Mon, 20 Nov 2017

Development and Optimization of Oral Fast Dissolving Film of Salbutamol Sulphate by Design of Experiment

Govind Shankar Pandey1,2*, Ratendra Kumar3, Rajiv Sharma4, Yogendra Singh4U.V.S Teotia1

1.Shri Venkateshwara University, Gajraula, J.P. Nagar, Uttar Pradesh, India

2.Intas Pharmaceutical Ltd., Ahmadabad, Gujrat, India

3.MIET, Meerut, Uttar Pradesh, India

4.Alembic pharmaceutical Ltd., Baddi, Himachal Pradesh, India


ABSTRACT

The present study aimed at development and evaluation oral fast dissolving film of Salbutamol Sulphate utilizing HPMC as a film forming polymer and PEG 1000 as a plasticizer. Response Surface Methodology was used to optimize the oral fast dissolving film formulation. In the design, concentration of HPMC and concentration of PEG 1000 was selected as independent variable. Tensile strength, elongation at break and elastic modulas was selected as dependent variable. The results of the study demonstrated a successful development of a film with optimum mechanical property and disintegration time. The adopted design was very much successful as an optimization tool in this present study. The optimized formulation was evaluated by SEM & FTIR and the results were found appropriate. The accelerated stability study indicated the stability of the optimized formulation up to 6 month. In the conclusion, it is advocated that the development of optimized oral fast dissolving film formulation was successful.

Key words: Plasticizer, Oral Fast Dissolving Film, Factorial Design, Elongation at break


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