We Claim:
1. A process for the preparation of a stable and highly pure crystalline Form 1 of
Bilastine essentially free of other crystalline forms, comprising:
a) providing a solution of Bilastine in n-butanol at a temperature of about 100°C to about reflux temperature of the solvent used under nitrogen atmosphere, wherein the quantity of n-butanol solvent required is at least about 8 volumes with respect to the quantity of Bilastine used;
b) optionally, subjecting the solution obtained in step-(a) to carbon treatment at reflux temperature to obtain a filtrate;
c) cooling the solution obtained in step-(a) or step-(b) to a temperature of below about 35°C to cause crystallization; and
d) collecting the highly pure crystalline Form 1 of Bilastine essentially free of other crystalline forms formed in step-(c).

2. The process of claim 1, wherein the crystalline Form 1 of Bilastine essentially free of other crystalline forms obtained by the process is characterized by an X-ray powder diffraction pattern having peaks expressed as 2-theta angle positions at about 11.33, 12.47, 15.14, 16.30 and 19.76 ± 0.2 degrees substantially in accordance with Figure 1; and/or an infra red (FT-IR) spectrum having main bands at about 3057, 2971, 2929, 2883, 2857, 1688, 1614, 1510, 1482, 1459, 1431,1381,1347,1325,1254,1121,1045,991, 972, 925, 830, 742,721 and 695 cm"1 ± 5 cm"1 substantially in accordance with Figure 2; and/or a Differential Scanning Calorimetric (DSC) thermogram having onset temperature at about 200.19°C and a sharp endotherm peak at about 201.65°C substantially in accordance with Figure 3.
3. The process of claim 2, wherein the crystalline Form 1 of Bilastine essentially free of other crystalline forms obtained by the process is further characterized by an X-ray powder diffraction pattern having additional 2-theta peaks at about 3.77, 10.60, 17.16, 18.94, 21.12, and 22.80 ± 0.2 degrees substantially in accordance with Figure 1.

4. The process of claim 1, wherein the amount of n-butanol solvent employed in step-(a) is about 8 volumes to about 12 volumes with respect to the quantity of Bilastine used.
j 5. The process of claim 4, wherein the amount of n-butanol solvent employed in step-(a) is about 9 volumes to about 10 volumes with respect to the quantity of Bilastine used.
6. The process of claim 1, wherein the solution in step-(a) is prepared by dissolving
) Bilastine (crude or pure) in n-butanol solvent at a temperature of about 100°C to
about the reflux temperature of the solvent used; and wherein the crystallization
in step-(c) is accomplished by cooling the solution while stirring at a
temperature of about 0°C to about 30°C for at least 20 minutes.
5 7. The process of claim 1, wherein the solution in step-(a) is prepared by dissolving Bilastine (crude or pure) in n-butanol solvent at the reflux temperature of the solvent used; and wherein the crystallization in step-(c) is accomplished by cooling the solution while stirring at a temperature of about 20°C to about 30°C for about 30 minutes to about 2 hours.
D
8. Highly pure crystalline Form 1 of Bilastine essentially free of other crystalline forms, characterized by an X-ray powder diffraction pattern having peaks expressed as 2-theta angle positions at about 11.33, 12.47, 15.14, 16.30 and 19.76 ± 0.2 degrees substantially in accordance with Figure 1; and/or an infra
5 red (FT-IR) spectrum having main bands at about 3057, 2971, 2929,2883,2857,
1688, 1614, 1510, 1482, 1459, 1431, 1381, 1347, 1325, 1254, 1121, 1045, 991, 972, 925, 830, 742, 721 and 695 cm"1 ± 5 cm"1 substantially in accordance with Figure 2; and/or a Differential Scanning Calorimetric (DSC) thermogram having onset temperature at about 200.19°C and a sharp endotherm peak at about
0 201,65°C substantially in accordance with Figure 3.

9. A pharmaceutical composition comprising highly pure crystalline Form 1 of Bilastine essentially free of other crystalline forms, wherein the crystalline Form 1 of Bilastine has a D90 particle size of less than or equal to about 100 microns; and wherein the crystalline Form 1 of Bilastine has a D50 particle size of less than or equal to about 60 microns.
10. The pharmaceutical composition of claim 9, wherein the crystalline Form 1 of Bilastine has a D90 particle size of about 2 microns to about 80 microns; and wherein the crystalline Form 1 of Bilastine has a D50 particle size of about 2 microns to about 50 microns.