Background and Importance In the case of the development of a generic drug, the approach is based almost exclusively on galenic and analytical developments. However, to facilitate formulation, it is still necessary to go through a pre-formulation stage. Therefore, a generic drug must meet the same quality, safety and efficacy requirements as the originator drug.
Aim and Objectives The objective of our work consists on a pre-formulation stage followed by a formulation stage in order to arrive at an optimal, stable and effective galenic formula and to develop a generic oral anti-diabetic drug based on acarbose 50 mg.
Material and Methods During the development of this generic specialty, a preliminary study of the raw materials was conducted (physico-chemical characteristics, rheological properties and compatibility study) in order to determine the quantitative formula and the manufacturing process. Then, 6 formulas were prepared in order to improve the flow time. The tablets obtained were tested for uniformity of mass, hardness, friability, disintegration time and dissolution in vitro. Subsequently, a comparative study of the dissolution profiles obtained with that of the reference drug was made by calculating the difference factor f2 and similarity f1 in order to determine the best formula.
Results The method for the determination of the active substance by HPLC has been validated. The raw material has been well studied and the choice of excipients and the method of manufacture have been justified. Formula F5 having a friability percentage equal to 0,16%, a disintegration time (5,9 min) and a dissolution profile similar to that of the reference specialty (f1 <15% and f2> 50%) was selected. It was considered the closest to the princeps.
Conclusion and Relevance The generic specialty formulated presented an equivalence in terms of in vitro dissolution with the reference specialty. Thus, comparative studies in 3 different pH environments need to be completed to judge this in vitro equivalence.
References and/or Acknowledgements 1. No conflict of interest.
Conflict of Interest No conflict of interest
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