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