Engineered Lipid Excellence For Topical Applications – IOI Oleo
Tried & Trusted, Quality & Innovation
With our nature-based excipients you can develop modern pharmaceutical topical formulations that combine functionality, regulatory compliance and a pleasant skin feel. While the advantages of localized drug delivery for acute conditions are clear, the issue of patient compliance becomes particularly significant in chronic skin diseases, where formulation techniques, sensory properties and the origin of ingredients can become important to achieving medication adherence.1
Our brands IMWITOR®️, MIGLYOL®️, SOFTIGEN®️, SOFTISAN®️,DYNASAN® and WITEPSOL® stand for proven quality, unique performance, and perceivable benefits in the final formulation.
The development and production of excipients for topical application started back in the 1950s at the former Chemische Werke Witten, now known as IOI Oleo GmbH. The state-of-the-art production guarantees the highest quality of vegetable-based esters, which act as multifunctional ingredients from emollients to emulsifiers,
and in turn the quality of medicine in our ethical environment. Our dedication and strict adherence to maximum product purity and safety are reflected in our regulatory set-up and our experience − quality you can rely on “Made in Germany”.
Our products are made from up to 100% vegetable, renewable raw materials. Sustainability is part of our daily activities as the entire IOI Group is not only RSPO (Round Table of Sustainable Palm Oil) certified but also one of the co-founders of this organization.
We operate the production facility of IOI Oleo GmbH in Witten under GMP guidelines, which is regularly checked by the German Health Authority. Since some of our excipients are used in interdisciplinary areas such as cosmeceuticals or nutraceuticals, and in view of our worldwide presence, we also follow other regulations and standards.
Emollients
The MIGLYOL® Emollients are widely used in the pharma industry as drug carriers; they possess superior solvent characteristics for lipophilic actives and high stability against stress factors and ageing.
These vegetable-based emollients are neutral oils that
off er a wide range of different sensory profi les from
light silicone-like to rich and caring. Refatting, even
superfatting and improvement of skin moisturization are
achieved without occlusion and risk for maceration.
IDEAL SENSORIAL CURVE
The MIGLYOL® emollient range off ers formulators the possibility of creating the ideal sensory experience thanks to the spectrum of spreading behaviour provided.
Miglyol® 128
Miglyol® 840
Miglyol® 8810
Miglyol® 812N
Miglyol® 829
CONSUMER BENEFITS:
- Sensory profile according to consumer needs
- Silicone-like skin feel possible
- Light skin feel possible
- Caring and rich skin feel possible
Special Cream Bases
SOFTISAN® 378
Chemical description/monograph name: Hard Fat, Adeps solidus
Listed in: Ph. Eur., USP–NF
Appearance: White to ebony colored solid fat
Melting Point °C: ~ 38
A refatting, nourishing emollient, drug carrier and consistency regulator that is ideal for all topical application forms, e.g. ointments, creams, lotions and pastes.
SOFTISAN® 649
Chemical description/monograph name: Bis-Diglyceryl Polyacyladipate-2
Appearance: Off-white opaque mass
Melting Point °C: ~ 35
This compliant and modern alternative to lanolin is used in
wound dressings and wound care products like creams and
ointments due to its high water uptake of more than 200%
and exceptional adhesion to skin and mucous membranes.
SOFTISAN® 601
Chemical description/monograph name: Glycerides, C12-C18 Mono- and Di-, Glyceryl Stearate,
PEG-4, Polyoxyethylene (25) Cetyl Stearyl Ether, PEG-32,
PEG-6, Medium-Chain Triglycerides, Glyceryl Ricinoleate (stabilized)
Appearance: Off-white soft pastilles
Melting Point °C: 40 – 45
Suitable for the preparation of skin-compatible, wash-off
O/W creams exhibiting a water content of up to 65%.
Water-free Formulations − In-vivo Studies
The majority of API candidates under clinical development are poorly water-soluble, and they can be sensitive to hydrolysis or adverse reactions-triggered by impurities. Thus, water-free formulating may be an idea that derives from technical needs, but offers a multitude of possibilities. For example, depending on product presentation, a water-free system may not require preservation or other stabilizers.
The results of the studies are convincing:
- Formulations based on SOFTISAN® 378 increased skin moisturization in a range of 40-60% according to Corneometer measurement.
- The scoring for skin softness of treated areas significantly increased from 1.7 to 2.8-3.5 on a clinical scale. Scoring was done by a dermatological expert.
Leading global expert and innovator of functionalised ester-based lipids
with added value for pharma solutions.
Emulsifiers
EMULSIFIER O/W
IMWITOR® 372 P
Chemical description/monograph name: Glyceryl Stearate Citrate
Appearance: Light brownish flakes
HLB value: 10 – 12
Melting Point °C: ~ 62
Oil-soluble O/W emulsifier, partly neutralized and anionic.
Viscosity enhancing, builds structures similar to lecithin,
stable emulsions at pH range 4 to 7.
100% natural, leaving a smooth and silky skin feel. This
hot processable emulsifier can be combined with a large
number of co-emulsifiers.
RECOMMENDED CONCENTRATION:
2 – 4% as main emulsifier
0.5 – 2.0% as co-emulsifier
EMULSIFIER W/O
IMWITOR® 600
Chemical description/monograph name:
Polyglyceryl-3 Polyricinoleate
Appearance: Amber colored liquid
HLB value: ~ 4
IMWITOR® 600 is a powerful W/O emulsifier with excellent stability even with a high water content.
It is especially suitable for soft or low viscous W/O emulsions with a non-greasy, pleasant skin feel.
RECOMMENDED CONCENTRATION:
2 to 4
Solubilizers & Penetration Enhancers
The formulation-specific suitability of individual raw materials depends, among other things requirements, on the expected polarity of the ingredients. Our products cover a wide range in polarity and can be brought into relation as follows:
All these products are fully miscible with each other, so that melting point, bioavailability, solubility, polarity or texture can be specifically adjusted.
Viscosity Regulators
Thickening of oil phases can be necessary to give the finished form the required consistency and skin feel. All recommended products are characterized by their neutral smell and are successfully used in topical forms such as lotions and creams as body-imparting and structure forming ingredients.
DYNASAN® 118
Chemical description/monograph name: Glyceryl Tristearate
Listed in: USP–NF, GRAS acc. to CFR 21 sec. 172.811
Appearance: Off-white, flakes and microfine powder
Melting Point °C: 69 – 73
SOFTISAN® 154
Chemical description/monograph name: Hydrogenated Palm Oil
Appearance: Off-white, flakes
Melting Point °C: 53 – 58
WITEPSOL® E 85
Chemical description/monograph name: Hard Fat, Adeps solidus
Listed in: Ph. Eur., USP–NF, JPE
Appearance: Pastilles
Melting Point °C: 42 – 44
See the full brochure on “Engineered Lipid Excellence For Topical Applications“ here
(click the picture to download the brochure)
Source: IOI Oleo GmbH brochure “Engineered Lipid Excellence For Topical Applications”
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