IMMEDIATE RELEASE FORMULATIONS OF CINACALCET

1 . A pharmaceutical composition, comprising:

(a) from 15 to 50% by weight cinacalcet HCl;

(b) from 30 to 80% by weight of one or more fillers; and

(c) from 5.1% to 7% by weight of one or more binders;

and optionally one or more disintegrants, one or more glidants and/or one or more lubricants or one or more other acceptable pharmaceutical excipients,

wherein each percentage by weight is relative to the total weight of the composition.

2 . Pharmaceutical composition according to claim 1 , comprising:

(b) from 35% to 70% by weight of one or more fillers.

3 . Pharmaceutical composition according to claim 1 , further comprising:

(d) from 10.1% to 15% by weight of one or more disintegrants.

4 . Pharmaceutical composition according to claim 1 , comprising:

(a) from 18% to 45% by weight cinacalcet HCl;

(b) from 35% to 64% by weight of one or more fillers;

(c) from 5.1% to 7% by weight of one or more binders; and

(d) from 10.1% to 12% by weight of one or more disintegrants.

5 . Pharmaceutical composition according to claim 1 , comprising:

(a) from 18% to 20% by weight cinacalcet HCl;

(b) from 60% to 64% by weight of one or more fillers;

(c) from 5.1% to 7% by weight of one or more binders; and

(d) from 10.1% to 12% by weight of one or more disintegrants.

6 . Pharmaceutical composition according to claim 1 , comprising:

(a) from 41% to 44% by weight cinacalcet HCl;

(b) from 35% to 40% by weight of one or more fillers;

(c) from 5.1% to 7% by weight of one or more binders; and

(d) from 10.1% to 12% by weight of one or more disintegrants.

7 . Pharmaceutical composition according to claim 4 , comprising:

(d) from 10.5% to 11.5% by weight of one or more disintegrants.

8 . Pharmaceutical composition according to claim 1 , comprising an intragranular phase, comprising:

(a) from 18% to 20% by weight cinacalcet HCl;

(b′) from 30% to 40% by weight of one or more fillers;

(c) from 5.1% to 7% by weight of one or more binders; and

(d′) from 5% to 6% by weight of one or more disintegrants;

and an extragranular phase, comprising:

(b″) from 25% to 28% by weight of one or more fillers;

(d″) from 5% to 6% by weight of one or more disintegrants; and

(e) from 0.2% to 1% by weight of one or more glidants.

9 . Pharmaceutical composition according to claim 1 , comprising an intragranular phase, comprising:

(a) from 41% to 44% by weight cinacalcet HCl;

(b′) from 25% to 30% by weight of one or more fillers;

(c) from 5.1% to 7% by weight of one or more binders; and

(d′) from 5% to 6% by weight of one or more disintegrants;

and an extragranular phase, comprising:

(b″) from 8% to 12% by weight of one or more fillers;

(d″) from 5% to 6% by weight of one or more disintegrants; and

(e) from 0.2% to 1% by weight of one or more glidants.

10 . Pharmaceutical composition according to claim 1 , comprising:

(c) from 5.5% to 6.5% by weight of one or more binders.

11 . Pharmaceutical composition according to claim 1 , comprising:

(f) from 0.2% to 1.5% by weight of one or more lubricants.

12 . Pharmaceutical composition according to claim 1 , wherein the cinacalcet HCl particles exhibits a D 50 ranging from 5 μm to 95 μm.

13 . A process for the manufacture of a pharmaceutical composition comprising cinacalcet HCl according to claim 1 , comprising the following steps:

(a) mixing cinacalcet HCl, the binders, a portion of the fillers and a portion of the disintegrants to form an intragranular phase;

(b) wet granulating the intragranular phase to form wet granules;

(c) sieving the wet granules;

(d) drying the wet granules and calibrating the dried granules;

(e) mixing and sieving the remaining portions of fillers and disintegrants with the glidants to form an extragranular phase;

(f) blending the extragranular phase with the dried granules;

(g) sieving the lubricants and blend them with the mixture of dried granules and the extragranular phase to form the final blend which is used for production of the tablets.

14 . A method of treating secondary hyperparathyroidism resulting from chronical kidney insufficiency in a patient in need thereof, said method comprising administering said patient a pharmaceutical composition according to claim 1 .

15 . A method of treating hypercalcaemia in patients with parathyroid carcinoma, said method comprising administering said patient a pharmaceutical composition according to claim 1 .