EMCOMPRESS

EMCOMPRESS

CaHPO * 2 H O
CaHPO
4 2
4
ANHYDROUS EMCOMPRESS

The ideal flow enhancer from a mineral source.

A filler for wet granulation and direct compression.
Great synergistic effect when used in combination
with Microcrystalline Cellulose.
Application in Pharmaceutical Formulations
Both and are used in
solid dosage forms to enhance flow, as atablet binder or as a capsule
diluent. As a binder, it is used because of its excellent flow properties
and deformation characteristic.
Calciumhydrogenphosphate (Dibasic Calcium Phosphate, DCP),
deforms by brittle fracture during compression.
particles fragment into smaller particles exposing less lubricant
surfaces for improved tablet binding. Hence, Magnesium Stearate has
almost no affect on the hardness and dissolution times of
EMCOMPRESS ANHYDROUS EMCOMPRESS
EMCOMPRESS
EMCOMPRESS

EMCOMPRESS
EMCOMPRESS
EMCOMPRESS
EMCOMPRESS
EMCOMPRESS
,

tablets. Additionally as a consequence of this

behaviour, there are no capping problems in tablets made with
Calciumhydrogenphosphate are reduced. Another
benefit, due to its compaction mechanism, is its reduced sensitivity
to tableting speed. Also, and lactose possess similar
galenic properties; therefore, can be used in place of
lactose during formulation development. is typically
applied in direct compression and is used as a calcium and phospho-
rous source in nutritional supplements.
Issue I/2006
Content page
Applications .........................................1
Chemical Nomenclature.........................1
Regulatory.............................................1
How does Improve Tablet
Matrices in a Blend with Microcrystalline
Cellulose ? ............................................2
in Combination with a
Swelling Superdisintegrant .....................2
Flowability .............................................2
Typical Use Level 2
Typical Formulations ......3
Differences between and
..................4
Particle size...........................................4
Binding properties .................................4
Crystal Structure and Application............4
Literature about ............4
Incompatibilities ....................................4
....................................
EMCOMPRESS
EMCOMPRESS
EMCOMPRESS
EMCOMPRESS
ANHYDROUS EMCOMPRESS
EMCOMPRESS

EMCOMPRESS

is listed in the Ph.Eur. and USP/NF.

E Classification E 341.
Regulatory:
Chemical Nomenclature:
Technical
Newsletter
ANHYDROUS EMCOMPRESS
Calcium Hydrogen Phosphate
Anhydrous Dibasic Calcium Phosphate
Calcium Monohydrogen Phosphate
Dicalcium Orthophosphate Dihydrate
CaHPO
136.1
7757-93-9

4
EMCOMPRESS

Calcium Hydrogen Phosphate Dihydrate

Dibasic Calcium Phosphate Dihydrate
Calcium Monohydrogen Phosphate Dihydrate
Dicalcium Orthophosphate Dihydrate
CaHPO * 2 H O
172.1
7789-77-7
4 2
Chemical name
Synonyms
Formula
Molecular weight
CAS Registry Number
Chemical Nomenclature:
Table 1
Page 1
Info-Hotline: + 49 (0) 79 67 / 1 52-312
EMCOMPRESS

particles
(brittle fracture)
A swelling superdisintegrant requires some resistance in the tab-
let matrix to develop its full disintegrating force. ,
because it is insoluble and non-elastic, provides such resistance.
Soluble materials, such as lactose, do not offer such resistance
and, consequently, disintegrate much slower.
EMCOMPRESS

Fig. 2 : The swelling disintegrant (blue) deforms a plastic particle (brown) but
disintegrates a non-elastic particle (red). EMCOMPRESS

EMCOMPRESS
VIVAPUR
EMCOCEL

is often
blended with or
to create a
synergistic combination. The
combination of brittle fracture
and plastic deformation
properties results in flowabi-
lity and compaction, which is
greater than the individual
components.
How does Improve Tablet Matrices
in a Blend with Microcrystalline Cellulose ?
EMCOMPRESS

EMCOMPRESS

in with a
Swelling Superdisintegrant
Combination
Applications:
Fig. 1 : Tablet matrix after compression
with MCC and . EMCOMPRESS

To improve flowability, the following ratios have been

demonstrated effective:
VIVAPUR 101 EMCOCEL 50M EMCOMPRESS
VIVAPUR 102 EMCOCEL 90M EMCOMPRESS


or :
40 : 60
or :
50 : 50
To improve compaction, the following ratio has been
demonstrated effective:
VIVAPUR 101 VIVAPUR 102 EMCOMPRESS
EMCOCEL 50M EMCOCEL 90M EMCOMPRESS


or :
or :
75 : 25
Typical Use Level
In combination with Microcrystalline Cellulose,
use levels depend on Microcrystalline Cellulose grade and total
formulation composition.
EMCOMPRESS

Flowability
EMCOMPRESS

is widely used in formulations due to its excellent

flow properties. Angle of repose is one method used to compare
flow properties of different materials.
Angle of repose
< 33
33 - 38
38 - 44
>44
Relationship between angle of repose and flow:
Flow
excellent flowability
good flow
problematic
not recommended for direct compression
EMCOMPRESS
ANHYDROUS EMCOMPRESS

31
28
Fast Flow Lactose 31
other Lactose 32 - 35
Sugar 31
Ibuprofen 47
CaCO Powder 50
Corn Starch 56
3
as a Tablet binder: 20 - 70 %
as a Diluent: 10 - 80 %
as a Capsule filler: 10 - 50 %
Technical
Newsletter
MCC particles
(plastic)
Table 2
Table 3
Table 4
Table 5
Table 6
Page 2
disintegrant water-soluble
lactose
EMCOMPRESS

(Calcium
Hydrogen
Phosphate
Dihydrate)
swelling
Dissolve remove
Issue I/2006
Info-Hotline: + 49 (0) 79 67 / 1 52-312
Info-Hotline: + 49 (0) 79 67 / 1 52-312
Typical Formulations: EMCOMPRESS

The proposal below is

. gives the non-water soluble, non-elastic
part of the matrix, which in combination with disintegrants reduces
the disintegration time significantly.
EMCOMPRESS

a tablet matrix for fast disintegrating

tablets
VIVAPUR / EMCOCEL
EMCOMPRESS
EXPLOTAB / VIVASTAR
PRUV

Microcrystalline Cellulose (Binder) 65.0 %
CaHPO * 2 H 0 (Filler) 33.0 %
Sodium Starch Glycolate (Superdisintegrant) 1.5 %
Sodium Stearyl Fumarate (Lubricant) 0.5 %
4 2
By using (Sodium Stearyl Fumarate), instead of Magnesium
Stearate as a lubricant, the resulting matrix is more hydrophyllic. In
a matrix with , water can penetrate faster than into a
lipophyllic matrix. In combination with , a water-
insoluble, non-elastic material, the disintegration time improves
significantly.
This is a
. improves the flow
and (Microcrystalline Cellulose) provides the hardness.
PRUV
PRUV
EMCOMPRESS
EMCOMPRESS
VIVAPUR

typical combination of Microcrystalline Cellulose and

Calciumhydrogenphosphate
Ascorbic acid 55.0 %
(Microcrystalline Cellulose) 20.0 %
(CaHPO * 2 H O) 22.0 %
(Croscarmellose Sodium) 2.0 %
Colloidal Silicone Dioxid 0.5 %
Magnesium Stearate 0.5 %
Results:
Diameter 13 mm
Height 4 mm
Weight 800 mg
Compression Force 26 kN
Hardness 7 kp
Disintegration time 16 sec
VIVAPUR 102
EMCOMPRESS
VIVASOL

4 2
An example of substance in combination with
Microcrystalline Cellulose and : EMCOMPRESS

a low dose active

The active ingredient, binders and disintegrants were mixed for 15
minutes in a Turbula mixer. The sieved blend of Magnesium
Stearate and Colloidal Silicone Dioxide was added and mixed for
another 5 minutes. The powder was directly compressed on a
Korsch EK0 tablet press.
Dissolution profile:
Diclofenac 10.0 mg
(Microcrystalline Cellulose) 31.3 mg
(CaHPO * 2 H 0) 77.2 mg
(Sodium Starch Glycolate) 5.3 mg
Colloidal Silicone Dioxid 0.6 mg
Magnesium Stearate 0.6 mg
Results:
7 mm
125 mg
6.8 kp
0.4 %
Disintegration time 103 sec
VIVAPUR 102
EMCOMPRESS
VIVASTAR

4 2
Diameter
Weight
Hardness
Friability
0 80
100
80
60
40
20
0
10 20 30 40 50 60 70
Diclofenac
Tablet
d
i
s
s
o
l
v
e
d
(
%
)
time (min)
Technical
Newsletter
Table 7
Table 8
Fig. 3
Table 9
Page 3
Issue I/2006
Literature about EMCOMPRESS :

Schmidt, P.C., Herzog, R.,

(3), 105 and 116 (1993)
Carstensen, J.T., Ertell,C.
Drug Dev. (7), 1121 (1990)
Pharm.World Sci. 15
Ind.Pharm. 16
Disclaimer:
The information provided in this brochure is based on thorough research and is believed
to be completely reliable. Application suggestions are given to assist our customers, but
are for guidance only. Circumstances in which our material is used vary and are beyond
our control. Therefore, we cannot assume any responsibility for risks or liabilities, which
may result from the use of this technical advice.
Differences Between
and
EMCOMPRESS
ANHYDROUS EMCOMPRESS

Fig. 4: Magnification: 200x

SEM of EMCOMPRESS

Fig. 5: Magnification: 200x

SEM of ANHYDROUS
EMCOMPRESS

Both materials have a median particle size ranging from 130 m

to 150 m. As illustrated by the SEMs lower case.Both materials
exhibit excellent crystallinity. Monoclinic crystal habit
EMCOMPRESS

Triclinic crystal habit

ANHYDROUS EMCOMPRESS

Fig. 7:
Fig. 6: Compaction force vs. tensile strength.
Formulation: (99 % Calciumhydrogenphosphate + 1 % Magnesium
Stearate).
As can be seen, is slightly more compressible
than
ANHYDROUS EMCOMPRESS
EMCOMPRESS

A
C
B
A
C
B
Tensile Strength as a Function of Compaction force
Particle Size
Binding Properties
0 20.0
2.5
2.0
1.5
1.0
0.5
0
2.5 5.0 7.5 10 12.5 15 17.5
ANHYDROUS EMCOMPRESS
EMCOMPRESS

T
e
n
s
i
l
e
S
t
r
e
n
g
t
h
(
M
P
A
)
Compaction Force (kN)
EMCOMPRESS ANHYDROUS EMCOMPRESS
ANHYDROUS
EMCOMPRESS

is denser, while
possesses a higher specific surface area. As a result,
produces harder compacts at equivalent forces.
Crystal Structure and Application
ANHYDROUS EMCOMPRESS
ANHYDROUS EMCOMPRESS

, which has no water, of crystalization is

less sensitive to interactions with gelatine capsules. Because of is
excellent flow, is an ideal flow enhancer
for capsule filling.
Technical
Newsletter
Page 4
WORLDWIDE HEADQUARTERS USA+Canada
JRS PHARMA GMBH+CO.KG JRS PHARMA LP, USA
JRS PHARMA
LEADING
THE WORLD
IN EXCIPIENTS
A Member of the JRS Group
2981 Route 22, Suite 1
Patterson, NY 12563-2359
Toll-Free: (800) 431-2457
Phone: (845) 878-3414
Fax: (845) 878-3484
E-mail: info@jrspharma.com
www.jrspharma.com, www.jrs.de
Holzmhle 1
D-73494 Rosenberg (Germany)
Phone: + 49 (0) 79 67 / 1 52-0
Fax: + 49 (0) 79 67 / 1 52-345
E-mail: info@jrspharma.de
www.jrspharma.de,
www.jrs.de
Customer Service: Customer Service: ++49 (0) 7967 / 152-312 (845) 878 3414
Incompatibilities :
Calciumhydrogenphosphate is incompatible with tetra-cycline
antibiotics and indomethacin. Due to its alkaline nature
Calciumhydrogenphosphate should also not be used with active
ingredients that are sensitive to a pH of 7.3 or above.
Issue I/2006
E-Version, Stand: 08.12.2005