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Question

Posted on: December 6 2018

Capsules with Calcitriol 0.0625 micrograms per capsule

Raw material not available. But we can use Rocaltrol as a source for Calcitrol.

Answer

For 30 Capsules We need 0.0625 X 30 = 1.875 micrograms of calcitriol  

1 capsule Rocaltrol contains 0.25 mcg of calcitriol dissolved in 0.17 ml of oil. For 1.875 MCG We need 7.5 capsules or a volume solution = 1.275 ml or completed 1.3 ml.

Rocaltrol has the following excipients: Butyl-Hydroxyanisol (E320), Butyl-Hydroxytolulene (E321), medium chain triglycerides, gelatine, glycerol (E422), compiled 83 (sorbitol (E420), mannitol (E421), hydrogenated and hydrolysed starch), Titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).

Only the first three interest us because most of the rest are attributed to the capsule wall.

Given medium chain triglycerides (or Miglyol) if oil is used we will use the same oil for the dilution of the oil we have taken from the capsules.

Taking into account a density for Miglyol = 0.94 1.3 ml = 1.12 g Rocatrol oil  . With an extra of 10% 1.25 g Rocatrol oil

For this preparation it is advisable to take an excess of 10%.

We can opt for hard capsules size n ° 2 or 1. Since     #1 has a volume of 0.5 ml we opt for this size. This means that if we fill the capsules for 80%;     We should have a total volume of 12   ML for 30 capsules and that a 0.4   ml solution should be filled per capsule.  

  Taking into account an additional of 10% is 12   ml = 13.2   ml

13.2   ml of Miglyol corresponds to 12.4   G. So the 1.25 g Rocatrol oil is diluted with Miglyol up to 12, 4g. After mixing, 0.4   ml of the dilution is filled with the help of a 1 ml syringe in each capsule.

Before closing the capsule, each cup is hushed in a cellulosic acetate solution as used for EC.   and then slid over the body. This is to hermetically close the capsule and avoid oil leaking.  

Maybe one can place the capsules upright on a piece of Styrofoam and store it in the refrigerator.  

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