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Question

Posted on: March 6 2013

Preparation of 60 capsules with 10.6 nanogram calcitriol with Rocaltrol speciality (0.5 µ g), how can we handle these soft capsules in hard capsules?

Answer

From the list of excipients (see below) we can find out that calcitriol is dissolved in a purified oil type Miglyol.
Butyl-Hydroxyanisol (E320), Butyl-Hydroxytolulene (E321), medium chain triglycerides, gelatine, glycerol, partially hydrogenated and hydrolysed starch, titanium dioxide (E171), red and yellow iron oxide (E172).
The prescribed dosage entails additional difficulties because in this case we need 60 capsules 700 Nanogram calcitriol and we go from soft capsules to 500 nanogram. In addition, the volume of oil solution in a capsule cannot be found.

Preparation

  1. Take two soft capsules and make an incision with a bistouri in the soft capsules and put them in a vial cooled with 15 ml of ether in the refrigerator;
  2. Press the capsules with a stick or a spatula to push the contents out and allow the ether to penetrate into the capsules; close the vial;
  3. Repeat this press again twice with an interval of 10 minutes.

transmit 700 nanogram on filler for capsules

  1. pour the ether solution into a small size cylinder cooled in the refrigerator and rinse the vial with 5 ml of ether;
  2. Add the coil solution to the measuring cylinder and apply the volume to an even or odd value (25 or 30 ml);
  3. calculate which volume should be measured using a syringe for a quantity of 700 nanogram; we assume that 1000 nanogram is dissolved in the ether;
  4. measures the calculated volume with a syringe;
  5. bring in a mortar the amount of filler, which is required for 60 capsules No 2;
  6. slowly divide the measured ether solution over the filler under continuous mixing with the pestle and let all ether evaporate;
Filling 60 Capsules: Divide the powder mixture evenly into 60 capsules No 2.