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Fuji Chemical introduces Fujicalin® - an innovative new
Dibasic Calcium Phosphate Anhydrous (DCPA) for superior
direct compression tabletting. Fujicalin provides
significantly improved compressibility and flowability
compared to conventional DCPA and Dibasic Calcium
Phosphate Dihydrate (DCPD).
Fujicalin®’s superior characteristics are due in large part to
its unique manufacturing process. Fuji has developed a
method of producing Fujicalin® by first restricting the
growth of the primary crystal during synthesis. This results
in a submicron sized crystal. Whereas, the primary crystal
size of conventional dibasic calcium phosphate is much
coarser. This difference in crystal size is demonstrated in
the two SEMs shown on this page. The process is
completed with a spray drying step which results in the
combining of these microcrystals into porous spheres with
greatly reduced inter-particle friction. Consequently,
Fujicalin® has demonstrated to have many superior and
unique characteristics not normally found in conventional
DCP excipient.
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FEATURES THAT MAKE FUJICALIN® UNIQUE
| 1. Highly Compressible |
| Fujicalin® is harder than conventional excipients under direct
compression pressure.
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| 2. Easy Blending and High Flowability |
| Fujicalin®’s spherical shape creates less friction so there is
superior flowability.
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| 3. Excellent Tablet Disintegration |
| Fujicalin® works with other disintegrants to promote rapid
disintegration regardless of tablet hardness.
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| 4. Non-Abrasiveness |
| Unlike the hard and rough granules of dicalcium phosphate
dehydrate, Fujicalin® granules have a smooth surface and are
not abrasive. |
| 5. Oil Adsorption Capability |
| Fujicalin®’s high degree of porosity is retained even under
high pressure, resulting in excellent oil adsorbing capability. |
| 6. Flexibility |
| Fujicalin® is approved for pharmaceutical and food excipient use. |
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Compressibility
Fujicalin® consistently shows comparable hardness under
any compression pressure as shown in Figure 1. Unlike the
hard, non-porous and rough granules of dicalcium phosphate
dihydrate, Fujicalin® granules are highly porous. Hence, the
force required to compress tablets of adequate and
acceptable hardness or tensile strength is considerably less.
Also, saturation in tablet hardness with pressure (the
tendency of tablet hardness to plateau) was not found.
Flowability
The angle of repose of various excipients were measured and
is shown in Figure 2. Fujicalin®’s smooth and spherical
granules maintain a lower repose angle, insuring high
flowability. As a result, deviations in the tablet weight and
hardness are reduced.
Disintegration
Fujicalin® has the fastest disintegration time regardless of
tablet hardness as shown in Figure 3. In contrast, Lactose
and MCC had a correlation between tablet hardness and
disintegration time. When it comes to aiding disintegration,
Fujicalin® proves to be an ideal excipient.
*Prior to testing the disintegration time of each excipient, 5% carmellose calcium was
added as a disintegrant and 0.5%
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Additional Features of Fujicalin® |
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Low hygroscopicity and a neutral pH in an aqueous
suspension give the product high stability with active
ingredients. |
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Tablet hardness is only slightly affected by blending time or
quantity of lubricants. |
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Stability of easily hydrolysable drugs is enhanced because
the product does not contain any water of crystallization.
Fujicalin®’s high true density leads to volume reduction
and high compactability. |
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Low friability.
Unlike lactose, Fujicalin® retains its compressibility in storage. |
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Will not dissolve in water but will dissolve quickly in gastric acid. |
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Micrometric properties of Fujicalin®, conventional DCPA and DCPD |
Scanning Electron Microphotographs of Fujicalin® and Conventional Dibasic Calcium Phosphates |
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Fujicalin® |
Conventional |
| 1µm scale |
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| 100µm scale |
Chemical Formula
| CaHPO4 - |
Dibasic Calcium Phosphate; |
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Calcium Hydrogen Phosphate |
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Pharmacopoeia & Regulatory Issue |
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Fujicalin® conforms to USP/NF, EP, and JP.
Dibasic calcium phosphate anhydrous or calcium
hydrogen phosphate is also applicable for food use.
US DMF Type IV filed in 1998.
Listed as GRAS (Generally Recognized As Safe)
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