Formulation and manufacturing process for calcium acetate capsules
The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.
1. A calcium acetate capsule formulation comprising flowable granules comprised of a pharmaceutically acceptable amount of calcium acetate along with other pharmaceutically acceptable adjuvants, wherein said granules are filled into and contained within a pharmaceutically acceptable capsule such that 667 mg of said calcium acetate on an anhydrous basis are present in said capsule that is size 00 or less.
2. The calcium acetate formulation of claim 1 wherein the calcium acetate has a bulk density of less than about 0.55 g/cc.
3. The calcium acetate formulation of claim 1 wherein the calcium acetate has a bulk density of less than about 0.50 g/cc.
4. The calcium acetate formulation of claim 1 wherein the calcium acetate has a bulk density of less than about 0.45 g/cc.
5. The calcium acetate formulation of claim 1 wherein the calcium acetate has a bulk density of from about 0.30 g/cc to about 0.45 g/cc.
6. The calcium acetate formulation of claim 1 wherein the pharmaceutically acceptable adjuvants are selected from disintegrants, diluents, lubricants, glidants and blends thereof.
7. The calcium acetate formulation of claim 6 wherein the adjuvants are selected from polyethylene glycol, magnesium stearate and blends thereof.
8. The calcium acetate formulation of claim 1 wherein the granules have a median particle size of from about 450 microns to about 600 microns.
9. The calcium acetate formulation of claim 1 wherein the granules are sized such that about 75% of the particles are retained on a 150 micron sieve.