Dear all,
My formulation contains almost 30% of vaseline and 8% yellow beeswax + APIs and other ingredients. The thickness of ointment in room temperature is acceptable, while in stability chamber it liquifies (Temperature=40 C, Humidity=60 %). Is it normal. If not, what is your solution?
Thank you very much in advance.
If you do not have hygroscopic ingredients, do a quick bench test of your formulation by heating it at 40 oC. Sometimes the melting point of excipients is depressed by the addition of other components. The melting point of Vaseline is typically between 40 and 70 °C.
If your API is soluble (even partially) in your excipients (vaseline and/or yellow beeswax) it will depress their melting points. Hence you should increase the amount of gelifying agent in the mixture or select another gelifying agent with a higher melting point than yellow besswax.
the liquefaction of the cream in stability chamber is not a failure criterion, based on ICH Q1A (R2): "some changes in physical attributes (e.g., softening of suppositories, melting of creams) may be expected under accelerated conditions."
the change such as chemical reaction, oxidation or phase separation are significant. The molten sample that has just been removed from the chamber must reach room temperature before evaluation.
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