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KMID : 0369820170470060497
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Jorunal of Korean Pharmaceutical Sciences
2017 Volume.47 No. 6 p.497 ~ p.505
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Design and evaluation of bilayer tablets of metformin hydrochloride and pioglitazone hydrochloride as combination drug therapy
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Prasanthi Boddu
Shilpa Karamchety Surya Kameswari
Rao Mudili Nagabhushana
Devi Ponukumati Uma
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Abstract
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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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KEYWORD
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Antihyperglycemic, Bilayer tablet, Fixed dose combination, Biguanides, Thiazolidinediones, Type 2 diabetes mellitus
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