Calcium Phosphate Excipients - Innophos

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TABLETING PROPERTIES <strong>Calcium</strong> <strong>Phosphate</strong>s in Wet Granulations The powdered calcium phosphates have been traditionally used in wet granulation processes. They are blended, size enlarged through the use of a binder and dried and sized for compression. The calcium phosphates can be granulated with a large variety of commonly used binders, including starch, pregelatinized starch, acacia, locust bean and guar gums, cellulosics such as methylcellulose, ethylcellulose, hydroxypropyl methylcellulose and polyvinylpyrrolidone. Some special facts to remember about the calcium phosphates are: ◆ Tricalcium phosphate will dry to its anhydrous form. ◆ Dicalcium phosphate anhydrous will remain anhydrous. ◆ Dicalcium phosphate dihydrate can lose some or all of its waters of hydration irreversibly during drying. Often, a granular calcium phosphate is used in a wet granulation process because of the advantages of granular over powdered products: ease of handling, smoother unit operation due to higher bulk densities, fewer fine particles and therefore less dust. A special grade of tricalcium phosphate, TRI-CAL-WG, which is a densified tricalcium phosphate, is designed for wet granulation (WG) use. Direct Compression Tableting with A-TAB ® A-TAB ® is also directly compressible to give hard compacts at moderate applied forces. Using tableting conditions like those used for DI-TAB ® , Figure 11 shows a compressibility profile for A-TAB ® slightly greater than for DI-TAB ® at the higher applied forces. A-TAB ® , like DI-TAB ® , is also compatible with microcrystalline cellulose. Figure 12 shows the expected increase in tablet hardness or crushing strength in A-TAB ® formulations containgin AVICEL ® PH-101. A-TAB ® tablets do not change in thickness or hardness after 1 month storage at room temperature or 50˚C. The data in Table 6 shows modest softening and a slight increase in disintegration time when tablets are stored in a desiccator over 75% relative humidity. This is most likely due to moisture uptake by the disintegrant at the high humidity. Tablet Hardness (kp) 35 30 25 20 15 10 Figure 11 Figure 12 40 35 30 25 A-TAB 20 ® 5 5 10 15 20 25 30 35 Compaction Force (kN) Tablet Hardness (kp) A-TAB ® + 20% AVICEL ® A-TAB ® + 10% AVICEL ® A-TAB ® 15 10 5 5 10 15 20 25 30 35 Compaction Force (kN) COMPRESSIBILITY PROFILE FOR A-TAB ® Data for 750 mg. tablets, 7/16-in. standard cup, Manestry B3B rotary tablet press. Vertical bars indicate standard deviation of tablet hardness. COMPRESSIBILITY PROFILE FOR A-TAB ® containing 10 and 20% AVICEL ® PH-101 microcrystalline cellulose. 13
Table 6 Properties Of Aged A-TAB ® Tablets Aging Conditions Hardness Weight Thickness Disintegration (kp) (mg) (mm) (min.) Initial 31 751 5.26 0.6 1 Month R.T., Closed 31 752 5.28 0.7 1 Month 50˚, Closed 29 751 5.27 0.9 1 Month, R.T., 75% R.H. 25 763 5.27 1.8 Tablets made at 30kN applied force; 7/16-in. standard cup tooling. 14
Page 1 and 2: Calcium Phosphate Excipients
Page 3 and 4: TABLE OF CONTENTS Page Number Clini
Page 5 and 6: For Direct Compression DI-TAB ® :
Page 7 and 8: Figure 2: Wet Granulation DRUG EXCI
Page 9 and 10: Calcium and Phosphorus Content Typi
Page 11 and 12: SCANNING ELECTRON PHOTOMICROGRAPHS
Page 13 and 14: % Water 15 10 5 Moisture Figure 9:
Page 15: Table 4 Typical Properties Of Calci
Page 19 and 20: Table 8 Properties Of Aged DI-TAB
Page 21 and 22: Relative A.N.C. (%) Figure 18 Antac
Page 23 and 24: Figure 21 Figure 22 20 20 Tablet Ha
Page 26 and 27: Appendix Units of Measurement (from
Page 28: Our name says it all… Innophos is

Calcium Phosphate Excipients - Innophos

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