 3633
Fax: 91 80 3027 0050
Fax: 61 2 9475 2211
Fax: 302-576-8567
CM 90 • 11
www.spipharma.com
CM 90 September 2012
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.
Figure 1: CS 95 is ideal when low volume, low weight and high calcium dose swallow tablets are required. CS 95
Figure 2: CS 95 consistently maintains a uniform particle size. #$ -&
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CS 95 • 12
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 95
0.920
1.226
47.7
25.0
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
DC Calcium Carbonate CS 95
DESCRIPTION White to off-white and free flowing powder CRITICAL PROPERTIES: Water Activity PSD on 60 mesh, % (cumulative) PSD on 200 mesh, % (cumulative) KF Water, % Calcium Carbonate, % Aerobic plate count, cfu/g Yeast and mold counts, cfu/g E. Coli Salmonella
NMT 0.7 6.5-43.2 45.9-80.9 0.4-1.5 92-98 NMT 2000 NMT 200 Negative 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
Europe/Middle East/Africa
Asia/Pacific
Australia Distribution Company
SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE 19809
SPI Pharma SAS Chemin du Vallon du Maire 13240 Septemes-Les Vallons France
SPI Pharma, Inc. – India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore – 560100 Karnataka, India
Anzchem 1 Braidwood Street Enfield NSW 2136 Australia
Tel: 302-576-8600 800-789-9755 Ext. 8600
Tel: 33 4 9196 3600
Tel: 91 80 3027 0005
Tel: 61 2 9475 2200
Fax: 33 4 9196 3633
Fax: 91 80 3027 0050
Fax: 61 2 9475 2211
www.spipharma.com
CS 95 May 2013
Fax: 302-576-8567
CS 95 • 14
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
Europe/Middle East/Africa
Asia/Pacific
Australia Distribution Company
SPI Pharma, Inc. Rockwood Office Park 503 Carr Rd., Suite 210 Wilmington, DE 19809
SPI Pharma SAS Chemin du Vallon du Maire 13240 Septemes-Les Vallons France
SPI Pharma, Inc. – India Branch 21 B, Veerasandra Industrial Area Hosur Road, Bangalore – 560100 Karnataka, India
Anzchem 1 Braidwood Street Enfield NSW 2136 Australia
Tel: 302-576-8600 800-789-9755 Ext. 8600
Tel: 33 4 9196 3600
Tel: Fax: Sales:
Tel: 61 2 9475 2200
Fax: 33 4 9196 3633
91 8110 669100 91 8110 669150 91 8110 669104
www.spipharma.com
Fax: 61 2 9475 2211
Fax: 302-576-8567 Calcium Brochure May 2013
