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Question

Posted on: April 17 2019

Dutasteride soft capsules should be lowered in dose from 0.5 mg per capsule to 0.15 mg.

So far we used kaolin as a carrier product, however this is not to get. Does corn starch also qualify for this?

Answer

Here the information received from the company

Dutasterid 0.5 mg drug product is presented as soft capsules containing an oily liquid.

I can inform you that the capsule content is composed of the following:     Glycerol monocaprylocaprate Type I;   Butylhydroxytoluene (BHT)-(E-321);   Dutasterid: 0.5 mg

The Total Capsule content weight is 350,035 mg.

The company added important the to  

"The capsules should be swallowed whole and should not be chewed or opened, as contact with the capsule content may result in irritation of the oropharyngeal mucosa. The capsules can be taken with or without food. "

Dosage

"adults (including elderly): The recommended dose of dutasteride is one capsule (0.5 mg) orally, once daily"

Sandoz only recommends the use of its products according to the information published in the SmPC (package leaflet). Opening The capsules is not included in the authorised label and would represent an off-label use, which cannot be recommended by Sandoz. Please Note that if used in this manner in a specific patient, it is under the responsibility of the corresponding healthcare professional and needs to be declared as off-label use to drug. Safety_ belgium@novartis.com

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composition   Capsule content: Butylhydroxytolulene (E321) Glycerol Monocaprylocapraat (type I)   Capsule Shell: Gelatine Glycerol titanium dioxide (E171), 13 Iron oxide yellow (E172),   other ingredients: triglycerides, medium chain Lecithin (may contain soybean oil) (E322) Water, purified     I therefore assume that the capsule content consists mainly of glyceryl monocaprylocapate   Type I = Imwitor 742 with a density of 0.95 g/ml   you are preparing 200 capsules and need 30 mg Dutasteride   1 capsule Dutasteride contains 0.5 mg/350 mg or/0.37 ml; this is 1.35 mg/ml   200 capsules N ° 2 have a total   volume of 200 x 0.37 ml = 74 ml, which should contain 30 mg Dutasteride.   But we are going to make a small excess being 80 ml solution, which should then contain 32.5 mg Dutasteride.   Suppose I have 70 capsules empty and x ml reception. The amount of Dutasteride in those x ml = 1.35 x and which must be equal to 32.5 mg Dutasteride. If not then you will   have to empty some extra capsules.       which x ml we supplement with Miglyol to 80 ml and with this solution we fill 200 capsules N ° 2.     The cups of the capsules must be placed manually on the bodies after the lower part of the cup in a CAP solution dipped. This operation   is performed to close the capsules so that no liquid runs out.