DESIGN AND CHARACTERIZATION OF A NEW SUGAR FREE FORMULATION OF VITAMINS C, E, B6 AND MINERALS Zn2+ AND Mn2+ FOR CHILDREN IN ORAL VIAL WITH PLUNGER AND TEAR OFF CAP

Abstract

Objective: Aim of present study was to provide a stable sugar free formulation that contains vitamins C, E, B6 and minerals Zn²⁺ and Mn²⁺ in a unique pharmaceutical dosage form which consists of a plunger containing granules closed with a tear-off cap and a number vial contains solution which is prepared specially to dissolve the last granules. Final form is closed and securely fastened with a plastic cap. This dosage form combines advantages of liquid dosages with those of solid dosages.

Methods: granules were prepared by means of wet granulation method and the granulator was consisted of alcohol and water (80:20). Product in its final form was evaluated for many parameters like, appearance, Loss on drying for granulated part, pH for solution part and assay. The formulation was subjected to stability studies as per ICH guidelines at temperatures and humidity of 40 C ͦ / 75% RH ± 5% RH for six months [1].

Results: results of stability studies for all vitamins and minerals were found within the limits but there was a significant change in assay of vitamins C and B6; in addition, there was failure in meeting the acceptance criteria for color of the granulated part.

Conclusion: it could be concluded that oral vial with plunger and tear off cap can be used as an alternative dosage form for minerals and vitamins, but additional testing at the intermediate storage condition 30°C/65% RH ± 5% RH " If long-term studies were conducted at 25°C /60% RH± 5% RH " should be conducted and evaluated against significant change criteria [1].