1. An amorphous solid dispersion of Mitapivat sulfate of formula (1) with one or
more pharmaceutically acceptable excipients.
2. The amorphous solid dispersion of Mitapivat sulfate as claimed in claim 1,
5 wherein one or more pharmaceutically acceptable excipients are selected from
hydroxypropyl beta cyclodextrin (HPβCD), polyvinylpyrrolidone-K-30 (PVPK-30), Soluplus, Eudragit, sulfobutylether-β-cyclodextrin (SBCED),
(Hydroxypropyl)methyl cellulose E3 (HPMC-E3), Hydroxypropyl cellulose
(HPC), Copovidone, Hydroxypropyl Methylcellulose Acetate Succinate
10 (HPMC-AS), Polyethylene Glycol 6000 (PEG-6000), maltose, maltodextrin,
mannitol, isomalt and/or its mixture thereof.
3. The amorphous solid dispersion of Mitapivat sulfate as claimed in claim 1,
wherein the ratio of Mitapivat sulfate and pharmaceutically acceptable carrier
is about 1:0.05 to about 1:5.
15 4. A process for preparation of solid dispersion of Mitapivat sulfate of formula
(1) with one or more pharmaceutically acceptable excipients, the process
comprising:
a) preparing a solution of Mitapivat sulfate of formula (1) together with one
or more pharmaceutically acceptable excipients in one or more solvents;
20 and
b) isolating the solid dispersion of Mitapivat sulfate of formula (1) with one
or more pharmaceutically acceptable excipients.
5. A process for the preparation of solid dispersion of Mitapivat sulfate of formula
(1) with one or more pharmaceutically acceptable excipients, the process
25 comprising:
a) providing a solution of Mitapivat sulfate of formula (1) in one or more
solvents,
b) adding one or more pharmaceutically acceptable excipient to the solution
obtained in step-a), and
30 c) isolating the solid dispersion of Mitapivat sulfate of formula (1) with one
or more pharmaceutically acceptable excipients.
24
6. The process for preparing solid dispersion of Mitapivat sulfate of formula (1)
as claimed in claim 4 and 5, wherein the solvent is selected from chloro
solvents, alcohol solvents, polar-aprotic solvents, polar solvents and/or mixture
thereof.
5 7. A pharmaceutical composition comprising solid dispersion of Mitapivat sulfate
of formula (1) of with one or more pharmaceutically acceptable excipients.
8. A process for the preparation of amorphous form of Mitapivat sulfate (1),
which comprising of:
a) dissolving Mitapivat sulfate (1) in one or more solvents,
10 b) optionally, adding one or more anti-solvent(s) to the solution obtained from
step a), and
c) isolating the amorphous form of Mitapivat sulfate (1).
9. The process as claimed in claim 8, wherein in step-a) the solvent is selected
from "alcoholic solvents" such as methanol, ethanol, n-propanol, isopropanol,
15 n-butanol, 2-methylpropan-1-ol, 2-butanol, t-butanol, and the like; "polaraprotic solvents such as N, N-dimethylacetamide, N,N-dimethylformamide,
dimethyl sulfoxide, N-methyl pyrrolidone (NMP) and the like; anti-solvent is
selected from ether solvents such as dimethyl ether, diisopropyl ether, diethyl
ether, methyl tert-butyl ether, 1 ,2-dimethbxy ethane, tetrahydrofuran, 1,4-
20 dioxane and the like.
10. The amorphous solid dispersion of Mitapivat sulfate (1) as claimed in claim
1, having an X-ray powder diffraction pattern substantially as shown in figure1