There
are three conditions that the compounding pharmacy strictly enforces. The first
rule is that you need to check the medication to make sure that it’s correct.
In the compounding pharmacy, there is an automation system that helps
individually package the powder formulation into the correct dosage. It is
important to only use one medication at a time with this machine to prevent any
cross contamination. Second, the correct dose must be used. No modifications
can be made in the middle of making the powder formulation. Third, the correct
quantity must be used.
When
working in this environment, one must take note of special precautions to
prevent contamination. You must wear a gown, a cap, and a special mask that
prevents small particles from entering. You also have to wash your hands twice,
making sure to pay special attention to the nail beds and the knuckles, which
are areas that tend to have more germs. There is a special brush available as
well to help get rid of the dead skin. When you are done, you can spray 75%
ethyl alcohol on your hands before putting on your gloves. You are now ready to start compounding.
Our
goal that afternoon was to make urso at three different strengths (16.7 mg, 25
mg, and 33.3 mg) using a 100 mg tablet. Urso is often used to treat small
gallstones or to treat primary biliary cirrhosis. The first ingredient we work
with is lactose monohydrate. This is somewhat equivalent to the syrup that we
have in the US that is used to make liquid formulations. The purpose of the
lactose is to make the medication taste better and to also increase the volume
(which is important for medications where we’re only using a small fraction).
How to create a powder formulation
1) Accurately measure out how much lactose you
need.
2) Add the appropriate amount of tablets for your
medication into the blender.
3) For medications that are likely to stick to the
blender (such as urso), add a little bit of
the lactose in as well.
4) After blending the lactose and the medication,
pour the contents into the mortar.
5) Make sure that you use the brush to get the
remaining powder in the blender.
6) Add the lactose and use the pestle to mix the
powder.
7) After you have made 60-80 rotations (both
clockwise and counterclockwise), pour the
contents onto wax paper.
8) Use a brush to get the remaining powder in the
mortar and pestle
9) Add the contents into the automatic machine to
separate the medication into unit dose
packaging.
Overall
I had a great time compounding the urso tablets into a power formulation. While
this can be somewhat of a labor intensive process, it is definitely help in
creating a formulation that is appropriate for the pediatric population.
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