Abstract
FORMULATION DEVELOPMENT OF AMLODIPINE IR TABLETS AS PER 2*2 FACTORIAL DESIGN (SELECTION OF BEST BINDER-DISINTEGRANT COMBINATION)

V. V. L. S. P. Sowjanya*, D.Madhurya, G.Vineela, G.Sony Chaitanya, Kaneez Fatima, G. Sahithi, G. Anusha

ABSTRACT

Amlodipine, is a widely prescribed anti-hypertensive drug belongs to class II under BCS classification and exhibit low and variable oral bioavailability due to its poor aqueous solubility. It needs enhancement in the dissolution rate in its formulation development. Binders such as Acacia and PVP K30 and use of superdisintegrant primojel and potatostarch are tried for enhancing the dissolution rate of amlodipine tablets. The objective of the present study is selection of best binder- disintegrant combination in order to enhance the dissolution rate of amlodipine IR tablets by 22 factorial design to achieve NLT 85% dissolution in 15 min. A total of four amlodipine IR tablet formulations were prepared using selected combinations of the two factors as per 22 factorial design. Amlodipine tablets were prepared by direct compression method and were evaluated for drug content, hardness, friability, disintegration time and dissolution rate characteristics. The dissolution rate (K1) values were analysed by ANOVA of factorial design. The individual and combined effects of binder and disintegrant on the dissolution rate (K1) of amlodipine tablets are highly significant (P<0.01). Amlodipine tablets formulated employing superdisintegrant Primojel at a level 5% of drug content and binder PVP K30 at 2% (Fab) disintegrated rapidly within 20 seconds and gave very rapid dissolution (100% in 15 min) fulfilling the target dissolution of NLT 85% in 15 min.

Keywords: Amlodipine tablets, Factorial design, binders (acacia and PVP K30), superdisintegrants( Primojel and potato starch).


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