Development of spherical iron(II) sulfate heptahydrate-containing solid particles with sustained drug release.

The aim of this work was to develop a simple, economic procedure for the manufacturing of coated iron(II) sulfate particles by using a crystallization technique for the development of round particles, followed by coating with a lipophilic material. Several batches of iron(II) sulfate heptahydrate were produced by a cooling crystallization, with variation of the crystallization parameters. The spherical crystals were coated with stearin. The products were characterized for particle size, roundness, bulk density and in vitro drug dissolution. Crystallization was performed from deionized water with no addition of seed crystals and by cooling by applying a linear cooling rate. The developed iron(II) sulfate crystals were round with average diameter of 729+/-165 microm. The best form for the sustained release of iron(II) sulfate was the sample HTP-2 which contained 11% of stearin relative to the iron(II) sulfate. The spherical crystallization of iron(II) sulfate is simple and fast, and does not require a dangerous, expensive solvent. The round particles can coat directly with lipophilic material which results in slow release of iron(II) sulfate and protects the iron(II) from oxidation and inhibits the loss of crystal water. The coated crystals can be filled into capsules to yield the final dosage form.