PRODUCT LIST · • Iodoformio Usp/NF. AJINOMOTO •tame polvere EP/USP Aspar • Aspartame fine granular EP/USP •tame granulare EP/USP Aspar Edulcorante, dolcificante intensivo

#FaravelliPharmaDivision

The Best ingredients for a healthy life

PRODUCT LIST

LISTINO PHARMA ok.indd 1 05/09/18 16:20


ECCIPIENTI PER OGNI VOSTRA ESIGENZA

Alcuni esempi:

uAGENTI FILMANTIuAMIDI E DERIVATIuANTIAGGLOMERANTIuCOLORANTI E PIGMENTIuCONSERVANTIuCORRETTORI DI pHuDILUENTIuDISGREGANTIuDOLCIFICANTI INTENSIVIuLEGANTIuLUBRIFICANTI-GLIDANTIuOPACIZZANTIuPLASTICIZZANTIuPOLIALCOLIuVISCOSIZZANTIuZUCCHERI


AGRIGUMuGOMMA ARABICA KORDOFAN La gomma arabica è una gomma naturale nota anche come gomma acacia, in quanto prodotta da due specie di acacia subsahariana: Acacia senegal ed Acacia seyal. È un eccipiente utilizzato soprattutto come stabilizzante o viscosizzante. • Spray dried EP/BP/NF • Agri Spray Acacia R • Agri Spray Acacia MGH

AJAY GROUPUno dei più importanti produttori dei derivati dello Iodio.Tutti i prodotti sotto elencati sono utilizzati come intermedi di sintesi chimiche o come fonte di iodio: • Acido iodidrico 57%• Potassio ioduro USP• Rame ioduro• Sodio ioduro BP/FU • Calcio iodato• Potassio iodato• Sodio Iodato• Iodoformio Usp/NF

AJINOMOTO• Aspartame polvere EP/USP•AspartamefinegranularEP/USP• Aspartame granulare EP/USPEdulcorante,dolcificanteintensivo

AKZONOBEL• Sodio Idrossido pellets EP/USP pure grade• Potassio Idrossido pellets EP/USP pure gradeRegolatoridipH/buffer,intermedidisintesi,reazionidisaponificazioneelavaggi.

I NOSTRI PARTNER



I NOSTRI PARTNER


BUDENHEIM• FOSFATI di CALCIO (DI-CAFOS® e TRI-CAFOS®) diluente Fosfati utilizzati per la produzione di forme solide sia per WG che per DC. Disponibili in varie granulometrie, sono utilizzati anche come principi attivi atipici nella formulazione di prodotti per la cura dell’osteoporosi.• FOSFATI di SODIO - utilizzati come regolatori di pH o come attivi in prodotti ad azione lassativa.• FOSFATO di POTASSIO - utilizzati come apportatori di K• FOSFATO di MAGNESIO - utilizzati come apportatori di Mg• ORTOFOSFATO di FERRO - utilizzati come apportatori di Fe

DI-CAFOS® A 150Dicalcium phosphate anhydrousCaHPO4

● ● ● 150 720 840 14 5.06) 23.0 ● ● ●

• Elevated surface area• Optimized tablet hardness • Use with APIs of poor tableting

properties • Superior flowability


● ● ● 60 1330 1500 11 7.1 0.25 ● ● ●

• Highly increased bulk density• Small surface area, minimized

water adsorption ideal for water-sensitive APIs

• Outstanding flowability

DI-CAFOS® D 160Dicalcium phosphate dihydrate CaHPO4 · 2 H2O

● ● ● 160 820 990 17 7.9 0.4 ● ● ●• Good compactibility • Good tablet hardness• Superior flowability

TRI-CAFOS® 500Tricalcium phosphate Ca5(PO4)3OH

● ● 100 500 580 14 6.5 85.0 ● ● ●

• Highly enlarged surface area• Improved tablet hardness• Increases tablet porosity reduction of disintegration times

• Good flowability


● ● ● 12 830 1600 48 6.8 1.25 ● ●• Powder with highly increased

bulk density• Neutral pH


● ● ● 14 550 1100 50 7.6 2.5 ● • Powder with lower bulk density


● ● 5 250 400 38 7.0 62.0 ●• Low bulk density powder with

large specific surface area• Neutral pH


● ● 5 350 750 53 7.0 15.0 ●

• Powder with enhanced bulk density

• Low specific surface area• Neutral pH

TRI-CAFOS® 200-7Tricalcium phosphate Ca5(PO4)3OH

● ● 4 200 420 51 7.0 66.0 ● ● ● ●

• Glidant material for multiple use in solid dosage preparations

• Reduced dust formation• High bulk density

M 52-85Dimagnesium phosphate trihydrate MgHPO4 · 3 H2O

● 120 900 1250 20 8.0 0.5 ● ● ● • Optimized for use in direct compression


● 15 500 900 50 8.0 1.7 ● ● • Powder for granulations and related processes

Product

Pharmacopeia Recommended Application

Special Properties

USP

NF

Ph.E

ur.

JP GP2)

Med

ian

Part

icle

Siz

e (µ

m)1)

Bulk

Den

sity

(g/l

)1)

Tapp

ed D

ensi

ty (g

/l)1)

Com

pres

sibi

lity

Inde

x (%

)1)

pH 10

% S

uspe

nsio

n1)

Spec

ific

Surfa

ce A

rea

(m2 /g

)1)

Dire

ct C

ompr

essi

on

Dry

Gra

nula

tion

Wet

Gra

nula

tion

Har

d Ca

psul

es

Soft

Caps

ules

Flow

Enh

ance

men

t

pH-R

egul

atio

n &

Buf

fer

Pharma Portfolio for Solid Dosage Forms

1) All values provided are approximate and not part of the specification 2) GP = German Pharmacopoeia (DAB) 3) Internal test method at 25°C 4) powder fineness described according to USP 37 5) not for parenteral applications 6) pH 20% suspension

Chemische Fabrik Budenheim KG ❘ Rheinstraße 27 ❘ 55257 Budenheim ❘ Germany ❘ Phone: +49 61 39 - 89 0 ❘ [email protected] ❘ www.budenheim.com


● ● ● 150 720 840 14 5.06) 23.0 ● ● ●

• Elevated surface area• Optimized tablet hardness • Use with APIs of poor tableting

properties • Superior flowability


● ● ● 60 1330 1500 11 7.1 0.25 ● ● ●

• Highly increased bulk density• Small surface area, minimized

water adsorption ideal for water-sensitive APIs

• Outstanding flowability


● ● ● 160 820 990 17 7.9 0.4 ● ● ●• Good compactibility • Good tablet hardness• Superior flowability


● ● 100 500 580 14 6.5 85.0 ● ● ●

• Highly enlarged surface area• Improved tablet hardness• Increases tablet porosity reduction of disintegration times

• Good flowability


● ● ● 12 830 1600 48 6.8 1.25 ● ●• Powder with highly increased

bulk density• Neutral pH


● ● ● 14 550 1100 50 7.6 2.5 ● • Powder with lower bulk density


● ● 5 250 400 38 7.0 62.0 ●• Low bulk density powder with

large specific surface area• Neutral pH


● ● 5 350 750 53 7.0 15.0 ●

• Powder with enhanced bulk density

• Low specific surface area• Neutral pH

TRI-CAFOS® 200-7Tricalcium phosphate Ca5(PO4)3OH

● ● 4 200 420 51 7.0 66.0 ● ● ● ●

• Glidant material for multiple use in solid dosage preparations

• Reduced dust formation• High bulk density


● 120 900 1250 20 8.0 0.5 ● ● ● • Optimized for use in direct compression


● 15 500 900 50 8.0 1.7 ● ● • Powder for granulations and related processes

Product


Special Properties

USP

NF

Ph.E

ur.

JP GP2)

Med

ian

Part

icle

Siz

e (µ

m)1)

Bulk

Den

sity

(g/l

)1)

Tapp

ed D

ensi

ty (g

/l)1)

Com

pres

sibi

lity

Inde

x (%

)1)

pH 10

% S

uspe

nsio

n1)

Spec

ific

Surfa

ce A

rea

(m2 /g

)1)

Dire

ct C

ompr

essi

on

Dry

Gra

nula

tion

Wet

Gra

nula

tion

Har

d Ca

psul

es

Soft

Caps

ules

Flow

Enh

ance

men

t

pH-R

egul

atio

n &

Buf

fer

Pharma Portfolio for Solid Dosage Forms

1) All values provided are approximate and not part of the specification 2) GP = German Pharmacopoeia (DAB) 3) Internal test method at 25°C 4) powder fineness described according to USP 37 5) not for parenteral applications 6) pH 20% suspension



I NOSTRI PARTNER


K 51-12Monopotassium phosphateKH2PO4

● ● 250 1200 1500 20 4.3(5%) 16.2 0.38 ●

• Moderately fine, crystalline powder• Shows fair flowability• Effective buffering systems in neutral pH

range with disodium phosphate

K 52-01Dipotassium phosphateK2HPO4

●5) 150 370 550 33 8.9(5%) 159.0 4.82 ● • Fine powder

• Hygroscopic material of high solubility

N 51-13Monosodium phosphate anhydrous NaH2PO4

● 150 900 1400 36 4.4(5%) 85.0 2.58 ● • Fine powder but increased dissolution

rate

N 51-15Monosodium phosphate anhydrous NaH2PO4

● 500 1200 1300 8 4.4(5%) 85.0 0.96 ●

• Coarse crystalline material of excellent powder flow

• Slower dissolution rate than N 51-13

N 51-10Monosodium phosphate monohydrate NaH2PO4 · H2O

● 650 1200 1300 8 4.4(5%) 97.8 0.91 ● • Coarse crystalline material of excellent

flowability

N 51-12Monosodium phosphate dihydrate NaH2PO4 · 2 H2O

● ● 680 1100 1200 8 4.3(5%) 110.5 2.04 ●

• Coarse crystalline material of excellent flowability

• Faster dissolution rate than the monohydrate form

• Low melting point

N 52-50Disodium phosphate anhydrousNa2HPO4

● ● 280 1300 1600 19 9.0(1%) 8.3 0.19 ●

• Moderately fine, crystalline powder• Shows fair flowability• Slightly slower dissolution rate than

N 52-52


● ● 280 1000 1600 38 9.0(1%) 8.3 0.32 ●

• Moderately fine, crystaline powder• Relatively low flowability• Enhanced dissolution rate compared to

N 52-50 and N 52-82

N 52-81Disodium phosphate anhydrous Na2HPO4

● ● 180 550 730 25 9.0(1%) 8.3 0.92 ●

• Fine powder material with passable flowability

• Fastest dissolution rate of all anhydrous disodium phosphate


● ● 30 700 1100 36 9.1(1%) 8.3 0.13 ●

• Very fine powder of lower flowability • Slower dissolution rate due to agglomera-

tion in contact with the solvent• Suitable for mixtures with other finely

powdered substances

N 52-27Disodium phosphate dihydrate Na2HPO4 · 2 H2O

● ● 220 900 1250 28 9.2(1%) 10.4 0.44 ●

• Moderately fine crystalline material• Lower flowability than N 52-71• Elevated dissolution rate

N 52-71Disodium phosphate dihydrateNa2HPO4 · 2 H2O

● ● 850 1100 1200 10 9.2(1%) 10.4 0.18 ●

• Coarse crystalline material of excellent flowability

• Slightly slower dissolution rate than N 52-27

N 52-11 Disodium phosphate heptahydrate Na2HPO4 · 7 H2O

● 850 950 1050 9 9.2(1%) 15.6 0.57 ● • Coarse crystalline substance

• Excellent powder flow properties

N 52-06Disodium phosphate dodecahydrateNa2HPO4 · 12 H2O

● ● 600 900 1000 10 9.2(1%) 20.8 0.73 ●

• Coarse crystalline material• Excellent powder flow• Very low melting point of 35°C

N 53-40 Trisodium phosphate anhydrousNa3PO4

● 40 800 1250 36 12.0(1%) 13.3 0.18 ●

• Very fine powder• Small particle size can be beneficial for

the formulation of powder mixtures

N 53-81Trisodium phosphate anhydrousNa3PO4

● 125 300 450 33 12.0(1%) 13.3 0.90 ●

• Fine granular material of enhanced flowability compared to N 53-40

• Faster dissolution rate

N 53-80Disodium phosphate dodecahydrate Na3PO4 · 12 H2O

● 600 900 1050 14 12.0(1%) 30.8 0.81 ● • Coarse crystalline powder

• Good powder flowability

Product


Special Properties4)

USP

NF

Ph.E

ur.

JP GP2)

Med

ian

Part

icle

Siz

e (µ

m)1)

Bulk

Den

sity

(g/l

)1)

Tapp

ed D

ensi

ty (g

/l)1)

Com

pres

sibi

lity

Inde

x (%

)1)

pH a

t 1%

or 5

% s

olut

ion1)

Solu

bilit

y1)

Dis

solu

tion

Rate

(g/m

in)1)

3)

Dire

ct C

ompr

essi

on

Dry

Gra

nula

tion

Wet

Gra

nula

tion

Har

d Ca

psul

es

Soft

Caps

ules

Flow

Enh

ance

men

t

pH-R

egul

atio

n &

Buf

fer

Pharma Portfolio for Liquid Dosage Forms

1) All values provided are approximate and not part of the specification 2) GP = German Pharmacopeia (DAB) 3) Internal test method at 25°C 4) powder fineness described according to USP 37 5) not for parenteral applications 6) pH 20% suspension


BUPM

-PH

-PS-

03AE

.1


I NOSTRI PARTNER


1

galenIQ™ (isomalt Ph.Eur., BP, USP-NF) - Product Range

*Typical data within specification of the different galenIQ™ grades

Direct compressionSachets, ODPs

Dry suspensionsDry compaction

galenIQ™ 720

galenIQ™ 721

DC-grade d50 200µm

DC-grade d50 180µm

1:1 GPS/GPM ratioSolubility in water: 25g/100g at 20°C

3:1 GPS/GPM ratioSolubility in water: 42g/100g at 20°C

BlendingCapsule fillingStarter pellets

Hot melt extrusion

galenIQ™ 960(also for melt extrusion)

d50* 380µm

SugarfreeCoating

galenIQ™ 981

d50 770 µm

High BoiledLozenges

d50 980µm

galenIQ™ 990

NLT 90% <50µm

NLT 90% <100µm

galenIQ™ 800

galenIQ™ 810

AgglomerationWet granulationDry compaction

Film Coating

galenIQ™ 801

agglomeratedmilled sieved

Particle size0 = small9 = big

TIPOLOGIE DISPONIBILI

BENEOgalenIQ® (Isomalto di grado farmaceutico), ottenuto a partire da saccarosio da barbabietola.Prodotto seguendo le più rigide linee guida GMP e conforme alle Farmacopee USP/NF, Ph. Eur, BP/JP. Approvato in Cina.Caratteristiche principali:• Toothfriendly• Basso apporto calorico• Basso indice glicemico, ideale per diabetici• Non dà luogo a reazione di Maillard• Bassa igroscopicitàIdealeperpreparazioniorali,solideeliquide;èimpiegatocomelegante,diluenteeagentefilmantee nel taste masking.


BOAI NKY PHARMACEUTICALS LTD. uPOLIVINILPIRROLIDONI POLVERE: PolyViscol™ K15, K25, K30, K60, K90uPOLYVISCOL™ SERIE VA (copolimeri di vinilpirrolidone con vinil acetato, PVP/VA copolimero) Filmante,fissativo,modificatorereologico POLVERE: PolyViscol™ VA64uSOLUZIONE ACQUOSA AL 50%: PolyViscol™ VA64WuORAREZ W 100 P Copolimero PVM/MA con proprietà mucoadesive, per oral care, migliora la solubilità dei disinfettanti per uso oraleuORAREZ MS Copolimero PVM/MA per paste adesive

CELANESEuACESULFAME DI POTASSIO CONFORME EP/USP

•DolcificanteintensivoSunett® a zero calorie, toothfriendly, non allergenico, ideale per la produzione di farmaci e OTC.

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POLYMERIC MICELLESMICROFIBERS NANOFIBERS HYDROGELS

CONTIPROuACIDO IALURONICO SALE SODICO POLVERE Grado farmaceutico, cosmetico e dietetico a diversi pesi molecolari

L'acidoialuronicoèunglicosaminoglicano:unpolisaccaridenonramificatoformato da residui di acido glucuronico, derivato dal glucosio, e N-acetilglucosamina.La molecola dell’acido ialuronico possiede una forte polarità e, di conseguenza, un elevato grado di idratazione e una elevata solubilità in acqua. Poiché è in grado di legare un notevole numero di molecole d'acqua, l’acido ialuronico mantiene quindi il grado di idratazione, turgidità, plasticità e viscosità della pelle e delle mucose.

FORME IALURONICHE


MecHAniSM MecHAniSMAPPlicAtiontARGet RecoMMendAtion

Anti-AdHeSive deviceS AbdominalPelvicThoracicSpinal surgery Surgery of paranasal sinus

Films, gels, textilesPostsurgery adhesions

Prevents adhesions of mucouse membrane

Molecular weight:chemically modified sodium hyaluronate

Joint viScoSuPPleMentAtion

KneeHip Ankle joint

IAT injectionsPre-filled syringes (2 – 6 ml)Osteoarthritis/ post-surgical treatment

Inhibition of the cartilage degradationStimulation of endogenous hyaluronic acid productionRestoration of the normal rheologiacal conditions

Molecular weight: 0.7 – 6 MDa native orchemically modified sodium hyaluronate

concentration:1 – 3%

APPlicAtiontARGet RecoMMendAtion

oPHtHAlMic SuRGeRy Eyes Injections

Pre-filled syringes 0.5 – 1 mlCataracts

Protection of tissue against damage caused by surgical equipment Cohesion of lens fragments for its better removal afterlens breakage

Molecular weight: ≥ 0.8 MDa

concentration:cohesive variant (1.0 - 1.5%)dispersive variant (3 - 5%)

oPHtHAlMoloGy eye drops (with APi), medium for lens

Eyes Drops, solutionOne-dose variant without preservativesMulti-dose variant with preservatives Syndrom of dry eyeInflammation of eye

Moisturizing of the eyeHelps preventing the systemic effect as a medium for APIOptimal medium for ophthalmic lens

Molecular weight:≥ 0.25 MDa

concentration:0.08 – 0.3%

Wound HeAlinG BurnsUlcersCutsDecubitusScars

BandagesGelsPatches

Modulates the inflammationAttracts water with growth factors Support of re-epithelializationScars reduction


concentration:0.2 - 2.5%

MezotHeRAPy EpidermisDermisSubcutaneous fat

Roller with micro-needles (1 ml)

Soft tissue augmentationEliminates skin depression


concentration:0.8 - 3%

deRMAl filleRS foR AeStHetic coRRection

Injections Soft tissue augmentationEliminates skin depression

Molecular weight:≥ 1 MDa, modified sodium hyaluronate (cross-linked)


dRuG deliveRy SySteM Local or systemic effect depends on the application

Topical, intravenous Sustained drug releasePrevents early drug activity

Molecular weight:modified sodium hyaluronate (hydrofobized)

Dermis

uRoloGy - cyStitiS Urinary bladderInterstitial cystitisChronical (bacterial) cystitis

Gel via catheter Molecular weight:≥ 0.25 MDa


Glycosaminoglycan layer regeneration effectReduction the chronical inflammation

incontinence UrinalFecal incontinence

Injectable gel to the neck of the bladder or submocosal layer of anal canal

Volume-barrierStrengthening the side of urethra/rectum

Molecular weight:1 MDa modified sodium hyaluronate

concentration:1.5%

cAndidiASiS Mycosis/CandidiasisVaginal dryness

Vaginal ovules filled with gel

Vaginal mucose hydrationMolecular weight:0.2 MDa


SPeRM SePARAtionMediuM foR in vitRo feRtilizAtion

Process in vivo fertilization

Transfer medium for embryos to uterusImmobilising medium for sperm

Optimal cell environmentSlowing down the movement of the sperm to allow the selection of the most matureviable spermatozoa


concentration:0.1% transfer medium1% immobilising medium

ARtificiAl

cARtilAGe GRAftS

Knee joint Gel, sponge Replacement of the cartilageMolecular weight:modified sodium hyaluronate

ARtificiAl Skin GRAftS

Damaged and burned skin

Hydrogels, textiles, foilsPossibility of in situ cross-linking

Cell scaffolds – homogenous implantation of various types of cells into the scaffold structureInduction of capillary growthPositively impacts the natural re-epithelialization process

Molecular weight:modified sodium hyaluronate

Bone HeAlinG Gel Scaffold for cell cultivationMolecular weight:modified sodium hyaluronate (cross-linked)


AnAeStHeSiA Surgical site Gel In combination with anaesthetics eliminates the pain caused by injection during aesthetics surgeriesAnaesthetic effect prolongation


concentration:0.2%

Bone defectsBone injuries

I NOSTRI PARTNER


LA NUOVA FRONTIERA DELLE APPLICAZIONI BIOTECH:


MecHAniSM MecHAniSMAPPlicAtiontARGet RecoMMendAtion

Anti-AdHeSive deviceS AbdominalPelvicThoracicSpinal surgery Surgery of paranasal sinus

Films, gels, textilesPostsurgery adhesions

Prevents adhesions of mucouse membrane

Molecular weight:chemically modified sodium hyaluronate

Joint viScoSuPPleMentAtion

KneeHip Ankle joint

IAT injectionsPre-filled syringes (2 – 6 ml)Osteoarthritis/ post-surgical treatment

Inhibition of the cartilage degradationStimulation of endogenous hyaluronic acid productionRestoration of the normal rheologiacal conditions

Molecular weight: 0.7 – 6 MDa native orchemically modified sodium hyaluronate

concentration:1 – 3%

APPlicAtiontARGet RecoMMendAtion

oPHtHAlMic SuRGeRy Eyes Injections

Pre-filled syringes 0.5 – 1 mlCataracts

Protection of tissue against damage caused by surgical equipment Cohesion of lens fragments for its better removal afterlens breakage

Molecular weight: ≥ 0.8 MDa

concentration:cohesive variant (1.0 - 1.5%)dispersive variant (3 - 5%)

oPHtHAlMoloGy eye drops (with APi), medium for lens

Eyes Drops, solutionOne-dose variant without preservativesMulti-dose variant with preservatives Syndrom of dry eyeInflammation of eye

Moisturizing of the eyeHelps preventing the systemic effect as a medium for APIOptimal medium for ophthalmic lens



Wound HeAlinG BurnsUlcersCutsDecubitusScars

BandagesGelsPatches

Modulates the inflammationAttracts water with growth factors Support of re-epithelializationScars reduction



MezotHeRAPy EpidermisDermisSubcutaneous fat

Roller with micro-needles (1 ml)

Soft tissue augmentationEliminates skin depression



deRMAl filleRS foR AeStHetic coRRection

Injections Soft tissue augmentationEliminates skin depression

Molecular weight:≥ 1 MDa, modified sodium hyaluronate (cross-linked)


dRuG deliveRy SySteM Local or systemic effect depends on the application

Topical, intravenous Sustained drug releasePrevents early drug activity

Molecular weight:modified sodium hyaluronate (hydrofobized)

Dermis

uRoloGy - cyStitiS Urinary bladderInterstitial cystitisChronical (bacterial) cystitis

Gel via catheter Molecular weight:≥ 0.25 MDa


Glycosaminoglycan layer regeneration effectReduction the chronical inflammation

incontinence UrinalFecal incontinence

Injectable gel to the neck of the bladder or submocosal layer of anal canal

Volume-barrierStrengthening the side of urethra/rectum

Molecular weight:1 MDa modified sodium hyaluronate

concentration:1.5%

cAndidiASiS Mycosis/CandidiasisVaginal dryness

Vaginal ovules filled with gel

Vaginal mucose hydrationMolecular weight:0.2 MDa


SPeRM SePARAtionMediuM foR in vitRo feRtilizAtion

Process in vivo fertilization

Transfer medium for embryos to uterusImmobilising medium for sperm

Optimal cell environmentSlowing down the movement of the sperm to allow the selection of the most matureviable spermatozoa


concentration:0.1% transfer medium1% immobilising medium

ARtificiAl

cARtilAGe GRAftS

Knee joint Gel, sponge Replacement of the cartilageMolecular weight:modified sodium hyaluronate

ARtificiAl Skin GRAftS

Damaged and burned skin

Hydrogels, textiles, foilsPossibility of in situ cross-linking

Cell scaffolds – homogenous implantation of various types of cells into the scaffold structureInduction of capillary growthPositively impacts the natural re-epithelialization process

Molecular weight:modified sodium hyaluronate

Bone HeAlinG Gel Scaffold for cell cultivationMolecular weight:modified sodium hyaluronate (cross-linked)


AnAeStHeSiA Surgical site Gel In combination with anaesthetics eliminates the pain caused by injection during aesthetics surgeriesAnaesthetic effect prolongation


concentration:0.2%

Bone defectsBone injuries

I NOSTRI PARTNER



I NOSTRI PARTNER


CP KELCOI prodotti CP Kelco hanno eccellenti proprietà gelatinizzanti, viscosizzanti e stabilizzanti.uGOMMA XANTANO Polisaccaride naturale prodotto per fermentazione dal batterio Xanthomonas campestris. Agente addensante, stabilizzante e viscosizzante. Grado farmaceutico con varie granulometrie • XANTURAL 75 e XANTURAL 180uGOMMA GELLANO Additivo utilizzato come agente addensante, di rivestimento e stabilizzante. Polisaccaride ad alto peso molecolare, prodotto per fermentazione dal batterio Pseudomonas elodea. • KELCOGEL CG - HA • KELCOGEL CG - LAuCARBOSSIMETILCELLULOSA SODICA Grado farmaceutico con ampio range di valori di viscosità. • CEKOLuCARRAGENINA Idrocolloide estratto da alga, addensante e viscosizzante. • GENUVISCO CG-131uPECTINA Idrocolloide di origine vegetale (mele e agrumi), addensante e stabilizzante per prodotti farmaceutici • GENUPECTIN USP/100 • GENUPECTIN USP/200

Dr. PAUL LOHMANN

uSALI MINERALI: • Acetati • Ascorbati • Bisglicinati •Carbonati(anchespecificiperCD) •Citrati(anchespecificiperCD) • Composti ferrosi • Fumarati • Gluconati • Glicerofosfati • Ossidi/Idrossidi • Lattati • Pidolati • Propionati • Succinati • Solfati • Tartrati • Altri prodotti

uPRODOTTI FUNZIONALI • Calcio Lattato Plus • Mix minerali: Sport Isotonic, Energy, Wellness Immune

uMINERALI MICROINCAPSULATI • Ferro fumarato • Ferro solfato secco • Magnesio ossido • Rame solfato monoidrato • Zinco ossido • Manganese solfato monoidrato

uTRITURAZIONI • Sodio selenito 1% i maltodestrina • Sodio molibdato 2H2O 1% in maltodestrina • Sodio molibdato 2H2O 1% in calcio carbonato • Cromo cloruro 6h2o 1% in maltodestrina

Gamma sali minerali ad uso iniettabile, microincapsulati e granulati per compressione diretta.


I NOSTRI PARTNER


uLOW ENDOTOXIN - Disponibili CEP e/o ASMF/DMF su richiesta per alcuni prodotti ad uso API

6

Low endotoxin products

Endotoxins are lipopolysaccharides (LPS) which are outer membrane components of gram-negative bacteria. By decomposing, these bacteria release lipopolysaccharides, which are toxic.1

Parenteral medicines such as solutions for dialysis, hemo- filtration and osmotherapy constitute a marked quality standard. Systemic parenteral application of infusions or injections with endotoxin quantities as low as 0.1 ng per kilogram of bodyweight can cause various physiological reactions, including fever, inflammation and sickness behavior in humans and animals2. Due to the high sensitive application form, the manufacture of parenteral medicines requires particular caution: it is subject to strict and specific regulatory requirements and is regulated by Chapter 2.6.14 of the European Pharmacopoeia (Ph.Eur.)3. In order to support manufacturers of parenteral products to comply with legal and quality requirements, Dr. Paul Lohmann® offers mineral salts with a very low content of endotoxins.

Within the biotech industry, low in endotoxin qualities are of special interest for cell cultures. Endotoxins can cause undesirable effects on cell proliferation or cell function. Due to the high purity of our products, highly sensitive cell lines can develop in an optimal and laboratory controlled environment.

◆ Low endotoxin minerals –exceeding purity ◆ For the production of parenteral medicines and biopharmaceuticals ◆ For optimal environment of cell lines ◆ GMP certified ◆ Purpose built plant

Available products in low endotoxin quality

Product Product no. Quality*** Metal content(per 100 g)

Endotoxin (LAL)

AcetateCalcium Acetate

515001001Ph. Eur.USP

approx. 24 % Ca max. 6.0 EU**/g

Magnesium Acetate 4-hydrate 511019001 Ph. Eur. approx. 11 % Mg max. 6.0 EU**/g

Potassium Acetate 515002001 Ph. Eur. approx. 40 % K max. 6.0 EU**/g

Sodium Acetate 3-hydrate511016001

Ph. Eur.USP

approx. 17 % Na max. 6.0 EU**/g

AspartateMagnesium DL-Aspartate 4-hydrate 501064001 DAB approx. 6 % Mg max. 6.0 EU**/g

Potassium DL-Aspartate 0.5 hydrate 501069001 DAB approx. 21.5 % K max. 6.0 EU**/g

CitrateCitric Acid anhydrous 503001001 Ph. Eur. max. 6.0 EU**/g

Monosodium Citrate anhydrous 502015001 DAC approx. 10.5 % Na max. 6.0 EU**/g

Trisodium Citrate anhydrous 502010012 USP approx. 27 % Na max. 6.0 EU**/g

Trisodium Citrate 2-hydrate502009001

Ph. Eur.USP

approx. 23.5 % Na max. 6.0 EU**/g

EDTACalcium Disodium EDTA

511085002 Ph. Eur.approx. 10 % Caapprox. 11 % Ca

max. 6.0 EU**/g

GlycerophosphateSodium Glycerophosphate 512045001 Ph. Eur. approx. 15 % Na max. 6.0 EU**/g

GluconateCalcium Gluconate 1-hydrate 503071003 Ph. Eur. approx. 9 % Ca max. 6.0 EU**/g

LactateSodium Lactate Solution; approx. 52 %; from L-Lactic Acid 512012112 Ph. Eur.

USPapprox. 10 % Na max. 6.0 EU**/g

Sodium Lactate Solution; approx. 60 %; from L-Lactic Acid 512012113

Ph. Eur. purityUSP


PhosphateMonosodium Phosphate 2-hydrate 503032002 Ph. Eur. approx. 15 % Na max. 6.0 EU**/g

Disodium Phosphate 12-hydrate 503031002 Ph. Eur. approx. 13 % Na max. 6.0 EU**/g

SuccinateSodium Succinate 6-hydrate 502045003 acc. to customer

requirementsapprox. 17 % Na max. 6.0 EU**/g

SulfateMagnesium Sulfate 7-hydrate 522014002 Ph. Eur. approx. 10 % Mg max. 6.0 EU**/g

Sodium Sulfate anhydrous 522017001 Ph. Eur. approx. 32 % Na max. 6.0 EU**/g

Further products under development /to be developed on customer request.

* LAL (Limulus amebocyte lysate) test accomplished according to Method A, as described in Ph.Eur.9.Ed. Every batch produced is tested for this parameter.

Low endotoxin qualities of Dr. Paul Lohmann® productsIn 2017, a purpose-built plant was brought into service. This plant is GMP-certified and solely dedicated for the production of low endotoxin qualities. Thus our production process of high purity mineral salts including the use of low endotoxin process water is especially conceptualized for the purpose of the production of parenteral medicines.

◆ �LAL test* according to Ph.Eur. is performed on every single batch.

◆ �Our customers can optimally integrate our low in endotoxin qualities in their process chain for the manufacture of parenteral dosage forms (please see blue text on the next page).

ApplicationsLow endotoxin mineral compounds can be used for the production of the following products:

◆��Solutions for injection◆��Solutions for infusion ◆��Solutions for inhalants◆��Solutions for parenteral nutrition◆��Solutions for� ◆ Dialysis� ◆ Peritoneal dialysis� ◆ Haemofiltration� ◆ Osmotherapy◆��Ophthalmic preparations◆��Biopharmaceuticals

Pharmaceutical manufacturers of preparations for infusion or injection are obliged to observe special regulations specified by the relevant pharmacopoeia and good manufacturing practices. We emphasize that our products are low in endotoxin content but not entirely free of endotoxins and not sterile. Therefore, these products must be treated with special procedures prior to their use in finished pharmaceutical products.

The pharmaceutical manufacturer must ensure that our products undergo special procedures and tests prior to being processed for infusion or injection preparations in order to induce their suitability for their intended purpose.

The information given in the document corresponds to our current knowledge. We warrant in the frame of our General Terms and Conditions of Sale that our products are manufactured in accordance with the specifications. However, we disclaim any liability with regard to the suitability of our products for a particular purpose or application or their compatibility with other substances. Tests have to be performed by the customer who also bears the risk in this respect. Nothing herein shall be construed as a recommendation to use our products in conflict with third parties‘ rights.

References1 Fennrich, S. et al.: More than 70 years of pyrogen detection: Current state

and future perspectives; Alternatives to laboratory animals: ATLA, 06/2016, pp 239-53

2 Salema, V., Pattnaik, P.: Removing endotoxin from biopharmaceutical solutions; Pharmaceutical Technology Europe, 10/2009, pp 36-38

3 European Medicines Agency (EMEA): Guideline on the Replacement of Rabbit Pyrogen testing by an Alternative Test for Plasma Derived Medicinal Products; 04/2009

** EU = Endotoxin Unit (equal to IU, International Unit)

*** You can find the versions of the pharmacopoeias in the specifications.

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NEW

NEW

NEW

NEW

NEW

NEW

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Low endotoxin products

Endotoxins are lipopolysaccharides (LPS) which are outer membrane components of gram-negative bacteria. By decomposing, these bacteria release lipopolysaccharides, which are toxic.1

Parenteral medicines such as solutions for dialysis, hemo- filtration and osmotherapy constitute a marked quality standard. Systemic parenteral application of infusions or injections with endotoxin quantities as low as 0.1 ng per kilogram of bodyweight can cause various physiological reactions, including fever, inflammation and sickness behavior in humans and animals2. Due to the high sensitive application form, the manufacture of parenteral medicines requires particular caution: it is subject to strict and specific regulatory requirements and is regulated by Chapter 2.6.14 of the European Pharmacopoeia (Ph.Eur.)3. In order to support manufacturers of parenteral products to comply with legal and quality requirements, Dr. Paul Lohmann® offers mineral salts with a very low content of endotoxins.

Within the biotech industry, low in endotoxin qualities are of special interest for cell cultures. Endotoxins can cause undesirable effects on cell proliferation or cell function. Due to the high purity of our products, highly sensitive cell lines can develop in an optimal and laboratory controlled environment.

◆ Low endotoxin minerals –exceeding purity ◆ For the production of parenteral medicines and biopharmaceuticals ◆ For optimal environment of cell lines ◆ GMP certified ◆ Purpose built plant

Available products in low endotoxin quality

Product Product no. Quality*** Metal content(per 100 g)

Endotoxin (LAL)

AcetateCalcium Acetate

515001001Ph. Eur.USP

approx. 24 % Ca max. 6.0 EU**/g

Magnesium Acetate 4-hydrate 511019001 Ph. Eur. approx. 11 % Mg max. 6.0 EU**/g

Potassium Acetate 515002001 Ph. Eur. approx. 40 % K max. 6.0 EU**/g

Sodium Acetate 3-hydrate511016001

Ph. Eur.USP

approx. 17 % Na max. 6.0 EU**/g

AspartateMagnesium DL-Aspartate 4-hydrate 501064001 DAB approx. 6 % Mg max. 6.0 EU**/g

Potassium DL-Aspartate 0.5 hydrate 501069001 DAB approx. 21.5 % K max. 6.0 EU**/g

CitrateCitric Acid anhydrous 503001001 Ph. Eur. max. 6.0 EU**/g

Monosodium Citrate anhydrous 502015001 DAC approx. 10.5 % Na max. 6.0 EU**/g

Trisodium Citrate anhydrous 502010012 USP approx. 27 % Na max. 6.0 EU**/g

Trisodium Citrate 2-hydrate502009001

Ph. Eur.USP


EDTACalcium Disodium EDTA

511085002 Ph. Eur.approx. 10 % Caapprox. 11 % Ca

max. 6.0 EU**/g

GlycerophosphateSodium Glycerophosphate 512045001 Ph. Eur. approx. 15 % Na max. 6.0 EU**/g

GluconateCalcium Gluconate 1-hydrate 503071003 Ph. Eur. approx. 9 % Ca max. 6.0 EU**/g

LactateSodium Lactate Solution; approx. 52 %; from L-Lactic Acid 512012112 Ph. Eur.

USPapprox. 10 % Na max. 6.0 EU**/g

Sodium Lactate Solution; approx. 60 %; from L-Lactic Acid 512012113

Ph. Eur. purityUSP


PhosphateMonosodium Phosphate 2-hydrate 503032002 Ph. Eur. approx. 15 % Na max. 6.0 EU**/g

Disodium Phosphate 12-hydrate 503031002 Ph. Eur. approx. 13 % Na max. 6.0 EU**/g

SuccinateSodium Succinate 6-hydrate 502045003 acc. to customer

requirementsapprox. 17 % Na max. 6.0 EU**/g

SulfateMagnesium Sulfate 7-hydrate 522014002 Ph. Eur. approx. 10 % Mg max. 6.0 EU**/g

Sodium Sulfate anhydrous 522017001 Ph. Eur. approx. 32 % Na max. 6.0 EU**/g

Further products under development /to be developed on customer request.

* LAL (Limulus amebocyte lysate) test accomplished according to Method A, as described in Ph.Eur.9.Ed. Every batch produced is tested for this parameter.

Low endotoxin qualities of Dr. Paul Lohmann® productsIn 2017, a purpose-built plant was brought into service. This plant is GMP-certified and solely dedicated for the production of low endotoxin qualities. Thus our production process of high purity mineral salts including the use of low endotoxin process water is especially conceptualized for the purpose of the production of parenteral medicines.

◆ �LAL test* according to Ph.Eur. is performed on every single batch.

◆ �Our customers can optimally integrate our low in endotoxin qualities in their process chain for the manufacture of parenteral dosage forms (please see blue text on the next page).

ApplicationsLow endotoxin mineral compounds can be used for the production of the following products:

◆��Solutions for injection◆��Solutions for infusion ◆��Solutions for inhalants◆��Solutions for parenteral nutrition◆��Solutions for� ◆ Dialysis� ◆ Peritoneal dialysis� ◆ Haemofiltration� ◆ Osmotherapy◆��Ophthalmic preparations◆��Biopharmaceuticals

Pharmaceutical manufacturers of preparations for infusion or injection are obliged to observe special regulations specified by the relevant pharmacopoeia and good manufacturing practices. We emphasize that our products are low in endotoxin content but not entirely free of endotoxins and not sterile. Therefore, these products must be treated with special procedures prior to their use in finished pharmaceutical products.

The pharmaceutical manufacturer must ensure that our products undergo special procedures and tests prior to being processed for infusion or injection preparations in order to induce their suitability for their intended purpose.

The information given in the document corresponds to our current knowledge. We warrant in the frame of our General Terms and Conditions of Sale that our products are manufactured in accordance with the specifications. However, we disclaim any liability with regard to the suitability of our products for a particular purpose or application or their compatibility with other substances. Tests have to be performed by the customer who also bears the risk in this respect. Nothing herein shall be construed as a recommendation to use our products in conflict with third parties‘ rights.

References1 Fennrich, S. et al.: More than 70 years of pyrogen detection: Current state

and future perspectives; Alternatives to laboratory animals: ATLA, 06/2016, pp 239-53

2 Salema, V., Pattnaik, P.: Removing endotoxin from biopharmaceutical solutions; Pharmaceutical Technology Europe, 10/2009, pp 36-38

3 European Medicines Agency (EMEA): Guideline on the Replacement of Rabbit Pyrogen testing by an Alternative Test for Plasma Derived Medicinal Products; 04/2009

** EU = Endotoxin Unit (equal to IU, International Unit)

*** You can find the versions of the pharmacopoeias in the specifications.

NEW

NEW

NEW

NEW

NEW

NEW

NEWGamma sali minerali ad uso iniettabile, microincapsulati e granulati per compressione diretta.


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FARACIDEuPARABENI • Faracide M: Methylparaben • Faracide E: Ethylparaben • Faracide P: Propylparaben • Faracide M sodium: Sodium methylparaben • Faracide ME: Methylparaben, ethyparaben in fenossietanolo • Faracide HMG: Sodium hydroxylmethylglycinate • Faracide PHX: Phenoxyethanol • Faracide DMDM Hydantoin: DMDM HydantoinuMISCELE LIQUIDE • Faracide liquid mix WB: Phenoxyethanol, methylparaben, ethylparaben, propylparaben

GALAM GROUPIl fruttosio (o levulosio) è un monosaccaride chetonico utilizzato come eccipiente per il riempimento di bustine o per la produzione di compresse masticabili.uFRUITOSE, disponibile in diverse granulometrie • "DU" • "MS“ • "S“ • "N"Il levulosio iniettabile viene utilizzato come prodotto per nutrizione parenterale.

GRACEuSYLOID FP SILICA EP/USP/JP •SYLOID72FP/244/FPSilica:glidante;compressione(ottimoprofilodidissoluzionee disgregazionepercompresseorodispersibili);filmcoating(rilascioprolungato,antitacking) • SYLOID AL-1 FP Silica: glidante; stabilizzante (controllo dell’umidità)uSYLOID XDP 3050 E 3150 Nuovogradodisilica,specificatamenteideataeottimizzataperformulazioniliquideeoil-based: • SIMPLE LIQUID TO SOLID TRANSFORMATION

HAYASHIBARA - NAGASE GROUPuTREALOSIO Disaccaride utilizzato per: • Stabilizzazione di emoderivati e plasmaderivati • Stabilizzazione di vaccini proteici • Trattamento della secchezza oculare (colliri) • Formulazione di liquidi per la conservazione di organi PresentaelevatastabilitàalcaloreealpH,altaaffinitàperlemolecolediacqua.Chimicamentestabile.uPULLULANO Polisaccarideconproprietàfilmantieleganti,usatoanchepercoating. È caratterizzato da eccellente adesività, rapidissima dissoluzione anche in acqua fredda, alta resistenza al calore e alle variazioni di pH.uMALTOSIO SUNMALT-S Maltosio monoidrato. Disaccaride ad azione energetica.


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HORIZONHorizon Specialties è membro del Thew Arnott Group, leader nella produzione di colori, coloranti, pigmenti e lacche di alta qualità per diversi settori.Horizon offre una gamma completa di colori per l'industria farmaceutica ampiamente usati in capsule di gelatina dure e morbide, rivestimenti per compresse, compresse e sciroppi.


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LOTTEAnyCoat-C è ipromellosa (idrossipropilmetilcellulosa). AnyCoat-P è ftalato ipromelloso (idrossipropile metilcellulosa ftalato). AnyCoat® è conforme a USP/NF, EP, JP, KP, disponibilità Kosher, ISO, DMF e COS. Disponibile in diverse viscosità (da 3 a 100.000 cps), può essere ampiamente usato per il rivestimento di capsule, granulazione, come legante, addensante, stabilizzante e per la produzione di capsule vegetali. AnyCoat-P può essere utilizzato come agente di rivestimento per la protezione degli API durante il transito gastrico.

NEW! AnyCoat CN-PLUS: distribuzione ottimizzata della particle size per un maggiore controllo della cellulasi, migliore scorribilità e lavorabilità per DC.

Application Tableof AnyCoat®

Package

Package

Fiber drum with polyethylene double bag inside

Net Weight

AnyCoat-C : 2910type - 25kg,

2906 & 2208type - 20kg

AnyCoat-P : 20kg

Functional Category

Effects

Once soluble in water and volatilized through solvent, AnyCoat® makes transparent film with high tensile strength

With pH dependent profile and filmforming capability, Anycoat® helps APIs dissolve not in stomach, but in intestine

AnyCoat® delivers binding property, and enhances the hardness of tablet

AnyCoat® provides the thickening property. The viscosity of AnyCoat® exponentially increases in relation to the concentration

AnyCoat® with hydrophobic and hydrophilic properties as well provides viscous and suspending aid

Compatible with APIs, AnyCoat® dissolves well in aqueous solution, delivering thickening and suspending aid

AnyCoat® delivers excellent film forming and gelling property, making high quality capsule

As a suspending aid and drug carrier for solid dispersion, AnyCoat® provides excellent properties

Hydrophilic matrix used along with AnyCoat® hydrates to create a gel layer, controlling drug release pattern

Usage

Tablet

Viscosity

Grade3 4 5 6 15 50 4 400 4,000 100 4,000 15,000 100,000 55 40

Substitution type 2910 2906 2208 220824 200731

Hypromellose Hypromellose Phthalate

Film CoatingAqueous Solvent

Enteric Coating

Sustained Release

Binder(Wet Granulation)

Thickening

Suspending

Dry Syrup

Capsule Making

Solid Dispersion

Liquid

Others

1~3%

5~30%

10~80%

2~5%

0.25~5.0%

0.25~5.0%

0.25~5.0%

80~97%

5%~

19

Highly recommended Recommended

AN3 AN4 AN5 AN6 AN15 AN50 BN4 BN40M BN40H CN10M CN40H CN15U CN10T HP50 HP55

18


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KLINGE CHEMICALSuSALI MINERALI • POTASSIO CLORURO EP • POTASSIO CLORURO INIETTABILE EP

MACCO ORGANIQUESProdotti utilizzati nel settore della nutrizione parenterale (con GMP e CEP):• CALCIO CLORURO 2H2O EP/USP• CALCIO SOLFATO 2H20 EP• MAGNESIO CLORURO 6H2O EP /BP • MAGNESIO SOLFATO 7H20 PHEUR (disponibile anche in versione LOW ENDOTOXIN)• SODIO SOLFATO ANIDRO EP

MONDO MINERALSTalco (Microtalc Pharma) per applicazioni farmaceutiche.Disponibile in differenti granulometrie:

PRODUCT ID PSD D50 PSD D98 DENSITY BRIGHTNESS MOISTURE CIE l*a*b*

MT PHARMA 5 1.7 µm 8 µm 0.20 g/cm³ 96 % 0.2 % 98.5 / 0.0 / 0.7





PSD Sedigraph 51XX


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MEGGLEIl lattosio è un disaccaride formato da unità di glucosio e galattosio. Si ottiene per estrazione, purificazioneecristallizzazionedelsierodilatte.Disponibilenelleversioniα-monoeß-anidro.

Product decision matrixProduct Category Tableting Powder preparations Regulatory Functionality Retest/Shelf-life Packaging Special features

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GranuLac® 70* � * � � � � � � � � 36 Months 25 kg paper bag

GranuLac® 140* � * � � � � � � � � 36 Months 25 kg paper bagGranuLac® 200* � * � � � � � � � � 36 Months 25 kg paper bagGranuLac® 230 � � � � � � � � 36 Months 25 kg paper bagSorboLac® 400 � � � � � � � � 36 Months 20 kg paper bagTablettose® 70 � � � � � � � � 36 Months 20 kg paper bag Reduced fi nes, improved fl owabilityTablettose® 80 � � � � � � � � 36 Months 25 kg paper bagTablettose® 100 � � � � � � � � 24 Months 20 kg paper bag Improved compactibility performanceFlowLac® 90 � � � � � � � � 36 Months 25 kg carton box Virtually dust-freeFlowLac® 100 � � � � � � � � 18 Months 25 kg paper bagFlowLac® 100 � � � � � � � � 24 Months 25 kg carton boxDuraLac® H** �� ** � � � � � � � � 36 Months 25 kg carton boxCellactose® 80 � � � � � � � � 36 Months 20 kg paper bag or carton box Diluent/binder combinationMicroceLac® 100 � � � � � � � � 18 Months 20 kg paper bag Diluent/binder combinationStarLac® � � � � � � � � 36 Months 25 kg paper bag Diluent/disintegrant combinationCombiLac® *** � � � � � � � � 24 Months 20 kg carton box Diluent/binder/disintegrant combinationRetaLac® � � � � � � � � 24 Months 12 kg carton box Controlled release matrix systemPrismaLac® 40 � � � � � � � � 36 Months 20 kg paper bagCapsuLac® 60 � � � � � � � � 36 Months 25 kg paper bagSacheLac® 80 � � � � � � � � 36 Months 25 kg paper bagSpheroLac® 100 � � � � � � � � 36 Months 25 kg paper bagInhaLac® 70 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 120 n/a n/a 24 Months 25 kg carton boxInhaLac® 230 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 251 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 400 n/a n/a 24 Months 15 kg carton boxInhaLac® 500 *** n/a n/a 12 Months 10 kg carton box

* Dual production sites in Germany and the US ** US production site*** In process

� � � � Excellent� � � � Very good� � � � Good� � � � Satisfactory� � � � Suffi cient� � � � Insuffi cient/not advised

Product decision matrixProduct Category Tableting Powder preparations Regulatory Functionality Retest/Shelf-life Packaging Special features

MEGGLE product Siev

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Mill

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Mic

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Spra

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Com

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liner

GranuLac® 70* � * � � � � � � � � 36 Months 25 kg paper bag

GranuLac® 140* � * � � � � � � � � 36 Months 25 kg paper bagGranuLac® 200* � * � � � � � � � � 36 Months 25 kg paper bagGranuLac® 230 � � � � � � � � 36 Months 25 kg paper bagSorboLac® 400 � � � � � � � � 36 Months 20 kg paper bagTablettose® 70 � � � � � � � � 36 Months 20 kg paper bag Reduced fi nes, improved fl owabilityTablettose® 80 � � � � � � � � 36 Months 25 kg paper bagTablettose® 100 � � � � � � � � 24 Months 20 kg paper bag Improved compactibility performanceFlowLac® 90 � � � � � � � � 36 Months 25 kg carton box Virtually dust-freeFlowLac® 100 � � � � � � � � 18 Months 25 kg paper bagFlowLac® 100 � � � � � � � � 24 Months 25 kg carton boxDuraLac® H** �� ** � � � � � � � � 36 Months 25 kg carton boxCellactose® 80 � � � � � � � � 36 Months 20 kg paper bag or carton box Diluent/binder combinationMicroceLac® 100 � � � � � � � � 18 Months 20 kg paper bag Diluent/binder combinationStarLac® � � � � � � � � 36 Months 25 kg paper bag Diluent/disintegrant combinationCombiLac® *** � � � � � � � � 24 Months 20 kg carton box Diluent/binder/disintegrant combinationRetaLac® � � � � � � � � 24 Months 12 kg carton box Controlled release matrix systemPrismaLac® 40 � � � � � � � � 36 Months 20 kg paper bagCapsuLac® 60 � � � � � � � � 36 Months 25 kg paper bagSacheLac® 80 � � � � � � � � 36 Months 25 kg paper bagSpheroLac® 100 � � � � � � � � 36 Months 25 kg paper bagInhaLac® 70 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 120 n/a n/a 24 Months 25 kg carton boxInhaLac® 230 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 251 *** n/a n/a 24 Months 25 kg carton boxInhaLac® 400 n/a n/a 24 Months 15 kg carton boxInhaLac® 500 *** n/a n/a 12 Months 10 kg carton box

* Dual production sites in Germany and the US ** US production site*** In process

� � � � Excellent� � � � Very good� � � � Good� � � � Satisfactory� � � � Suffi cient� � � � Insuffi cient/not advised


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NISSO HCPIdrossipropilcellulosa (HPC) è un polimero solubile in acqua e in solventi polari, chimicamenteinerteeconeccellentiproprietàlegantiefilmanti.Disponibile in varie tipologie che si differenziano nel peso molecolare e nella viscosità.Ognisingolatipologiasipresentainduedifferentigranulometrie(polverestandardefine).Nipponèinoltrel’unicoproduttoreadaveresulmercatounatipologiadiHPC“super-fine”particolarmente indicata in compressione diretta. APPLICAZIONI FARMACEUTICHE:• Formulazioni solide orali (granulazione, DC)• Formulazioni a rilascio prolungato• Formulazioni semisolide• Solubility enhancementIl prodotto è conforme a USP/NF, EP, JP

PETER GREVENLIGAMED è la linea di stearati per l'industria farmaceutica. Si tratta di stearati vegetali prodotti in una linea totalmente dedicata e disponibili con due differentiareesuperificiali.Inoltre Peter Greven produce una nuova linea di acido stearico da palmacertificatoRSPO (SCCS) ad uso medicale e food (LIGAMED e LIGAFOOD). Alcune referenze sono disponibili sia in versione RSPO MB (Mass Balance) che SG (Segregated).uMAGNESIO STEARATO VEGETALE • LIGAMED MF2V • LIGAMED MF3VAltri prodotti: uCALCIO STEARATO VEGETALE • LIGAMED CPR2V • LIGAMED CPR2KuZINCO STEARATOuALLUMINIO STEARATOuSODIO STEARATOuPOTASSIO STEARATOuACIDO STEARICO • LIGAMED SA-2V

CORBION - PURACProdotto utilizzato nel settore della nutrizione parenterale:uCALCIO GLUCONATO • ORALE EP • INIETTABILE USPDiversi tipi di sali come fonte per l’integrazione minerale:uFERRO GLUCONATO USPuMAGNESIO GLUCONATO USPuPOTASSIO GLUCONATO USPuZINCO GLUCONATO USP


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ROQUETTEuFECOLA DI PATATE batteriologica FU/EPuMALTODESTRINE a vari DE • Glucidex 2,6,9,12,17,19 • Glucidex 21,29,39,40,47 - Sciroppo di glucosio disidratatouGLUCOSIO • Flolys e Roclys - Glucosio sciroppouDESTROSIO • Destrosio anidro EP/USP • Lycadex Pf FU/EP/USP - Destrosio monoidrato apirogeno • Roferose - Destrosio monoidrato EP/USPuAMIDI diluenti insolubili, anche leganti • Amido di frumento TB, Ph.Eur •LycatabCeLycatabM-AmidimodificatiepregelatinizzatiperCD • Amido mais giglio 2TBS - extra bianco Ph.EuruSORBITOLO USP/EP diluente,dolcificante • Neosorb 70/70 non cristallizzabile anche 70/70 SB • Neosorb 70/20 cristallizzabile • Neosorb apirogeno • Neosorb polvere con varie granulom.: P20/60- P30/60-P60W-P100TuMANNITOLO FU/EP/USP diluentesolubile(dolcificanteinferiorealsaccarosio) • Pearlitol C polvere a varie granulometrie • Pearlitol apirogeno • Pearlitol SD e DC per compressione diretta con varie granulometrieuMALTITOLO EP/USP/NF poliolo(dolcificante,diluente,legante) • Maltisorb P a varie granulometrie • Lycasin 80/55 - soluzione di maltitolouXILITOLO EP/USP/NF • Xilisorb polvere e per compressione direttauGLUCONO DELTA LATTONEuPEARLITOL FLASH - Co-processato con proprietà leganti e disgreganti per la formulazione di compresse orodispersibiliuBETACICLODESTRINA - KLEPTOSE

Materie prime prodotte seguendo le più rigide linee guida GMP e conformi alle principali farmacopee USP/NF, Ph. Eur. Soluzioni eccipientistiche per la formulazione di cpr, cps, pellets attraverso l’utilizzo di diversi processi produttivi(granulazioneadumido/secco,compressionediretta,aumentoscorrevolezzacapsulefilling),Ultimamente il range di prodotti si è arricchito, grazie all'acquisizione delle MCC di Blanver/ItacelCellulose microcristalline NF/EP Pharma grade: uMICROCEL® 101, 102, 112, 200

Disgreganti:uEXPLOSOL® - Na Amido Glicolato Efficace superdisgregante utile nella dissoluzione, utilizzato nelle formulazioni solide grazie alla sua elevata capacità di assorbimento. Non contiene zucchero amido. uSOLUTAB® - Croscaramellose sodicouSOLUTAB® IP - Croscaramellose sodico Identity Preserved NON GMO

Addensanti/stabilizzanti:uTABULOSE SC® Cellulosa microcristallina + carbossimetilcellulosa (MCC+CMC)


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SÜDZUCKER AGIl saccarosio è un disaccaride composto da una molecola di glucosio e una molecola di fruttosio. È ampiamente utilizzato nell‘industria farmaceutica per il riempimento di bustine, per la produzione di compresse masticabili, succhiabili ed effervescenti, confettatura, coating e sciroppi.

uSACCAROSIO EP/USP: • calibrato (disponibile con varie granulometrie) • polvere con amido • icing sugar, polvere senza amido

uSACCAROSIO per compressione diretta - LINEA COMPRI I saccarosi denominati COMPRI sono agglomerati e vengono impiegati direttamente per la compressione. Sonoparticolarmenteefficientiinfasedilavorazione(ancheconcomprimitriciadaltavelocità) e si contraddistinguono per l‘ottima scorrevolezza ed uniformità. In alcuni di essi viene addizionata una % di maltodestrina. •Comprizucker“O”(100%saccarosio) • Comprizucker M3 (con 3% maltodestrine)

uSCIROPPO DI SACCAROSIO 66,5% e 72,7%



AACESULFAME KACIDO AMINOACETICOACIDO L-ASPARTICOACIDO BENZOICOACIDO BORICO GRANULAREACIDO CITRICO ANIDRO CRISTALLI E POLVEREACIDO CITRICO MONO CRISTALLI E POLVEREACIDO L-GLUTAMMICO ACIDO IALURONICO SALE SODICOACIDO IODIDRICO 57% ACIDO LATTICO 80%-88%-90%ACIDO MALICOACIDO SALICILICO NON VOLUM.ACIDO SORBICOACIDO STEARICOACIDO TARTARICO POLVERE E SEMOLATOAGAR AGAR AMIDO DI FRUMENTO AMIDO DI MAIS POLVERE E PER CD AMIDO MAIS PREGELATINIZZATOAMMONIO BICARBONATOAMMONIO CARBONATOAMMONIO CLORUROAMMONIO CITRATO AMMONIO FOSFATOAMMONIO FORMIATOAMMONIO GLICIRIZZINATOAMMONIO SOLFATOAMMONIO SOLFOITTIOLATOL-ARGININA ASPARTATO, BASE, HCLASPARTAME POLVERE E FINE GRANULAR

BBETACICLODESTRINEBIOTINABHA-BUTILIDROSSIANISOLOBHT-BUTILIDROSSITOLUOLO A

CCALCIO ACETATOCALCIO ASCORBATOCALCIO BISGLICINATOCALCIO CARBONATO PESANTE E PER CDCALCIO CARBONATO PRECIPITATOCALCIO CITRATOCALCIO CLORURO BIIDRATOCALCIO FOSFATO BIBASICO ANIDRO E BIIDRATO PER CDCALCIO FOSFATO TRIBASICO ANIDRO PER CD CALCIO GLICEROFOSFATOCALCIO GLUCONATO ORALE ED INIETTABILECALCIO GLUTAMMATO CALCIO IDROSSIDOCALCIO IODATO CALCIO LATTATOCALCIO LATTOGLUCONATO

CALCIO D-SACCARATOCALCIO SOLFATOCALCIO STEARATO VEGETALE PHARMACARRAGENINECARBOSSIMETILCELLULOSA SODICACARBOSSIMETILGLUCANOL-CARNITINA BASE TARTRATOCAROTENOIDI NATURALI E SINTETICICELLULOSA MICROCRISTALLINA CELLULOSA ACETATO FTALATOCERA API BIANCA GOCCECHININA HCL (NO API)L-CISTEINA BASEL-CISTEINA MONO HCLCOLINA BITARTRATO CROSCARAMELLOSE SODICOCROSPOVIDONE

DDESTROSIO ANIDRODESTROSIO MONOIDRATODHADIETILAMMINA SALICILATODIPOTASSIO GLICIRRIZINATO

EE.D.T.A. BISODICO-TETRASODICO POLVERE EP/USPETERE GUAIACOLGLICERICO (NO API)

FFECOLA DI PATATEFENOSSIETANOLOFERRO CITROAMMONIACALE ROSSO E VERDEFERRO FUMARATOFERRO GLUCONATO FERRO LATTATOFERRO OROTATOFERRO ORTOFOSFATOFERRO OSSIDO SACCARATOFERRO SOLFATOFOSFATI DI CA E NA E KFRUTTOSIO EP/USP

GGLICERILMONOSTEARATOGLICERINA VEGETALEGLICOLE PROPILENICOGLICOLE SALICILATOGLUCONO DELTA LATTONEGLUCOSIO SCIROPPOGOMMA ARABICA POLVERE E SPRAY-DRIED GOMMA DRAGANTE GOMMA GELLANOGOMMA GUAR GOMMA LACCA DECERATAGOMMA XANTANO XANTURAL USP

LE NOSTRE MATERIE PRIME




H HPMC - IDROSSIPROPILMETILCELLULOSAHPMC - IDROSSIPROPILMETILCELLULOSA FTALATOHPC - IDROSSIPROPILCELLULOSA

I ISOMALTOIODURI

LLATTATILATTOFERRINA LATTOSIO ANIDROLATTOSIO MONOIDRATO POLVERELATTOSIO MONOIDRATO CDLATTOSIO INHALERLATTOSIO SPRAY-DRIEDLECITINA SOIALEVILITELEVULOSIO

MMAGNESIO ACETATO TETRAIDRATOMAGNESIO DL-ASPARTATO TETRAIDRATOMAGNESIO L-ASPARTATO BIIDRATOMAGNESIO CARBONATO LEGGERO, PESANTE E CDMAGNESIO CITRATOMAGNESIO CLORURO 6H20MAGNESIO FOSFATOMAGNESIO GLICEROFOSFATO MAGNESIO GLUCONATOMAGNESIO IDRATO PESANTEMAGNESIO LATTATO 2H2O EPMAGNESIO NITRATO 6H2O PUROMAGNESIO OSSIDO LEGGEROMAGNESIO OSSIDO PESANTE E PER CDMAGNESIO SOLFATO SECCOMAGNESIO SOLFATO 7H2OMAGNESIO STEARATO VEGETALE PHARMAMALTITOLOMALTODESTRINE A VARI DE EP/USPMALTOSIO EPMANGANESE CARBONATOMANNITOLO POLVERE E INIETTABILEMANNITOLO PER CDMENTOLO NATURALE METILE SALICILATO BP 93

NNEOESPERIDINA DIIDROCALCONEBUTILE P IDROSSIBENZOATO - NIPABUTYLETILE P IDROSSIBENZOATO - NIPAGINAMETILE P IDROSSIBENZOATO - NIPAGIN-MPROPILE P IDROSSIBENZOATO - NIPASOL MNITRATI

PPARABENI SINGOLI E IN MISCELAPECTINEPEG - POLIETILENGLICOLIPOLIDESTROSIO POLISORBATIPOLIVINILPIRROLIDONE IODATOPOLIVINILPIRROLIDONE K 25, K 30 E K 90 POLIVINILPIRROLIDONE WA64 EPPOTASSIO ACETATOPOTASSIO DL-ASPARTATO DAB LOW ENDOTOXINPOTASSIO BICARBONATOPOTASSIO CARBONATOPOTASSIO CITRATO TRIBASICO E ANIDROPOTASSIO CLORUROPOTASSIO FOSFATO POTASSIO IDRATO GOCCEPOTASSIO IODATOPOTASSIO IODUROPOTASSIO SOLFATOPOTASSIO SOLFOGUAIACOLATOPOTASSIO SORBATOPOTASSIO TARTRATO NEUTROPULLULANO

RRAME CITRATO 2.5 H2O RAME CLORURORAME GLUCONATORAME IODURORAME FOSFATO

SSACCARATI SACCARINA SODICASACCAROSIO CALIBRATOSACCAROSIO LIQUIDO SACCAROSIO PER CD SILICIO BIOSSIDOSODIO ACETATO ANIDRO SODIO ACETATO TRIIDRATOSODIO AMIDO GLICOLATO SODIO ASCORBATOSODIO BENZOATOSODIO BICARBONATOSODIO BORATO 10H20SODIO CARBONATO ANIDROSODIO CICLAMATOSODIO CITRATO BIBASICO 1.5H20SODIO CITRATO MONOBASICO ANIDROSODIO CITRATO TRIBASICO ANIDRO SODIO CITRATO TRIBASICO 2H2OSODIO CLORUROSODIO FOSFATO (VARI GRADI)SODIO GLUCONATO POLVERESODIO L-GLUTAMMATO



SODIO IDRATO GOCCESODIO IODATOSODIO IODUROSODIO LATTATOSODIO METAPERIODATOSODIO SOLFATO ANIDROSORBITOLO LIQUIDOSORBITOLO POLVERE A VARIE GRANULOMETRIESTEVIASUCRALOSIO

TTALCOTITANIO BIOSSIDOTREALOSIO

VVITAMINA C

X - ZXILITOLO POLVEREZINCO ACETATO 2H2OZINCO CITRATO TRIIDRATOZINCO CLORURO ANIDROZINCO GLUCONATOZINCO LATTATOZINCO OSSIDOZINCO SOLFATO



NOTE



V I A M E D A R D O R O S S O , 8 - 2 0 1 5 9 M I L A N O - W W W . F A R A V E L L I . I T - P H A R M A @ F A R A V E L L I . I T


Documents

PRODUCT LIST · • Iodoformio Usp/NF. AJINOMOTO •tame polvere EP/USP Aspar • Aspartame fine granular EP/USP •tame granulare EP/USP Aspar Edulcorante, dolcificante intensivo