We claim:
1. A solid dispersion comprising of Salcaprozate sodium with one or more active
pharmaceutical ingredients.
2. The solid dispersion of claim 1, wherein the active pharmaceutical ingredient is selected
5 from the group consisting of: Suvorexant, Risdiplam, Asciminib Hydrochloride, Mitapivat,
Relugolix, Bempedoic acid, Cariprazine hydrochloride, Selexipag, Pimavanserin,
Tavaborole, Crisaborole, Cannabidiol, Viloxazine hydrochloride, Tafamidis, Pitolisant
hydrochloride, Ribociclib, Rucaparib, Eluxadoline, Abemaciclib, Venetoclax, Roxadustat,
Apalutamide, Betrixaban, or combinations thereof.
10 3. The solid dispersion of claim 1, wherein the active pharmaceutical ingredient is a
therapeutically active peptide.
4. The solid dispersion of claim 1, wherein the solid dispersion has improved stability,
improved solubility, or improved membrane permeability.
5. A process for the preparation of a solid dispersion of Salcaprozate sodium with one or more
15 active pharmaceutical ingredients, said process comprises:
(a) dissolving Salcaprozate sodium with one or more active pharmaceutical ingredients in
one or more solvents, and
(b) isolating solid dispersion of Salcaprozate sodium with one or more active
pharmaceutical ingredients.
20 6. A process for the preparation of a solid dispersion of Salcaprozate sodium with Suvorexant,
which comprises:
(a) dissolving Salcaprozate sodium and Suvorexant in one or more solvents; and
(b) isolating solid dispersion of Salcaprozate sodium with Suvorexant.
wherein, the characteristic XRPD pattern as depicted in Figure 4;
25 7. A process for the preparation of a solid dispersion of Salcaprozate sodium with Risdiplam,
said process comprises:
(a) dissolving Salcaprozate sodium and Risdiplam in one or more solvents, and
(b) isolating solid dispersion of Salcaprozate sodium with Risdiplam.
wherein, the characteristic XRPD pattern as depicted in Figure 5;
30 8. A process for the preparation of a solid dispersion of Salcaprozate sodium with Asciminib
hydrochloride, said process comprises:
(a) dissolving Salcaprozate sodium and Asciminib hydrochloride in one or more solvents,
and
(b) isolating solid dispersion of Salcaprozate sodium with Asciminib hydrochloride.
22
wherein, the characteristic XRPD pattern as depicted in Figure 6;
9. A process for the preparation of a solid dispersion of Salcaprozate sodium with Selexipag,
said process comprises:
(a) dissolving Salcaprozate sodium and Selexipag in one or more solvents, and
5 (b) isolating solid dispersion of Salcaprozate sodium with Selexipag.
wherein, the characteristic XRPD pattern as depicted in Figure 7;
10. A process for the preparation of a solid dispersion of Salcaprozate sodium with Pitolisant
hydrochloride, said process comprises:
(a) dissolving Salcaprozate sodium and Pitolisant hydrochloride in one or more solvents,
10 and
(b) isolating solid dispersion of Salcaprozate sodium with Pitolisant hydrochloride
wherein, the characteristic XRPD pattern as depicted in Figure 8;
11. A process for the preparation of a solid dispersion of Salcaprozate sodium with Olaparib,
said process comprises:
15 (a) dissolving Salcaprozate sodium and Olaparib in one or more solvents; and
(b) isolating solid dispersion of Salcaprozate sodium with Olaparib
wherein, the characteristic XRPD pattern as depicted in Figure 9;
12. The process as claimed in any of the proceeding claims wherein, the ratio of Salcaprozate
sodium with active pharmaceutical ingredient ranges from about 0.4 to 1 and 20: 1
20 13. The process as claimed in any of the proceeding claims, wherein the solvent is selected
from a group consisting of N, N-dimethylformamide, N, N-dimethylacetamide,
dimethylsulfoxide, 1-methyl-2-pyrrolidone, 1-methyl-2-piperidone, 1,3-dimethyl-2-
imidazolidinone, acetonitrile, acetone, dichloromethane, ethyl acetate, tetrahydrofuran,
acetone, methanol, ethanol, isopropanol, water, and any combination thereof.
25 14. The process as claimed in any of the proceeding claims, wherein isolating involves
removal of solvent from the reaction is carried out by at least one of evaporation, spray
drying, and freeze drying.
15. The solid dispersion of claim 1, wherein the dispersion is a stable amorphous solid
dispersion comprising Salcaprozate sodium with one or more active pharmaceutical
30 ingredients.
16. A pharmaceutical composition comprising a therapeutically effective amount of the
solid dispersion of claim 1.
17. A composition comprising: Salcaprozate sodium
23
wherein Salcaprozate sodium comprises one or more impurity is present in an
amount that is greater than zero and equal to or less than 1 weight percent of the
composition and metal impurities less than 10ppm
18. A composition comprising: Salcaprozate sodium
5 wherein Salcaprozate sodium is having specific surface area less than (SSA) 25 m2/gm
19. A process for the preparation of pure Salcaprozate sodium, comprising the steps of:
a) providing Salcaprozate sodium (1) in a suitable solvent;
b) treating the reaction mixture with activated charcoal.
c) passing the reaction mixture through resin column; and
10 d) isolating pure Salcaprozate sodium (1)
wherein Salcaprozate sodium contains less than 10ppm of colour impurities and
characterized by X-Ray powder diffraction pattern as shown in figure 1, and DSC
as shown in figure 2
20. The process as claimed in claim 19, wherein the solvent is selected from methanol,
15 ethanol, isopropyl alcohol, n-propanol, butanol and/or mixture thereof.