excipient guide gattefosse
DESCRIPTION
Fatty Acid EstersTRANSCRIPT
PHARMACEUTICAL EXCIPIENTSORAL TOPICAL RECTAL
QUICK PRODUCT REFERENCE GUIDE
PHARMACEUTICAL PERFORMANCE POWERED BY GATTEFOSSÉ
FROM MULTI-FUNCTIONAL EXCIPIENTS
TO DRUG DELIVERY SOLUTIONS
WORLDWIDE PRESENCE
UNMATCHED TECHNICAL SUPPORT
UNIQUE FORMULATION SOLUTIONS
DSHEA: DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT
E471 AND E477: EUROPEAN FOOD ADDITIVE
EP: EUROPEAN PHARMACOPEIA
FCC: FOOD CHEMICAL CODEX
GRAS: GENERALLY RECOGNIZED AS SAFE
IIG: FDA INACTIVE INGREDIENT GUIDE
JPED: JAPANESE PHARMACEUTICAL EXCIPIENT DIRECTORY
JSFA: JAPANESE STANDARDS FOOD ADDITIVE
SELF: SELF EMULSIFYING LIPID FORMULATION
USFA: US FOOD ADDITIVE
USIFA: US INDIRECT FOOD ADDITIVE
USP-NF: US PHARMACOPEIA-NATIONAL FORMULARY
TABLE OF ACRONYMS
DIRECT COMPRESSION
HOT MELT COATING
ADSORPTION ONTO SOLIDS
MELT GRANULATION
SPRAY COOLING
MELT EXTRUSION
HOMOGENIZATION
EMULSIFICATION
MELTING
OUR PRODUCTS ARE DESIGNED TO MEET THE FORMULATION CHALLENGES OF RAPIDLY DEVELOPING MARKETS,NOTABLY IN SOLUBILITY AND BIOAVAILABILITY ENHANCEMENT AS WELL AS SUSTAINED RELEASE APPLICATIONS.
FURTHER TO THESE FUNCTIONALITIES, GATTEFOSSÉ LIPIDS HAVE BEEN APPLIED IN A NUMBER OF WELL ESTABLISHED FORMULATION TECHNIQUES TO CREATE NOVEL AND EFFECTIVE DOSAGE FORMS OF VARYING PHYSICAL ATTRIBUTES SUCH AS POWDERS, GRANULES, TABLETS AND CAPSULES.
PRODUCT
DESCRIPTION ORAL
TOPI
CAL
RECT
AL OR
VAGI
NAL
REGULATORYSTATUS
CAPRYOL™90
COMPRITOL®888 ATO
COMPRITOL®HD 5 ATO
Behenoyl polyoxyl-8 glycerides
Glyceryl behenate
GELUCIRE® 33/01
GELEOL™ MONO AND
DIGLYCERIDES NF
Propylene glycol monocaprylateType II (monoesters > 90%)
CAPRYOL™PGMC
Mono & diglycerides NFGlyceryl monostearate EP
Propylene glycol monocaprylateType I (monoesters > 60%)
Hard fat
Geloil Hard fatGELUCIRE®
39/01
IIG, USP-NF, FCC, USFA, JSFA
Liquid - Oily vehicle; Solubilizer
IIG, USP-NF, FCC, USFA, JSFA
Liquid - Oily vehicle; Solubilizer
IIG, USP-NF, EP, FCC, GRAS, JSFA
Atomized powder - Lubricant; Sustained release agent; Taste masking agent; Lipidic matrix
USP-NF pendingAtomized powder - Lubricant for effervescent, chewable and fast dissolving tablets
IIG, USP-NF, EP, FCC, GRAS, E471, JSFA
Pellets - Semi solid vehicle; Non-ionic thickener for emulsions
IIG, USP-NF, JPED, Grandfathered under DSHEA, JSFA
Waxy solid - Inert vehicle; Carrier or protective matrix for sensitive drugs
Glyceryl stearate (and) PEG-75 stearate
GELOT™64
IIGPellets - O/W Emulsifi er for diffi cultactives, alcoholic extracts, polar lipids, high heat stability and pH range of 3 to 12
IIG, USP-NF, EP, JPED, Grandfathered under DSHEA, JSFA
Pellets - Inert vehicle; Carrier or protective matrix; Sustained release agent
Geloil GELUCIRE®
44/14IIG, USP-NF, EP, USFA
Waxy solid - Solubility and bioavailability enhancer; Lipidic matrix; Component of SELF
Lauroyl polyoxyl-32 glycerides
GELUCIRE®
50/13Stearoyl polyoxyl-32 glycerides
IIG, USP-NF, EP, USFA
Pellets - Solubility and bioavailabilityenhancer; Lipidic matrix; Component of SELF
LABRAFAC®LIPOPHILE WL 1349
Medium chain triglyceridesIIG, USP-NF, JPED, Grandfathered under DSHEA, JSFA
Liquid - Oily vehicle; Solubilizer
Geloil LABRAFAC®
PGIIG, USP-NF pending, USFA, E477, JSFA
Liquid - Oily vehicle; Solubilizer;Bioavailability enhancer; Component of SELF
Propylene glycol dicaprylocaprate
LABRAFIL®M1944CS
Oleoyl polyoxyl-6 glycerides IIG, USP-NF, EPLiquid - Oily vehicle; Solubilizer; Bioavailability enhancer; Component of SELF
Geloil LABRAFIL®M2125CS
IIG, USP-NF, EPLiquid - Oily vehicle; Solubilizer; Bioavailability enhancer; Component of SELF
Linoleoyl polyoxyl-6 glycerides
LABRAFIL®M2130CS
Lauroyl polyoxyl-6 glycerides EPWaxy solid - Oily vehicle; Solubilizer; Bioavailability enhancer; Component of SELF
FORM - APPLICATION
Geloil LABRASOL® IIG, USP-NF, EPLiquid - Solubilizer; Bioavailability enchancer; Component of SELF
Caprylocaproyl polyoxyl-8glycerides
GELUCIRE®
43/01Hard fat
IIG, USP-NF, EP, JPED, Grandfathered under DSHEA, JSFA
Pellets - Inert vehicle; Carrier or protective matrix; Sustained release agent
LAUROGLYCOL™
FCCPropylene glycol monolaurateType I (monoesters 45-70%)
EPLiquid - Oily vehicle; Solubilizer; Bioavailability enhancer; Component of SELF
MAISINE™
35-1Glyceryl monolinoleate
USP-NF, EP, FCC,GRAS, E471, JSFA
Viscous liquid - Oily vehicle; Solubilizer;Bioavailability enhancer; Component of SELF
MONOSTEOL™ Propylene glycolmonopalmitostearate
IIG, EP,Grandfathered underDSHEA
Liquid - Thickening agent; Stabilizer foremulsions
MONTHYLE™ Ethylene glycolpalmitostearate and stearate
IIG, USP-NF, EPPellets - Thickening agent; Stabilizer foremulsions
OVUCIRE®
SERIESHard fat (semi-syntheticglycerides) + additive(s)
/Waxy solid or pellets - Unique blends with varying texture and wettingproperties adapted for vaginal pessaries
PECEOL™ Glyceryl monooleateIIG, USP-NF, EP, FCC, GRAS, E471, JSFA
Viscous liquid - Oily vehicle; Solubilizer;Component of SELF
PLUROL®
DIISOSTEARIQUEPolyglyceryl-3 diisostearate EP
Liquid - W/O emulsifi er for lotions and creams; Excellent for dispersions & apolar oils
PLUROL®
OLEIQUE CC497Polyglyceryl-3 dioleate
IIG, FCC, USFA,E471, JSFA
Viscous liquid - Solubility and bioavailability enhancer; Cosurfactant for emulsions
PRECIROL®
ATO 5Glyceryl palmitostearate
IIG, USP-NF, EP, FCC, GRAS, JSFA
Atomized Powder - Lubricant; Sustained release agent; Taste masking agent; Lipidic matrix
SUPPOCIRE®
STANDARD SERIESHard fat (semi-syntheticglycerides)
IIG, USP-NF, EP,JPED
Waxy solid or pellets - Universal bases(interesterifi ed lipids) for suppositories and pessaries; compatible with many actives
SUPPOCIRE®
N TYPEHard fat (semi-syntheticglycerides)
IIG, USP-NF, EP,JPED
Waxy solid or pellets - Suppository bases (esterifi ed lipids) for high rate of manu-facture and high mechanical resistance
SUPPOCIRE®
P TYPESaturated polyglycolyzedglycerides
IIG, USP-NF, EP,JPED
Waxy solid or pellets - Amphiphilic sup-pository bases for enhancing solubility and bioavailability
TEFOSE®
63PEG-6 stearate (and) glycolstearate (and) PEG-32 stearate
IIGWaxy solid - O/W Emulsifi er for topical and vaginal creams; High mucosal toler-ance; Low-energy, one-pot processing
PRODUCT DESCRIPTIONREGULATORY
STATUS FORM - APPLICATION
TEFOSE®
1500PEG-6 stearate (and) PEG-32 stearate
IIG, JPEDWaxy solid - O/W Emulsifi er for fl uid emulsions (lotions) and soft creams
TRANSCUTOL®
HPDiethylene glycol monoethyl ether (>99.9%)
IIG, USP-NF, EP, USIFA
Liquid - Highest purity solubilizer; Component of SELF, emulsions and microemulsions
TRANSCUTOL®
PDiethylene glycol monoethyl ether (>99.7%)
IIG, USP-NF, EP, USIFA
Liquid - High purity solubilizer; Topical penetration enhancer; Component of microemulsions
ORAL
TOPI
CAL
RECT
AL OR
VAGI
NAL
LAUROGLYCOL™
90Propylene glycol monolaurateType II (monoesters > 90%)
EPLiquid - Oily vehicle; Solubilizer; Bioavailability enhancer; Component of SELF
WE REMAIN COMMITTED TO ADVANCING KNOWLEDGE
SCIENTIFIC ARTICLES, POSTERS, FORMULINKS AND TECHNICAL BULLETINS
ACTIVE MEMBER OF VARIOUS GLOBAL ASSOCIATIONS AND ORGANIZATIONS (AAPS, CRS, IPEC...)
PARTICIPATION IN SYMPOSIA AND WORKSHOPS WITH SPEAKERS, POSTERS, AND PRESENTATIONS
GENERAL OR CUSTOMIZED TRAINING ON LIPIDIC EXCIPIENTS (LIPID SCHOOLS)
SPONSOR OF SCIENTIFIC AWARDS FOR LIPID BASED DRUG DELIVERY (AAPS)
OVER 40 YEARS OF ORGANIZED SUPPORT FOR ST. RÉMY DE PROVENCE CONFERENCES
FORWARD THINKING SINCE 1880
GATTEFOSSÉ USA650 FROM ROAD, SUITE 176PARAMUS, NEW JERSEY 07652
TELEPHONE: +1.201.265.4800FAX: +1.201.265.4853
EMAIL: [email protected]
WEBSITE: WWW.GATTEFOSSECORP.COM
GATTEFOSSÉ WORLDWIDE CORPORATE HEADQUARTERS
36 CHEMIN DE GENAS - BP 603F-69804 SAINT-PRIEST CEDEX - FRANCE
TELEPHONE: +33.472.22.98.00FAX: +33.478.90.45.67
WEBSITE: WWW.GATTEFOSSE.COM
GATTEFOSSÉ IS A LEADING PROVIDER OF EXCIPIENTS AND FORMULATION SOLUTIONS
FOR THE HEALTH INDUSTRIES WORLDWIDE