EFFECT OF ADDITIVES ON INTRANASAL PREPARATION OF CYANOCOBALAMIN
Keywords:
intranasal, cyanocobalamin, partition coefficient, permeationAbstract
The following study involves formulation and evaluation of intranasal preparation of cyanocobalamin. The design of the formula was achieved by preformulation studies of each of solubility, partition, permeation and stability of cyanocobalamin. HPLC (stability indicating assay) wasused only in the stability studies of cyanocobalamin, other parameters were analyzed using a prevalidated spectrophotometric analytical method. In the meantime,such selected adjuncts should have no significant effects on the physical characteristics of the intranasal drops. All components included in the formula were tested regarding their effects on the tested parameter. Also, they were investigated regarding their effect on each parameter tested including the permeation pattern. The latter parameter could be a substitute for in vivo bioavailability, since the data proved that such parameter is highly indicative. Based on the above studies a formula of intranasal drops of cyanocobalamin was designed to contain ingredients suitable for nasal administration. Such formula achieve another important goal which is improving the patient compliance. The formula contains: Cyanocobalamin 0.5%, Sodium metabisulphite 0.5%, β-cyclodextrin 0.5%, Glycerol 10% and Benzalkonium chloride 0.1%. All ingredients were dissolved in a solution prepared at pH value 5.6 using citrate/phosphate buffer.
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