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

Authors

  • Ruba Kello Formulation development department, R&D Laboratories, Asia Pharmaceutical Industries, Aleppo, Syria.

Keywords:

Vitamins, Minerals, Granulation, Stability, Oral vial

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].

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Author Biography

Ruba Kello, Formulation development department, R&D Laboratories, Asia Pharmaceutical Industries, Aleppo, Syria.

i am a senior formulation suppervisor in R&D lab. at asia pharmaceutical industries for three years and up tp now, i have also one year experience in Ibn alhytham pharma in the same field. i have two bachelor's degrees one in pharmacy from Akalamoon university and the other in Chemistry from Aleppo university.

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Published

31-08-2014

How to Cite

Kello, R. “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”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 6, no. 8, Aug. 2014, pp. 95-98, https://journals.innovareacademics.in/index.php/ijpps/article/view/1299.

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Original Article(s)