PEARLITOL - PharmaCompass.com · 2017. 1. 27. · Roquette PEARLITOL mannitol P A G E 4 PEARLITOL...

PEARLITOL®

M A N N I T O L F O RP H A R M A C E U T I C A L A P P L I C A T I O N S

q12016Brochure PEARLITOL-Anglais_Brochure PEARLITOL-Anglais 19/06/12 15:09 Page23

mannitol

Roquette ➤ PEARLITOL mannitol

P A G E 1

• 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

S U M M A R Y

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P E A R L I T O L m a n n i t o l

12016Brochure PEARLITOL-Anglais_Brochure PEARLITOL-Anglais 19/06/12 14:56 Page1


P A G E 2

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I N T R O D U C T I O N

Roquette is one of the leading companies providing starch derivativesand polyols and has developed a wide range of products and servicesespecially dedicated to the pharmaceutical and cosmetic industries.Based on this experience Roquette has been widening its range ofpolyol excipients through technical innovations, combining qualitywith performance. Roquette offers a wide range of polyols and amongstthem, PEARLITOL mannitol.

PEARLITOL is a brand name of a range of mannitol dedicated to themanufacture of medicines. Mannitol presents the following features:

➢ Very low hygroscopicity: it does not promote hydrolysisreaction.

➢ Very high chemical stability due to its polyol structure,mannitol does not undergo reducing reaction or discolorationreaction 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 freeformulation.

Mannitol offers unique physical and chemical characteristics andsuperior performances, making it the best choice in excipients.



P A G E 3

CHO

HO

OH

CH2OH

OH

OH

OH

CHO

HO

CH2OH

HO

OH

OH

CH2OH

HO

CH2OH

HO

OH

OH

CH2OH

HO

CH2OH

OH

OH

H2Ni

++

Mannitol and sorbitol are separated by their difference inaqueous solubility (water is the only process solvent). Theisolated mannitol is a white crystalline powder of very highpurity. It is further transformed into a complete range ofPEARLITOL mannitol powders which is manufactured in a dedicated ISO 9002 certified plant.

The range of mannitol consists of 8 different grades:

➢ PEARLITOL 160 C standard mannitol

➢ PEARLITOL 50 C fine grade

➢ PEARLITOL 25 C very fine grade

➢ PEARLITOL PF pyrogen free grade

➢ PEARLITOL 100 SD spray-dried grade for directcompression

➢ PEARLITOL 200 SD spray-dried grade for directcompression

➢ PEARLITOL 300 DC fine granulated grade fordirect compression

➢ PEARLITOL 400 DC medium granulated grade for direct compression

➢ PEARLITOL 500 DC coarse granulated grade for direct compression

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D E S C R I P T I O N

Mannitol takes its

name from manna,

a sweet exsudate from

the manna ash (Fraxinus

ornus), of which it is

the major constituent.

Mannitol also occurs

in olives, figs and larches,

in certain species of edible

fungi, and in seaweed

(laminaria species).

D-mannitol was originally

obtained industrially

by an extraction process.

Whereas, since the

beginning, Roquette has

developped a manufacture

process of mannitol based

upon starch, natural raw

material of vegetable

origin. Starch is

transformed into a glucose

mannose solution which

gives mannitol through

catalytic hydrogenation

according to the following

reaction:

Glucose + Mannose Sorbitol + Mannitol



P A G E 4

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PEARLITOL mannitol comply with the mannitol monographs of the differentpharmacopeia including:

➢ European Pharmacopeia

➢ USP

➢ Japanese Pharmacopeia

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

CH2OH

HO

CH2OH

HO

OH

OH

Mannitol is a polyol with a molecular weight of 182.17 and its empirical formula isC6H14O6. The chemical structure is the following:

Molecular weightFormula

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..Conformities

D E S C R I P T I O N



P A G E 5

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The following diagram compares thesweetness of mannitol with sucrose anddifferent polyols:

Mannitol is approximately half as sweet as sucrose or xylitol.

Sweetness

0

0.2

0.4

0.6

0.8

1

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The joint FAO/WHO Expert Committee on Food Additives (JECFA) has decided in its 30th

report (1987) not to specify an acceptable daily intake for mannitol. This means that mannitol issafe. This decision was based on a complete biotoxicological file.

In Europe, the Scientific Committee for Food (SCF) has followed JECFA’s decision in 1989regarding the acceptable daily intake.

Safety

Polyols’ sweetness

Sucrose Mannitol Sorbitol Maltitol Xylitol

P H Y S I O L O G I C A L P R O P E R T I E S

Mannitol occurs

naturally as a slightly

sweet white crystalline

powder, that gives a

cooling sensation in

the mouth.



P A G E 6

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A minor part of the ingested mannitol is partiallyabsorbed and metabolised. It is passivelyabsorbed in the upper gastrointestinal tract (asopposed to glucose which is actively absorbed).Mannitol is then partially oxidised into D-fructoseby mannitol dehydrogenase and metabolisedthrough a non insulinic glycogenolytic pathway.

The major part of the ingested mannitol is notabsorbed and goes through to the colon where it is fermented by the colonic microflora.

The mannitol which is absorbed is nonmetabolised, and is directly excreted through the kidney in the urine.

The ingestion of mannitol in large quantities canlead to flatulence, laxative effects (osmotic typedue to water flowing into intestine lumen). Theseeffects depend on the individual physiologic state,alimentary bolus and its composition.

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

Dental aspects

Mannitol is not fermented by the human buccal microflora. Thus, it is neither acidogenic norcariogenic and these properties grant it a particular status in tooth decay prevention.



P A G E 7

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Mannitol is remarkably stable:

- it does not react with diluted acids, buffer solutions or amino groups. No Maillard reactionof 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).

Due to its chemical properties and itsvery high purity, Mannitol is non-hygroscopic. Mannitol takes up wateronly above relative humidities of97% at 20°C and 40°C.

Stability

Mannitol is soluble in different solvents at 20°C (part/part)*:

➢ Water : 1 in 5.5➢ Ethanol (95%) : 1 in 83➢ Ether : practically insoluble➢ Glycerin : 1 in 18➢ Propanol-2 : 1 in 100➢ Alkalis : soluble

A negative heat of solution is the origin of the cooling effect experienced afteringestion of mannitol powder (value of - 30 cal/g).* From “Handbook of Pharmaceutical Excipients” Third Edition, p. 325, A.H. Kibbe, Pharmaceutical Press, London, UK.

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Solubility

05

10152025303540

0

9.1

1519

25

31

37,5

10 20 30 40 50 60 70

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12.3

Mannitol’s solubility in water

Sorption Isotherms

Temperature (°C)

% of mannitol

010

2030

40

50

60

70

80

90

0 50 100

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Relative humidity (%)

Percentage of water in the product

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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

Hygroscopicity

40°C

20°C



P A G E 8

Mannitol can be used as therapeuticagent in order to increase diuresis inconcentrated solutions (15% and20%); see values on the curvehereafter.

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..Osmolality

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..Crystalline forms

Melting point

Mannitol Osmolality

0

200

400

600

1000

1200

800

0 20 40 60 80 100 120 140 160

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Quantity g/kg water

Number of milliosmols/kg water


Mannitol is crystallised as the ß form and complies with the identification tests of differentmajor Pharmacopoeias. Other crystalline forms (� and �) can be observed anddifferentiated by infrared spectrometry or by X ray diffraction. The melting range is thesame for the 3 forms and lies between 165°C and 169°C.



P A G E 9

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Spectrometry

Mannitol - ß - Infrared Spectrum

Wave number/cm-1

% transmission

Mannitol - � - Infrared Spectrum

Wave number/cm-1

% transmission

Mannitol - � - Infrared Spectrum

Wave number/cm-1

% transmission


Infraredabsorptionspectra (KBr)

Infrared absorptionspectrometry is anidentification methodcapable of detecting thecrystalline polymorphism of tested products.

The spectrum of Mannitol is typical of the ß form ofmannitol.

The spectrum ofPEARLITOL SD mannitolshows it to be mainly in the� form which is due to itsparticular manufacturingprocess.

This form of mannitol can betransformed into the ß formafter dissolution andrecrystallisation, as requiredby the identification test inmannitol monograph.

100.0

80.0

60.0

40.0

20.0

0.04000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0

100.0

80.0

60.0

40.0

20.0

0.04000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0

100.0

80.0

60.0

40.0

20.0

0.04000.0 3500.0 3000.0 2500.0 2000.0 1750.0 1500.0 1250.0 1000.0 750.0 500.0



P A G E 10

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Mannitol - 1H NMR Spectrum

Deplacement chimique (�) em ppm

Mannitol - 13C NMR Spectrum

Deplacement chimique (�) em ppm


The symmetry of the mannitol molecule leads to a simple three singlets 13C NMR spectrum.

NMR Spectra

Mannitol gives the following 1H and 13C Nuclear Magnetic Resonance (NMR) spectra:

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



P A G E 11

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).

■ Particle size

Typical values of particle sizesof mannitol crystallinepowders are given forguidance only (mean diameter,laser diffraction):

➢ PEARLITOL 160 C:160 microns approx.

➢ PEARLITOL 50 C:50 microns approx.

➢ PEARLITOL 25 C:25 microns.

Characteristics

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P A G E 12

■ Dry forms

PEARLITOL mannitol crystalline powders are highly recommended for the manufactureof dry forms (granules, pellets, tablets) obtained by granulation. The different particlesizes, the non hygroscopicity, the absence of water and the stability give superiorperformances 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 andprevents it from collapse. Moreover, due to its polyol structure, mannitol acts as a cryoprotective agent.

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

PEARLITOL

■ Rheology

These values are given for guidance only.

Applications


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P A G E 13


PEARLITOL DC

PEARLITOL 200 SD

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

granular powders are available:

➢ PEARLITOL 100 SD,

➢ PEARLITOL 200 SD,

➢ PEARLITOL 300 DC,

➢ PEARLITOL 400 DC,

➢ PEARLITOL 500 DC.

PEARLITOL mannitolgranular powders are freeflowing and excellent diluent-binders for direct compressionapplications (fast dissolvingtablets, chewable tablets…).

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

PEARLITOL

These values are given for guidance only.

■ Rheology

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.PEARLITOL®

mannitol granular powders



P A G E 14


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 200 SD is a filler andbinder which is effective in variousconditions. It shows excellentperformance even at high tablettingspeed, allowing high productivity.

PEARLITOL mannitol granularpowders give good hardness resultsunder industrial compressionconditions. These results demonstratethat PEARLITOL mannitol granularpowders are effective fillers andbinders for DC applications.

PEARLITOL200 SD

PEARLITOL400 DC

0

20

40

60

80

100

120

140

20 25 30 35 40 45 50 55 60 65 70

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Compactibility

Compression force (kN)

Hardness (N)

20

40

60

80

100

120

20000 50000 70000 100000

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86 8480 82

PEARLITOL 200 SD

Rotation speed (tablets/H)

Hardness (N)

Hardness variation as a function of the tabletting rotation speed

Compactibility of PEARLITOLon rotative FETTE P 1000

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P A G E 15

■ Lubrication sensitivity

PEARLITOL mannitol is tested in compression with magnesium stearate. It does notmake any difference to the hardness of tablets even if the time taken to mix PEARLITOLmannitol and magnesium stearate varies from 2 to 30 minutes. This property ensures acertain reliability for the production.

Compression pressure (Mpa)

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0.5

1

1.5

2

2.5

3

0 50 100 150 200 250 300

Mix: 2 min

Mix: 30 min

Hardness profile as a function of the mixing time with lubricant

PEARLITOL 400 DC

PEARLITOL 400 DC data was kindly provided by Pr K.J. Steffens, Institute ofPharmaceutical Technology, Bonn University, Germany.

Hardness (Mpa)


00.5

1

1.5

22.5

3

3.5

0 50 100 150 200 250 300 350 400

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25%

0%

PEARLITOL 400 DC

Hardness (Mpa)

■ Dilution potential

Formulations based on PEARLITOL mannitol are able to incorporate high proportions ofnon DC active substance.

Compression profile without and with ascorbic acid

0

0,5

1

1,5

2

2,5

3

50 100 150 200 250 300

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PEARLITOL 200 SD


0%

25%

Hardness (Mpa)

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020 30 40 50 60 70 80 90

50

100

150

200

PEARLITOL 200 SD

Compression Force (kN)

Mix: 2 min

Mix: 30 min

Hardness (N)


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P A G E 16


■ Fast dissolving/chewable tablets

Below is an example of a formulation of achewable/fast dissolving/dispersible tablet, containingtaste masked dextromethorphan hydrobromide.

■ Preparation

1. Mix for 5 minutes in a TURBULA (1) mixer PEARLITOL® 200 SD, Dextromethorphan HBr,KLEPTOSE DC (betacyclodextrin) and SodiumStarch Glycolate.

2. Magnesium stearate is added and mixed for 5 minutes in the TURBULA (1) mixer.

3. Compression on a FROGERAIS (2) machinewith 10 mm diameter flat bevelled punch.

➢ Tablet mass: 350 mg➢ Hardness: 48 N➢ Disintegration time: 40 s

PEARLITOL DC and SD mannitol granular powder are used in all types of tablets:

➢ fast dissolving tablets,

➢ chewable tablets,

➢ effervescent tablets,

➢ standard tablets.

Applications

Taste Masked Dextromethorphan Dispersible Tablet

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(1) TURBULA: trademark of Willy A. Bachofen AG Maschinenfabrik, BASEL (Switzerland),(2) FROGERAIS: trademark of SVIAC/Schindler VITRY/SEINE (France).

PEARLITOL 200 SD 45.5%

Sodium Starch Glycolate3.0%

Magnesium stearate1.5%

Dextromethorphan hydrobromide

7.1%

KLEPTOSE DC42.9%



P A G E 17

■ Preparation

In a LOEDIGE (4) mixer pour and mix for 5 minutes in 6 steps:

1. Tartaric acid and sodium bicarbonate,

2. Ascorbic acid and sodium ascorbate,

3. PEARLITOL® 200 SD, orange flavour and sodium saccharinate,

4. Add a third of PEG 6000 and sodium benzoate in 3 steps.

5. Compression on EXACTA 21 (5) machine with 20 mm flat bevelled punch

➢ Tablet mass: 2.25 g➢ Hardness: 60 N➢ Disintegration time: around 1 minute

Vitamin C effervescent tablets

XPEARLITOL 200 SD9.4%

Sodium bicarbonate30.8%

Granulated tartaric acid26.4%

Coated ascorbic acid20.0%

Granulated sodium ascorbate 4.7%

Sodium benzoate3.7%

PEG 60002.8%

Orange flavour1.8%

Sodium saccharinate0.4%

Simethicone2,8%


Sodium saccharinate0.2%

Antacid chewable tablets

PEARLITOL 200 SD50,6% Aluminium hydroxide

22,2%

Magnesium hydroxide22,2%

Mint flavour1,0%

■ Preparation

Mixing steps in a TURBULA(1) mixer:

➢ 10 mn for PEARLITOL 200 SD and simethicone,

➢ 5 mn with hydroxides, flavor andsodium 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➢ Schleuniger hardness: 100 N


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(1) TURBULA: trademark of Willy A. Bachofen AG Maschinenfabrik, BASEL (Switzerland),(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 18


Aluminium hydroxide20.1%

Magnesium hydroxide5.0%


Mint flavour1,0%

PEARLITOL 400 DC72.4%

■ Preparation

Mixing steps in a TURBULA (1) mixer : 5 minutes for aluminium hydroxide, 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➢ Thickness: 4.30 mm➢ Schleuniger Hardness: 75 N

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.

Antacid chewable tablets

Other applications

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(1) TURBULA: trademark of Willy A. Bachofen AG Maschinenfabrik, BASEL (Switzerland),(3) FROGERAIS: trademark of SVIAC/Schindler VITRY/SEINE (France).



P A G E 19

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P E A R L I T O L ® P F

■ Physical and chemicalcharacteristics

PEARLITOL PF complies with the different existingmonographs:

➢ European Pharmacopeia➢ USP➢ Japanese Pharmacopeia

Roquette has been

manufacturing raw materials

for the preparation of

injectable products for over

25 years. PEARLITOL PF

mannitol pyrogen free grade

has been developed and

introduced to the leading

companies, world-wide.

PEARLITOL PF

is manufactured and

controlled according to

the highest existing standards

and supplied throughout

the world.

Characteristics

■ Biological and microbiologicalcharacteristics

Roquette performs endotoxins tests and pyrogenicsubstances detection on rabbits in its ownlaboratories. These tests are carried out according tothe recommendations of the various Pharmacopeia.Due to our experience and total control of ourproduction, Roquette is able to offer PEARLITOL PFwith the following specifications:

➢ Endotoxin: 2.5 E.U./g maxi➢ Total viable count: 100 col./g maxi➢ Yeast: 10 col./g maxi➢ Moulds: 10 col./g maxi

PEARLITOL PF is usually used in 5% and 10%solutions as a diuretic agent.

It can be incorporated in complex solutions whichmay contain mineral salts.

PEARLITOL PF is highly recommended for themanufacture of freeze-dried injectable preparationsbecause of its cryoprotective effect, osmoticproperties, physical stability, non hygroscopicity andexcellent chemical inertness (no reaction with the amine function).

Applications



P A G E 20

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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 anddevelopment scientists assisted by adedicated application laboratory are at yourdisposal for further information andassistance regarding the use of Mannitol.

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P E A R L I T O L ® P A C K A G I N G

PEARLITOL mannitol packaging exists invarious sizes and presentations:

The information contained in this document is to the best of our knowledge true andaccurate but all instructions, recommendations or suggestions are made without anyguarantee. Since the conditions of use are beyond our control, we disclaim anyliability 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 thesedata or suggestions infringes any patent. No part of this document may be reproduced by any process without our priorwritten permission.

® Registered trademarks of Roquette Frères© Roquette Frères S.A. - 06/2012

Strippable BagPaper + Polythene

25 kg

Cardboard BoxPolythene + Box

25 kg

DrumPolythene + fibre drum

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


FRANCERoquette FrèresCorporate Headquarters1 rue de la Haute Loge62136 Lestrem - FranceTelephone: + 33 3 21 63 36 00Fax: + 33 3 21 63 38 50

BELGIUMJ.V Roquette & BarentzExcelsiorlaan 7 Box 21930 Zaventem - BelgiumTelephone: + 00 32 2 714 13 00

DENMARKRoquette ApSGydevang 39-41DK - 3450 AllerødTelephone: + 45 69 663 200Fax: + 45 69 663 209

FINLANDRoquette Nordica OyAhventie 4A, 20FI-02170 Espoo – FinlandTelephone: + 358 9 315 85 700Fax: + 358 9 8632 113

GERMANYRoquette GmbHDarmstädter Landstrasse 18260598 Frankfurt - DeutschlandTelephone: + 49 69 60 91 050Fax: + 49 69 60 91 05 59

ITALYRoquette Italia S.p.AVia Serravalle 2615063 Cassano SpinolaAlessandria - ItaliaTelephone: + 39 0 143 7741Fax: + 39 0 143 477 295

ROMANIARoquette Romania S.A.Platforma IndustrialàSud-Vest Nr 5205200 Calafat – Dolj - RomaniaTelephone: + 40 251 333 067Fax: + 40 251 306 262

SPAINRoquette Laisa España, S.AAvenida Jaime I, S/N.46450 Benifaió - Valencia - EspañaTelephone: + 34 96 178 98 00Fax: + 34 96 178 98 10

UNITED KINGDOMRoquette UK LtdSallow RoadWeldon Industrial EstateCorby Northants NN17 5JXUnited KingdomTelephone: + 44 15 36 273000Fax: + 44 15 36 263873

RUSSIAOOO Roquette Rus17, Vorontsovskaya streetBusiness Center “Mosenka Capital Plaza”109147; Moscow - RussiaTelephone: +7 (495) 775-75-87Fax: +7 (495) 775-75-88

CHINARoquette ShanghaiRoom 505— K. Wah Centre,1010 Huai Hai Zhong Road,Shanghai 200031 - P.R. ChinaTelephone: + 86 21 54 03 99 22Fax: + 86 21 54 03 66 06

INDIARoquette India Private LimitedOffice n° 702, 7th Floor Powai PlazaHiranandani Gardens - PowaiMumbai 400 076 - IndiaTelephone: + 91 22 2570 6775Fax: + 91 22 2570 6770

Roquette Riddhi Siddhi12A & 14B, Abhishree Corporate Park,Opp. Madhurya Restaurant,Ambli Bopal Road, Ambli Ahmedabad – 380058, Gujarat - IndiaTelephone: + 91 79 7102 1000Fax: + 91 79 7102 1011

JAPANRoquette Japan K.K.Tokyo Head Office2F, Kasuga Business Center Building1-15-15 Nishikata - Bunkyo-KuTokyo 113-0024 - JapanTelephone: + 81 3 3830 1510Fax: + 81 3 3830 1525

KOREARoquette Korea Ltd.12th FL., Samheung Yeoksam bldg., Teheran-ro 14-gil 5, Gangnam-gu 735-10Yeoksam dong, Kangnam Ku,Seoul 135-923 - KoreaTelephone: + 82 2 2141 3400Fax: + 82 2 2141 3482

SINGAPORERoquette Singapore Pte. Ltd298 Tiong Bahru Road,#14-02/03 Central Plaza,Singapore 168730 - SingaporeTelephone: + 65 6416 3377

ROQUETTE WORLDWIDE

EUROPE

ASIA

AMERICA

USARoquette America Inc.Geneva Innovation Center2211 Innovation DriveGeneva, IL 60134 - USATelephone: + 1 630 463 9430Fax: + 1 630 232 2157

MEXICORoquette México S.A. de C.VBlvd. Bernardo Quintana 9750 of 321Fracc. Centro sur Queretaro Qro.CP 76090 - MéxicoTelephone: + 52 44 2229 1270Fax: + 52 44 2229 1270

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mTURKEYRoquette Tarım ve Gıda San. ve Tic. Ltd. Sti.Büyükdere Cad. Harman Sok.Duran I·ş merkezi No:4 K:3 34394 Levent I·stanbul - TurkeyTelephone: + 90 212 234 83 73 Fax: + 90 212 234 83 74

AdressesGB031213.indd 1 13/12/13 09:04

PEARLITOL - PharmaCompass.com · 2017. 1. 27. · Roquette PEARLITOL mannitol P A G E 4 PEARLITOL...

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