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. Capsules comprising calcium acetate produced in accordance with a process comprising the steps of:
a) blending a portion of a pharmaceutically acceptable amount of calcium acetate and a first lubricant and then passing the blend through a mill to deagglomerate the blend and then mixing the deagglomerated blend to form a first blend;
b) adding to the first blend, the remaining portion of the pharmaceutically acceptable amount of the calcium acetate to a portion of a pharmaceutically acceptable amount of a second lubricant, blending and mixing to form a second blend;
c) passing the second blend of step b) through a mill to deagglomerate the second blend and mixing again;
d) granulating the second blend of step c) using a roller compactor to form a granulated product;
e) passing the granulated product of step d) through a comil to size the granules to a pharmaceutically acceptable size;
f) adding the second blend and the remaining pharmaceutically acceptable amount of the second lubricant and blending to form a final blend comprising flowable granules;
g) filling the final blend of step f) into pharmaceutically acceptable capsules using an encapsulation device, wherein said granules are filled into and contained within said capsules such that 667 mg of said calcium acetate on an anhydrous basis are present in each said capsule that is size 00 or less.
2. The capsules of claim 1 wherein the calcium acetate has a bulk density of less than about 0.55 g/cc.
3. The capsules of claim 1 wherein the calcium acetate has a bulk density of less than about 0.50 g/cc.
4. The capsules of claim 1 wherein the calcium acetate has a bulk density of less than about 0.45 g/cc.
5. The capsules 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 capsules of claim 1 wherein the first lubricant is polyethylene glycol.
7. The capsules of claim 6 wherein the second lubricant is magnesium stearate.
8. The capsules of claim 1 wherein said granules have a median particle size of from about 450 microns to about 600 microns.
9. The capsules of claim 1 wherein said granules are sized such that about 75% of the particles are retained on a 150 micron sieve.