Formulation and manufacturing process for calcium acetate capsules
View Patent ↗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 capsule containing a calcium acetate formulation comprising flowable granules, the flowable granules being comprised of calcium acetate and an adjuvant, and the flowable granules being granulating a dry blend comprising calcium acetate and an adjuvant under pressure in a roller compactor, wherein the flowable granules comprise a tap density, the tap density being such that 667 mg of the calcium acetate on an anhydrous basis of the flowable granules can be filed into a size 00 capsule.
2. The capsule of claim 1 , the granules being granulated under hydraulic pressure.
3. The capsule of claim 1 , the adjuvant being a lubricant, glidant, disintegrants or diluents.
4. The capsule of claim 3 , the adjuvant being polyethylene glycol.
5. The capsule of claim 3 , the adjuvant being magnesium stearate.
6. The capsule of claim 1 , the flowable granules not being compressed into a tablet or caplet before being filled into the capsule.
7. The capsule of claim 1 , the flowable granules being filled into the capsule using an encapsulation device.
8. The capsule of claim 1 , the capsule containing 667 mg of calcium acetate on an anhydrous basis.
9. The capsule of claim 1 , the capsule being size 00.
10. The capsule of claim 1 , the capsule having a dissolution in water such that at least 86% of the calcium acetate is dissoluted within 10 minutes.
11. The capsule of claim 1 , the capsule having a dissolution in water such that at least 96% of the calcium acetate is dissoluted within 15 minutes.
12. The capsule of claim 1 , the capsule having a dissolution in water such that at least 95% of the calcium acetate is dissoluted within 10 minutes.
13. The capsule of claim 1 , the capsule having a dissolution in water such that at least 100% of the calcium acetate is dissoluted within 15 minutes.
14. The capsule of claim 1 , the flowable granules having a median particle size of from about 450 microns to about 600 microns.
15. The capsule of claim 1 , the flowable granules being sized such that about 75% of the particles are retained on a 150 micron sieve.