بعنوان يك محلول تزريقي Anti-D-IgG فرمولاسيون فراورده

Formulation of Anti-Rh (I)) immunoglobulin preparation

Anti-D 1gCi is widely used to prevent hemolytic disease of the newborn. Maintenance of the structural integrity of this therapeutic protein is essential for its efficacy in relation to physiological and pharmacological activities. The aim of this study was to formulate the Anti-l) lgG as a parentcral dosage form using suitable buffers and different stabilizing agents. Therefore, after purification, the Anti-D lgG preparation was firstly formulated in different buffers including citrate (pH 4.5), acetate (pl 15.5), and phosphate (pi 1 6.5 and 7.5) with the concentration of 10, 25, 50 and 100 mM. The formulations were then incubated at 57 C for 411 and the transmittance was measured at 580 nm. Among the different buffers. the acetate buffer with the concentration of I0 niM had the highest stability effect on the Anti-D lgG. Then, Glycine (Gly), polysorbatc 80 and mannitol. in different concentrations were incorporated to the acetate buffer (pit 5.5, 10 mM) containing Anti-D lgG, as stabilizing agents and the stability was investigated as before. Among 16 formulations, the formulation containing Gly, 0.3 M; polysorbatc 80, 0.1%; and mannitol 7% had the highest stability. The stability of the formulations was also studied according to British Pharmacopeia (1W) based on biological activity. The result indicated that the loss of Anti-D potency of the aforementioned formula is only 9.57 ± 0.25% of initial value that meets the requirement set by 13P. Conclusion could he made that this formula could be introduced as a candidate formulation of the Anti-D lgG as a parenteral dosage form.