Farnaz Monaggemzadeh
1,2, Fatemeh Ebrahimi
3, Parvin Zakeri-Milani
4, Hadi Valizadeh
2*1 Department of Pharmaceutical and food Control, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
2 Drug Applied Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
3 Biotechnology Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
4 Liver and Gastrointestinal Diseases Research Center and Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
Purpose:
In this research the effect of vitamin B1
and B6 on cyanocobalamin stability in commercial light protected
parenteral formulations and upon adding stabilizing agents will be investigated
and best formulation composition and proper storage condition will be introduced.
Methods:
In this research some additives such as co solvents and tonicity adjusters, surfactants, antioxidants
and chelating
agents as well as buffer solutions, were used to improve the
stability of the parenteral mixed formulations of B12 in the presence
of other B vitamins (B1 and B6). Screening tests and accelerated
stability tests were performed according to ICH guidelines Q1A
(R2).
Results: Shelf life evaluation revealed
the best formulation and the proper storage condition. The results indicated
the first kinetic models for all tested formulations and the optimum pH value
was determined to be 5.8. There was no evidence of B12 loss when
mixed with B1 and B6 in a medical syringe at room
temperature for maximum of 8 hours.
Conclusion: It is necessary to formulate
vitamin B12 mixed parenteral solutions using proper phosphate
buffers (pH=5.8) and to indicate “Store in refrigerator” on the mixed
parenteral formulations of vitamin B12 with other B vitamins, which
has not been expressed on the label of tested Brand formulations at the time of
this study.