NITISINONE oral capsule with Total sale year 2015: $ 98.5 Million & No generic available

NITISINONE is available in CAPSULE form with 2MG , 5 MG, 10 MG strength.

Formulation Development of NITISINONE Capsule...

The intrinsic physico-chemical properties of the active substance were taken into account for the development of an oral solid formulation. During the development of the product different excipients were used. A sufficiently stable preparation was obtained using pregelatinised starch as single excipient (diluent).

Pregelatinised starch is the only excipient for the powder mixtures. Gelatin and titanium dioxide (E 171) are used for the capsules shell, and antifoam, iron oxide black (E 172), shellac, soya lecithin are used in the imprint. All the excipients comply with the Ph. Eur. The bovine gelatin used is in compliance with the European Commission Decision 2001/2/EC regulating the use of material presenting risks as regards transmissible spongiform encephalopathy. The components of the ink have been properly specified. The excipients have been chosen based on their function and on their compatibility with the active substance and with each other.