Mann

12016Brochure PEARLITOL-Anglais_Brochure PEARLITOL-Anglais 19/06/12 15:09 Page23
PEARLITOL ®
M A N N I TO L F O R
P H A R M A C E U T I C A L A P P L I C AT I O N S
q
mannitol P E A R L I T O L m a n n i t o l
. . . . . . . . . . . . . . . . . . . .
S U M M A R Y
• Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2
• Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3
- Molecular weight - Formula
- Conformities
• Physiological properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 5
- Sweetness
- Safety
- Metabolism and tolerance
- Dental aspects
• Physical and chemical properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
- Stability
- Solubility
- Hygroscopicity
- Osmolality
- Crystalline forms - Melting point
- Spectrometry
Infrared absorption Spectra
NMR Spectra
• Functional properties and applications .................... page 11
®
- PEARLITOL mannitol crystalline powders
- PEARLITOL® mannitol granular powders
• PEARLITOL® PF .................................................... page 19
®
• PEARLITOL Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 20
• PEARLITOL® International technical support .......... page 20
P A G E 1
Ro q u e t t e ➤ PEARLITOL mannitol
I N T R O D U C T I O N
. . . . . . . . . . . . . .
Roquette is one of the leading companies providing starch derivatives
and polyols and has developed a wide range of products and services
especially dedicated to the pharmaceutical and cosmetic industries.
Based on this experience Roquette has been widening its range of
polyol excipients through technical innovations, combining quality
with performance. Roquette offers a wide range of polyols and amongst
them, PEARLITOL mannitol.
PEARLITOL is a brand name of a range of mannitol dedicated to the
manufacture of medicines. Mannitol presents the following features:
➢ Very low hygroscopicity: it does not promote hydrolysis
reaction.
➢ Very high chemical stability due to its polyol structure,
mannitol does not undergo reducing reaction or discoloration
reaction with amino groups (Chemical Inertness).
➢ Wide range of possible applications:
➢ For different forms:
- injectable (in solutions or freeze dried)
- oral (tablet, chewable tablet, fast dissolving tablet,
hard capsule, sachets).
➢ For different processes:
- wet or dry granulation
- direct compression
- freeze-drying.
Moreover, mannitol is non cariogenic and allows sugar free

formulation.
Mannitol offers unique physical and chemical characteristics and
superior performances, making it the best choice in excipients.
P A G E 2
D E S C R I P T I O N
. . . . . . . . . . . . . .
Mannitol takes its
name from manna,
CHO CHO CH2 OH CH2 OH
a sweet exsudate from OH HO OH HO
the manna ash (Fraxinus HO HO HO HO

H2
+ Ni
+
OH OH OH OH
ornus), of which it is
OH OH OH OH
the major constituent. CH2 OH CH2 OH CH2 OH CH2 OH
Mannitol also occurs

Glucose + Mannose Sorbitol + Mannitol
in olives, figs and larches,
in certain species of edible
Mannitol and sorbitol are separated by their difference in
fungi, and in seaweed aqueous solubility (water is the only process solvent). The
(laminaria species). isolated mannitol is a white crystalline powder of very high
purity. It is further transformed into a complete range of
D-mannitol was originally
PEARLITOL mannitol powders which is manufactured
obtained industrially in a dedicated ISO 9002 certified plant.
by an extraction process. The range of mannitol consists of 8 different grades:
Whereas, since the ➢ PEARLITOL 160 C standard mannitol
beginning, Roquette has ➢ PEARLITOL 50 C fine grade
➢ PEARLITOL 25 C very fine grade
developped a manufacture
➢ PEARLITOL PF pyrogen free grade
➢ PEARLITOL 100 SD
process of mannitol based
spray-dried grade for direct
upon starch, natural raw compression
material of vegetable ➢ PEARLITOL 200 SD spray-dried grade for direct
compression
➢ PEARLITOL 300 DC
origin. Starch is
fine granulated grade for
transformed into a glucose direct compression
mannose solution which ➢ PEARLITOL 400 DC medium granulated grade
for direct compression
gives mannitol through
➢ PEARLITOL 500 DC coarse granulated grade
catalytic hydrogenation for direct compression
according to the following
reaction:
P A G E 3
D E S C R I P T I O N
. . . . . . . . . . . . . .
Molecular weight
Formula
Mannitol is a polyol with a molecular weight of 182.17 and its empirical formula is
C6H14O6. The chemical structure is the following:
CH2 OH
HO
HO
OH
OH
CH2 OH
Mannitol is registered under CAS number 69-65-8 and EINECS 200-711-8.

. . . . . . . . . . . . . .
Conformities
PEARLITOL mannitol comply with the mannitol monographs of the different
pharmacopeia including:
➢ European Pharmacopeia
➢ USP
➢ Japanese Pharmacopeia
P A G E 4
P H Y S I O L O G I C A L P R O P E R T I E S
. . . . . . . . . . . . .
Sweetness
The following diagram compares the
sweetness of mannitol with sucrose and
Mannitol occurs different polyols:
naturally as a slightly
Polyols’ sweetness
sweet white crystalline
...................................................
...................................................
...................................................
...................................................
1
powder, that gives a 0.8
cooling sensation in 0.6
0.4
the mouth.
0.2
Sucrose Mannitol Sorbitol Maltitol Xylitol
Mannitol is approximately half as sweet as sucrose

or xylitol.
. . . . . . . . . . . . .
Safety
The joint FAO/WHO Expert Committee on Food Additives (JECFA) has decided in its 30 th
report (1987) not to specify an acceptable daily intake for mannitol. This means that mannitol is
safe. This decision was based on a complete biotoxicological file.
In Europe, the Scientific Committee for Food (SCF) has followed JECFA’s decision in 1989
regarding the acceptable daily intake.
P A G E 5
P H Y S I O L O G I C A L P R O P E R T I E S
. . . . . . . . . . . . . .
Metabolism
and tolerance
A minor part of the ingested mannitol is partially
absorbed and metabolised. It is passively
absorbed in the upper gastrointestinal tract (as
opposed to glucose which is actively absorbed).
Mannitol is then partially oxidised into D-fructose
by mannitol dehydrogenase and metabolised
through a non insulinic glycogenolytic pathway.
The major part of the ingested mannitol is not
absorbed and goes through to the colon where it
is fermented by the colonic microflora.
The mannitol which is absorbed is non
metabolised, and is directly excreted through
the kidney in the urine.
The ingestion of mannitol in large quantities can
lead to flatulence, laxative effects (osmotic type
due to water flowing into intestine lumen). These
effects depend on the individual physiologic state,
alimentary bolus and its composition.
. . . . . . . . . . . . . .
Dental aspects
Mannitol is not fermented by the human buccal microflora. Thus, it is neither acidogenic nor
cariogenic and these properties grant it a particular status in tooth decay prevention.
P A G E 6
P H Y S I C A L A N D C H E M I C A L P R O P E R T I E S
. . . . . . . . . . . . .
Stability
Mannitol is remarkably stable:
- it does not react with diluted acids, buffer solutions or amino groups. No Maillard reaction
of the type: R-CHOH-CHO + R’-NH2 RCO-CH2-NHR’+ H2O
- it does not undergo discoloration reaction at temperatures below 220°C or 240°C
(depending on prevailing conditions).
. . . . . . . . . .
Solubility
Mannitol is soluble in different solvents Mannitol’s solubility in water
at 20°C (part/part)*:
➢
..................................
..................................
..................................
..................................
..................................
..................................
..................................
40
Water : 1 in 5.5
➢
35 37,5
Ethanol (95%) : 1 in 83
% of mannitol
30 31
➢ Ether : practically insoluble 25 25
➢
20
19
Glycerin : 1 in 18
➢
15 15
10 12.3
Propanol-2 : 1 in 100
➢
9.1
5
Alkalis : soluble 0
0 10 20 30 40 50 60 70
A negative heat of solution is the origin Temperature (°C)

of the cooling effect experienced after
ingestion of mannitol powder (value
of - 30 cal/g).
. . . . . . . . . . . . . .
* From “Handbook of Pharmaceutical Excipients” Third Edition,

p. 325, A.H. Kibbe, Pharmaceutical Press, London, UK.
Hygroscopicity
Due to its chemical properties and its Sorption Isotherms
very high purity, Mannitol is non-
hygroscopic. Mannitol takes up water
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
..........................................
90
Percentage of water in the product
40°C
only above relative humidities of 80
20°C
97 % at 20°C and 40°C. 70
60
50
40
30
20
10
0
0 50 100
Relative humidity (%)
P A G E 7
. . . . . . . . . . . . . .
Osmolality
Mannitol can be used as therapeutic Mannitol Osmolality
agent in order to increase diuresis in
concentrated solutions (15 % and
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
.................................................
1200
Number of milliosmols/kg water

20 %); see values on the curve
1000
hereafter.
800
600
400
200
0
0 20 40 60 80 100 120 140 160
Quantity g/kg water

. . . . . . . . . . . . . .
Crystalline forms
Melting point
Mannitol is crystallised as the ß form and complies with the identification tests of different
major Pharmacopoeias. Other crystalline forms (Ȋ and Ȏ) can be observed and
differentiated by infrared spectrometry or by X ray diffraction. The melting range is the
same for the 3 forms and lies between 165°C and 169°C.
P A G E 8
. . . . . . . . . . . . .
Spectrometry
Infrared Mannitol - Ȋ- Infrared Spectrum

absorption
100.0
spectra (KBr)
80.0
Infrared absorption
% transmission
spectrometry is an 60.0
identification method
capable of detecting the 40.0
crystalline polymorphism
20.0
of tested products.
0.0
The spectrum of Mannitol 4000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0
is typical of the ß form of Wave number/cm -1

mannitol.
The spectrum of
Mannitol - ß- Infrared Spectrum
PEARLITOL SD mannitol
shows it to be mainly in the
100.0
Ȋ form which is due to its
particular manufacturing 80.0
process.
% transmission
60.0
This form of mannitol can be
transformed into the ß form 40.0
after dissolution and

20.0
recrystallisation, as required
by the identification test in 0.0
4000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0
mannitol monograph.
Wave number/cm -1
Mannitol - Ȏ- Infrared Spectrum
100.0
80.0
% transmission
60.0
40.0
20.0
0.0
4000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0
Wave number/cm -1
P A G E 9
. . . . . . . . . . . . . .
NMR Spectra
Mannitol gives the following 1H and 13C Nuclear Magnetic Resonance (NMR) spectra:
Mannitol - 1H NMR Spectrum Mannitol - 13

C NMR Spectrum
4.9 4.8 4.7 4.6 4.5 4.4 4.3 4.2 4.1 4.0 3.9 3.8 3.7 3.6 3.5 3.4 3.3 3.2 3.1 79 78 77 76 75 78 79 80 4.1 4.0 3.9 3.8 3.7 3.6 3.5 3.4 3.3 3.2 3.1
Deplacement chimique (Ȏ) em ppm Deplacement chimique (Ȏ) em ppm
The symmetry of the mannitol molecule leads to a simple three singlets 13C NMR spectrum.
P A G E 10
F U N C T I O N A L P R O P E R T I E S A N D A P P L I C A T I O N S
. . . . . . . . . . . .
PEARLITOL®
mannitol
crystalline powders
3 grades of PEARLITOL
mannitol crystalline powders
are available:
➢ PEARLITOL 160 C,
➢ PEARLITOL 50 C,
➢ PEARLITOL 25 C.
The high purity, stability
and non hygroscopicity
of PEARLITOL mannitol
crystalline powders mean
that they are the excipient of
choice for pharmaceutical
applications (granulation,
freeze-drying).
Characteristics
■ Particle size
Typical values of particle sizes

of mannitol crystalline
powders are given for
guidance only (mean diameter,
laser diffraction):
➢ PEARLITOL 160 C:
160 microns approx.
➢ PEARLITOL 50 C:
50 microns approx.
➢ PEARLITOL 25 C:
25 microns.
P A G E 11
. . . . . . . . . . . . .
■ Rheology
PEARLITOL 160 C 50 C 25 C
Poured density (g/mL) 0.66 0.55 0.49
Tapped density (g/mL) 0.85 0.78 0.74
Ability to settle (mL) 25 46 60
Haussner ratio 1.29 1.42 1.51
Flowability (funnel; s) infinite infinite infinite
Angle of repose (°) 47 50 50
These values are given for guidance only.
Applications
■ Dry forms
PEARLITOL mannitol crystalline powders are highly recommended for the manufacture
of dry forms (granules, pellets, tablets) obtained by granulation. The different particle
sizes, the non hygroscopicity, the absence of water and the stability give superior
performances and improved productivity (ease of drying).
■ Freeze-drying
Mannitol is an interesting excipient for freeze-drying.

Its solubility and hygroscopicity properties make it an excellent diluent in this application.
Mannitol gives the freeze-dried material an aerated, light and porous structure and
prevents it from collapse. Moreover, due to its polyol structure, mannitol acts as
a cryoprotective agent.
P A G E 12
. . . . . . . . . . . . .
PEARLITOL®
mannitol
granular powders
PEARLITOL DC and SD
mannitol granular powders
has been especially designed
for direct compression
applications.
A range of different particle
sizes and densities of
PEARLITOL mannitol PEARLITOL DC
granular powders are available:
➢ PEARLITOL 100 SD,
➢ PEARLITOL 200 SD,
➢ PEARLITOL 300 DC,
➢ PEARLITOL 400 DC,
➢ PEARLITOL 500 DC.
PEARLITOL 200 SD
PEARLITOL mannitol
granular powders are free
flowing and excellent diluent-
binders for direct compression
applications (fast dissolving
tablets, chewable tablets…).
■ Rheology
PEARLITOL 100 SD 200 SD 300 DC 400 DC 500 DC
Poured density (g/mL) 0.48 0.45 0.62 0.68 0.64

Tapped density (g/mL) 0.57 0.52 0.69 0.76 0.72
Ability to settle (mL) 18 16 8 10 11
Haussner ratio 1.19 1.16 1.11 1.12 1.12
Flowability (funnel; s) 6 6 7 8 8
Angle of repose (°) 39 38 39 37 39
These values are given for guidance only.
P A G E 13
. . . . . . . . . . . . .
PEARLITOL mannitol granular powders offer all the required properties of a DC excipient:
➢ Excellent free flowing,
➢ Good compactibility with low friability,
➢ No sensitivity to tabletting speed,
➢ No lubricant sensitivity,
➢ Good dilution potential.
■ Compression property
PEARLITOL mannitol granular Compactibility of PEARLITOL

powders give good hardness results on rotative FETTE P 1000
under industrial compression
Compactibility
conditions. These results demonstrate
....................................
....................................
....................................
....................................
....................................
....................................
....................................
....................................
....................................
....................................
140
PEARLITOL
that PEARLITOL mannitol granular 120 200 SD
Hardness (N)
powders are effective fillers and 100

PEARLITOL
80 400 DC
binders for DC applications. 60
40
20
0
20 25 30 35 40 45 50 55 60 65 70
Compression force (kN)
PEARLITOL 200 SD is a filler and Hardness variation as a function

binder which is effective in various of the tabletting rotation speed
conditions. It shows excellent
PEARLITOL 200 SD
performance even at high tabletting
............................
............................
............................
............................
............................
............................
............................
............................
120
speed, allowing high productivity. 100

Hardness (N)
80 86 84 82
80
60
40
20
20000 50000 70000 100000
Rotation speed (tablets/H)
P A G E 14
15
S
mannitol
P A G E
N
400
25%
..................................................................
Formulations based on PEARLITOL mannitol are able to incorporate high proportions of
O
make any difference to the hardness of tablets even if the time taken to mix PEARLITOL
Mix: 30 min
350
0%
mannitol and magnesium stearate varies from 2 to 30 minutes. This property ensures a
Mix: 2 min
..................................................................
300
I
PEARLITOL
PEARLITOL mannitol is tested in compression with magnesium stearate. It does not
..........................................................................
T
Compression pressure (Mpa)

300
..................................................................
PEARLITOL 400 DC
PEARLITOL 400 DC
250
A
..........................................................................
PEARLITOL 400 DC data was kindly provided by Pr K.J. Steffens, Institute of

250
C
Hardness profile as a function of the mixing time with lubricant
..................................................................
200
➤
..........................................................................
I
200
Ro q u e t t e
..................................................................
L
150
Compression profile without and with ascorbic acid

..........................................................................
150
P
..................................................................
100
P
..........................................................................
100
..................................................................
A
50
50
..........................................................................
..................................................................
D
0
3
2.5
2
1.5
1
0.5
0
3.5
3
2.5
2
1.5
1
0.5
0
N
Pharmaceutical Technology, Bonn University, Germany.

A
Hardness (Mpa) Hardness (Mpa)

S
E
. . . . . . . . . . . . .
I
Mix: 30 min
Mix: 2 min
300
T
.........................................................................
90
.............................................................
25%
R
■ Lubrication sensitivity
certain reliability for the production.
80
E
.............................................................
250
.........................................................................
PEARLITOL 200 SD
PEARLITOL 200 SD
P

70
Compression Force (kN)

.............................................................
O
■ Dilution potential
200
R
0%
.........................................................................
60
.............................................................
non DC active substance.

P
50
.............................................................
150
.........................................................................
L
40
A
.............................................................
100
N
.........................................................................
30
.............................................................
O
I
20
50
200
150
100
50
0
T
3
2,5
2
1,5
1
0,5
0
C
Hardness (N) Hardness (Mpa)

N
U
F
. . . . . . . . . . . . .
PEARLITOL DC and SD mannitol granular powder are used in all types of tablets:
➢ fast dissolving tablets,
➢ chewable tablets,
➢ effervescent tablets,
➢ standard tablets.
Applications
■ Fast dissolving/chewable tablets
Below is an example of a formulation of a

chewable/fast dissolving/dispersible tablet, containing
taste masked dextromethorphan hydrobromide.
■ Preparation Taste Masked Dextromethorphan Dispersible Tablet
1. Mix for 5 minutes in a TURBULA (1) mixer Magnesium stearate

PEARLITOL® 200 SD, Dextromethorphan HBr, 1.5%
Sodium Starch Glycolate Dextromethorphan
KLEPTOSE DC (betacyclodextrin) and Sodium 3.0% hydrobromide
Starch Glycolate. 7.1%
2. Magnesium stearate is added and mixed

for 5 minutes in the TURBULA (1) mixer.
3. Compression on a FROGERAIS (2) machine
with 10 mm diameter flat bevelled punch.
➢ Tablet mass: 350 mg
KLEPTOSE DC
42.9 %
➢ Hardness: 48 N
➢ Disintegration time: 40 s PEARLITOL 200 SD
45.5%
(1) TURBULA: trademark of Willy A. Bachofen AG Maschinenfabrik, BASEL (Switzerland),

(2) FROGERAIS: trademark of SVIAC / Schindler VITRY/SEINE (France).
P A G E 16
. . . . . . . . . . . . .
■ Preparation Vitamin C effervescent tablets
In a LOEDIGE (4) mixer pour and mix Granulated tartaric acid

Coated ascorbic acid
for 5 minutes in 6 steps: 26.4%
20.0 %
1. Tartaric acid and sodium bicarbonate,

2. Ascorbic acid and sodium ascorbate,
3. PEARLITOL® 200 SD, orange flavour
and sodium saccharinate,
XPEARLITOL 200 SD
4. Add a third of PEG 6000 9.4 %
and sodium benzoate in 3 steps. Sodium bicarbonate Granulated sodium ascorbate
30.8% 4.7 %
5. Compression on EXACTA 21 (5) Sodium benzoate
machine with 20 mm flat bevelled punch 3.7 %
PEG 6000
➢ Tablet mass: 2.25 g

Sodium saccharinate 2.8%
➢ Hardness: 60 N
0.4% Orange flavour
1.8%
➢ Disintegration time: around 1 minute
■ Preparation Antacid chewable tablets

Mixing steps in a TURBULA (1) mixer: PEARLITOL 200 SD
➢ 10 mn for PEARLITOL 200 SD

50,6 % Aluminium hydroxide
22,2 %
and simethicone,
➢ 5 mn with hydroxides, flavor and
sodium saccharinate, then sieving
on 500 µm,
➢ 5 mn with stearate.
Compression on a single press EXACTA 21 (5)
with 16 mm diameter flat bevelled punch
➢ Tablet mass: 895 mg
Magnesium hydroxide
22,2 %
➢ Schleuniger hardness: 100 N Sodium saccharinate Simethicone

0.2% 2,8 %
Magnesium stearate
Mint flavour
1.0 %
1,0%

(4) LOEDIGE: trademark of Gebrüder Loedige Maschinenbau GmbH, PADERBORN (Germany)
(5) EXACTA: trademark of FETTE: Wilhem Fette GmbH, SCHWARZENBEK, B. HAMBURG (Germany).
P A G E 17
. . . . . . . . . . . . .
■ Preparation Antacid chewable tablets
Mixing steps in a TURBULA (1) mixer :
PEARLITOL 400 DC
5 minutes for aluminium hydroxide, 72.4 %
magnesium hydroxide.
Add the flavour and PEARLITOL 400 DC.
Add the magnesium stearate and mix
for 5 minutes.
Compression on a FROGERAIS (3) machine
with 13 mm diameter flat bevelled punch.
➢ Tablet mass: 800 mg Aluminium hydroxide
➢ Thickness: 4.30 mm
20.1 %
➢ Schleuniger Hardness : 75 N
Magnesium hydroxide
Mint flavour 5.0 %
1,0 % Magnesium stearate
1.5%
Other applications
PEARLITOL 200 SD and 300 DC, 400 DC, 500 DC

are recommended for applications in which flowability
is of importance: hard capsule filling, sachets…
PEARLITOL 300 DC, 400 DC and 500 DC can also
be used as neutral carriers onto which active substances are poured or sprayed.

(3) FROGERAIS: trademark of SVIAC / Schindler VITRY/SEINE (France).
P A G E 18
®
P E A R L I T O L P F
. . . . . . . . . . . . . .
Roquette has been Characteristics
manufacturing raw materials ■ Physical and chemical
for the preparation of characteristics
injectable products for over PEARLITOL PF complies

with the different existing
25 years. PEARLITOL PF monographs:
mannitol pyrogen free grade ➢ European Pharmacopeia
➢ USP
has been developed and
➢ Japanese Pharmacopeia
introduced to the leading
■ Biological and microbiological
companies, world-wide.
characteristics
PEARLITOL PF
Roquette performs endotoxins tests and pyrogenic
is manufactured and substances detection on rabbits in its own
controlled according to
laboratories. These tests are carried out according to
the recommendations of the various Pharmacopeia.
the highest existing standards Due to our experience and total control of our
production, Roquette is able to offer PEARLITOL PF
and supplied throughout
with the following specifications:
the world. ➢ Endotoxin: 2.5 E.U./g maxi
➢ Total viable count: 100 col./g maxi
➢ Yeast: 10 col./g maxi
➢ Moulds: 10 col./g maxi
Applications
PEARLITOL PF is usually used in 5 % and 10 %

solutions as a diuretic agent.
It can be incorporated in complex solutions which
may contain mineral salts.
PEARLITOL PF is highly recommended for the
manufacture of freeze-dried injectable preparations
because of its cryoprotective effect, osmotic
properties, physical stability, non hygroscopicity and
excellent chemical inertness
(no reaction with the amine function).
P A G E 19
®
P E A R L I T O L P A C K A G I N G
. . . . . . . . . . . . . .
PEARLITOL mannitol packaging exists in
various sizes and presentations:
Strippable Bag Cardboard Box Drum
Paper + Polythene Polythene + Box Polythene + fibre drum
25 kg 25 kg 50 kg
PEARLITOL 160 C X X
PEARLITOL 50 C X X
PEARLITOL 25 C X
PEARLITOL PF X
PEARLITOL 100 SD X (20 kg)

PEARLITOL 200 SD X
PEARLITOL 300 DC X
PEARLITOL 400 DC X
PEARLITOL 500 DC X
I N T E R N A T I O N A L T E C H N I C A L S U P P O R T
. . . . . . . . . . . . . .
At Roquette, a team of pharmacists and

development scientists assisted by a
dedicated application laboratory are at your
disposal for further information and
assistance regarding the use of Mannitol.
The information contained in this document is to the best of our knowledge true and
accurate but all instructions, recommendations or suggestions are made without any
guarantee. Since the conditions of use are beyond our control, we disclaim any
liability for loss and/or damage suffered from use of these data or suggestions.
Furthermore, no liability is accepted if use of any product in accordance with these
data or suggestions infringes any patent.
No part of this document may be reproduced by any process without our prior
written permission.
P A G E 20
® Registered trademarks of Roquette Frères
Ro q u e t t e ➤ PEARLITOL mannitol © Roquette Frères S.A. - 06/2012
R O Q UE T T E W ORL D W I D E
www.roquette.com
EUROPE TURKEY
Roquette Tarım ve Gıda
FRANCE San. ve Tic. Ltd. Sti.
Roquette Frères Büyükdere Cad. Harman Sok.
Corporate Headquarters Duran I·ş merkezi No:4 K:3
1 rue de la Haute Loge 34394 Levent I·stanbul - Turkey
62136 Lestrem - France Telephone: + 90 212 234 83 73
Telephone: + 33 3 21 63 36 00 Fax: + 90 212 234 83 74
Fax: + 33 3 21 63 38 50
BELGIUM A M E RI C A
J.V Roquette & Barentz USA
Excelsiorlaan 7 Box 2 Roquette America Inc.
1930 Zaventem - Belgium Geneva Innovation Center
Telephone: + 00 32 2 714 13 00 2211 Innovation Drive
DENMARK Geneva, IL 60134 - USA
Roquette ApS Telephone: + 1 630 463 9430
Gydevang 39-41 Fax: + 1 630 232 2157
DK - 3450 Allerød MEXICO
Telephone: + 45 69 663 200 Roquette México S.A. de C.V
Fax: + 45 69 663 209 Blvd. Bernardo Quintana 9750 of 321
Fracc. Centro sur Queretaro Qro.
FINLAND CP 76090 - México
Roquette Nordica Oy Telephone: + 52 44 2229 1270
Ahventie 4A, 20 Fax: + 52 44 2229 1270
FI-02170 Espoo – Finland
Telephone: + 358 9 315 85 700
Fax: + 358 9 8632 113 A SI A
GERMANY
CHINA
Roquette GmbH
Roquette Shanghai
Darmstädter Landstrasse 182 Room 505— K. Wah Centre,
60598 Frankfurt - Deutschland 1010 Huai Hai Zhong Road,
Telephone: + 49 69 60 91 050 Shanghai 200031 - P.R. China
Fax: + 49 69 60 91 05 59 Telephone: + 86 21 54 03 99 22
ITALY Fax: + 86 21 54 03 66 06
Roquette Italia S.p.A INDIA
Via Serravalle 26 Roquette India Private Limited
15063 Cassano Spinola Office n° 702, 7th Floor Powai Plaza
Alessandria - Italia Hiranandani Gardens - Powai
Telephone: + 39 0 143 7741 Mumbai 400 076 - India
Fax: + 39 0 143 477 295 Telephone: + 91 22 2570 6775
Fax: + 91 22 2570 6770
ROMANIA
Roquette Romania S.A. Roquette Riddhi Siddhi
Platforma Industrialà 12A & 14B, Abhishree Corporate Park,
Sud-Vest Nr 5 Opp. Madhurya Restaurant,
205200 Calafat – Dolj - Romania Ambli Bopal Road, Ambli
Telephone: + 40 251 333 067 Ahmedabad – 380058, Gujarat - India
Fax: + 40 251 306 262 Telephone: + 91 79 7102 1000
Fax: + 91 79 7102 1011
SPAIN
Roquette Laisa España, S.A JAPAN
Avenida Jaime I, S/N. Roquette Japan K.K.
46450 Benifaió - Valencia - España Tokyo Head Office
Telephone: + 34 96 178 98 00 2F, Kasuga Business Center Building
Fax: + 34 96 178 98 10 1-15-15 Nishikata - Bunkyo-Ku
Tokyo 113-0024 - Japan
UNITED KINGDOM Telephone: + 81 3 3830 1510
Roquette UK Ltd Fax: + 81 3 3830 1525
Sallow Road KOREA
Weldon Industrial Estate Roquette Korea Ltd.
Corby Northants NN17 5JX 12th FL., Samheung Yeoksam bldg.,
United Kingdom Teheran-ro 14-gil 5, Gangnam-gu 735-10
Telephone: + 44 15 36 273000 Yeoksam dong, Kangnam Ku,
Fax: + 44 15 36 263873 Seoul 135-923 - Korea
RUSSIA Telephone: + 82 2 2141 3400
OOO Roquette Rus Fax: + 82 2 2141 3482
17, Vorontsovskaya street SINGAPORE
Business Center Roquette Singapore Pte. Ltd
“Mosenka Capital Plaza” 298 Tiong Bahru Road,
109147; Moscow - Russia #14-02/03 Central Plaza,
Telephone: +7 (495) 775-75-87 Singapore 168730 - Singapore
Fax: +7 (495) 775-75-88 Telephone: + 65 6416 3377
AdressesGB031213.indd 1 13/12/13 09:04

Mann

Загружено:

Сведения о документе

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Mann

Загружено:

Авторское право:

Доступные форматы

12016Brochure PEARLITOL-Anglais_Brochure PEARLITOL-Anglais 19/06/12 15:09 Page23

Moreover, mannitol is non cariogenic and allows sugar free

the manna ash (Fraxinus HO HO HO HO

Mannitol also occurs

Mannitol is registered under CAS number 69-65-8 and EINECS 200-711-8.

sweet white crystalline

powder, that gives a 0.8

cooling sensation in 0.6

Sucrose Mannitol Sorbitol Maltitol Xylitol

Mannitol is approximately half as sweet as sucrose

➢ Ether : practically insoluble 25 25

A negative heat of solution is the origin Temperature (°C)

* From “Handbook of Pharmaceutical Excipients” Third Edition,

Relative humidity (%)

Number of milliosmols/kg water

Quantity g/kg water

Infrared Mannitol - Ȋ- Infrared Spectrum

is typical of the ß form of Wave number/cm -1

after dissolution and

Mannitol - Ȏ- Infrared Spectrum

Mannitol - 1H NMR Spectrum Mannitol - 13

The high purity, stability

and non hygroscopicity

crystalline powders mean

that they are the excipient of

choice for pharmaceutical

Typical values of particle sizes

These values are given for guidance only.

Mannitol is an interesting excipient for freeze-drying.

mannitol granular powders

has been especially designed

for direct compression

A range of different particle

sizes and densities of

PEARLITOL mannitol PEARLITOL DC

granular powders are available:

➢ PEARLITOL 100 SD,

➢ PEARLITOL 200 SD,

➢ PEARLITOL 300 DC,

➢ PEARLITOL 400 DC,

➢ PEARLITOL 500 DC.

PEARLITOL 100 SD 200 SD 300 DC 400 DC 500 DC

Poured density (g/mL) 0.48 0.45 0.62 0.68 0.64

These values are given for guidance only.

PEARLITOL mannitol granular Compactibility of PEARLITOL

powders are effective fillers and 100

Compression force (kN)

PEARLITOL 200 SD is a filler and Hardness variation as a function

speed, allowing high productivity. 100

Rotation speed (tablets/H)

Compression pressure (Mpa)

Compression pressure (Mpa)

PEARLITOL 400 DC data was kindly provided by Pr K.J. Steffens, Institute of

Hardness profile as a function of the mixing time with lubricant

Compression profile without and with ascorbic acid

Pharmaceutical Technology, Bonn University, Germany.

Hardness (Mpa) Hardness (Mpa)

certain reliability for the production.

Compression pressure (Mpa)

Compression Force (kN)

non DC active substance.

Hardness (N) Hardness (Mpa)

Below is an example of a formulation of a

■ Preparation Taste Masked Dextromethorphan Dispersible Tablet