We claim:
1. A hydroxypropyl methylcellulose capsule filled with a composition
5 comprising isavuconazonium sulfate and atleast one pharmaceutically
acceptable excipients, wherein the composition is stable for at least eighteen
months when stored at 250C± 20C/60%RH ± 5%RH and the composition is
devoid of drying agents that stabilizes the isavuconazonium sulfate against
hydrolysis during storage.
10 2. The capsule of claim 1, wherein the composition is having less than 15%w/w
of water content.
3. The capsule of claim 1, wherein the composition comprising of 30 to 70% by
weight of isavuconazonium sulfate to the total weight of the composition.
4. The stable composition of claim 1, comprising of pharmaceutically
15 acceptable excipients are microcrystalline cellulose, talc, colloidal silicon
dioxide and stearic acid.
5. The stable composition of claim 1, wherein the composition comprising of
not more than 5.0%w/w of individual known impurity and not more than
0.5%w/w of any individual unknown impurity.
20 6. The stable composition of claim 1, wherein the composition comprising of
not more than 10.0%w/w of total impurities.
7. A process for the preparation of stable isavuconazonium sulfate composition
comprising of:
a) mixing isavuconazonium sulfate and one or more pharmaceutically
25 acceptable excipient to obtain homogeneous blend composition;
b) optionally storing the blend under nitrogen purging and with a desiccant;
c) encapsulation of final blend composition into a
hydroxypropylmethylcellulose capsule;
d) optionally storing the capsules under nitrogen purging and with a
30 desiccant;
e) packing capsule into a blister with a desiccant.
8. The blister of claim 7, wherein the desiccant is a silica gel.
9. The stable composition of claims 1-8, wherein the composition is prepared
using isavuconazonium sulfate stored at -200C.
10. The stable composition of claims 1-9, wherein the composition is indicated
5 for the of invasive aspergillosis or invasive mucormycosis.