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

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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

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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