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SEPPIC An affiliate of Pharmaceutical and Nutraceutical Offer
SEPPIC
An affiliate of
Pharmaceutical and Nutraceutical Offer
Air Liquide, French group, world leader in gases for
industrial applications and healthcare
Air Liquide supplies to food and pharmaceutical
industries with N2, CO2, O2…
2010 turnover : 13,5 billions €
1 million customers worldwide
9 360 patents and 2 500 inventions
42 300 employees
Member of Air Liquide Group since 1986
2011 turnover: 260 millions €
Industrial sites: Castres - France,
Shanghai - China
3 500 m2 of laboratories, research budget: 8 millions €,
more than 100 researchers, 140 patents in 10 years
630 employees
Commercial subsidiaries and offices: Germany, Italy, United
Kingdom, USA, China, Singapore, Brazil, India, Colombia
3 Customer Demonstration Centers: France, China, US
SEPPIC, Air Liquide subsidiary
Industrial specialities
Pharmacy & NutritionCosmetic
Adjuvants for Vaccine & Injectable
Commercial activities
Excipients
Actives
+ Surfactants + Emollients+ Thickeners + Emulsifiers
+ Preservatives
+ Moisturizers + Free rad. scavengers+ Smoothers + Anti wrinkle
Excipients
Actives and ingredients
+ Surfactants + Emulsifiers-Solubilizers+ Film-coatings + Binders-Fillers
+ Mineral salts + Stevia+ Nutritional ingredients
+ Injectable surfactants+ Adjuvants for vaccines
+ Functional additives+ Surfactants for coating, inks
Oil field, Paper, Glass Frosting
SEPPIC, renowned specialist of excipients, actives and ingredientsdedicated to pharmaceutical, nutraceutical and food applications
Pharmacy & Nutrition activity
Solid oral dosage forms(excipients)
Liquid & semi-solid oraldosage forms
(excipients)
Topical dosage forms(excipients)
Actives – Ingredients(all forms)
Customerapplications
Nutritional actives
Mineral salts
Sweeteners
Actives - Ingredients
Excipients
SEPPIC Solutions
Film-coatings
Binders for compression
Bioavailabilityenhancers
Surfactants
Disintegrants
& Services
Galenic expertise
Application laboratory
Tests and productdevelopments in
partnership
Process optimisation
Encapsulation technology
Trainings:Sepischool-Dermoschool
Regulatory support
SOLID ORAL DOSAGE FORMSOFFER
Solid oral dosage forms
LIQUID & SEMI-SOLIDORAL DOSAGE FORMS
OFFER
Solubilizers & Emulsifiers (1/4)
Solubilizers non ionic surfactants
Montanox, Polysorbates
- Hydrophilic surfactants, soluble or dispersiblein water
- Stable in acidic or alkaline media (pH: 4 to 10)and in presence of electrolytes
- Excellent solubilizers of essential oils
Simulsol, Castor oil based solubilizer
- Soluble or dispersible in water andvegetable oils
- Stable in acidic or alkaline media andin presence of electrolytes
- Often used for hot solubilisation
Use: alone or with a co-solubilizer to enhance solubility of poorly or nonsoluble in water active
Formulation of syrups, suspensions but also tablets, capsules, creams…
Actives Advised solubilizer
Fenofibrate,Ibuprofen
Montanox 20 PHA PREMIUM
Ibuprofzne,Carbamazepine,Verapamil,Diclofenac
Montanox 80 PHA PREMIUM
Paclitaxel,Diclofenac
Simulsol 1285 PHA
Tramadol,Progesterone
Simulsol 1292 PHA
Carbamazepine,Diclofenac,Ciclosporine
Simulsol 4000 P
Examples of solubilized actives
Emulsifiers non ionic surfactants
Solubilizers & Emulsifiers (2/4)
Montanox, Polysorbates
- Hydrophilic surfactants to form O/W emulsions
- Soluble and dispersible in water and organicsolvents
Montane, Sorbitan esters
- Lipophilic surfactants to formW/O emulsions
- Soluble and dispersible in oil
Simulsol, Ethoxylated fatty acids
- Hydrophilic surfactants to formvery stable O/W emulsions
- Soluble or dispersible in water
- Intended for emulsions containinglow proportions of oil phase
Simultaneous use of 2 surfactants: one hydrophilic and the other lipophilic,to formulate very stable emulsions
Optimisation of emulsion formulation by testing (through experiments)various concentrations of each surfactant
Formulation of syrups, suspensions but also creams, ointments…
Solubilizers & Emulsifiers (3/4)
Quality Requirements
DF+ Dioxan Free+ Cosmetic grade+ Statistical control of EP conformity
PHA PREMIUM
+ GMP+ Conformed to EP – USP+ Cleaning of vessels with the same product family+ Suppliers audited+ Manufacturing process controlled by quality assurance
PPI
+ Usable injectable product+ GMP+ Conformed to EP – USP – JP+ Cleaning validation+ Final filtration and packaging in controlled atmosphere+ Microbiological control and endotoxins analyses
Regulation : solubilizers and emulsifiers
SEPPIC surfactants are ISO 9001 certified
Strong demand from the pharmaceutical industry to have excipients inconformity with GMP guidelines. SEPPIC has developed a new surfactantrange – PHA PREMIUM – that fully complies with future excipients GMPrequirements, outlined in PQG-IPEC guideline
PREMIUM
Solubilizers & Emulsifiers (4/4)
Chimical name (EO) Function Quality
Montane 20 Sorbitan laurate Lipophilic emulsifier DF – PHA PREMIUM – PPI
Montane 60 Sorbitan stearate Lipophilic emulsifier DF – PHA PREMIUM*
Montane 80 Sorbitan oleate Lipophilic emulsifier DF – PHA PREMIUM – PPI
Montane 85 Sorbitan trioleate Lipophilic emulsifier DF – PHA
Montanox 20 Polysorbate 20Mono-laurate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM – PPI
Montanox 60 Polysobate 60Mono-stearate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM* – PPI
Montanox 80 Polysobate 80Mono-oleate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM – PPI
Simulsol M 45 Macrogol stearate (8) Hydrophilic emulsifier PHA
Simulsol M 52 Macrogol stearate (40) Hydrophilic emulsifier PHA
Simulsol 2599 Macrogol oleate (10) Hydrophilic emulsifier PHA
Simulsol 1285Macrogol glycerolricinoleate (50)
Solubilizer PHA
Simulsol 1292Macrogol glycerolhydroxystearate (25)
Solubilizer PHA
Simulsol 4000 PPolyoxyl-40-hydrogenatedcastor oil (40)
Solubilizer PHA
DF: cosmetic grade PPI: injectable grade * available in june 2012
&
Rebaten
Steviten
SteviaExtract
Liquid & semi-solid oral forms
Solubilizers
Emulsifiers
Montanox
Montane
Simulsol
Sorbitan
esters
Polysorbates
Ethoxylatedmacrogols
Solubilizers for
Direct Compression
Sepitrap™
Purolite
IER
Taste
masking
TOPICAL DOSAGE FORMSOFFER
Solubilizers non ionic surfactants
Use: alone or with a co-solubilizer to enhance solubility of poorly or nonsoluble in water active and thus to improve its bioavailability
Formulation of syrups, suspensions but also tablets, capsules, creams…
Montanox, Polysorbates
- Hydrophilic surfactants, soluble or dispersiblein water
- Stable in acidic or alkaline media (pH: 4 to 10)and in presence of electrolytes
- Excellent solubilizers of essential oils
Simulsol, Castor oil based solubilizers
- Soluble or dispersible in water andvegetable oils
- Stable in acidic or alkaline media andin presence of electrolytes
- Often used for hot solubilisation
Examples of solubilized actives
Solubilizers & Emulsifiers (1/6)
Actifs Solubilisant conseillé
Kétoconazole Montanox 60 PHA PREMIUM
Diclofenac Montanox 80 PHA PREMIUM
Diclofenac Simulsol 1285 PHA
Progesterone Simulsol 1292 PHA
Diclofenac Simulsol 4000 P
Emulsifiers non ionic surfactants
Montane, Sorbitan esters
- Lipophilic surfactants to formW/O emulsions
- Soluble and dispersible in oil
Solubilizers & Emulsifiers (2/6)
Montanox, Polysorbates
- Hydrophilic surfactants to form O/W emulsions
- Soluble and dispersible in water and organicsolvents
Simulsol, Ethoxylated fatty acids
- Hydrophilic surfactants to formvery stable O/W emulsions
- Soluble or dispersible in water
- Intended for emulsions containinglow proportions of oil phase
Simultaneous use of 2 surfactants: one hydrophilic and the other lipophilic,to formulate very stable emulsions
Optimisation of emulsion formulation by testing (through experiment)various concentration of each surfactant
Formulation of creams, ointments but also syrups, suspensions …
SEPPIC surfactants are ISO 9001 certified
Strong demand from the pharmaceutical industry to have excipients inconformity with GMP guidelines. SEPPIC has developed a new surfactantrange – PHA PREMIUM – that fully complies with future excipients GMPrequirements, outlined in PQG-IPEC guideline
Solubilizers & Emulsifiers (3/6)
Quality Requirements
DF+ Dioxan Free+ Cosmetic grade+ Statistical control of EP conformity
PHA PREMIUM
+ GMP+ Conformed to EP – USP+ Cleaning of vessels with the same product family+ Suppliers audited+ Manufacturing process controlled by quality assurance
PPI
+ Usable injectable product+ GMP+ Conform to EP – USP – JP+ Cleaning validation+ Final filtration and packaging in controlled atmosphere+ Microbiological control and endotoxins
PREMIUMRegulation : solubilizers and emulsifiers
DF: cosmetic grade PPI: injectable grade * available in june 2012
Solubilizers & Emulsifiers (4/6)
Chimical name (EO) Function Quality
Montane 20 Sorbitan laurate Lipophilic emulsifier DF – PHA PREMIUM – PPI
Montane 60 Sorbitan stearate Lipophilic emulsifier DF – PHA PREMIUM
Montane 80 Sorbitan oleate Lipophilic emulsifier DF – PHA PREMIUM – PPI
Montane 85 Sorbitan trioleate Lipophilic emulsifier DF – PHA
Montanox 20 Polysorbate 20Mono-laurate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM – PPI
Montanox 60 Polysobate 60Mono-stearate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM – PPI
Montanox 80 Polysobate 80Mono-oleate (20)
Hydrophilic emulsifierSolubilizer
DF – PHA PREMIUM – PPI
Simulsol M 45 Macrogol stearate (8) Hydrophilic emulsifier PHA
Simulsol M 52 Macrogol stearate (40) Hydrophilic emulsifier PHA
Simulsol 2599 Macrogol oleate (10) Hydrophilic emulsifier PHA
Simulsol 1285Macrogol glycerolricinoleate (50)
Solubilizer PHA
Simulsol 1292Macrogol glycerolhydroxystearate (25)
Solubilizer PHA
Simulsol 4000 PPolyoxyl-40-hydrogenatedcastor oil (40)
Solubilizer PHA
Solubilizers & Emulsifiers (5/6)
Chimical name (EO) Function Quality
Simulsol P4 Macrogol lauryl ether (4) Hydrophilic emulsifier PHA
Simulsol P23 Macrogol lauryl ether (23) Hydrophilic emulsifier PHA
Simulsol 58 Macrogol cetostearyl ether (20) Hydrophilic emulsifier PHA
Simulsol 68 Macrogol cetostearyl ether 22) Hydrophilic emulsifier PHA
Simulsol 165 PHA, glucerol-based surfactant combined with apolyoxyethylenated emulsifier
Intended for use in acidic or electrolyte-containing O/W emulsion
Used alone: as self-emulsifier wax:
+ disperses easily in water
+ acts as emulsifier, effective opacifyingagent and gelling agent
Concentration Consistency Stability5% Fluid milk Good
10% Milk Excellente
15% Thick milk Excellente
20% Liquid cream Excellente
25% Thick cream Excellente
Solubilizers & Emulsifiers (6/6)
Montane, Montanox, Simulsol, valuable surfactants to simplify thechoice of emulsifying systems in the development of the various formulationsthat can be used in pharmaceuticals
Ointments, creams , gels, lotions, onguents…
Oil/Water emulsions
SIMULSOL™ 165 PHAMONTANE™ 60 PHA PREMIUM /MONTANOX™ 60 PHA PREMIUMMONTANE™ 60 PHA PREMIUM/SIMULSOL™ 58 PHASIMULSOL™ P 4 PHA/SIMULSOL™ P 23 PHASIMULSOL™ M 52 PHA/MONTANE™ 60 PHA
Water/Oil emulsions MONTANE™ 80 PHA PREMIUM, MONTANE™ 85 VG PHA
Lipophilic anhydrous ointmentsMONTANE™ 80 PHA PREMIUMMONTANE™ 85 VG PHA
Hydrophilic anhydrous ointments SIMULSOL™ 165 PHA
Topical forms
SolubilizersEmulsifiers
Sepineo P600 Co-polymer
Emulsifier – thickener – stabilizer
Sepineo SE 68 APG self-emulsifier
Montane Sorbitan Esters
Montanox Polysorbates
Simulsol Ethoxylated macrogolsINNOVATION in formulationemulsion – gel – cream
Foaming agents
Amonyl Betaine amphoteric derivatives
Oramix APG, non-ionic
Foaming agent for antiseptic formulation
Foaming agent
Amonyl, Betaine derivatives
- Amphoteric foaming agent
- Soluble in water, very stable and lowsensitivity to pH variation to form astable foam
Solubilisation of antimicrobial active agents without altering their properties
Use in antiseptic products and as foaming agent in hydro-alcoholic gel, shampooand other antiseptic products
Oramix, APG: AlkylPolyGlucoside
- Non-ionic foaming agent
- Can be easily combined with other cationic,anionic ornon-ionic agents
Chemical name Foaming aptitudeCleansingproperties
Oramix NS 10 DecylglucosideVery good, developsgood volume of foam
Very good
Amonyl 265 BA Betaine CocoalkyldimethylGood, resistant to highcontent in electrolyte
Good &bacteriostatic
propertiesAmonyl 380 BA Betaine Cocoamidopropyl
Amonyl 440 NI Betaine Cocoamidopropyl - -
Amonyl 675 SBHydroxySulfobetaineCocoamidopropyl
Stable, resistant to highcontent in electrolyte
Good
Sepineo P600 (1/2)
SEPINEO™ P600, 3 in 1 polymer, to formulate instantly non tacky gels orcreams showing non greasy and light texture
Thickening power, in aqueous or organic medium over a large pH range
Stabilizing power, not sensitive to shear, use at low concentration to stabilize andmaintain viscosity of oil/water emulsions
Emulsifying polymer, no HLB calculation, to obtain an innovative texture gel-cream
Ready to use liquid form, easy to handle at room temperature, no neutralization, norehydratation
DMF type IV
GELaqueous, hydro-alcoholic,
with solvents…
GEL - CREAMEmulsions with
Different oily phases
+ Water+ Water
+ Water+ Water++ OilOil
Sepineo P600 (2/2)
SEPINEO™ P600, simple process at room temperature
Water/oil emulsion, formulated in indirect mode with an intern phase up to 90%
Gel, single phase for hydrophilic actives
Hydro-alcoholic gel, ethanol up to 70%, often used to increase API solubility andpermeability
Anhydrous gel, support dedicated to water sensitive API
Gel-cream, 2 phases system (up to 40% of lipophilic phase) without emulsionprocess at room temperature
Increase compliance:
+ light texture
+ non sticky
+ non greasy…
Technical presentation
Technical presentation
Sepineo SE 68
SEPINEO™ SE 68, AlkylPolyGlucoside (APG) self-emulsifier promoting verystable oil in water emulsion
Self-emulsifier dedicated to form emulsion with no HLB calculation and without specificaddition of fatty phase. It is possible to achieve anhydrous emulsion with water sensitiveactives
Innovative texture with pronounced rheo-fluidity, hence favouring a uniform andhomogenous spreading of API at the skin surface improve compliance
Natural polymer - non ethoxylated - with excellent skin tolerance, stable over a widerange of pH and with electrolytes
Wide compatibility with fatty phases, thanks to its glucolipid structure
Emulsion stable with various fatty phase concentrations, up to 60%
DMF type IV
Sepineo SE 68 is able topromote liquid crystals,regardless of the nature of oilphase: esters, silicon oils,vegetable oils…
Lamellar bi-layers obtained with SEPINEO SE 68 fully surround the oil droplet andform a stable, rigid shell preventing coalescence
ACTIVES – INGREDIENTSOFFER
&
REBATEN
STEVITENStevia Extract
naturalsweeteners
Actives and Ingredients
Anti-carie Anti-fungal
Intestinal antiseptic Rubefacients
Other pharmaceutical actives
NaturalNutritional
Actives
PROLIVOLS
AROLIA EXTRAMELEXTRAMEL
PROVINOLS
CERAMOSIDESCERAMOSIDES
Mineral SaltsMineral Salts
(API and nutritional(API and nutritionalgrades)grades)
FeNa
CaMg
ZnLi
CuMn
K
GIVOMAG
MagnesiumGlycerophosphate
Calci-pressDestab Descote
Heavy MgO
GIVOCALCalcium
Glycerophosphate
AminoAcids
Nutritional actives
AntioxidantAntiageDermonutrition
Cardiovascularhealth& LipidMetabolism
Stress, fatigue&Cognitivehealth
Sportnutrition& vitality
WeightcontrolSlimming
Bone health Menopause
EXTRAMELEncapsulated melonSuperoxide dismutase
AROLIAAçai extractPolyphenols
PROVINOLSRed wine extractPolyphenols
PROLIVOLSOlive extractPolyphenols
GIVOCALCalciumGlycérophosphate
GIVOMAGMagnesiumGlycerophosphate
REBATEN 97%Stevia extractRebaudioside A
CERAMOSIDESWheat extractCeramides and DGDG
Other minerals:Cu, Zn, Fe, Mn, K
NotaLes seules spécifications analytiques garanties sont celles figurant dans le bulletin d’analyse fourni à chaque livraison de produit.SEPPIC* ne donne aucune garantie, implicite, expresse ou légale, autre que la garantie limitée décrite ci-dessus, pour le produit objet de ce document. Sans préjudice desdispositions qui précèdent, SEPPIC* ne donne aucune garantie quant à la qualité loyale et marchande du produit ou à son aptitude à un usage particulier. L’utilisationet/ou la vente du produit, seul ou associé à d’autres marchandises, se feront sous la seule responsabilité du client. Les informations contenues dans ce document sontfournies gracieusement, et sont données à titre indicatif ; elles sont basées sur l’état des connaissances de SEPPIC* relatives au produit à cette date et sont données debonne foi. Ces informations sont destinées à des personnes ayant une compétence technique et les utilisant à leurs risques et périls. Etant donné que l’utilisation de cesinformations est en dehors du contrôle de SEPPIC*, SEPPIC* ne donne aucune garantie, implicite ou expresse, et n’assume aucune responsabilité quant à l’utilisation deces informations. En particulier, le client devra vérifier qu’il ne contrevient pas à des brevets existants.
* SEPPIC étant :
SEPPIC S.A. Head Office SEPPIC Japan Office SEPPIC Italia Srl22 Terrasse Bellini 75, quai d'Orsay Air Liquide Japan's office Via Quarenghi 2792806 Puteaux 75007 Paris Granpark Tower 3-4-1 Shibaura 20151 MilanoFRANCE FRANCE Minato-ku, Tokyo 108-8509 ITALYTel. : +33 (0)1 42 91 40 00 JAPAN Tel : +39 02 [email protected] Tel : +81 3 6414 6725 [email protected]
SEPPIC UK Ltd SEPPIC Inc. SEPPIC Pologne Office SEPPIC Brasil
50, Salisbury Road 30, Two Bridges Road, suite 210 CCIF Rua Libero Badaro, 182PO Box 338 - Hounslow - TW4 6SH Fairfield, Ul. Widok 8 8° andar - CentroENGLAND New Jersey 07004-1530 00-023 Varsovie 01008-000 Sao Paolo SPTel. : +44 208 577 8800 USA POLAND [email protected] Tel. : +1 973 882 5597 Tel : +48 22 690 68 73 Tel : +55 11 3242 3911
[email protected] [email protected] [email protected]
SEPPIC Asia Singapore SEPPIC Dubaï Office SEPPIC Gmbh SEPPIC Colombia SAS120 Lower Delta Road # 13 – 11 Dubaï Airport Free Zone Von-der-Wettern-STR.27 Calle 71 N°10-40Cendex Center West Wing 4 B, Suite 144 51149 Köln Edificio Orbe 71 of 401Singapore 169208P.O. Box _ 54638, Po Box 54638 Dubaï GERMANY BogotaSINGAPORE UAE Tel. : +49 (0) 2203-89830-20 COLOMBIATel : +65 6278 6711 Tel : +971 4 239 5565 [email protected] Tel : +(571) 702 44 [email protected] [email protected] [email protected]
SEPPIC Chine SEPPIC Mumbai
Room 510 Jin Tai Bulding B-110, Knox Plaza58 South Mao Ming Road MindSpace, Off Chincholi bunder rdShanghai 200020 Malad (W) Mumbai – 400064CHINA INDIATel : +86 (21) 64 66 01 49 Tel : +91 22 [email protected] [email protected]
5640/GB/02/November 2011
