W O R L D W I D E P O S I T I O N
`
`P H A R M A C E U T I C A L
`
`P E R F O R M A N C E
`
`P O W E R E D
`
`B Y G A T T E F O S S É
`
`O R A L R O U T E
`E X C I P I E N T S
`
`G A T T E F O S S É R E G I O N A L A F F I L I A T E S
`
`2nd Edition Dec. 2004 - 3000 ex
`
`SWITZERLAND
`Gattefossé AG
`Haldenstrasse 11
`CH-6006 LUZERN
`Tel. +41 41 418 40 44
`Fax +41 41 418 40 59
`
`GERMANY
`Gattefossé (Deutschland) GmbH
`Rheincenter, Hauptstrasse 435
`D-79576 WEIL-AM-RHEIN
`Tel. +49 7621 720 07
`Fax +49 7621 79 22 93
`
`REPUBLIC OF KOREA
`(liaison office)
`Gattefossé Korea
`# 202, Gyongbok mansion, 1638-2,
`Seocho-Dong, Seocho-Gu,
`SEOUL 137-880
`Tel. +82 2 582 8956/8957
`Fax +82 2 582 9127/9128
`
`CANADA
`Gattefossé Canada, Inc.
`170 Atwell Drive
`Suite 580
`TORONTO, ON M9W 5Z5
`Tel. +1 416 243 5019
`Fax +1 416 243 8628
`
`U.S.A.
`Gattefossé Corporation
`650 From Road
`Paramus, NEW JERSEY 07652
`Tel. +1 201 265 4800
`Fax +1 201 265 4853
`
`UNITED KINGDOM
`Gattefossé (UK) Limited
`Arc House, Terrace Road South
`Binfield, Bracknell,
`BERKSHIRE RG42 4PZ
`Tel. +44 1344 861 800
`Fax +44 1344 451 400
`
`SPAIN
`Gattefossé España, S.A.
`• Av. Diagonal 460 6° A
`E-08006 BARCELONA
`Tel. +349 3 416 05 20
`Fax +349 3 415 35 46
`• C/Padilla, 73, 1° B
`E-28006 MADRID
`Tel. +349 1 402 13 11/16 12
`Fax +349 1 402 00 82
`
`FRANCE
`Gattefossé France
`Parc des Barbanniers
`5 Promenade de la Bonnette
`F-92632 GENNEVILLIERS Cedex
`Tel. +33 1 41 47 19 00
`Fax +33 1 41 47 19 29
`
`ITALY
`Gattefossé Italia s.r.l.
`Via Derganino 20
`I-20158 MILANO
`Tel. +39 02 39314073
`Fax +39 02 66200440
`
`C O R P O R A T E H E A D Q U A R T E R S
`GATTEFOSSÉ: 36 chemin de Genas - BP 603 - F-69804 SAINT-PRIEST Cedex - FRANCE
`Tel. +33 4 72 22 98 00 - Fax: +33 4 78 90 45 67 - E-mail: infopharma@gattefosse.com
`www.gattefosse.com
`
`AFAQ N°1993/1018b
`
`GATTEFOSSÉ is an independent multinational company which creates,
`develops and manufactures specialized ingredients for the pharmaceutical
`and personal care industries.
`Present in almost 50 countries worldwide, GATTEFOSSÉ provides extensive
`expertise in lipochemistry, biology and extraction from natural sources.
`
`GATTEFOSSÉ offers the pharmaceutical industry innovative functional
`lipidic excipients for bioavailability improvement, sustained release
`formulation, lubrication, taste-masking, solubilization and penetration
`enhancement.
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`

`

`ORAL DELIVERY WITH LIPIDS…
`
`ANSWERING THE NEED FOR FORMULATION SOLUTIONS
`
`Oral drug delivery remains the most preferred route of administration for many drugs. It is however a
`route that poses enormous challenges in the absorption of drugs. The gastrointestinal (GI) tract is a hostile
`environment with complex metabolic barriers to absorption. Moreover, a growing number of newly
`developed drugs have recorded low solubility and complex bioavailability issues which cannot be addressed
`with conventional formulation approaches.
`Fortunately, solutions to poor oral absorption may be found with lipid-based drug delivery systems. Recent
`advances in understanding the influence lipids have on bioavailability, an increasing number of lipidic
`excipients with acceptable regulatory and safety profiles, and emerging lipid based technologies, have
`greatly improved the odds of success with the “lipid approach”. Nowadays, lipidic excipients are applied
`in sustained release, immediate release, taste masking, and bioavailability enhancement formulations, and
`in a number of techniques including direct compression, melt granulation, hot melt coating
`(GATTECOAT® process), and capsule molding.
`Gattefossé is a leading innovator and supplier of lipidic excipients and lipid-based technologies worldwide.
`Serving the pharmaceutical industry for more than a century, Gattefossé has developed a wide range of
`products that meet the needs of the pharmaceutical industry.
`
`Quality first
`Gattefossé products are derived from vegetable origin and manufactured in an ISO 9001 version 2000
`certified facility. High quality and batch-to-batch consistency are guaranteed by Gattefossé’s good
`manufacturing practices.
`Safety and regulatory
`Gattefossé is devoted to the manufacture of products that meet the highest safety and regulatory standards
`set by national and international authorities.
`Safety of our ingredients is supported in part by in-vitro and in-vivo studies, and largely is due to their
`history of use in the marketplace.To support IND, NDA or ANDA filings, Gattefossé can provide customers
`a letter of authorization to refer to our Product Drug Master Files registered with the FDA. Numerous
`commercial references are available throughout the world.
`Advantages of formulating with lipids
`One of the many advantages of formulating with Gattefossé lipids is the elimination of water or organic
`solvents from the process. Examples include: substitution of conventional wet granulation with melt
`granulation using lipids and replacing solvent based polymeric coatings with lipid based hot melt
`agglomeration or coating. Such substitutions lead to highly attractive cost savings while eliminating
`environmental concerns.
`Quite often, a reduced number of excipients is necessary to solve formulation problems.
`Lipid based formulations
`Gattefossé offers a comprehensive range of excipients with varying solubilizing properties, different
`thermoplastic behaviours (based on melt characteristics) and self-emulsifying properties (identified with
`HLB values), that can be applied in a number of applications to achieve a desired drug release profile.
`Recent advances in pharmaceutical technologies allow not only the development of liquid or semi-solid
`formulations filled in capsules, but also the production of solid multiparticulate forms, e.g. microgranules,
`pellets and even tablets.
`
`Sustained Release Agents… See pages 4-5
`
`With lipidic excipients, it is possible to form either a water insoluble matrix or a hydrophobic film around
`an active drug, leading to a controlled release dosage form. This is easily achieved by selecting the
`appropriate lipid excipient(s) in combination with suitable formulation techniques. For example, sustained
`release may be achieved with COMPRITOL® 888 ATO in direct compression or melt granulation using
`excipient levels ranging from 10 to 30% w/w. When hot melt agglomeration or coating in a fluidized air
`bed is considered, the same excipient will provide a sustained release profile at lower ratios (from a few
`percent to 20% w/w), without the need for solvents. Alternately, solid dispersions in capsules may lead to
`sustained release dosage forms. Furthermore, other new techniques, such as prilling, spray chilling, melt
`extrusion, etc… will allow the formulation of solid dispersion using lipid excipients to produce sustained
`release multiparticulate dosage forms.
`Consequently, a variety of physical forms i.e. granules, pellets or tablets may be obtained.
`
`Bioavailability and solubility enhancers… See pages 6-7 and 8-9
`
`Many scientific articles have been written on the role of lipids in enhancing the oral bioavailability of poorly
`water-soluble compounds. Gattefossé offers a wide range of bioavailability enhancers used in binary
`mixtures as simple oily phase to solubilize the active, or used in the creation of more complex formulations
`such as Self-Emulsifying Drug Delivery Systems (SEDDS) and Self-MicroEmulsifying Drug Delivery
`Systems (SMEDDS®). Self-emulsifying systems tend to instantly form micelles when in contact with
`aqueous media or GI fluids, leading to pseudo-solubilization and enhanced absorption of drug actives. The
`semi-solid and liquid excipients are mainly dedicated to filling in soft and hard gelatin capsules. Most of
`the excipients are compatible with gelatin capsules, HPMC capsules and also softgels. Nevertheless,
`Gattefossé has recently developed new formulation techniques that allow formulation of solid dosage forms
`from liquid and semi-solid excipients. Hence, all liquid and semi-solid excipients listed in this brochure can
`be used directly in capsules, but also in the production of multiparticulate forms, e.g. microgranules, pellets
`and even tablets.
`
`Protection of the API and/or taste-masking agents… See pages 4-5
`
`By forming a lipophilic film and acting as an efficient barrier against water migration, oxygen, or bad taste,
`lipid excipients have proven to be of high interest for many fragile molecules requiring protection.
`
`Powdered lubricants… See pages 10-11
`
`Gattefossé has developed a unique line of spray-cooled excipients. Initially used as "problem solvers", these
`excipients have become first choice lubricants in tabletting and capsule filling applications.
`
`2
`
`ORAL
`
`ORAL
`
`SMEDDS®, COMPRITOL®, GATTECOAT® are registered trademarks of Gattefossé s.a.s.
`
`3
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`

`

`O R A L
`SUSTAINED RELEASE AND TASTE MASKING AGENTS
`
`Products
`Products
`
`Chemical
`Chemical
`description
`description
`
`Regulatory Applications
`Regulatory Applications
`status*
`status (2)
`
`Acid
`Acid
`value
`value
`mg KOH/g
`mg KOH/g
`
`Saponification Hydroxyl
`Iodine
`Saponification Hydroxyl
`Iodine
`value
`value
`value
`value
`value
`value
`gI2/100g mg KOH/g
`mg KOH/g
`gI2/100g mg KOH/g
`mg KOH/g
`
`Melting
`Melting
`range °C
`point
`(drop point)
`°C
`
`HLB
`
`S U S T A I N E D R E L E A S E A G E N T S
`
`Sustained release agent used in tablets, granules and
`COMPRITOL® 888 ATO Glyceryl behenate USP/NF
`and COMPRITOL® 888
`capsules. Used in techniques requiring excipient with (i)
`EP/JPED
`PELLETS
`FCC/GRAS high melting point and (ii) rapid recrystallization upon cooling.
`JSFA
`
`< 4
`
`< 3
`
`145 - 165
`
`COMPRITOL® E
`
`Glyceryl behenate
`
`Same applications as COMPRITOL® 888 ATO or
`JPED
`FCC/GRAS COMPRITOL® 888 PELLETS adapted to food
`E471/JSFA supplement industry.
`
`PRECIROL ATO 5®
`
`Glyceryl
`palmitostearate
`
`Sustained release agent used in tablets, granules and
`USP/NF
`capsules. Used in techniques requiring excipient with (i)
`EP/JPED
`GRAS/FCC low melting point and (ii) high thermoplastic behaviour.
`JSFA
`
`< 5
`
`< 3
`
`137 - 157
`
`< 6
`
`< 3
`
`175 - 195
`
`Glyceryl
`palmitostearate
`
`E471
`
`Same applications as PRECIROL ATO 5® adapted to food
`supplement industry.
`
`< 2
`
`< 2
`
`165 - 180
`
`/
`
`/
`
`/
`
`/
`
`70
`
`74
`
`56
`
`57
`
`2
`
`2
`
`2
`
`2
`
`BIOGAPRESS™
`VEGETAL BM
`297 ATO
`
`GELUCIRE® 50/13
`
`USP/NF
`Stearoyl
`macrogolglycerides EP
`(1)
`
`Bioavailability enhancer with sustained release properties
`when filled into capsules at high concentration.
`High thermoplastic behaviour.
`
`< 2
`
`< 2
`
`67 - 81
`
`36 - 56
`
`50
`
`13
`
`T A S T E - M A S K I N G A G E N T S
`
`PRECIROL ATO 5®
`
`Glyceryl
`palmitostearate
`
`Taste-masking agent used in granules, pellets or tablets.
`USP/NF
`Forms homogenous lipidic film when used in techniques such
`EP
`FCC/GRAS hot melt agglomeration, coating or melt granulation.
`JSFA
`
`< 6
`
`< 3
`
`175 - 195
`
`BIOGAPRESS™
`VEGETAL BM 297 ATO
`
`Glyceryl
`palmitostearate
`
`E471
`
`Same applications as PRECIROL ATO 5® adapted to food
`supplement industry.
`
`< 2
`
`< 2
`
`165 - 180
`
`/
`
`/
`
`56
`
`57
`
`2
`
`2
`
`CUSTOMER SERVICE
`In addition to being a supplier of high-quality
`ingredients, Gattefossé provides its customers
`with an unparalleled level of support services,
`including:
`
`• responsive sales representatives
`• training sessions
`by technical experts
`
`• in-house product support
`• customized technical support.
`
`TECHNICAL ASSISTANCE
`
`Hot Melt Coating (GATTECOAT® process)
`and Melt Pelletization/Melt Granulation
`technologies are available through the
`expertise of our formulators working on Fluid
`Bed Coater (GPCG1, GLATT) or on high
`shear mixers (Mipro,
`Procept; VG25,
`GLATT).
`
`(1) Macrogolglycerides = Polyoxylglycerides
`
`4
`
`(2) Abbreviations: USP/NF = US Pharmacopeia/National Formulary, EP = European Pharmacopeia, GRAS = Generally Recognized As Safe,
`FCC = Food Chemicals Codex, JSFA = Japanese Standard of Food Additives, JPED = Japanese Pharmaceutical Excipients Directory.
`
`ORAL
`
`ORAL
`
`COMPRITOL®, GATTECOAT®, GELUCIRE®, PRECIROL ATO 5® are registered trademarks of Gattefossé s.a.s.
`
`2
`5
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`

`

`SEMI-SOLID AND LIQU ID BIOAVAILABITY ENHANCERS
`
`Products
`
`Chemical
`description
`
`Regulatory Applications
`status (2)
`
`Acid
`value
`mg KOH/g
`
`Saponification Hydroxyl
`Iodine
`value
`value
`value
`gI2/100g mg KOH/g
`mg KOH/g
`
`Melting
`point
`°C
`
`HLB
`
`S E M I - S O L I D B I O A V A I L A B I L I T Y E N H A N C E R S
`GELUCIRE® 44/14
`Lauroyl
`USP/NF
`Low melting point bioavailability enhancer used alone
`macrogol
`EP
`or as surfactant in self-emulsifying system. Can be used to
`glycerides (1)
`pending
`form solid dispersion or in physical mixture with active drug.
`
`GELUCIRE® 50/13
`
`Stearoyl
`macrogol
`glycerides (1)
`
`USP/NF
`EP
`
`High melting point bioavailability enhancer used alone
`or as surfactant in self-emulsifying system. Can be used to
`form solid dispersion or in physical mixture with active drug.
`
`L I Q U I D B I O A V A I L A B I L I T Y E N H A N C E R S
`
`CAPRYOL™ PGMC
`
`Propylene glycol
`caprylate
`
`JPED/JSFA Liquid solubilizer and absorption enhancer. Can be used
`FCC/USFA alone or as co-surfactant in self-emulsifying system.
`
`CAPRYOL™ 90
`
`Propylene glycol
`monocaprylate
`
`JPED/JSFA Liquid solubilizer and absorption enhancer. High solubilizing
`FCC/USFA capacities. Can be used alone or as co-surfactant in
`self-emulsifying system.
`
`LABRAFIL® M 1944 CS Oleoyl macrogol
`glycerides (1)
`
`USP/NF
`EP
`
`Liquid solubilizer and absorption enhancer. Can be used
`alone or as oily phase in self-emulsifying system.
`
`LABRAFIL® M 2125 CS Linoleoyl
`USP/NF
`macrogolglycerides (1)EP
`
`Liquid solubilizer and absorption enhancer. Can be used
`alone or as oily phase in self-emulsifying system.
`
`< 2
`
`< 2
`
`< 0.5
`
`< 1
`
`< 2
`
`< 2
`
`< 2
`
`79 - 93
`
`36 - 56
`
`44
`
`< 2
`
`67 - 81
`
`36 - 56
`
`50
`
`< 1
`
`< 1
`
`285 - 310
`
`270 - 290
`
`/
`
`/
`
`75 - 95
`
`150 - 170
`
`45 - 65
`
`90 - 110
`
`150 - 170
`
`/
`
`NA
`
`NA
`
`NA
`
`NA
`
`14
`
`13
`
`5
`
`6
`
`4
`
`4
`
`CUSTOMER SERVICE
`In addition to being a supplier of high-quality
`ingredients, Gattefossé provides its customers
`with an unparalleled level of
`support services, including:
`
`• responsive sales representatives
`• training sessions
`by technical experts
`
`• in-house product support
`• customized technical support.
`
`LABRASOL™
`
`USP/NF
`Caprylocaproyl
`macrogolglycerides (1)EP
`
`Liquid solubilizer and absorption enhancer. Can be used
`alone or as surfactant in self-emulsifying system.
`
`LAUROGLYCOL™ FCC
`
`Propylene glycol
`laurate
`
`EP/JPED/FCCLiquid solubilizer and absorption enhancer. Can be used
`USFA/JSFA alone or as surfactant in self-emulsifying system.
`
`LAUROGLYCOL™ 90
`
`Propylene glycol
`monolaurate
`
`Liquid solubilizer and absorption enhancer. High solubilizing
`EP/JPED
`FCC/USFA capacities. Can be used alone or as co-surfactant in
`E477/JSFA self-emulsifying system.
`
`MAISINE™ 35-1
`
`Glyceryl
`monolinoleate
`
`PECEOL™
`
`Glyceryl
`monooleate
`
`Liquid, readily dispersible solubilizing agent. Can be used
`USP/NF
`as the oily phase in self-emulsifying system. Particulary
`EP/JPED
`FCC/GRAS adapted to increase bioavailability of high log P active drug.
`E471/JSFA
`
`Liquid, readily dispersible solubilizing agent. Can be used
`USP/NF
`as the oily phase in self-emulsifying system. Particulary
`EP/JPED
`FCC/GRAS adapted to increase bioavailability of high log P active drug.
`E471/JSFA
`
`PLUROL® OLEIQUE
`CC497
`
`Polyglyceryl
`oleate
`
`Liquid solubilizer and absorption enhancer. Can be used
`JPED
`FCC/USFA alone or as co-surfactant in self-emulsifying system.
`E475/JSFA
`
`85 - 105
`
`170 - 205
`
`NA
`
`14
`
`TECHNICAL ASSISTANCE
`
`< 2
`
`< 2.5
`
`< 2.5
`
`/
`
`< 1
`
`< 1
`
`210 - 245
`
`/
`
`NA
`
`200 - 230
`
`195 - 235
`
`NA
`
`Expertise in semi-solid technology
`for bioavailability improvement is offered in
`our application laboratory.
`
`Pilot scale Hibar System equipment
`is available for semi-automatic filling of liquids
`and semi-solids into hard gelatin capsules.
`
`Contract development is also available.
`
`4
`
`5
`
`4
`
`3
`
`< 2
`
`100 - 140 160 - 180
`
`< 3
`
`69 - 95
`
`150 - 170
`
`/
`
`/
`
`NA
`
`NA
`
`< 6
`
`60 - 80
`
`135 - 155
`
`195.5 - 243.5 NA
`
`10
`
`6
`
`(1) Macrogolglycerides = Polyoxylglycerides
`
`(2) Abbreviations: USP/NF = US Pharmacopeia/National Formulary, EP = European Pharmacopeia, JPED = Japanese Pharmaceutical Excipients Directory,
`USFA = US Food Additive, FCC = Food Chemical Codex.
`
`ORAL
`
`ORAL
`
`GELUCIRE®, LABRAFIL®, PLUROL® are registered trademarks of Gattefossé s.a.s
`
`7
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`

`

`SEMI-SOLID AND LIQU ID VEHICLES
`
`Products
`
`Chemical
`description
`
`Regulatory Applications
`status (1)
`
`Acid
`value
`mg KOH/g
`
`Saponification Hydroxyl
`Iodine
`value
`value
`value
`gI2/100g mg KOH/g
`mg KOH/g
`
`Melting
`point
`°C
`
`HLB
`
`S E M I - s O L I D V E H I C L E S
`GELUCIRE® 33/01
`Glycerol
`USP/NF
`esters of
`fatty acids
`
`Semi-solid oily carrier for hard and soft gelatin
`capsule formulations. Protects active ingredients
`from light, moisture and oxidation.
`
`GELUCIRE® 39/01
`
`GELUCIRE® 43/01
`
`Glycerol
`esters of
`fatty acids
`
`Glycerol
`esters of
`fatty acids
`
`USP/NF
`EP/JPED
`JSFA
`
`Waxy carrier for hard gelatin capsule formulations.
`Protects active ingredients from light,
`moisture and oxidation.
`
`USP/NF
`EP/JPED
`JSFA
`
`Waxy carrier for hard gelatin capsule formulations.
`Protects active ingredients from light,
`moisture and oxidation.
`
`L I Q U I D V E H I C L E S
`LABRAFAC™ LIPO
`Medium chain
`WL 1349
`triglycerides
`
`USP/NF
`EP/JPED
`JSFA
`
`Clear, fluid oil for liquid and soft
`gelatin capsule formulations.
`
`LABRAFAC™ PG
`
`Propylene glycol
`dicaprylocaprate
`
`Clear, oily carrier for liquid and soft
`EP/JPED
`USFA/E477 gelatin capsule formulations.
`JSFA
`
`< 1
`
`< 3
`
`230 - 255
`
`< 20
`
`< 0.20
`
`< 2
`
`225 - 245
`
`< 10
`
`< 0.20
`
`< 2
`
`220 - 240
`
`< 6
`
`33
`
`39
`
`43
`
`< 0.20
`
`< 1
`
`310 - 360
`
`< 10
`
`NA
`
`< 0.20
`
`< 0.5
`
`320 - 340
`
`< 10
`
`NA
`
`1
`
`1
`
`1
`
`1
`
`2
`
`CUSTOMER SERVICE
`In addition to being a supplier of high-quality
`ingredients, Gattefossé provides its customers
`with an unparalleled level of
`support services, including:
`
`• responsive sales representatives
`• training sessions
`by technical experts
`
`• in-house product support
`• customized technical support.
`
`TECHNICAL ASSISTANCE
`
`Our scientists are ready to help you with your
`formulation needs. Our application laboratory
`expertise makes your
`preformulation search easier.
`
`Product
`
`Chemical
`description
`
`Regulatory Application
`status (1)
`
`S O L V E N T
`TRANSCUTOL® HP
`
`Diethylene glycol
`monoethyl ether
`
`USP/NF
`EP
`
`Powerful solubilizer.
`
`Acid
`value
`mg KOH/g
`
`Peroxide
`value
`meq02/kg
`
`2-Methoxyethanol
`ppm
`
`2-Ethoxyethanol Ethylene
`ppm
`glycol
`ppm
`
`Purity
`%
`
`< 0.10
`
`< 8
`
`< 20
`
`< 50
`
`< 20
`
`> 99.9
`
`8
`
`(1) Abbreviations: USP/NF = US Pharmacopeia/National Formulary, EP = European Pharmacopeia, GRAS = Generally Recognized As Safe,
`FCC = Food Chemicals Codex, JSFA = Japanese Standard of Food Additives, JPED = Japanese Pharmaceutical Excipients Directory, USFA = US Food Additive.
`
`ORAL
`
`ORAL
`
`GELUCIRE®,TRANSCUTOL® are registered trademarks of Gattefossé s.a.s
`
`9
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`

`

`LUBRICANTS
`
`Products
`
`Chemical
`description
`
`Regulatory Applications
`status (1)
`
`Acid
`value
`mg KOH/g
`
`Saponification Hydroxyl
`Iodine
`value
`value
`value
`gI2/100g mg KOH/g
`mg KOH/g
`
`Melting
`point
`°C
`
`HLB
`
`L U B R I C A N T S
`
`Inert lubricant with binding properties. Problem solver when
`COMPRITOL® 888 ATO Glyceryl behenate USP/NF
`chemical incompatibility, capping, lamination.
`EP/JPED
`FCC/GRAS Insensitive to mixing conditions.
`JSFA
`
`COMPRITOL® E
`
`Glyceryl behenate
`
`Same applications as COMPRITOL® 888 ATO but
`JPED
`FCC/GRAS adapted to food supplement industry.
`E471
`JSFA
`
`PRECIROL ATO 5®
`
`Glyceryl
`palmitostearate
`
`Lubricant with binding properties.
`USP/NF
`Insensitive to mixing conditions.
`EP/JPED
`FCC/GRAS Recommended for lubrication of powders filled into capsules.
`JSFA
`
`< 4
`
`< 3
`
`145 - 165
`
`< 5
`
`< 3
`
`137 - 157
`
`< 6
`
`< 3
`
`175 - 195
`
`BIOGAPRESS™
`VEGETAL BM 297 ATO
`
`Glyceryl
`palmitostearate
`
`E471
`
`Same applications as PRECIROL ATO 5® but adapted to
`food supplement industry.
`
`< 2
`
`< 2
`
`165 - 180
`
`/
`
`/
`
`/
`
`/
`
`70
`
`74
`
`56
`
`57
`
`2
`
`2
`
`2
`
`2
`
`A WORLD OF IDEAS
`Regardless of the stage of your product
`development, we encourage you to take
`advantage of the formulation support we
`offer. The information provided in this
`brochure is only an overview of our extensive
`body of knowledge on oral formulations.
`With representatives located throughout the
`world, Gattefossé is able to share a world of
`ideas and to provide technical support. For
`more information on Gattefossé products,
`please contact the local office listed on the
`back cover or visit our website at
`www.gattefosse.com.
`
`The information included in this brochure is presented in good faith and we believe that it is correct, but no warranty as to accuracy of results
`or fitness for a particular use is given, nor is freedom from patent infringement to be inferred. It is offered solely for your consideration,
`investigation and verification. The user shall determine under his responsibility, the use and the security conditions of the information, and
`will remain the only one responsible in case of damageable consequences. Before using a GATTEFOSSÉ product, or any other product
`mentioned in this literature, read, understand and follow the information contained in most recent Material Safety Data sheet.
`
`10
`
`(1) Abbreviations: USP/NF = US Pharmacopeia/National Formulary, EP = European Pharmacopeia, GRAS = Generally Recognized As Safe,
`FCC = Food Chemicals Codex, JSFA = Japanese Standard of Food Additives, JPED = Japanese Pharmaceutical Excipients Directory.
`
`COMPRITOL®,PRECIROL ATO 5® are registered trademarks of Gattefossé s.a.s
`
`11
`
`ORAL
`
`ORAL
`
`Purdue 2007
`Collegium v. Purdue, PGR2018-00048
`
`