19
are used.
Melting semisolid substances using max. 85°C/185°F hot water can be achieved
by three methods:
1. Addition of hot water (≤ 85°C/ 185°F)
2. Covering with cold water – heat up to 200 ml in the hot-water bath ≤ 85 °C/185 °F.
3. Covering with cold water – careful heating in the microwave (mind max. temperature)
To attain an even structure, heated emulsions should be stirred until they have cooled
to room temperature with a few intervalled strokes using a water jacket or by using
cooling phases at medium speed during which the UNGUATOR® Jars are placed in
the refrigerator, if necessary.
4.4.3 Normal
(Mixing semisolid substances from low-viscous to pasty).
Examples: Off-the-shelf pharmaceutical ointments with base(s), concentrated
active substances with base(s), liquid active ingredients in base(s)
First the ointment base should be weighed out into the UNGUATOR® Jar. Then the remaining
constituents should be added accordingly.
4.4.4 Suspension <2%
(Mixing semisolid substances with a portion of microfine, agglomerated, optionally
finegrained solid substances of less than 2 %).
Examples: Cortisones, antibiotics, fungicides, metronidazole
We recommend using the UNGUATOR® SMB.
If there is no concentrated active substance, we recommend a pregrinding process
e.g. by use of a pregrind program in the case of a suspension with a content of less
than 2% active ingredients. For pregrinding, the solids with low base content
are weighed out into the UNGUATOR® Jar. The movable bottom remains in the
lowest position, in order to make use of the full capacity of the jar including both lid
and bottom areas for the dispersion process. The degree of dispersion reached by
pregrinding should be checked to ensure that no active substance particles or
agglomerates are too large, either microscopically or using a strong magnifying glass.
Usually, the spreading on a glassplate (e.g. object slide) is sufficient to prevent inhomogeneity.
Eventually the pregrinding process needs to be repeated depending on the examination.
