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Design and evaluation of bilayer tablets of metformin hydrochloride and pioglitazone hydrochloride as combination drug therapy

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Abstract

The primary objective of the present investigation was to formulate and evaluate fixed dose bilayer tablet of two antihyperglycemic agents with different mechanisms of action to improve glycemic control in patients with type 2 diabetes. A secondary objective is to ensure that metformin release should be less in stomach and completely released in alkaline pH within the stipulated hours. Hence, metformin hydrochloride (500 mg) sustained release (SR) layer was formulated using various release retardant polymers such as hydroxy propyl methyl cellulose, xanthan gum and sodium carboxy methyl cellulose in three different ratios of 1:0.3, 1:0.4 and 1:0.5, such that therapeutically effective levels can be maintained. Immediate release (IR) layer of pioglitazone hydrochloride (15 mg) was formulated using super disintegrant (crosspovidone) in four different ratios of 1:0.2, 1:0.4, 1:0.6 and 1:0.8. The formulated fixed dose bilayer tablets were subjected to various physiochemical evaluations like weight variation, friability, hardness, drug content, in vitro drug release kinetics and stability studies. The optimized formulation (F8) showed the maximum drug release up to 60 min in IR layer and up to 12 h in SR layer. Formulation F8 was found to be stable at room temperature for a period of 3 months. From the study it is evident that a promising bilayer tablet of pioglitazone hydrochloride and metformin hydrochloride can be developed using crosspovidone (disintegrant) and xanthan gum (release retardant polymer).

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Acknowledgments

All the authors declare that they have no conflict of interest. The article does not contain any studies relating use of animal and human subjects performed by any of authors. The authors would like to express their gratitude to Spectrum Pharma Labs, Hyderabad, India for performing the FTIR analysis.

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Authors and Affiliations

  1. Department of Pharmaceutical Technology, Viswanadha Institute of Pharmaceutical Sciences, Vishakhapatnam, Andhra Pradesh, 531173, India

    Boddu Prasanthi, Karamchety Surya Kameswari Shilpa, Mudili Nagabhushana Rao & Ponukumati Uma Devi

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  1. Boddu Prasanthi
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  2. Karamchety Surya Kameswari Shilpa
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  3. Mudili Nagabhushana Rao
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  4. Ponukumati Uma Devi
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Correspondence to Boddu Prasanthi.

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Prasanthi, B., Shilpa, K.S.K., Nagabhushana Rao, M. et al. Design and evaluation of bilayer tablets of metformin hydrochloride and pioglitazone hydrochloride as combination drug therapy. Journal of Pharmaceutical Investigation 47, 497–505 (2017). https://doi.org/10.1007/s40005-016-0276-6

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  • DOI: https://doi.org/10.1007/s40005-016-0276-6

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