9623 AP List de Produits GB REVUE:frt:210x297mm … de Produits_GB_REVUE:.....frt:210x297mm ... PEARLITOL® C • Mannitol ... formulation of orodispersible tablets. PEARLITOL

9623_AP_List de Produits_GB_REVUE:.....frt:210x297mm

www.roquettepharma.com

ROQUETTE, through its production units (in Europe, in Asia and in the United States) and its international distribution network, will assure a constant quality of products and services throughout the whole world.

® Registered trademark of Roquette Frères - © Roquette Frères S.A. - 07/2010

Supplier performance and reliability as good as it should be?

FILM FORMING AND COATING POLYMERS

• Modifi ed starch-based polymers - LYCOAT® • Tablet coating - LYCOAT® RS

FAST DISSOLVE AND CHEWABLE TABLETS (ODT)• Mannitol powders - PEARLITOL® C • Mannitol compound - PEARLITOL® Flash • Sorbitol powders - NEOSORB® P

DILUENTS AND FILLERS FOR TABLETS/CAPSULES

• Mannitol powders - PEARLITOL® C • Starches (native, modifi ed and pregelatinized) • Maltodextrin - GLUCIDEX®

DIRECT COMPRESSION

• Mannitol powders - PEARLITOL® DC and SD • Sorbitol powders - NEOSORB® P and NEOSORB® P DC • Xylitol powders - XYLISORB® DC • Partially pregelatinized starch - LYCATAB® C

BINDERS FOR WET GRANULATION

• Pregelatinized starch - LYCATAB® PGS

MOLECULAR ENCAPSULATION, TASTE-MASKING AND DISSOLUTION ENHANCER

• Betacyclodextrin - KLEPTOSE® • Methyl Cyclodextrin - CRYSMEB

SYRUPS, SEMI-SOLIDS AND SOFTGELS

• Liquid Sorbitol - NEOSORB® 70% • D-Sorbitol and sorbitan solution - POLYSORB® 85/70/00 as plasticizer

PYROGEN-FREE CARBOHYDRATES FOR INJECTABLE AND DIALYSIS SOLUTIONS

• Dextrose - LYCADEX® PF • Sorbitol - NEOSORB® PF • Hydroxy-Propyl betacyclodextrin - KLEPTOSE® HP and HPB Parenteral grades

DISINTEGRANTS AND SUPERDISINTEGRANTS

• Wheat starch, corn starch, potato starch

DIETARY FIBER, PROTEINS AND MINERAL SUPPLEMENTS

• Soluble dextrin - NUTRIOSE® FB and NUTRIOSE® FM • Non-GMO pea protein - NUTRALYS®

• Ready to use system – ReadiLYCOAT™• Thin fi lm delivery systems - LYCOAT® NG

• Mannitol powders - PEARLITOL® DC and SD• Xylitol powders - XYLISORB®

• Maltitol powders - SweetPearl™ • Partially pregelatinized starch - LYCATAB® C • Dextrose

• Mannitol compound - PEARLITOL® Flash• Maltitol powders - SweetPearl™ DC • Co-processed starch and lactose – STARLAC ®• Betacyclodextrin for direct compression - KLEPTOSE® DC

• Maltodextrin - LYCATAB® DSH

• Hydroxy-Propyl Betacyclodextrin - KLEPTOSE® HP and HPB

• Maltitol syrup - LYCASIN®

• Mannitol - PEARLITOL® PF• Sodium Gluconate Pharma

• Sodium starch glycolate - GLYCOLYS®

• Co-processed starch and CaCO3 - LYCATAB® Mineral• Chlorella microalga - ALGOMED®

® ®

® ®

® ®

® ®

® ®

®

®

®

®

®

®

®

® ®

® ®

® ®

®

KLEPTL i n e ®

KLEPTL i n e ®®

KLEPTL i n e ®

KLEPTL i n e ®

KLEPTL i n e ®®

KLEPT pL i n e c a p s KLEPTOSE ® L i n e c a p s ®

KLEPTOSE ® L i n e c a p s KLEPTOSE ® L i n e c a p s KLEPTOSE ® L i n e c a p s ®

KLEPTOSE ® L i n e c a p s KLEPTOSE ® LL i n e c a p s KLEPTOSE ® L i n e c a p s ®




New taste

masking Solutions

KLEPTOSE ® Linecaps

w w w . r o q u e t t e p h a r m a . c o mThe information contained in this technical bulletin is to our best knowledge true and accurate but all instructions, recommendations or suggestions are made without guarantee.

Furthermore, no liability is accepted if use of any product in accordance with these data or suggestions infringes any patent.® Registered trademark from ROQUETTE Frères

© Copyright August 2011

E n h a n c e d s o l u b i l i t y o f A P I

Pure Water KLEPTOSE ® Linecaps 17 (100 mg/ml)

G o o d c o m p l e x a t i o n

KLEPTOSE ® Linecaps 17

Hydrocortisone (x 2 fold),

Dexamethasone (x 6 fold),

Ketoprofen (x 2 fold)

Carrier

0.32 ± 0.05

0.09 ± 0.01

0.22 ± 0.04

Hydrocortisone

Dexamethasone

Ketoprofen 7

0.70 ± 0.06

0.60 ± 0.04

0.39 ± 0.02

Ligand

Menthol

Methyl paraben

Propyl paraben

Complex level

100%

100%

100%

®

®

®

®®

®

11274DepMaltodextrine.indd 2-311274DepMaltodextrine.indd 2-3 10/08/11 13:0810/08/11 13:08


is a good taste masking technology applicable for:

• A wide range of dosage forms: liquids, chewable tablets, ODT,suspensions…

• Cost effective solution for OTC and nutraceutical products (ex: herbal products)


is a pea maltodextrin which forms a fl exible

adaptable amylose helix freely soluble in water

Amylose derived from pea starch is organized in helices with a hydrophilic external

surface due to the presence of hydroxyl groups and with a hydrophobic internal

surface due to the presence of hydrogen atoms. This helical structure confers the

amylose the necessary characteristics for the encapsulation of active principles

or fl avourings. Amylose is capable of masking bitter taste of drugs by decreasing

the overall amount of drug particles exposed to taste buds.

Key Technical benefi ts –Tested and Approved based on data available

The taste profi le of Paracetamol solutions has been determined in presence of

KLEPTOSE® Linecaps 17 using a taste sensing system SA 402B, Insent Inc.,

Japan, equipped with 7 lipid membrane sensors.

Encapsulating agent in 1:1 and 2:1 molar ratio

The use of KLEPTOSE® Linecaps 17 reduces the bitterness ofparacetamol.

MwSolubility in

waterRetrogradation

risk

12000KLEPTOSE ® Linecaps 17

Very soluble Low

M a s k i n g b i t t e r t a s t e o f p a r a c e t a m o l

30

20

10

0

-10

-20

-30

-40

-50

-60

-70

-80

Sen

sora

n tw

ort

(mV

)

Paracetamol

2 mg/ml

Paracetamol

150 mg + 2 mg/ml

75 mg + 2 mg


150 mg

75 mg


+

▲

New taste

masking Solutions KLEPTOSE ® Linecaps®



is a good taste masking technology applicable for:

• A wide range of dosage forms: liquids, chewable tablets, ODT,suspensions…

• Cost effective solution for OTC and nutraceutical products (ex: herbal products)


is a pea maltodextrin which forms a fl exible

adaptable amylose helix freely soluble in water

Amylose derived from pea starch is organized in helices with a hydrophilic external

surface due to the presence of hydroxyl groups and with a hydrophobic internal

surface due to the presence of hydrogen atoms. This helical structure confers the

amylose the necessary characteristics for the encapsulation of active principles

or fl avourings. Amylose is capable of masking bitter taste of drugs by decreasing

the overall amount of drug particles exposed to taste buds.

Key Technical benefi ts –Tested and Approved based on data available

The taste profi le of Paracetamol solutions has been determined in presence of

KLEPTOSE® Linecaps 17 using a taste sensing system SA 402B, Insent Inc.,

Japan, equipped with 7 lipid membrane sensors.

Encapsulating agent in 1:1 and 2:1 molar ratio

The use of KLEPTOSE® Linecaps 17 reduces the bitterness ofparacetamol.

MwSolubility in

waterRetrogradation

risk

12000KLEPTOSE ® Linecaps 17

Very soluble Low

M a s k i n g b i t t e r t a s t e o f p a r a c e t a m o l

30

20

10

0

-10

-20

-30

-40

-50

-60

-70

-80

Sen

sora

n tw

ort

(mV

)

Paracetamol

2 mg/ml

Paracetamol

150 mg + 2 mg/ml

75 mg + 2 mg


150 mg

75 mg


+

▲

New taste

masking Solutions KLEPTOSE ® Linecaps®


® ®

® ®

® ®

® ®

® ®

®

®

®

®

®

®

®

® ®

® ®

® ®

®

KLEPTL i n e ®

KLEPTL i n e ®®

KLEPTL i n e ®

KLEPTL i n e ®

KLEPTL i n e ®®

KLEPT pL i n e c a p s KLEPTOSE ® L i n e c a p s ®

KLEPTOSE ® L i n e c a p s KLEPTOSE ® L i n e c a p s KLEPTOSE ® L i n e c a p s ®





New taste

masking Solutions


w w w . r o q u e t t e p h a r m a . c o mThe information contained in this technical bulletin is to our best knowledge true and accurate but all instructions, recommendations or suggestions are made without guarantee.


© Copyright August 2011

E n h a n c e d s o l u b i l i t y o f A P I

Pure Water KLEPTOSE ® Linecaps 17 (100 mg/ml)

G o o d c o m p l e x a t i o n


Hydrocortisone (x 2 fold),

Dexamethasone (x 6 fold),

Ketoprofen (x 2 fold)

Carrier

0.32 ± 0.05

0.09 ± 0.01

0.22 ± 0.04

Hydrocortisone

Dexamethasone

Ketoprofen 7

0.70 ± 0.06

0.60 ± 0.04

0.39 ± 0.02

Ligand

Menthol

Methyl paraben

Propyl paraben

Complex level

100%

100%

100%

®

®

®

®®

®


PEARLITOL® FlashMELT-IN-THE-MOUTH MAGIC WITH MANNITOL?

9539_BRO_Pearlitol_FLASH4 23/09/09 10:47 Page 1


Roquette PEARLITOL® Flash: Melt- in-the-mouth magic with mannitol?

P A G E 1

• A uniquely pleasing taste experience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3

• An intrinsic composition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 4• No superdisintegrant required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 4• A low lubricant level required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 5

• Robust tablets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7

• Excellent compactibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 8• Good dilution potential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 9• Impact of tabletting speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 10

• Quick disintegration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11

• In vivo disintegration test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 12• Pharmacopoeial testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 13• In vitro test correlated with in vivo test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 14

• Easy formulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 15

• PEARLITOL® Flash. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 17

• Definition and regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 18• Powder characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 18• Particle size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 19• Low hygroscopicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 19

C O N T E N T S

..

..

..

..

..

..

..

..

..

..

..

PEARLITOL®

FlashPEARLITOL ® Flash


P A G E 2




P A G E 3

A uniquely pleasing taste experience


P A G E 4


..

..

..

..

..

..

..

A u n i q u e l y p l e a s i n g t a s t e e x p e r i e n c e

An intrinsiccompositionPEARLITOL® mannitol is already well-known for itspleasant and mild sweet taste.

With PEARLITOL® Flash, a mannitol starchcompound, orodispersible tablets melt in the mouthwith a very creamy, smooth texture and a uniquelypleasing taste experience.

No superdisintegrantrequiredTo achieve rapid disintegration of orodispersibletablets, superdisintegrants are usually added in largequantity and can impair the mouthfeel.

PEARLITOL® Flash is a self-disintegrating mannitolcompound so no superdisintegrant is required in theformulation of orodispersible tablets.

PEARLITOL® Flash gives

orodispersible tablets (ODT) of

exceptional taste thanks to its:

• intrinsic composition

• self-disintegrating properties

• low level of lubricant required


Better compliance thanks to a uniquely pleasing taste experience, largely appreciatedfrom paediatrics to geriatrics.

Clean labelling with two long-established ingredients of natural origin that opens upopportunities in nutraceutical formulations.

A u n i q u e l y p l e a s i n g t a s t e e x p e r i e n c e

A low lubricant level requiredUsing PEARLITOL® Flash, 0.4% lubricant issufficient to ensure a direct compression process.

This also contributes to a better taste of the tablet, ashigh levels of lubricant produce a taste that manyconsumers find objectionable.

At 0.3% ejection force drastically increased. Above0.4% no significant differences were observed in thecompression process and in tablet characteristics.Hence the optimum lubricant level in the testedconditions is 0.4%.

Trials were carried out on a single-punch press KorschXP1 fitted with 13mm diameter flat punches withbevelled edges. Magnesium stearate (Barlöcher vegetal)was used as lubricant at levels varying from 0.3% to1.2%.

Compression force (kN)

Mg stearate 1.2% Mg stearate 0.8% Mg stearate 0.4% Mg stearate 0.3%

Ejec

tion

forc

e (N

)

10 15 20 250

100

200

300

400

500

..

..

..

..

..

..

..

Ejection force as a function of lubricant ratio


P A G E 5


P A G E 6




P A G E 7

Robust tablets


P A G E 8


ExcellentcompactibilityPEARLITOL® Flash enables the production of highquality orodispersible tablets, with classical DirectCompression.

A 15 kN compression force is sufficient to obtaintablets with suitable hardness, friability anddisintegration time characteristics as illustrated below.

Trials carried out on a Korsch XP1 press fitted with13mm diameter flat bevelled-edge punches. 500 mgorodispersible tablets, evaluated using PharmacopoeialTests.

..

..

..

..

..

..

..

R o b u s t t a b l e t s

Compression force (kN)

Disintegration time (s)Hardness (N)Friability (%)

Dis

inte

grat

ion

time

(s)

Har

dnes

s (N

)

Fria

bilit

y (%

)

100

20

40

60

80

100

120

15 20 250.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

PEARLITOL® Flash has been

specifically designed for

ordispersible tablets using a

Direct Compression process.



P A G E 9

..

..

..

..

..

..

..


Good dilutionpotentialPEARLITOL® Flash makes it possible to produce veryrobust tablets, even at high dilution. Dilution potentialis illustrated with acetaminophen.

Trials carried out on a Korsch XP1 press fitted with13mm diameter flat bevelled-edge punches. 500 mgorodispersible tablets, evaluated using PharmacopoeialTests. Results shown for a 25 kN compression force.

% Acetaminophen

% PEARLITOL® Flash

Disintegration time (s)Hardness (N)Friability (%)

Dis

inte

grat

ion

time

(s)

Har

dnes

s (N

)

Fria

bilit

y (%

)

0

10

20

30

40

50

10 20 30 40 50

90 80 70 60 50

60

70

80

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7Disintegration time (s)Hardness (N)Friability (%)


P A G E 10


Impact of tablettingspeedTrials were carried out on a single-punch press with atabletting speed varying from 10 to 60 tablets /minute. Tabletting speed has limited impact ondisintegration time.

Trials carried out on a Korsch XP1 press fitted with13mm diameter flat bevelled-edge punches. 500 mgorodispersible tablets, evaluated using PharmacopoeialTests. Results shown for a 15 kN compression force.

Tabletting speed (tablets/mn)

Disintegration time

Dis

inte

grat

ion

time

(s)

8.5 20 30 40 50 600

20

40

60

80

100

120

..

..

..

..

..

..

..


Disintegration time as a function of tabletting speed

Classical Direct Compression equipment can be used, thanks to excellent compactibility.

Robustness of tablets allows traditional blister packaging to be used.



P A G E 11

Quick disintegration


P A G E 12


..

..

..

..

..

..

..

Q u i c k d i s i n t e g r a t i o n

Trials were carried out on a Korsch XP1 press, fittedwith 13mm diameter flat bevelled-edge punches forhydrochlorothiazide tablets and fitted with 7mmdiameter flat bevelled-edge punches for sodiumfluoride tablets.

Other NUTRIOSE® grades have been developed for specific applications.

PEARLITOL® Flash

Active

Magnesium stearate

In vivodisintegration testTests have been carried out on tablets containingdifferent actives to evaluate the in vivo disintegrationtime. Tablets formulas and characteristics are givenin the table below.

Total

Weight (mg)

Thickness (mm)

Hardness (N)

Friability (%)

Hydrochlorothiazidetablets

94.6%

5.0%

0.4%

Sodium fluoridetablets

97.4%

2.2%

0.4%

77.4 ± 1.3

0.26

82.8 ± 2.3

0.16

505.4 ± 0.7

2.96 ± 0.01

104.4 ± 0.2

1.93 ± 0.01

100% 100%

Quick disintegration is the key

parameter for orodispersible

tablets. Consumers expect a

complete disintegration in

about 30-40s. In vivo and in

vitro tests have been developed

to measure this time on tablets.



P A G E 13

..

..

..

..

..

..

..


PharmacopoeialtestingODT must disintegrate within 3 minutes, accordingto European Pharmacopoeia disintegration testconditions. In vitro disintegration tests according tomajor pharmacopoeias are performed in a largequantity of water, and therefore do not match exactlywhat happens in the mouth, where a limited quantityof saliva is available for disintegration. No correlation exists between Pharmacopoeiadisintegration test and in vivo disintegration test.

ODT tablets with PEARLITOL® Flash lead typicallyto disintegration times of less than 3 minutes usingthe Pharmacopoeial test, depending on the ODTformulation and the tablet size. The above describedtablets were evaluated using Pharmacopoeialdisintegration test. Results are given below.

In vitro disintegration time (s)


81 ± 13


70 ± 7

In vitro disintegration time was measured below 3 minutes.

In vivo disintegration time was measured by a panelof 8 people. Results are given below.

In vivo disintegration time (s)


20 ± 5


22 ± 2

In vivo disintegration time was measured below 1 minute.


P A G E 14


In vitro testcorrelated with invivo testAn in vitro test has been developed to mimic the invivo disintegration, with excellent correlation.

A charge of 3N is applied on top of an ODT. Twomillilitres of water are added (equivalent to the salivavolume). The change in charge is recorded. As thetablet disintegrates, charge decreases. The typicalcurve obtained is given for illustration.0 10

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Time (s)

Char

ge (N

)

20 30 40 50 60 70 80

Tablet desagregates in lessthan 40s, as visualized by the sudden collapse of applied charge

Quick disintegration of PEARLITOL® Flash ODTs makes possible “On-the-go” use andquick onset of action.

..

..

..

..

..

..

..




P A G E 15

Easy formulation


P A G E 16


..

..

..

..

..

..

..

E a s y f o r m u l a t i o n

With PEARLITOL® Flash, formulation is simplifiedbecause fewer excipients are required:• no superdisintegrant• minimum level of lubricant• minimum quantity of intense sweeteners or flavours



P A G E 17

PEARLITOL® Flash


Definition andregulationPEARLITOL® Flash is a compound of mannitol andextra white maize starch. Both ingredients comply withpharmaceutical and food regulations and can be usedfor pharmaceutical and nutraceutical orodispersibletablets.

PowdercharacteristicsPEARLITOL® Flash is designed for Direct Compressionorodispersible tablets. It has excellent flow properties.

Indicative values; Hosokawa and Pharmacopoeia funnel test.

..

..

..

..

..

..

..

P E A R L I T O L ® F l a s h

Bulk density (g/ml) 0.52

Tapped density (g/ml) 0.62

Haussner ratio 1.19

Angle of repose (°) 43

Ability to settle (ml) 16

Flowability (funnel, s) 5.5

Loss on drying (%) 1.1

P A G E 18



Particle size

..

..

..

..

..

..

..

P E A R L I T O L ® F l a s h

D10 (µm) 80

Mean diameter (µm) 200

D90 (µm) 300

Target R.H. (%)

Chan

ge In

Mas

s (%

) - D

ry

0.0

5.0

10.0

15.0

20.0

25.0

30.0

0 10 20 30 40 50 60 70 80 90 100

Low hygroscopicityPEARLITOL® Flash is stable to humidity as illustratedin the figure below.

Particle Diameter (µm)

Cum

ulat

ive

> V

olum

e (%

)

Diff

eren

tial

Volu

me

(%)

00.4 1 2 4 6 10 20 40 60 100 200 400 1000 2000

0

1

2

3

4

5

6

7

8

20

40

60

80

100


P A G E 19

Indicative values; Beckman Coulter Laser Particle sizeanalyser.


To contact us:

ROQUETTEPharmaceutical and Cosmetics Business Unit

62080 Lestrem Cedex France

Telephone: 33 (0)3 21 63 36 00Fax: 33 (0)3 21 63 94 64

Pharma.business.unit@roquette.comwww.roquettepharma.comwww.roquettenutra.com


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.

® Registered trademarks of Roquette Frères

© Roquette Frères S.A. - 09/2009


ww

w.r

oque

tteph

arm

a.co

mROQUETTE WORLDWIDE

FRANCERoquette FrèresCorporate Headquarters62080 Lestrem cedex – FranceTelephone: + 33 3 21 63 36 00Fax: + 33 3 21 63 38 50

FINLANDRoquette Nordica OyPL 11 P.O.BFIN-02171 Espoo – FinlandTelephone: + 358-9502 4410Fax: + 358-9-502 44111

GERMANYRoquette GmbHSchaumainkai 4560596 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 5Calafat – Dolj - RomaniaTelephone: + 40 251 333 065Fax: + 40 251 329 215

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

CHINARoquette ShanghaiRoom 501, 505, 506, K. Wah CentreNo. 1010, Huai Hai Zhong RoadShanghai 200031 - ChinaTelephone: + 86 21 54039922Fax: + 86 21 54036606

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

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

KOREARoquette Korea Ltd.17th floorKangnam Building. 1321 - 1Seocho-dong, Seocho-KuSeoul 137 – 070 - KoreaTelephone: + 82 2 2141 3400Fax: + 82 2 2141 3482

EUROPE

AMERICA

ASIA

USARoquette America, Inc.1417 Exchange StreetPO Box 6647Keokuk. IA 52632 – 6647 - USATelephone: + 1 319 524 - 5757Fax: + 1 319 526 – 2345

RUSSIAOOO Roquette Rus1A, Semenovskaya squareBusiness center “Sokolinaya Gora”13-th floor107023 Moscow - RussiaTelephone : + 7 495 627 76 61Fax : + 7 495 627 76 62


XXYLISORB DCx y l i t o l

XXYLISORB® DCx y l i t o l


XXYLISORB®DCx y l i

XXYLISOx y l

XXYLISOx y

XXYLISx y



XYLISORB DCx y l i t o l

XYLISORB® DCx y l i t o l








®

®

®®

®

®®®®®®®®®®®®®®®®®®®®

XYLISORB® DC is a new granulated

xylitol specifically designed for Direct

Compression of smooth chewable

tablets.

Create pleasant smooth chewable tablets with new

The information contained in this technical bulletin is to our best knowledge true and accurate but all instructions, recommendations or suggestions are made without guarantee.


© Copyright September 2010

XYLISORB® DC XYLISORB® DC gives smooth chewable tablets with

◗ an attractive mouthfeel resulting from the singular combination of its refreshing taste and smooth texture

◗ fl exibility in formulation, with this robust DC ingredient

◗ reliability of a pharma supplier

XYLISORB® DC:k e y b e n e f i t s

www.roquettenutra.com

XYLISORB® DC is part of the Roquette Direct Compression polyols range, which includes sorbitol, maltitol,

mannitol and other xylitol powders.

Powder characteristics

Burst of freshness For smooth texture tablets

Nutrition benefits

Formulation benefits

Formulation example

Slightly hygroscopic powder

Dynamic Vapor Sorpt ion at 20°C

Excellent compactibility

Particle size adapted to smooth chewable tablets

Beckman Coulter Laser Part ic le s ize analyser

0.4 0.6 200010006004002001006040201086421

Particle Diameter (µm)

Diffe

rent

ial V

olum

e (%

)

9

8

7

6

5

4

3

2

1

0

A directly compressible granulated xylitol For appealing smooth chewable tablets

20

15

10

5

00

Relative humidity (%) 5010 20 30 40 60 70 80 90

Wat

er U

ptak

e at

Equ

ilibriu

m (%

)

◆

◆

◆◆◆◆◆◆◆◆◆◆◆◆◆◆◆

◆ ◆ ◆ ◆ ◆◆

300

250

200

150

100

50

00

Compression Force (kN)1510 20 25

Hard

ness

Erw

eka

TBH3

0 (N

)

◆

◆

◆

◆

400

350

300

250

200

150

100

50

01.25

Tablet Density1.35 1.40 1.451.30 1.551.50

Hard

ness

Erw

eka

TBH3

0 (N

)

◆

◆

◆

0.71

0.79

10

6

43

Aerated bulk density (g/ml)

Tapped bulk density (g/ml)

Compressibility (%)

Flowability funnel (time, s)

Angle of repose (°)

140

300

460

D10 (µm)

Mean (µm)

D90 (µm)

Fette P1000 rotative press, biconvex tablets, 10 mm diameter, 5 mm thickness, 1% Mg stearate

Frogerais Single Punch Press, biconvex tablets, 13 mm diameter, 6 mm thickness, 1% Mg Sterate

XYLISORB® DC Xylitol freshness is a combination of its high solubility at mouth temperature and negative heat of dissolution. This intense refreshing effect combines well with cool fl avors such as mint. Xylitol sweetness is equivalent to sucrose’s one, which gives the tablet an astonishing sweet cool taste.

XYLISORB® DC Xylitol gives a very smooth texture to the chewable tablets, that almost melt in the mouth.Whether used alone or in combination with other polyols of Roquette portfolio, XYLISORB® DC offers the formulator a full palette of textures.

XYLISORB® DC Xylitol provides also benefi ts thanks to

◗ Well established dental benefi ts

◗ Low calorie ingredient

◗ Low glycaemic index

These nutrition benefi ts are valuable in nutraceutical applications.

XYLISORB® DC Xylitol provides benefi ts for the formulator thanks to

◗ easy-to-use ingredient

◗ natural origin ingredient

◗ stability and compatibility

◗ reliability

◗ formulation fl exibility enabling creativity

I N D I C A T I V E V A L U E S

Documents

9623 AP List de Produits GB REVUE:frt:210x297mm … de Produits_GB_REVUE:.....frt:210x297mm ... PEARLITOL® C • Mannitol ... formulation of orodispersible tablets. PEARLITOL