SEPPIC. Pharmaceutical and Nutraceutical Offer. An affiliate of

Transcription

1 SEPPIC Pharmaceutical and Nutraceutical Offer An affiliate of

2 SEPPIC, Air Liquide subsidiary Air Liquide, French group, world leader in gases for industrial applications and healthcare Air Liquide supplies to food and pharmaceutical industries with N 2, CO 2, O turnover : 13,5 billions 1 million customers worldwide patents and inventions employees Member of Air Liquide Group since turnover: 260 millions Industrial sites: Castres - France, Shanghai - China m 2 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

3 Commercial activities Excipients Cosmetic Surfactants Emollients Thickeners Emulsifiers Actives Preservatives Moisturizers Free rad. scavengers Smoothers Anti wrinkle Pharmacy & Nutrition Excipients Surfactants Emulsifiers-Solubilizers Film-coatings Binders-Fillers Actives and ingredients Mineral salts Stevia Nutritional ingredients Adjuvants for Vaccine & Injectable Injectable surfactants Adjuvants for vaccines Industrial specialities Functional additives Surfactants for coating, inks Oil field, Paper, Glass Frosting

4 Pharmacy & Nutrition activity SEPPIC, renowned specialist of excipients, actives and ingredients dedicated to pharmaceutical, nutraceutical and food applications Customer applications Solid oral dosage forms (excipients) Liquid & semi-solid oral dosage forms (excipients) Topical dosage forms (excipients) Actives Ingredients (all forms) SEPPIC Solutions Excipients Film-coatings Binders for compression Bioavailability enhancers Surfactants Disintegrants Actives - Ingredients Nutritional actives Mineral salts Sweeteners & Services Galenic expertise Application laboratory Tests and product developments in partnership Process optimisation Encapsulation technology Trainings: Sepischool-Dermoschool Regulatory support

5 SOLID ORAL DOSAGE FORMS OFFER

6 Solid oral dosage forms

7 LIQUID & SEMI-SOLID ORAL DOSAGE FORMS OFFER

8 Solubilizers & Emulsifiers (1/4) Solubilizers non ionic surfactants Use: alone or with a co-solubilizer to enhance solubility of poorly or non soluble in water active Formulation of syrups, suspensions but also tablets, capsules, creams Montanox, Polysorbates - Hydrophilic surfactants, soluble or dispersible in 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 and vegetable oils - Stable in acidic or alkaline media and in presence of electrolytes - Often used for hot solubilisation Examples of solubilized actives Actives Fenofibrate, Ibuprofen Ibuprofzne, Carbamazepine, Verapamil, Diclofenac Paclitaxel, Diclofenac Tramadol, Progesterone Carbamazepine, Diclofenac, Ciclosporine Advised solubilizer Montanox 20 PREMIUM Montanox 80 PREMIUM Simulsol 1285 Simulsol 1292 Simulsol 4000 P

9 Solubilizers & Emulsifiers (2/4) Emulsifiers non ionic surfactants 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 Montane, Sorbitan esters Montanox, Polysorbates - Lipophilic surfactants to form W/O emulsions - Hydrophilic surfactants to form O/W emulsions - Soluble and dispersible in oil Simulsol, Ethoxylated fatty acids - Hydrophilic surfactants to form very stable O/W emulsions - Soluble or dispersible in water - Intended for emulsions containing low proportions of oil phase - Soluble and dispersible in water and organic solvents

10 Solubilizers & Emulsifiers (3/4) Regulation : solubilizers and emulsifiers SEPPIC surfactants are ISO 9001 certified PREMIUM Strong demand from the pharmaceutical industry to have excipients in conformity with GMP guidelines. SEPPIC has developed a new surfactant range PREMIUM that fully complies with future excipients GMP requirements, outlined in PQG-IPEC guideline Quality DF PREMIUM PPI Requirements Dioxan Free Cosmetic grade Statistical control of EP conformity GMP Conformed to EP USP Cleaning of vessels with the same product family Suppliers audited Manufacturing process controlled by quality assurance Usable injectable product GMP Conformed to EP USP JP Cleaning validation Final filtration and packaging in controlled atmosphere Microbiological control and endotoxins analyses

11 Solubilizers & Emulsifiers (4/4) Chimical name (EO) Function Quality Montane 20 Sorbitan laurate Lipophilic emulsifier DF PREMIUM PPI Montane 60 Sorbitan stearate Lipophilic emulsifier DF PREMIUM* Montane 80 Sorbitan oleate Lipophilic emulsifier DF PREMIUM PPI Montane 85 Sorbitan trioleate Lipophilic emulsifier DF Montanox 20 Polysorbate 20 Montanox 60 Polysobate 60 Montanox 80 Polysobate 80 Mono-oleate (20) Solubilizer Solubilizer Solubilizer Simulsol M 45 Macrogol stearate (8) Simulsol M 52 Macrogol stearate (40) Simulsol 2599 Macrogol oleate (10) Solubilizer Solubilizer Solubilizer Mono-laurate (20) Mono-stearate (20) Macrogol glycerol ricinoleate (50) Macrogol glycerol Simulsol 1292 hydroxystearate (25) Polyoxyl-40-hydrogenated Simulsol 4000 P castor oil (40) Simulsol 1285 DF: cosmetic grade DF PREMIUM PPI DF PREMIUM* PPI DF PREMIUM PPI PPI: injectable grade * available in june 2012

12 Liquid & semi-solid oral forms Rebaten & Steviten Montane Sorbitan esters Stevia Extract Montanox Polysorbates Purolite Simulsol IER Ethoxylated macrogols Emulsifiers Solubilizers Sepitrap Solubilizers for Direct Compression Taste masking

13 TOPICAL DOSAGE FORMS OFFER

14 Solubilizers & Emulsifiers (1/6) Solubilizers non ionic surfactants Use: alone or with a co-solubilizer to enhance solubility of poorly or non soluble in water active and thus to improve its bioavailability Formulation of syrups, suspensions but also tablets, capsules, creams Montanox, Polysorbates - Hydrophilic surfactants, soluble or dispersible in water Examples of solubilized actives Actifs Solubilisant conseillé - Stable in acidic or alkaline media (ph: 4 to 10) and in presence of electrolytes Kétoconazole Montanox 60 PREMIUM - Excellent solubilizers of essential oils Diclofenac Montanox 80 PREMIUM Diclofenac Simulsol Soluble or dispersible in water and vegetable oils Progesterone Simulsol Stable in acidic or alkaline media and in presence of electrolytes Diclofenac Simulsol 4000 P Simulsol, Castor oil based solubilizers - Often used for hot solubilisation

15 Solubilizers & Emulsifiers (2/6) Emulsifiers non ionic surfactants 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 Montane, Sorbitan esters Montanox, Polysorbates - Lipophilic surfactants to form W/O emulsions - Hydrophilic surfactants to form O/W emulsions - Soluble and dispersible in oil Simulsol, Ethoxylated fatty acids - Hydrophilic surfactants to form very stable O/W emulsions - Soluble or dispersible in water - Intended for emulsions containing low proportions of oil phase - Soluble and dispersible in water and organic solvents

16 Solubilizers & Emulsifiers (3/6) Regulation : solubilizers and emulsifiers PREMIUM SEPPIC surfactants are ISO 9001 certified Strong demand from the pharmaceutical industry to have excipients in conformity with GMP guidelines. SEPPIC has developed a new surfactant range PREMIUM that fully complies with future excipients GMP requirements, outlined in PQG-IPEC guideline Quality DF PREMIUM PPI Requirements Dioxan Free Cosmetic grade Statistical control of EP conformity GMP Conformed to EP USP Cleaning of vessels with the same product family Suppliers audited Manufacturing process controlled by quality assurance Usable injectable product GMP Conform to EP USP JP Cleaning validation Final filtration and packaging in controlled atmosphere Microbiological control and endotoxins

17 Solubilizers & Emulsifiers (4/6) Chimical name (EO) Function Quality Montane 20 Sorbitan laurate Lipophilic emulsifier DF PREMIUM PPI Montane 60 Sorbitan stearate Lipophilic emulsifier DF PREMIUM Montane 80 Sorbitan oleate Lipophilic emulsifier DF PREMIUM PPI Montane 85 Sorbitan trioleate Lipophilic emulsifier DF Montanox 20 Polysorbate 20 Montanox 60 Polysobate 60 Montanox 80 Polysobate 80 Mono-oleate (20) Solubilizer Solubilizer Solubilizer Simulsol M 45 Macrogol stearate (8) Simulsol M 52 Macrogol stearate (40) Simulsol 2599 Macrogol oleate (10) Solubilizer Solubilizer Solubilizer Mono-laurate (20) Mono-stearate (20) Macrogol glycerol ricinoleate (50) Macrogol glycerol Simulsol 1292 hydroxystearate (25) Polyoxyl-40-hydrogenated Simulsol 4000 P castor oil (40) Simulsol 1285 DF: cosmetic grade DF PREMIUM PPI DF PREMIUM PPI DF PREMIUM PPI PPI: injectable grade * available in june 2012

18 Solubilizers & Emulsifiers (5/6) Chimical name (EO) Function Quality Simulsol P4 Macrogol lauryl ether (4) Simulsol P23 Macrogol lauryl ether (23) Simulsol 58 Macrogol cetostearyl ether (20) Simulsol 68 Macrogol cetostearyl ether 22) Simulsol 165, glucerol-based surfactant combined with a polyoxyethylenated emulsifier Intended for use in acidic or electrolyte-containing O/W emulsion Used alone: as self-emulsifier wax: Concentration 5% 10% 15% 20% 25% Consistency Fluid milk Milk Thick milk Liquid cream Thick cream Stability Good Excellente Excellente Excellente Excellente disperses easily in water acts as emulsifier, effective opacifying agent and gelling agent

19 Solubilizers & Emulsifiers (6/6) Montane, Montanox, Simulsol, valuable surfactants to simplify the choice of emulsifying systems in the development of the various formulations that can be used in pharmaceuticals Ointments, creams, gels, lotions, onguents Oil/Water emulsions SIMULSOL 165 MONTANE 60 PREMIUM /MONTANOX 60 PREMIUM MONTANE 60 PREMIUM/SIMULSOL 58 SIMULSOL P 4 /SIMULSOL P 23 SIMULSOL M 52 /MONTANE 60 Water/Oil emulsions MONTANE 80 PREMIUM, MONTANE 85 VG Lipophilic anhydrous ointments MONTANE 80 PREMIUM MONTANE 85 VG Hydrophilic anhydrous ointments SIMULSOL 165

20 Topical forms Solubilizers Emulsifiers Montane Sorbitan Esters Montanox Polysorbates INNOVATION in formulation emulsion gel cream Simulsol Ethoxylated macrogols Sepineo P600 Co-polymer Emulsifier thickener stabilizer Sepineo SE 68 APG self-emulsifier Foaming agents Amonyl Betaine amphoteric derivatives Oramix APG, non-ionic

21 Foaming agent Foaming agent for antiseptic formulation Solubilisation of antimicrobial active agents without altering their properties Use in antiseptic products and as foaming agent in hydro-alcoholic gel, shampoo and other antiseptic products Amonyl, Betaine derivatives Oramix, APG: AlkylPolyGlucoside - Amphoteric foaming agent - Non-ionic foaming agent - Soluble in water, very stable and low sensitivity to ph variation to form a stable foam - Can be easily combined with other cationic, anionic ornon-ionic agents Chemical name Oramix NS 10 Decylglucoside Amonyl 265 BA Betaine Cocoalkyldimethyl Amonyl 380 BA Betaine Cocoamidopropyl Amonyl 440 NI Betaine Cocoamidopropyl Amonyl 675 SB HydroxySulfobetaine Cocoamidopropyl Foaming aptitude Cleansing properties Very good, develops good volume of foam Very good Good, resistant to high content in electrolyte Good & bacteriostatic properties - - Stable, resistant to high content in electrolyte Good

22 Sepineo P600 (1/2) SEPINEO P600, 3 in 1 polymer, to formulate instantly non tacky gels or creams 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 and maintain 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, no rehydratation DMF type IV Water Water Oil GEL aqueous, hydro-alcoholic, with solvents GEL - CREAM Emulsions with Different oily phases

23 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 and permeability Anhydrous gel, support dedicated to water sensitive API Gel-cream, 2 phases system (up to 40% of lipophilic phase) without emulsion process at room temperature Increase compliance: light texture non sticky non greasy Technical presentation

24 Sepineo SE 68 SEPINEO SE 68, AlkylPolyGlucoside (APG) self-emulsifier promoting very stable oil in water emulsion Self-emulsifier dedicated to form emulsion with no HLB calculation and without specific addition of fatty phase. It is possible to achieve anhydrous emulsion with water sensitive actives Innovative texture with pronounced rheo-fluidity, hence favouring a uniform and homogenous spreading of API at the skin surface improve compliance Natural polymer - non ethoxylated - with excellent skin tolerance, stable over a wide range 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 to promote liquid crystals, regardless of the nature of oil phase: esters, silicon oils, vegetable oils Technical presentation Lamellar bi-layers obtained with SEPINEO SE 68 fully surround the oil droplet and form a stable, rigid shell preventing coalescence

25 ACTIVES INGREDIENTS OFFER

26 Actives and Ingredients Mg Ca Fe CERAMOSIDES Na PROLIVOLS K Mn Cu Zn Li Amino Acids Natural Nutritional Actives AROLIA Mineral Salts PROVINOLS EXTRAMEL GIVOMAG (API and nutritional GIVOCAL Magnesium Glycerophosphate grades) Calcium Glycerophosphate Calci-press Destab Descote Heavy MgO REBATEN & STEVITEN Other pharmaceutical actives Anti-carie Anti-fungal Intestinal antiseptic Rubefacients Stevia Extract natural sweeteners

27 Nutritional actives Antioxidant Antiage Dermonutrition EXTRAMEL Encapsulated melon Superoxide dismutase AROLIA Açai extract Polyphenols PROVINOLS Red wine extract Polyphenols PROLIVOLS Olive extract Polyphenols GIVOCAL Calcium Glycérophosphate GIVOMAG Magnesium Glycerophosphate REBATEN 97% Stevia extract Rebaudioside A CERAMOSIDES Wheat extract Ceramides and DGDG Other minerals: Cu, Zn, Fe, Mn, K Cardiovascular health & Lipid Metabolism Stress, fatigue & Cognitive health Sport nutrition & vitality Weight control Slimming Bone health Menopause

28 Nota Les 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 des dispositions 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 utilisation et/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 sont fournies 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 de bonne 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 ces informations est en dehors du contrôle de SEPPIC*, SEPPIC* ne donne aucune garantie, implicite ou expresse, et n assume aucune responsabilité quant à l utilisation de ces informations. En particulier, le client devra vérifier qu il ne contrevient pas à des brevets existants. * SEPPIC étant : SEPPIC S.A. 22 Terrasse Bellini Puteaux FRANCE Tel. : 33 (0) [email protected] Head Office 75, quai d'orsay Paris FRANCE SEPPIC Japan Office Air Liquide Japan's office Granpark Tower Shibaura Minato-ku, Tokyo JAPAN Tel : [email protected] SEPPIC Italia Srl Via Quarenghi Milano ITALY Tel : [email protected] SEPPIC UK Ltd 50, Salisbury Road PO Box Hounslow - TW4 6SH ENGLAND Tel. : [email protected] SEPPIC Inc. 30, Two Bridges Road, suite 210 Fairfield, New Jersey USA Tel. : [email protected] SEPPIC Pologne Office CCIF Ul. Widok Varsovie POLAND Tel : [email protected] SEPPIC Brasil Rua Libero Badaro, andar - Centro Sao Paolo SP BRAZIL Tel : [email protected] SEPPIC Gmbh Von-der-Wettern-STR Köln GERMANY Tel. : 49 (0) [email protected] SEPPIC Colombia SAS Calle 71 N Edificio Orbe 71 of 401 Bogota COLOMBIA Tel : (571) [email protected] SEPPIC Asia Singapore SEPPIC Dubaï Office 120 Lower Delta Road # Dubaï Airport Free Zone Cendex Center West Wing 4 B, Suite 144 Singapore P.O. Box _ 54638, Po Box Dubaï SINGAPORE UAE Tel : Tel : [email protected] [email protected] SEPPIC Chine Room 510 Jin Tai Bulding 58 South Mao Ming Road Shanghai CHINA Tel : 86 (21) [email protected] SEPPIC Mumbai B-110, Knox Plaza MindSpace, Off Chincholi bunder rd Malad (W) Mumbai INDIA Tel : [email protected] 5640/GB/02/November 2011