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EXCELLENCE IN
OLEOCHEMICAL EXCIPIENTS AND APIs
Emulsifiers .................................................................................................... 14
Specialties ...................................................................................................... 16
Abbreviations:
Contents | 3
EXCIPIENTS
We have gathered our activities for the pharmaceutical industry under the umbrella of IOI OLEOCHEMICAL PHARMA,
with a strong commitment to quality and regulatory leadership in pharmaceutical oleochemicals.
Our pharmaceutical excipients for topical, oral, and rectal applications as well as our oleochemical-based active pharma
ceutical ingredients for enteral and parenteral applications have been enjoying a good reputation for decades.
The WITEPSOL® product range with its different types is the worldwide leading market standard for suppository
bases (adeps solidus). Our MIGLYOL® brand comprises our MCT oil as well as related C8-C10 fatty acid esters. The
IMWITOR® product family provides functionalized lipids for drug delivery systems. With DYNASAN®, we offer mono
acid triglycerides for various applications requiring precise physico-chemical characteristics.
Highest quality standards are continuously improved and controlled by the relevant German authority and US-FDA as well
as throughout regular customer audits by multinational companies. Our strict commitment to quality is confirmed by the
repeated granting of EU-GMP certification as well as repeated US-FDA approval.
Together with the first CEP ever granted for MCT, several type IV DMFs as well as one type II DMF submitted to the US
Food and Drug Administration, we demonstrate our self-conception as one of the leaders in quality and regulatory affairs
for oleochemical specialities in pharmaceutical applications.
Our expert team with decades of experience will be happy to provide you with individual solutions for your pharma
ceutical formulations.
4 | Contents EXCIPIENTS | 5
1 Liquid lipids
Liquid lipids are fatty acid esters. They are neutral carriers for various pharmaceutical applications. Because of their polarity,
they exhibit superior solvent characteristics for some active drugs (compared to hydrocarbons).
Product Chemical description/monograph name Listed in Appearance Viscosity Properties and applications
mPa· s 20 ° C
C8 /C10 Triglycerides
MIGLYOL® 808 Tricaprylin — Oily liquid * ~ 23 Neutral, stable, penetration enhancer, drug carrier, dermal and oral use, solvent.
MIGLYOL® 810 N Triglycerides, Medium-Chain Ph. Eur., USP-NF, JPE, Oily liquid * ~ 28 Neutral, stable, penetration enhancer, drug carrier, solvent, oral use, dermal use.
US DMF Type IV, No. 800
MIGLYOL® 812 N Triglycerides, Medium-Chain Ph. Eur., USP-NF, JPE, CEP R0-CEP Oily liquid * ~ 30 Lipid component in parenteral nutrition. Neutral, stable, solubilizer and carrier
Drug Substance 2012-410-Rev 01, US DMF Type II, for oil-soluble actives.
No. 27975
MIGLYOL® 812 N Triglycerides, Medium-Chain Ph. Eur., USP-NF, JPE, Oily liquid * ~ 30 Neutral, stable, penetration enhancer, drug carrier as well as solvent for oral and dermal use.
Excipient US DMF Type IV, No. 800
MIGLYOL® 818 Caprylic/Capric/Linoleic Triglyceride — Oily liquid * ~ 31 Neutral, stable, drug carrier, oral and dermal use. The oil is stabilized with an antioxidant.
MIGLYOL® 829 Caprylic/Capric/Succinic Triglyceride — Light yellowish ~ 260 Neutral, stable oil of high viscosity and with a density of ~ 1.01, based on MCT and
oily liquid succinic acid. Superfatting agent and emulsion stabilizer.
C8 /C10 Esters
MIGLYOL® 840 Propylene Glycol Dicaprylocaprate Ph. Eur., USP-NF Oily liquid * ~ 11 Oil component, high spreading emollient with low viscosity.
Other Esters
DYNACET® 285 Acetylated Monoglycerides GRAS acc. to 21 CFR sect. 172.828 Oily liquid * ~ 30 Food grade softener, plasticizer and solvent. Stable hydrophilic oil.
MIGLYOL 128® NON-GMP Cocoyl Caprylocaprate Ph. Eur. Slightly yellowish ~ 11 Fast spreading emollient, refatting agent.
oily liquid
SOFTISAN® 645 Bis-Diglyceryl Polyacyladipate-1 — Yellowish ~ 6.000 Liquid lanolin substitute, adhesive to skin and wet mucous membranes, suitable for
liquid syrup wound dressing systems and irritated skin, non-occlusive.
Product Chemical description/monograph name Listed in Melting Point Hydroxyl value Properties and applications
°C mg KOH/g
WITEPSOL® H 5 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 34.0–36.0 max. 5 WITEPSOL® H grades (except H 19) are hard fats with a low hydroxyl value of max. 15.
They comprise mainly of triglycerides with portions of max. 15% of diglycerides and max.
WITEPSOL® H 12 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 32.0–33.5 5–15 1% of monoglycerides.
WITEPSOL® H 19 is a hard fat containing certain amounts of Glyceryl Ricinoleate* (stabilized)
WITEPSOL H 15
®
Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 33.5–35.5 5–15
which lead to a slightly higher hydroxyl value compared to the other H grades.
WITEPSOL H 19
®
Hard Fat + Glyceryl Ricinoleate* (stabilized) — 33.5–35.5 20–30 They are characterized by a small gap between melting and solidification temperatures, show-
ing a low tendency towards posthardening (polymorphism).
WITEPSOL® H 32 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 31.0–33.0 max. 3 Shock cooling should be avoided because of their brittleness.
WITEPSOL® H 35 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 33.5–35.5 max. 3
WITEPSOL H 37
®
Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 36.0–38.0 max. 3
WITEPSOL® W
WITEPSOL® W 25 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 33.5–35.5 20–30 WITEPSOL® W grades are hard fats with hydroxyl values between 20 and 50. They comprise
a mixture of 65–80% of triglycerides, 10–35% of diglycerides and 1–5% of monoglycerides.
WITEPSOL® W 32 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 32.0–33.5 40–50 Correspondingly, they have a wider gap between melting and solidification temperatures
and are therefore more insensitive (elastic) to shock cooling. They solidify more slowly. The
WITEPSOL® W 35 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 33.5–35.5 40–50
amount of partial glycerides delays the sedimentation of solid active ingredients and pro
WITEPSOL W 45
®
Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 33.5–35.5 40–50 motes wetting of mucous membranes.
WITEPSOL® S
WITEPSOL® S 51 Hard Fat + Polyoxyethylene (25) Cetyl Stearyl Ether US DMF No. 420 30.0–32.0 55–70 WITEPSOL® S grades contain special additives. They are suitable for manufacturing vaginal
+ Glyceryl Ricinoleate* (stabilized) and rectal preparations, requiring a more intensive wetting of mucosae, a greater dispersability,
or an enhanced absorption. They all contain an ethoxylated emulsifier which makes them
WITEPSOL® S 55 Hard Fat + Polyoxyethylene (25) Cetyl Stearyl Ether US DMF No. 420 ~ 35** 50–65 suitable for use in aqueous or ethanolic/aqueous active ingredients (emulsion suppositories).
+ Beeswax
WITEPSOL® S 58 Hard Fat + Polyoxyethylene (25) Cetyl Stearyl Ether US DMF No. 420 31.5–33.0 60–70
+ Glyceryl Ricinoleate* (stabilized)
* Compound contains unsaturated components; interactions with oxygen must be considered. ** Due to additive beeswax, determination of solidification point is recommended.
Product Chemical description/monograph name Listed in Melting Point Hydroxyl value Properties and applications
°C mg KOH/g
WITEPSOL® E 75 Hard Fat + Beeswax US DMF No. 420 ~ 38* * max. 15 WITEPSOL® E grades are hard fats with a melting range above body temperature. They can
be used to raise the melting point if active ingredients are processed which will decrease the
WITEPSOL® E 76 Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 37–39 30–40 melting point.
WITEPSOL E 85 ®
Hard Fat, Adeps solidus Ph. Eur., USP-NF, JPE, US DMF No. 420 42–44 5–15
SOFTISAN® 378 Hard Fat, Adeps solidus Ph. Eur., USP-NF ~ 38 7–17 Hard fat with softer consistency, similar to natural lard, but stable, odorless, emollient in
creams, capsule filling mass.
DYNASAN® 110* Tricaprin — 29–31 max. 10 In powders as fast-melting component and to prevent clumping.
DYNASAN 112 *®
Trilaurin — 43–46 max. 10 In ointments and creams as body-imparting and structure-forming component.
DYNASAN 114 ®
Trimyristin — 55–58 max. 10 A high melting point lipid for use in modified/sustained release in oral solid dosage matrices.
Effective lubricant for tablets/capsules.
DYNASAN® 116 Tripalmitin — 63–68 max. 10 A high melting point lipid for use in modified/sustained release in oral solid dosage matrices.
Effective lubricant for tablets/capsules. Hot melt extrusion, hot melt coating, solid lipid
DYNASAN® 118 Glyceryl Tristearate USP-NF, GRAS acc. to CFR 21 sect. 172.811 69–73 max. 5 nanoparticles.
DYNASAN® P 60 (F) NON-GMP Hydrogenated Palm Oil USP-NF 58–62 max. 10 Palmitic/stearic triglycerides, suitable for hot melt coating, USP type I.
SOFTISAN® 154 Hydrogenated Palm Oil — 53–58 max. 10 Suitable for hot melt coating, similar to hydrogenated vegetable oil.
* Available on demand only, but can be offered in sample volumes. ** Due to additive beeswax, determination of solidification point is recommended.
Product Chemical description/monograph name Listed in Appearance Melting Point Content of Properties and applications
°C monoglycerides
IMWITOR® 491 Glyceryl Monostearate USP-NF Off-white powder 66–77 > 90.0% Lipophilic matrix for oral solid dosage forms (granulation, hot
melt technique). Tablet lubricant, emulsion stabilizer, dispers
ing agent for pigments. More than 90.0% of monoglycerides,
stabilizer, stiffening and dispersing agent.
IMWITOR® 900 (F) P Glycerol Monostearate 40–55%, Type I Ph. Eur., USP-NF* Off-white powder 54–64 40–55% Lipophilic matrix for oral solid dosage forms (granulation, hot
melt technique). 40 to 55% of monoglycerides, used as tablet
lubricant, emulsion stabilizer, dispersing agent for pigments
IMWITOR® 900 K Glycerol Monostearate 40–55%, Type II Ph. Eur., USP-NF* Off-white powder 54–64 40–55%
and for sustained release.
IMWITOR® 960 K Glyceryl Monostearate, self-emulsifying B. P. Flakes 56–61 > 30% Self-emulsifying GMS for dermal use.
IMWITOR® 308 NON-GMP Glycerol Monocaprylate, Type II Ph. Eur., USP-NF Crystalline solid 27–33 > 80.0% Emulsifier, co-surfactant, excellent antibacterial properties.
IMWITOR® 742 Glycerol Monocaprylocaprate, Type I Ph. Eur., USP-NF Liquid to pasty/solid ~ 25 45.0–75.0% Penetration enhancer, solvent, defoaming agent in
effervescent tablets.
IMWITOR® 928 Glyceryl Cocoate — White, similar to hard fat 33–36 40–55% Dispersing agent for solids and oils, solubilizer in suppositories.
IMWITOR 988 ®
Glycerol Monocaprylate, Type I Ph. Eur., USP-NF Clear, oily liquid ~ 23 45.0–75.0% Penetration enhancer, solvent.
IMWITOR® 948 Glycerol Mono-Oleate Ph. Eur., USP-NF Yellowish, liquid to pasty liquid 32.0–52.0% O/W stabilizer, forms gels in excess water. Contains an antioxidant.
SOFTIGEN® 701 Glyceryl Ricinoleate** (stabilized) — Yellowish, liquid to pasty ~ 25 > 40% Stabilized skin-protective agent, waterdispersible
W/O co-emulsifier.
Product Chemical description/monograph name Listed in Appearance HLB value Properties and applications
IMWITOR® 600 NON-GMP Polyglyceryl-3 Polyricinoleate — Yellow to ~4 FCC-compliant W/O emulsifier for systems of low viscosity.
brownish liquid
O/W Emulsifiers
IMWITOR® 491 Glyceryl Monostearate USP-NF Off-white powder ~4 Lipophilic matrix for oral solid dosage forms (granulation, hot melt technique). Tablet lubricant,
emulsion stabilizer, dispersing agent for pigments. More than 90.0% of monoglycerides, stabilizer,
stiffening and dispersing agent.
IMWITOR® 900 (F) P Glycerol Monostearate 40–55%, Type I Ph. Eur., USP-NF Off-white powder ~3 Lipophilic matrix for oral solid dosage forms (granulation, hot melt technique). 40 to 55% of
monoglycerides, used as tablet lubricant, emulsion stabilizer, dispersing agent for pigments and
IMWITOR® 900 K Glycerol Monostearate 40–55%, Type II Ph. Eur., USP-NF Off-white powder ~3 for sustained release.
IMWITOR® 960 K Glyceryl Monostearate, self-emulsifying B. P. Flakes 9–12 Self-emulsifying GMS, for dermal use.
IMWITOR® 372 P Glyceryl Stearate Citrate — Light brownish 10–12 Partly ionic, still oil-soluble emulsifier, similar to lecithin for stable emulsions
flakes at pH range 4 to 7.
IMWITOR® 375 Glyceryl Citrate/Lactate/Linoleate/Oleate — Yellow to brown ~ 11 Suitable for use in the preparation of SMEDDS. Partly ionic, still oil-soluble emulsifiers, similar
ish sticky liquid to lecithin for stable emulsions at pH range 4 to 7.
14 | Emulsifiers Emulsifiers | 15
5 Specialties
Fatty acid esters, further modified or compounded, help creating specific pharmaceutical formulations.
Product Chemical description/monograph name Listed in Appearance Melting point Properties and applications
°C
Special Esters
MIGLYOL® Gel 840 B Propylene Glycol Dicaprylocaprate — Oleogel, brownish softpaste — Heat-stable oleogel, maintains viscosity between 0 °C and 100 °C, e.g. for
Dicaprate (and) Stearalkonium water and temperature-resistant formulations. Soft lamellar structure for easy
Hectorite (and) Propylene Carbonate distribution on skin. Consistency and viscosity stabilizer in emulsions.
DYNACET® 285 Acetylated Monoglycerides GRAS acc. to 21 CFR sect. 172.828 Oily liquid — Food grade softener, plasticizer, and solvent. Stable hydrophilic oil.
SOFTISAN® 601 Glycerides, C12-C18 mono- and di-, Glyceryl Stearate, — Off-white soft pastilles 40–45 Water-free self-emulsifying system, ready-to-use O/W cream base, suitable to
PEG-4, Polyoxyethylene (25) Cetyl Stearyl Ether, process a variety of pharmaceutical active ingredients.
PEG-32, PEG-6, Medium-Chain Triglycerides,
Glyceryl Ricinoleate* (stabilized)
SOFTISAN® 645 Bis-Diglyceryl Polyacyladipate-1 — Yellowish liquid syrup — Liquid lanolin substitute, adhesive to skin and wet mucous membranes, suit
able for wound dressing systems and irritated skin, non-occlusive.
SOFTISAN® 649 Bis-Diglyceryl Polyacyladipate-2 — Off-white opaque mass ~ 35 Semi-solid lanolin substitute, adhesive to skin and wet mucous membranes,
suitable for wound dressing systems and irritated skin, non occlusive.
SOFTIGEN® 701 Glyceryl Ricinoleate* (stabilized) — Yellowish, liquid to pasty ~ 25 Stabilized skin-protective agent, water-dispersible W/O co-emulsifier.
SOFTIGEN® 767 Macrogol-6 Glycerol Caprylocaprate Ph. Eur. Clear liquid ~ 14 Suitable for use in the preparation of SEDDS. Solubilizer for drugs, wetting
and refatting agent. Soluble in water and hydrophilic oils (e.g. MCT oil).
16 | Specialties Specialties | 17
6 Register
of chemical/monograph names
A Acetylated Monoglycerides DYNACET® 285 6, 16 H Hard Fat, Adeps solidus WITEPSOL® H 5, H 12, H 15, H 32, H 35, H37 8, 10
WITEPSOL® W 25, W 32, W 35, W 45
WITEPSOL® E 76, E 85
B Bis-Diglyceryl Polyacyladipate-1 SOFTISAN® 645 6, 16
SOFTISAN® 378
Hard Fat + Beeswax WITEPSOL® E 75 10
Bis-Diglyceryl Polyacyladipate-2 SOFTISAN 649®
16
Hard Fat + Polyoxyethylene (25) WITEPSOL® S 55 8
Cetyl Stearyl Ether + Beeswax
C Caprylic/Capric/Linoleic Triglyceride MIGLYOL® 818 6
Hard Fat + Polyoxyethylene (25) Cetyl Stearyl Ether WITEPSOL® S 58, S 51 8
Caprylic/Capric/Succinic Triglyceride MIGLYOL 829®
6 + Glyceryl Ricinoleate* (stabilized)
Cocoyl Caprylocaprate NON-GMP MIGLYOL® 128 6 Hard Fat + Glyceryl Ricinoleate* (stabilized) WITEPSOL® H 19 8
G Glycerides, C12-C18 mono- and di-, Glyceryl Stearate, SOFTISAN® 601 16 Hydrogenated Palm Oil SOFTISAN® 154 10
PEG-4, Polyoxyethylene (25) Cetyl Stearyl Ether,
PEG-32, PEG-6, Medium-Chain Triglycerides,
Glyceryl Ricinoleate* (stabilized) M Macrogol-6 Glycerol Caprylocaprate SOFTIGEN® 767 16
Glycerol Monocaprylate, Type II NON-GMP IMWITOR® 308 12 Medium-Chain, Triglyceride MIGLYOL® GEL T 16
(and) Stearalkonium Bentonite
Glycerol Monocaprylocaprate, Type I IMWITOR® 742 12
(and) Propylene Carbonate
Glycerol Mono-Oleate IMWITOR 948®
12
Medium-Chain, Triglyceride MIGLYOL® GEL B 16
Glycerol Monostearate 40–55%, Type I NON-GMP IMWITOR 900 (F) P
®
12, 14 (and) Stearalkonium Hectorite
(and) Propylene Carbonate
Glycerol Monostearate 40–55%, Type II IMWITOR® 900 K 12, 14
Glyceryl Ricinoleate* (stabilized) SOFTIGEN® 701 12, 16 Propylene Glycol Dicaprylocaprate MIGLYOL® 840 6
* Compound contains unsaturated components; interactions with oxygen must be considered. Trilaurin ** DYNASAN® 112 10
DYNASAN 114 ®
Trimyristin 10 MIGLYOL 812 N Drug Substance
®
Medium-Chain Triglyceride 6
DYNASAN 116 ®
Tripalmitin 10 MIGLYOL 812 N Excipient
®
Medium-Chain Triglyceride 6
DYNASAN® P 60 (F) NON-GMP Hydrogenated Palm Oil 10 MIGLYOL® 829 Caprylic/Capric/Succinic Triglyceride 6
MIGLYOL 840 ®
Propylene Glycol Dicaprylocaprate 6
I IMWITOR 308 ®
NON-GMP Glycerol Monocaprylate, Type II 12 MIGLYOL® Gel 840 B Propylene Glycol Dicaprylocaprate 16
Dicaprate (and) Stearalkonium
IMWITOR® 372 P Glyceryl Stearate Citrate 14 Hectorite (and) Propylene Carbonate
IMWITOR® 375 Glyceryl Citrate/Lactate/Linoleate/Oleate 14
MIGLYOL® Gel B Medium-Chain, Triglyceride 16
IMWITOR 491 ®
Glyceryl Monostearate 12, 14 (and) Stearalkonium Hectorite
(and) Propylene Carbonate
IMWITOR® 600 NON-GMP Polyglyceryl-3 Polyricinoleate 14
MIGLYOL® Gel T Medium-Chain, Triglyceride 16
IMWITOR® 742 Glycerol Monocaprylocaprate, Type I 12
(and) Stearalkonium Bentonite
IMWITOR® 900 (F) P Glycerol Monostearate 40-55, Type I 12, 14 (and) Propylene Carbonate
IMWITOR 900 K
®
Glycerol Monostearate 40-55, Type II 12, 14
IMWITOR® 960 K Glyceryl Monostearate, self-emulsifying 12, 14 SOFTISAN® 154 Hydrogenated Palm Oil 10
IMWITOR 988 ®
Glycerol Monocaprylate, Type I 12 SOFTISAN 378 ®
Hard Fat, Adeps solidus 10
20 | Register of trademarks and product names Register of trademarks and product names | 21
7 Register
of trademarks and product names
WITEPSOL H 5 ®
Hard Fat, Adeps solidus 8
WITEPSOL H 12®
Hard Fat, Adeps solidus 8
WITEPSOL H 32®
Hard Fat, Adeps solidus 8
WITEPSOL H 35®
Hard Fat, Adeps solidus 8
WITEPSOL W 32®
Hard Fat, Adeps solidus 8
We reserve the right to make any changes as a result of technological progress or developments. No guarantee or warranty
is implied or intended as to any particular properties of our products. The customer is not exempted from the obligation
to conduct careful inspection and testing of incoming goods. Reference to trademarks used by other companies is neither
a recommendation, nor should it give the impression that products of other companies cannot be used. All IOI Oleochemicals
business transactions are exclusively governed by our General Business Terms and Conditions – please see www.ioioleo.de
(Terms and Conditions)
22 | Register of trademarks and product names Register of trademarks and product names | 23
Contact
IOI Oleo GmbH
Hamburg, Germany | +49 40 28 00 31-0 | pharma@ioioleo.de | www.ioioleo.de