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

Patel, Sandip Kumar Mangal Bhai; Chaniara, Bhavin R.; Chudasama, J. J.; Shekhawat, Amit S.
June 2011
Journal of Pharmacy Research;Jun2011, Vol. 4 Issue 6, p1861
Academic Journal
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 shield instacoat 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.Coating process parameters like atomizing air pressure and inlet air temperature were optimized using 3² 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 three months,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.


Related Articles

  • �-Lactams as Inhibitors of Serine Enzymes. Konaklieva, M.I. // Current Medicinal Chemistry - Anti-Infective Agents;Jul2002, Vol. 1 Issue 3, p215 

    For nearly six decades, penicillins have been used widely to treat bacterial infections. The development of multidrug resistance, however, has reduced the effectiveness of �-lactams as antimicrobial drugs. A main contributor to b-lactam resistance is the production of �-lactamases, and...

  • Susceptibility Profile of Klebsiella pneumoniae Isolates from Pus to Beta Lactam/Beta Lactamase Inhibitor Combinations. Hussain, Tahir; Nighat, Faridah; Jamal, Muhsin; Andleeb, Saadia // World Journal of Zoology;2014, Vol. 9 Issue 2, p115 

    Beta lactam antibiotics are the most important and frequently used antimicrobial agents worldwide. However, bacteria have circumvented their efficacy by producing enzymes-the beta lactamases that degrade beta lactam antibiotics. To overcome these resistance mechanism beta lactam/beta lactamase...

  • Putting Fungi to Work: Harvesting a Cornucopia of Drugs, Toxins, and Antibiotics. Kück, Ulrich; Bloemendal, Sandra; Teichert, Ines // PLoS Pathogens;Mar2014, Vol. 10 Issue 3, p1 

    The article examines the role of fungi as producers of life-saving drugs. Topics covered include the effects of some fungi on human health such as Aspergillus terreus, Claviceps purpurea and Ashbya gossypii, the role of horizontal gene transfer in the diversity of fungal metabolism, and the...

  • When to use the newer beta-lactam antibiotics. Rosenfeld, Elaine; Shaughnessy, Allen F. // Patient Care;9/15/1995, Vol. 29 Issue 14, p119 

    Studies the use of the new beta-lactam antibiotics and some third generation cephalosporin drugs. Brief on the fungus Cephalosporium acremonium; Description of oral agents Cefixime, Cefpodoxime proxetil, Cefprozil and Loracarbef, and parental agents Ceftazidine, Aztreonam, Imipenem/cilastatin...

  • Beta-Lactam Antibiotic Therapy in Febrile Granulocytopenic Patients. Winston, Drew; Ho, Winston; Bruckner, David; Champlain, Richard // Annals of Internal Medicine;12/1/91, Vol. 115 Issue 11, p849 

    Presents a study which compared the efficacy, toxicity and cost-effectiveness of double beta-lactam therapy with monotheraphy in febrile granulocytopenic patients. Study design; Materials and methods used; Results.

  • Bactericidal activity of oral beta-lactam antibiotics in plasma and urine versus isogenic Escherichia coli strains producing broad-and extended-spectrum beta-lactamases.  // Croatian Medical Journal;2005, Vol. 46 Issue 4, p718 

    Presents an abstract of the study "Bactericidal activity of oral beta-lactam antibiotics in plasma and urine versus isogenic Escherichia coli strains producing broad-and extended-spectrum beta-lactamases," by B. Bedenic et al.

  • Amoxicillin/clavulanic-acid.  // Reactions Weekly;2/13/2016, Vol. 1588 Issue 1, p28 

    The article is a case report of negative provocation test results with beta-lactam antibiotics.

  • N-Thiolated �-Lactams. Long, T.E.; Turos, E. // Current Medicinal Chemistry - Anti-Infective Agents;Jul2002, Vol. 1 Issue 3, p251 

    N-Thiolated �-lactams are �-lactam compounds that have a sulfur substituent on the nitrogen center. They represent a broad and growing family of bioactive molecules. In this review we provide a summary of the known biological properties of the different classes of N-thiolated...

  • �-Lactamases and their Inhibitors: An Update. Micetich, R.G.; Salama, S.M.; Maiti, S.N.; Reddy, A.V.N.; Singh, R. // Current Medicinal Chemistry - Anti-Infective Agents;Jul2002, Vol. 1 Issue 3, p193 

    The �-lactam antibiotics perhaps form the best studied and most used (in volume and sales) antibiotics in the world today. The extensive and in many cases, uncontrolled use of the �-lactam antibiotics, particularly in developing countries and for veterinary uses, has resulted in the...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics