TM

Crodabase

SQ

Chemical Description: Mineral Oil and Polyethylene

INCI name: Paraffinum liquidum, Polyethylene
CAS: 8042-47-5 and 9002-88-4
Crodabase SQ is a smooth and oily translucent gel formed by a combination of mineral oil and high-molecular
weight hydrocarbon waxes.
Crodabase SQ can be used in different veterinary applications, such as topical, oral and intra-mammary. As a
versatile excipient, Crodabase SQ can be used in different animal species including large animals and pets.
Crodabase SQ is used as the basis for high-quality ointment formulations, with excellent spread ability and soft
sensorial benefits in topical applications. Efficacy tests performed with Crodabase SQ have shown that the
product contributes to the actives absorption process by the skin and forms a protective film that enables its
recovery.
It is ideal for use in cold process and presents high
stability under temperature variations. Crodabase SQ is
able to maintain desired consistency and texture across
a wide range of temperatures before melting at a
temperature between 88 and 91C. Consequently, one
of the main advantages of Crodabase SQ over other oily
bases, like Petrolatum, is that it does not liquefy at
temperatures found in tropical climates, nor does it
harden excessively when exposed to relatively low
temperatures.
Besides, its ease of handling, makes Crodabase SQ an
extremely versatile raw material for use in a wide variety
of end products. In many cases it does not require heating, another vehicle or process to incorporate the active
ingredient into the base.
Crodabase SQ enables pharmaceutical formulators to create high quality end products that feel soft and
smooth, and are easy to spread and apply to the animals skin or even in oral and intra-mammary routes.
Functional benefits
- Stable under temperature variations
- Cost effective: reduces the process time as it does not require heating in order to incorporate the actives and
excipients.
- Easy to use in manipulation processes.
- Excellent spread ability in the animals skin
- Resistant to gamma rays sterilization
- Compatible with different APIs to topical applications, although it has lipophilic characteristic some hydrophilic
(Estradiol) and lipophilic (Nistatin) APIs could be solubilized and delivered
- High viscous gel which allows a localized treatment on the affected area
Product applications
- Topical applications to treat wounds, post-surgical wounds, inflammatory process, accelerating the recovery
of the skin barrier.
- Intra-mammary formulations to treat mastitis in bovines.
- Oral applications in nutraceutical products to race horses and pets, anti-inflammatory and gastrointestinal
disorders.

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Superior Stability
Due to its semi-solid structure with melting point between 88C and 91C, Crodabase SQ is able to keep its
consistency and texture in a wide temperature range.
A stability test at 45C was conducted for 12 months evaluating 3 different batches of Crodabase SQ as shown
below:

Penetrometer ASTM D937

According to the Graphic, Crodabase SQ remained stable throughout time keeping its natural consistency. It
was observed that Crodabase SQ has advantages when compared to other oily basis since it does not liquefy
at the temperatures found in tropical climates nor does it harden when exposed to low temperatures.
Stability after Irradiation
To prove the Crodabase SQ stability under irradiation, the product was submitted to gamma irradiation at
different levels: 5, 10, 15, 20 and 25 kGy. The results show that Crodabase SQ can be sterilized by gamma
irradiation, a process commonly used in ophthalmic and in anti-mastitis formulations.
Comparative studies: Crodabase SQ x Petrolatum
Crodabase SQ enables the cold incorporation of polar and non-polar ingredients, which simplifies the final
product development and manufacturing processes.
In order to prove the base versatility, two excipients with different chemical structures were chosen to be
incorporated in the Crodabase SQ and Petrolatum. It was evaluated the compatibility of the excipients and the
handling process.
Incorporation study of Crodamazon Buriti into the basis
One of Crodas studies was compared the incorporation of Crodamazon Buriti (reddish vegetable oil/non-polar
structure) in Petrolatum and Crodabase SQ at room temperature:
The pictures below show the raw materials used in the test:

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Crodabase SQ

Petrolatum

Crodamazon Buriti

In the study, 400 g of Crodabase SQ and Petrolatum were added in bequer, and under stirring, Crodamazon
Buriti were added into the basis.
After 2 minutes under stirring, it was possible to observe incorporation of Crodamazon Buriti into Crodabase
SQ and Petrolatum. The pictures below show the results:

Petrolatum

Crodabase SQ

Mixer IKA Labortechnik- 500 rpm

25C/2C / Relative Humidity 50% 5%
The recipient with Crodabase SQ showed better incorporation of Crodamazon Buriti when compared to the
Petrolatum recipient, which proves its outstanding dispersion properties. The formation of a more
homogeneous mixture proves that Crodabase SQ is easy to manipulate and enables quick and easy
incorporation of veterinary actives.
Incorporation study of hydrophilic dye into the basis
The test with Crodabase SQ, Petrolatum and Crodamazon Buriti could demonstrate the superiority of
Crodabase SQ in incorporate oily excipients, forming a product more homogeneous than Petrolatum.
Lipophilic basis, due to its hydrophobic nature, could have a few tendencies in solubilize actives with high
polarity. Therefore, another test was proposed in order to compare Crodabase SQ and Petrolatum in
comparison to the incorporation of hydrophilic excipients.
As comparative standard, 15 grams of mineral oil and water were weighed in 2 beaker and than 6 grams of
hydrophilic dye FD&C Yellow n 5 were incorporated in each beaker. After handling stirring, it was observed
that in the beaker containing water, the dye completely solubilized, with a yellow intense coloring.
In the beaker containing mineral oil, the dye could not be totally solubilized therefore the coloring that it was
observed was a turbid yellow-pink. The pictures below demonstrate the beakers containing water and mineral
oil after the incorporation of the same dye.

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Water

Mineral Oil

For this incorporation test, 300 grams of Crodabase SQ and Petrolatum were weighted into 2 beakers and
under stirring yellow dye were added into the basis. It was possible to observe the incorporation of yellow dye
into Crodabase SQ and Petrolatum. The pictures below show the results:

Crodabase SQ

Petrolatum

Mixer IKA Labortechnik- 800 rpm/10 minutos

25C/2C / Relative Humidity 50% 5%
It was possible to verify that the yellow dye has more affinity for Crodabase SQ than Petrolatum due to the
coloring formed after the incorporation test.
The coloring observed in the beaker containing Crodabase SQ is closest to the standard containing water.
However, in the beaker containing Petrolatum, the coloring observed is more similar to the beaker that contains
mineral oil.

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After the incorporation test of Crodamazon Buriti (oil soluble) and the yellow dye (water soluble) into Crodabse
SQ it was concluded that Crodabase SQ showed more versatility to incorporate hydrophilic and hydrophobic
excipients.
According to Fini and colleagues (2008) the drug solubility in the vehicle is also an important factor for drug
penetration across the skin or artificial membranes because will influence both the drug concentration gradient
and partition coefficient between the vehicle and the membrane.
Efficacy Test
During the test of Croda, Crodabase SQ did not lead or contribute to any cutaneous irritation or adverse
sensitivity effects; neither caused phototoxicity nor photoallergy. It is, therefore, considered suitable for topical
veterinary applications.
Efficacy tests performed as corneometry, evaporimety and sebumetry studies with Crodabase SQ have shown
that the product contributes to the actives absorption process by the skin and forms a protective film that
enables its recovery when compare to Petrolatum.
Formulating with Crodabase SQ
Crodabase SQ is an easy-to-manipulate product with excellent dispersion properties that enable the direct
incorporation of active ingredients on the basis, with no need to use other excipients.
Due to these characteristics, Crodabase SQ is compatible with different topical veterinary applications, such as
wound treatment, pain-relief, anti-inflammatory, nutraceutical products and among others.
Regarding our tests and its chemical characteristics (Mineral Oil and Polyethylene) Crodabase SQ is not a
good environment to microorganisms growth, but some excipients as natural guns, natural extracts, proteins,
etc. are suitable to develop the microorganisms growth therefore it is important to evaluate the correct
preservative system from the final formulation.
Find below some examples of formulations developed with Crodabase SQ:
Product/INCI name
Wound
treatment
ointment

Pain-relief
ointment
Antiinflammatory
ointment

% w/w

Crodabase SQ (Mineral Oil and Polyethylene) To 100

Zinc Oxide (Zinc Oxide)
20%
Medilan (Lanolin)
2%
Nystatin (Nystatin)
1%
Crodabase SQ (Mineral Oil and Polyethylene) To 100
Camphor (Camphor)
4%
Methyl Salicylate (Methyl Salicylate)
4%
Menthol (Menthol)
2%
Crodabase SQ (Mineral Oil and Polyethylene) To 100
Hydrocortisone Acetate (Hydrocortisone Acetate)
1%

Method
Mix Nystatin and Zinc Oxide
until homogeneity.
Incorporate Medilan into
Crodabase SQ and then add
the powder mixture.
Crush Menthol with Camphor
until homogeneity.
Solubilize the mixture in the
Methyl Salicylate.
Add the mixture directly into
Crodabase SQ
Incorporate the
Hydrocortisone Acetate
directly into Crodabase SQ.

Toxicological Data
According to the official literature, Crodabase SQ can be considered a safety excipient to be used in animal
product applications.
1. The polyethylene and Mineral Oil that compose Crodabase SQ are USP/NF monograph compliant.
2. LD50 of the polyethylene in rats (oral): 2g/Kg and the Mineral Oil LD50 in rats (oral) is 22g/Kg.
3. LD50 mixture:14.705,88 mg/Kg . According to GHS the product is safety to be used in oral route.
4. Mineral oil is GRAS approved. Included in the FDA Inactive Ingredients Guide for oral capsules and
tablets, topical, transdermal, vaginal and ophthalmic preparations.

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5. Crodabase SQ did not induce the process of cutaneous irritation or sensitization and did cause neither
photo toxicity nor photo allergy during the study period and is considered as approved for topical use.

References:
1. Final Report on the Safety Assessment of Polyethylene. International Journal of Toxicology, 26 (Suppl 1), 115-127,
2007.
2. Mineral Oil. Handbook of Pharmaceutical Excipients, Third edition, 345, 2000.
3. United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS).

Non-warranty
The information in this publication is believed to be accurate and is given in good faith, but no representation or warranty as to its
completeness or accuracy is made. Suggestions for uses or applications are only opinions. Users are responsible for determining the
suitability of these products for their own particular purpose. No representation or warranty, expressed or implied, is made with respect to
information or products including, without limitation, warranties of merchantability, fitness for a particular purpose, non-infringement of any
third party patent or other intellectual property rights including, without limit, copyright, trademark and designs. Any trademarks identified
herein are trademarks of the Croda group of companies.

Croda do Brasil Ltda Rua Croda, 580, Distrito Industrial, Campinas, SP, Brasil
Tel +55 19 3765 3500 E-mail marketingla@croda.com www.croda.com/healthcare

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