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Formulation,development and Evaluation of film coated tablet containing Cefixime and Potassium clavulanate

Author(s): Sandip kumar Mangal bhai Patel*,Bhavin R Chaniara,J.J.Chudasama,Amit S Shekhawat

Journal: Journal of Pharmacy Research
ISSN 0974-6943

Volume: 4;
Issue: 6;
Start page: 1861;
Date: 2011;
Original page

Keywords: Bilayer tablet | Cefixime | Potassium Clavulanate | Kyron T 314 | Experiment design.

The considerations for preparation of bilayer tablet of good quality are to prevent cross contamination between two layers,to produce a clear visual separation between two layers,accurate and individual weight control of two layers. B-lactam antibiotic (Cefixime) given with B lactamase inhibitor(Potassium Clavulanate) in treatment of UTI’s,otitis media and COPD.But Cefixime occurs as trihydrate form as potassium clavulanate is to much hygroscopic there is possibility to absorb water of crystallization from Cefixime removed during processing step. Therefore here in my study physical separation of the two active ingredient was done by formulating bilayer tablet. Avoidance of absorbing moisture from potassium Clavulanate done by film coating of formulated bilayer core tablet with moist shieldinstacoat material. Formerly two separate layer were compressed by addition of S.S.G(1%,2%,4%),C.C.S(0.5%,1%,2%) and Kyron T314 (0.5%,1%,2%) as super disintegrants, Avicel PH 102 as diluent, talc (2%) and magnesium stearate(1%) as lubricant,temperature not exceeding 250c and humidity not exceeding 35%R.H.Coatingprocess parameters like atomizing air pressure and inlet air temperature were optimized using 3 2 full factorial design in Design Expert sowtware Formulated film coated bilayer tablets were evaluated for weight variation,thickness, friability, hardness, disintegration, invitro dissolution and stability study of threemonths,also compared with marketed product.Results of calculation of similarity factor (f2) shown that ,formulation containing 4%S.S.G,2%C.C.S,2%Kyron T 314 much more similarity to reference product.Formulation batch code CV9 (2%Kyron T 314) shown f2 value 99.78, thus it can also used as super disintegrant as well as dissolution enhancer of Cefixime(BCS Class 4).Bilayer tablet shows much more stability then marketed single layer tablet.