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Протокол разработки МЛФ (Препарат сравнения (Реология (Shear rate…
Протокол разработки МЛФ
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Препарат сравнения
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Реология
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Rheology of the sample would influence the area of application which in turn could affect the permeation profile.
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Drying profile - % release mass upon time (h) _ Solvent evaporation leading to shift in the ratio D/UD drug
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Стресс-тесты
- Viscosity vs. Time – After the emulsion is made, measure the original viscosity and periodically thereafter to detect any large changes. If a 10% deviation from the original viscosity results in less than 3 months at room temperature, this is a sign or an unstable emulsion.
- Centrifuge – Subjecting the emulsion to a 5 - 10 g force for several minutes will test the resistance to creaming. Although this test exerts an artificially elevated gravitational force on the emulsions, it can determine the yield strength of the emulsion that assists in maintaining stability to phase separation.
- Emulsion Droplet Size Analysis – Image (microscope) or other analytical size analysis may detect a broad droplet size distribution in Pemulen™ polymeric emulsions o/w emulsions. Unlike conventional emulsions, this is not a predictor of emulsion instability.
- Heat Storage Test – Viscosity rise of less than 20% over original values after storage of samples at 50°C for one month indicates room temperature stability for one year. A viscosity rise is the precursor to visible creaming. Be sure there is as little head space as possible, as the water in the emulsion may evaporate and recondense, forming a liquid layer that may be mistakenly identified as a broken emulsion.
