Brochure Meggle Lactoses

Lactose ExcipientsExcipients for Direct Compression, Granulation, Capsules, Sachets, Pellets, Powder Blends, Dry Powder Inhaler

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Presented by

MEGGLE worldwide

Headquarters

MEGGLE Group WasserburgBG Excipients & TechnologyMegglestrae 6 1283512 WasserburgGermanyPhone +49-(0)80 71-73-4 76Fax +49-(0)80 71-73-3 [email protected]

Regional Offices

MEGGLE USA Inc.50 Main Street, 10th FloorWhite Plains, NY, 10606USA

MEGGLE PrishtinaPrishtinaKosovoUNMIK

MEGGLE Group ShanghaiRoom 301, Block 6Lane 289 Bisheng RoadZhangjiang Hi-Tech ParkPudong New Area 201204 ShanghaiChina

MEGGLE Japan Co.,Ltd Ginza 1- Chome Bldg., 11 F15 - 4, Ginza 1- Chome/Chuo-KuTokyo 104 - 0061Japan

MEGGLE Singapore45 Jalan Pemimpin #06 - 00Foo Wah Industrial Building577197Singapore

MEGGLE Excipients & Technology

To the best of our knowledge,the information contained herein isaccurate. However nothing hereincontained shall be construed toimply any warrantee or guarantee.

MEGGLE Group WasserburgBG Excipients & TechnologyMegglestrae 6 1283512 WasserburgGermanyPhone +49-(0)80 71-73-4 76Fax +49-(0)80 71-73-3 20service.pharma@meggle.dewww.meggle-pharma.dewww.meggle-pharma.comwww.meggle-pharma.cnwww.jp.meggle-pharma.com

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Know-how

MEGGLE achieved through excellent productquality and intelligent innovations aleading position globally in excipients. Inmore than 50 years market presence wedeveloped a broad, unparalleled product portfolio. It comprises besides excipients for wet granulation and capsule filling alsostate of the art specialties for direct com-pression and dry powder inhalers. Ourcustomers are mainly producers of pharmaceutical products and nutritionalsupplements. However the functionality of our products is also appreciated by thecosmetic and detergent industry.

Innovation and Service

For our customers a team of experts is constantly available in all questionsconcerning development, production,application and refinement of excipients.Regardless of custom manufacturing ordevelopment cooperation: we committedourselves to share our experience with ourpartners. We are bound to innovationand are therefore in constant contact withvarious scientific institutions all over theglobe.

Our Mission

As a leading manufacturer of lactose it isour endeavor to offer our customers world-wide always the optimal product for theirrespective application. Already today ourproducts exceed internationally acceptedquality standards. In terms of maximalcustomer orientation we are constantly improving our service.

Our Vision

Our long term targets are:To maximize the benefit of our customerthrough development of innovativehighly sophisticated products, also fornew application formsTo expand our independent leading position in development and improvementof excipientsTo support our customers in the develop-ment of new formulationsTo expand our global network of compe-tent representations and subsidiaries

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MEGGLE worldwide

Wherever your are:we are at your side

The products of MEGGLE are enjoying anexcellent reputation around the globe andare used in more than 100 countries of the world. A worldwide network of represen-tations and subsidiaries guarantees, that distribution, consultation and service are always of the quality you rightly expect from us.

Headquarters Wasserburg

Regional Offices New York Prishtina Shanghai Singapore Tokyo

For contact details see page 36

Agencies

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MEGGLE headquarters in Wasserburg/Germany

Please visit our homepage:www.meggle-pharma.com

Our literature data base is now open foryou around the clock. On the MEGGLEhomepage you will find all relevant factsabout our products and their respectiveapplications. Of course also as download.

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-lactose-monohydrate Ph. Eur. USP-NF JP

crystallinepowder blends, capsule/sachet filling, pellets, dry powder inhaler, wet granulation, premixes

sieved

PrismaLac 40 InhaLac 70

InhaLac 120

InhaLac 230

CapsuLac 60

SacheLac 80

SpheroLac 100

milled

GranuLac 70

GranuLac 140

GranuLac 200

GranuLac 230

SorboLac 400

agglomerated

Tablettose 70

Tablettose 80

Tablettose 100

spray-dried

FlowLac 100

Cellactose 80

MicroceLac 100

StarLac

modifieddirect compression

Compoundsdirect compression

spray-dried

MEGGLE Excipients

FlowLac 90

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3Excipients & Technology 3 4MEGGLE worldwide

roduct overview 6Grades/product overview Content 7Conte

Sieved Lactose Product overview 8 Product description 10Sieved Lactose for Dry Powder Inhaler Product overview 12 Product description 14

Milled Lactose Product overview 16 Product description 18

Information for Direct Compression 20

Agglomerated Lactose [DC] Product overview 22 Product description 24

Spray-dried Lactose [DC] Product overview 26 Product description 26

Compounds [DC] Cellactose 80 28 MicroceLac 100 30 StarLac 32

General Specification 34Contact 35

Content Siev

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acto

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illed

Lac

tose

Agg

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ray-

drie

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[DC]

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PrismaLac 40CapsuLac 60SacheLac 80SpheroLac 100

Sieved Laactose

Ph. Eur. USP-NF JP

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99

Siev

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acto

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FlowabilitySieved LactoseLeaked mass [g] 50 45 40 35 30 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 Time [s]

PrismaLac 40 CapsuLac 60SacheLac 80

Erichsen funnel mod. 321, orifice: 4 mm

Sieve data Lactose type PrismaLac 40 CapsuLac 60 SacheLac 80 SpheroLac 100specified/typical specified/typical specified/typical specified/typical

Particle size distribution < 63 m 20 %/ 9 %Method: < 100 m 10 %/ 5 % 20 %/ 5 %Mechanical sieve shaker < 150 m / 15 % / 78 %

< 200 m 10 %/ 4 % 75 %/ 98 %< 250 m 40 70 %/ 60 % / 63 % / 99.5 %< 400 m 90 %/ 99 % 98 %/100 %< 500 m / 65 %< 630 m / 90.5 % 97 %/100 %< 800 m 97 %/100 %

Density poured [g/l] /470 /590 /600 /690

Density tapped [g/l] /540 /700 /710 /840

Product description

Coarse lactose is fractionated into productswith a narrow particle size distribution by sieving.

Sieved lactose consists of mono crystals riety of theand agglomerates. The variety of the

llows for an optimal selectionproducts allows for an for the intended application.for the i

Due to its good blending properties and excellent flowability these products aremost suitable for capsule/sachet filling and powder blends. Compactibility of sieved lactoses is moderate.

Application

Capsule fillingSachet fillingPowder blendsTriturations

Product features

Excellent flowabilityNarrow particle size distributionGood blending propertiesHigh storage stability

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Sieved Lactose

Ph. Eur. USP-NF JP

PrismaLac 40

Application:Powder blends

500 m

500500500500 m m mm Typical histogramPrismaLac 40Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500 600 700 800 900 1000

Particle size [m]

CapsuLac 60

Application:Capsule fillingSachet fillingPowder blendsTriturations

Typical histogramCapsuLac 60Mass [%]100908070605040302010

00 100 200 300 400 500 600 700 800 900 1000

Particle size [m]

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11

500 m

5005005005 000 m m m

SacheLac 80

Application:Capsule fillingSachet fillingPowder blendsTriturations

Typical histogramSacheLac 80Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

SpheroLac 100

Application:PelletsTriturationsPowder blends

Typical histogramSpheroLac 100Mass [%]100908070605040302010

00 100 200 300 400 500

Particle size [m]

Siev

ed L

acto

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Sieved Lactose for Dry Powder Inhaleractose for Dry Powder Inhal

InhaLac 70InhaLac 120InhaLac 230

Ph. Eur. USP-NF JP

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Flowability Sieved Lactose for Dry Powder InhalerLeaked mass [g] 50 45 40 35 30 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 Time [s]

InhaLac 70 [1] InhaLac 120 [1]

InhaLac 230 [2]

Erichsen funnel mod. 321, orifice: [1] 4 mm, [2] 6 mm

Sieve data Lactose type InhaLac 70 InhaLac 120 InhaLac 230typical typical typical

Particle size distribution d10 110 m 90 m 45 mMethod: d50 200 m 130 m 90 mLaserdiffraction d90 300 m 190 m 135 m

Density poured [g/l] 590 700 710

Density tapped [g/l] 660 790 820

Hausner ratio 1.1 1.13 1.15

Product description

InhaLac stands for sieved lactose incrystalline form, which is in particular suitable for use in Dry Powder Inhalers.

InhaLac is available in a broad spectrumwability,of sieve cuts. Excellent flowability,

tly defined particle surface preeminently defined pdefinition and physical-chemical stability definitioare the requirements for excipients forDry Powder Inhalers.

InhaLac attributes its unique performance to the extremely narrow particle sizedistribution. InhaLac is practically free of amorphous lactose.

Siev

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Sieved Lactose for Dry Powder Inhaler

500 m

InhaLac 70

Particle size distribution [Laser diffraction]InhaLac 70

Distribution density [%] Cumulative distribution [%] 100 20 90 18 80 16 70 14 60 12 50 10 40 8 30 6 20 4 10 2 0 0 0 10 100 1000

Particle size [m]

Ph. Eur. USP-NF JP

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15

500 m

500 m

InhaLac 120


Distribution density [%] Cumulative distribution [%] 100 30 90 80 70 60 50 40 30 20 10 0 0 0 10 100 1000

Particle size [m]

InhaLac 230


Distribution density [%] Cumulative distribution [%] 100 25 90 80 20 70 60 15 50 40 10 30 20 5 10 0 0 0 10 100 1000

Particle size [m]

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20

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Siev

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Milled Lacctose

GranuLac 70GranuLac 140GranuLac 200GranuLac 230SorboLac 400

Ph. Eur. USP-NF JP

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Sieve data Lactose type GranuLac 70 GranuLac 140 GranuLac 200 GranuLac 230 SorboLac 400specified/typical specified/typical specified/typical specified/typical specified/typical

Particle size distribution < 32 m 40 %/ 30 % 45 75 %/ 55 % / 75 % 90 %/ 97.5 %Method: < 63 m 90 %/ 96 % / 99.5 %Air-jet sieving < 100 m 40 60 %/ 50 % 80 %/ 90 % 90 %/ 98.4 % / 99.5 %

< 400 m 95 %/ 99.5 % < 630 m /100%

Density poured [g/l] /715 /660 /535 /465 /390

Density tapped [g/l] /900 /890 /800 /760 /630

Product description

GranuLac types and SorboLac 400consist of fine lactose particles.

Due to its good compressibility andblending properties lactose is the most

et granulation.frequently used filler for wet granulation.

Milled lactose has a limited flowability Milled laand therefore has to be granulated beforethe production of tablets.

Application

Wet granulationPremixesTriturations

nMedia for fermentationEnhancement of flavorsEnhancemen

Product features

Good compressibilityGood blending propertiesNarrow particle size distributionHigh storage stabilityHigh batch to batch consistency

Mill

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GranuLac 70

100 m Typical histogramGranuLac 70Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500 600 700

Particle size [m]

Milled Lactose

GranuLac 140

Typical histogramGranuLac 140Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

200 m

GranuLac 200

Typical histogramGranuLac 200Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

200 m

Ph. Eur. USP-NF JP

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GranuLac 230

Typical histogramGranuLac 230Mass [%]100908070605040302010

00 100 200 300 400 500

Particle size [m]

SorboLac 400

Typical histogramSorboLac 400Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

2002002002000 m m mm

100100100100 m m mm

Mill

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2020

Direct Compression [DC]

Direct Compression [DC]

Tablets are the most frequently used formin pharmaceutical applications. They areconvenient, easy to administer and production is relatively cheap. Moreover the prescribed and required dose is applied with a high degree of precision.

History

Until the early sixties tablets have been produced in a complicated multistep procedure. The development of modified lactose and microcrystalline cellulose as well as improvement of tablet presses revolutionized the technology of compactionand made a simple three step compaction,

sible.the so called direct compression, possible.

Economical advantages

The most obvious advantage of direct compression compared to the traditional wet granulation is the economy, due to reduction of costs for equipment, operatingand validation.

Technological advantages

The technological advantage of direct compression compared to wet granulation is the improved stability of the active ingredient through:

No exposure to heatNo exposure to humidity

In addition direct compression allows for a simplified optimization of disintegration.

Excipients

The right choice of excipients for direct compression is more critical than for wet granulation. None of the traditional excipients provides the required good flowability and excellent compactability required for direct compression. Therefore traditional excipients have to be modified.

Equipment: Less production machinery necessary Less production area necessary Less production equipment necessaryCosts for development and production: Improvement of total variable cost of production Reduction of production time for one batch Reduction of labor cost Improvement of effectiveness per work space Reduction of validation cost

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DC-Compounds

The ideal filler-binder for direct compressiongives high compressibility, good bindingproperties, high adhesion capacity and a

. All theselow sensitivity to lubricants. All thesearacteristics can be achieveddesired characteristic

by co-processing. The MEGGLE Groupby co-pwas one of the first manufacturers whointroduced a co-processed excipient,consisting of two traditional excipients,in the market.

DC compounds have been developed to:stic effectachieve a synergistic effect

achieve an optimal functionalityachieve an opeliminate undesired weaknesses

It is generally accepted, that the sphericalshape of the spray-dried particles is responsible for the excellent flowability and that the composition of the co-proces-sed products accounts for the goodcompressibility. All co-processed MEGGLEproducts consist of a major fraction of abrittle material [-lactose-monohydrate] and a minor fraction of a plastic material[powdered cellulose, microcrystalline cellulose or corn starch]. The plasticdeforming material improves thecompressibility.

With Cellactose 80 and MicroceLac 100a higher hardness yield could be achievedcompared to the physical mixture of therespective ingredients.

With StarLac the disintegration of the direct compression compound is fastercompared to the physical mixture.

Tablet Compression

Blending/Lubrication

Dispensing/Screening

Direct Compression:

ProductionThe MEGGLE production process combines efficiency with a high degree of quality and absolute

cleanliness.

Particle structureThe MEGGLE DC-excipients contain

the know-how of 20 years of and development your research and development your

guarantee for optimal functionality.

FlowabilityThe excellent flowability of

MEGGLE DC-excipients provides for trouble free processing.

BlendingBlending is the crucial step in

direct compression. MEGGLE DC-excipients demonstrate

excellent blending properties.

CompactionYou can rely on the functionality

of MEGGLE DC-excipients also with high output ratios

in modern rotary presses.

Direct CompressionDirect compression reduces

compaction to three uncomplicated, economical

production steps.

Research and DevelopmentMEGGLE DC-excipients undergo a

sequence of tough quality tests before marketing.

Advisory ServiceA team of cordial industry

pharmacists assists you in all questions concerning

compaction.

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Agglomerated Lactose [DC]

Ph. Eur. USP-NF JP

Tablettose 70Tablettose 80Tablettose 100

Direct Compression

FlowabilityAgglomerated Lactose [DC]Leaked mass [g] 60 55 50 45 40 35 30 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 Time [s]

Tablettose 70 Tablettose 80Tablettose 100


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Sieve data Lactose type Tablettose 70 Tablettose 80 Tablettose 100specified/typical specified/typical specified/typical

Particle size distribution < 63 m 6 %/ 3 % 20 %/ 13 % 25 %/ 12 %Method: < 150 m / 25 % / 42 %Mechanical sieve shaker < 180 m 40 75 %/ 53 %

< 200 m 30 70 %/ 56 % < 250 m 60 90 %/ 77 %< 400 m / 93 % 85 %/ 93 %< 500 m 98 %/100 % 96 %/100 %< 630 m 97 %/100 %

Density poured [g/l] /548 /610 /570

Density tapped [g/l] /670 /738 /690

CompactibilityAgglomerated Lactose [DC]Crushing force [N]250

200

150

100

50

00 50 100 150 200 250 300

Compaction pressure [MPa]

Tablettose 70 Tablettose 80Tablettose 100

Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg

Product description

Tablettose 70/80/100 are tradenames for agglomerated lactose[-lactose-monohydrate accordingto Ph. Eur. USP-NF JP].

Tablettose developed for was especially developed forpression. It combines the gooddirect compression. It c

flowability of a coarse lactose ideally withflowabithe good compactibility of a fine milledlactose.

Application

Conventional compactionFilling of capsules/sachets [in particular Tablettose 70]Effervescent tabletsArtificial sweetener tabletsArtificial swe

Product features

Tablettose 70/80/100 are stable and non-hygroscopicast disintegration through the high totalFast disintegration through the high total

surface area of the excipientA structured surface and pure white appearance are ideal for table topsweetener formulationsGood flowability guarantees trouble freeand economical filling of capsules andsachetsHigh and stable degree of whiteness

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Ph. Eur. USP-NF JP

Agglomerated Lactose [DC]

Tablettose 70

Typical histogramTablettose 70Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500 600 700

Particle size [m]

500 m

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500 m

Tablettose 80

Typical histogramTablettose 80Mass [%]100908070605040302010

00 100 200 300 400 500 600 700

Particle size [m]

Tablettose 100

Typical histogramTablettose 100Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500 600 700

Particle size [m]

200 m

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[DC]Spray - dried Lactose

Ph. Eur. USP-NF JP

FlowLac 90FlowLac 100

Direct CompressionSieve data Lactose type FlowLac 90 FlowLac 100 specified/typical specified/typicalParticle size distribution < 32 m 5 %/ 2 % 10 %/ 5 %Method: < 100 m 25 40 %/ 30 % 20 45 %/ 34 %Air-jet sieving < 200 m 85 %/ 92 % 80 %/ 88 %

< 250 m / 99 % / 98 %

Density poured [g/l] /600 /620

Density tapped [g/l] /660 /710

Product description

FlowLac 90FlowLac 90 is the trade name of a spray-dried -lactose-monohydrate [modified]according to Ph. Eur. USP-NF JP.

Due to its unique production process FlowLac 90 does have almost no fines, has an outstanding hardness yield and a fast disintegration. FlowLac 90 can be used therefore basically for all direct compression formulations. This makes avirtually dust-free production with anoptimum output possible.

FlowLac 100FlowLac 100 is a spray-dried -lactose-monohydrate [Ph. Eur. USP-NF JP].

As FlowLac 100 demonstrates an excellentflowability and an extraordinary compactibility it is in particular suitable for direct compression.

Product features

FlowLac 90An excellent compressible excipient with outstanding compaction profile extraordinary for a spray-dried lactoseFast disintegration profile extraordinaryfor a spray-dried lactoseAlmost no fines therefore virtually dust freeIdeal for capsule/sachet filling due to its excellent flowability

Application

FlowLac 90 Low to high dosage formulationsFormulations with poorly flowing active ingredientsChewable tabletsCapsule/sachet filling

FlowLac 100Low dosage formulationsChewable tabletsCapsule/sachet filling

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FlowabilitySpray-dried Lactose [DC]Leaked mass [g]

55 50 45 40 35 30 25 20 15 10 5 0 0 10 20 30 40 50 60 70 80 Time [s]

FlowLac 90 FlowLac 100Erichsen funnel mod. 321, orifice: 4 mm

300 m

500 m

FlowLac 90Typical histogramFlowLac 90Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

FlowLac 100Typical histogramFlowLac 100Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

CompactibilitySpray-dried Lactose [DC]Crushing force [N]300

250

200

150

100

50

00 50 100 150 200 250 300


FlowLac 90 FlowLac 100Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg

FlowLac 100The spray-drying process leads to an excellent compressible excipientFast disintegration through rapiddissolution in waterVery good content uniformity of low dosage tablets trough adhesion of activeingredients on the porous surfacePleasant taste and mouth feeling of chewable tabletsIdeal features for capsule/sachet fillingby excellent flowability

Spra

y-dr

ied

Lact

ose

[DC]

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Cellactose 80

C]Compounds [DC

Product description

Cellactose 80 is a spray-dried compound,consisting of 75 % -lactose-monohydrate[Ph. Eur. USP-NF JP] and 25 % powderedcellulose [Ph. Eur. USP-NF].

This product was developed in particularfor direct compression, as it combines fillerand binder properties of its two ingredientsideally, which allows for a simplified and economical compaction.

LoA for DMF and MEGGLE monographavailable on request

Application

Herbal extract tabletsChewable tabletsMineral salt tabletsCores for coatingOblong tablets

Direct Compression

Sieve dataCellactose 80 specified/typicalParticle size distribution < 32 m 20 %/ 9 %Method: < 160 m 35 65 %/ 56 %Air-jet sieving < 250 m 80 %/ 95 %

Density poured [g/l] /380

Density tapped [g/l] /500

FlowabilityCellactose 80Leaked mass [g]40353025201510

50

0 10 20 30 40 50 60 70 80Time [s]

Cellactose 80Erichsen funnel mod. 321, orifice: 4 mm

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Com

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Product features

Good content uniformity through low segregation tendency of the activeingredientSmooth surface of the resulting cores for

oatingeasy and economical coatingtion of delicate activeCompaction of delica

ingredients through excellent ingrecompressibilityConsistent tablet hardness throughconstant lactose/cellulose ratioHigh weight consistency at all compactionspeeds through good flowabilityHigh degree of whiteness of tablets

Typical histogramCellactose 80Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

Cellactose 80

CompactibilityCellactose 80Crushing force [N] 250

200

150

100

50

0 0 50 100 150 200 250 300


Cellactose 80Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg

200 m

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MicroceLac 100

C]Compounds [DC

Product description

MicroceLac 100 is a spray-driedcompound consisting of 75 % -lactose-monohydrate [Ph. Eur. USP-NF JP] and 25 % microcrystalline cellulose[Ph. Eur. USP-NF JP].

MicroceLac 100 is the synergisticcombination of the filler lactose and the dry binder MCC.

LoA for DMF and MEGGLE monographavailable on request

Application

Production of small tabletsFormulations containing mineralsOblong tabletsFormulations with high content of activeingredientsFormulations with poor flowable,micronized active ingredients

Direct Compression

Sieve dataMicroceLac 100 specified/typicalParticle size distribution < 32 m 15 %/ 9 %Method: < 160 m 45 70 %/ 56 %Air-jet sieving < 250 m 90 %/ 96 %



FlowabilityMicroceLac 100Leaked mass [g]4540353025201510

50

0 10 20 30 40 50 60 70 80Time [s]

MicroceLac 100Erichsen funnel Mod. 321, orifice: 4 mm

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Com

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Product features

Excellent compressibility for high dosageformulationsLow aggregation tendency guaranteesconsistent flowability

s through fixedConstant tablet hardness through fixedactose/MCCratio of lactose/MCC

High weight consistency at variousHighcompaction speeds

Typical histogramMicroceLac 100Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

MicroceLac 100

CompactibilityMicroceLac 100Crushing force [N] 250

200

150

100

50

0 0 50 100 150 200 250 300


MicroceLac 100Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg

200 m

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StarLac

C]Compounds [DC

Direct Compression

Sieve dataStarLac specified/typicalParticle size distribution < 32 m 15 %/ 7 %Method: < 63 m / 14 %Air-jet sieving < 100 m / 21 %

< 160 m 35 65 %/ 50 %< 250 m 80 %/ 90 %< 315 m /100 %



FlowabilityStarLac

Leaked mass [g]504540353025201510

50

0 10 20 30 40 50 60 70 80Time [s]

StarLac


Product description

StarLac is a spray-dried compound consisting of 85 % -lactose-monohydrate[Ph. Eur. USP-NF JP] and 15 % GMO free white cornstarch [Ph. Eur. USP-NF].

LoA for DMF and MEGGLE monograph available on request

StarLac was developed in particular for direct compres-sion. It combines a superior

ibility flowability and compressibility ry disintegra-with extraordinary disin

erties.tion properties

StarLac is a product co-marketed by MEGGLE and Roquette. For furtherinformation and availability in your

DisintegrationStarLac

Disintegration time [s]180150120

906030

080 100 120 140 160 180 200 220


StarLac Physical blendPress: Kilian types, tablets: 10 mm, weight: 320 mg,Mg-stearate 0.5 %

geographic region please contact yourlocal Roquette or MEGGLE partner.

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Com

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Application

Low dosage formulationsCores for coatingHomeopathic formulations

aturesProduct features

Optimized disintegration propertiesExcellent hardness yield by spray-dryingprocessExcellent flowability leads to high tablet weight uniformityHigh shear stabilityExcellent storage stability

Typical histogramStarLac

Mass [%] 100 90 80 70 60 50 40 30 20 10 0 0 100 200 300 400 500

Particle size [m]

StarLac

CompactibilityStarLac

Crushing force [N] 250

200

150

100

50

0 0 50 100 150 200 250 300


StarLac

Press: Korsch EK 0, tablets: 8 mm, weight: 240 mg

200 m

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ose MonohydrateGeneral Specification Lacto

Definition

All MEGGLE lactose complies with the corresponding monograph -lactose-monohydrate of the European Pharmacopoeia [Ph. Eur.]

This monograph is harmonized between Ph. Eur., USP-NF and JP.

Characteristics

White or almost white, odorless and sweet-tasting powder. It is free but slowly soluble in water, practically insoluble in ether and absolute alcohol.

Method Specification

Identity Ph. Eur. conforms

PurityAppearance of solution Ph. Eur. conformsAcidity or alkalinity Ph. Eur. < 0.4 ml: 0.1 N NaOHSpecific optical rotation Ph. Eur. 54.4 55.9Absorbance Ph. Eur. 400 nm: < 0.04 270 300 nm: < 0.07 200 220 nm: < 0.25Heavy metals Ph. Eur. < 5 ppmWater Ph. Eur. 4.5 5.5 %Loss on drying -lactose-monohydrate USP-NF < 0.5 % modified -lactose-monohydrate < 1.0 %Sulphated ash Ph. Eur. < 0.1 %

Microbial contaminationTotal viable aerobic count Ph. Eur. NMT 100/gMoulds Ph. Eur. NMT 10/gYeasts Ph. Eur. NMT 10/gEscherichia coli Ph. Eur. neg./10 gPseudomonas aeruginosa Ph. Eur. neg./10 gStaphylococcus aureus Ph. Eur. neg./10 gSalmonella spp. Ph. Eur. neg./10 g

Storage at room temperature in tightly closed containers under dry and odourfree conditions

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Lactose ExcipientsExcipients for Direct Compression, Granulation, Capsules, Sachets, Pellets, Powder Blends, Dry Powder Inhaler

GB 0

3/09

Pe 1

5 S

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Presented by

MEGGLE worldwide

Headquarters

MEGGLE Group WasserburgBG Excipients & TechnologyMegglestrae 6 1283512 WasserburgGermanyPhone +49-(0)80 71-73-4 76Fax +49-(0)80 71-73-3 [email protected]

Regional Offices

MEGGLE USA Inc.50 Main Street, 10th FloorWhite Plains, NY, 10606USA

MEGGLE PrishtinaPrishtinaKosovoUNMIK

MEGGLE Group ShanghaiRoom 301, Block 6Lane 289 Bisheng RoadZhangjiang Hi-Tech ParkPudong New Area 201204 ShanghaiChina

MEGGLE Japan Co.,Ltd Ginza 1- Chome Bldg., 11 F15 - 4, Ginza 1- Chome/Chuo-KuTokyo 104 - 0061Japan

MEGGLE Singapore45 Jalan Pemimpin #06 - 00Foo Wah Industrial Building577197Singapore

Brochure Meggle Lactoses

Documents

Transcript of Brochure Meggle Lactoses