Objective:

Developing a new formulation of heparin sodium injection in solution of 5.000 IU/mL.

Methods:

Three variants of formulations were tested and three batches were prepared at laboratory scale. Three pilot batches were also scaled up with stability checking for 12 months of shelf life and 6 months accelerated.

Results:

The formulation composed of heparin sodium (5.000 IU/mL), chlorobutanol as preserve, two buffers (monobasic sodium phosphate/dibasic sodium phosphate) and water for injection, as a vehicle; 6R bulbs, transparent and colorless, met the quality requirements. Biological potency and pH control were stable in the three batches prepared at laboratory scale.

Conclusions:

The results obtained in the latter demonstrated the feasibility of the technological development of this medicine, fulfilling the quality characteristics of the injectables.

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