Gerard Q. De Guzman1,2,3,4,5,6,7,9, Jan Karlo T. Ecalne3,4, Benjel A. Andaya4,5, Ma. Danica I. Ramil5,8, Rhian Jaymar D. Ramil5,8*, Ronald P. Cabral9
1The Graduate School, University of Santo Tomas, Espana Blvd., Sampaloc, Manila, Philippines 1015.
2College of Pharmacy and 3The Graduate School, Adamson University, San Marcelino St., Malate, Manila, Philippines 1000.
4School of Pharmacy and 5The Graduate School, Centro Escolar University, 9 Mendiola St., San Miguel, Manila, Philippines, 1005.
6College of Pharmacy, Virgen Milagrosa University Foundation, Martin F. Posadas Ave., San Carlos City, Pangasinan, Philippines, 2420.
7College of Pharmacy, De La Salle Health Sciences Institute, Congressional Avenue, Dasmarinas, Cavite, Philippines, 4114.
8Department of Pharmacy, College of Health Sciences, Mariano Marcos State University, City of Batac, Ilocos Norte, Philippines, 2906.
9Francisco Q. Duque Medical Foundation, Lyceum Northwestern University, Tapuac Dist., Dagupan City, Pangasinan 2400
*Address for Corresponding Author
Rhian Jaymar D. Ramil
Department of Pharmacy, College of Health Sciences, Mariano Marcos State University, Brgy. 16 Quiling Sur, City of Batac, Ilocos Norte, Philippines, 2906
Mobile No.: (63927) 733 9565
Objective: This study was conducted to develop a sustained release tablets of clarithromycin by wet granulation based on different combination ratios of cashew gum (CG) and hydroxy propyl methyl cellulose (HPMC) as retarding hydrophilic colloidal polymers. Materials and methods: The formulation was optimized on the basis of acceptable tablet properties and in vitro drug release. Results: Clarithromycin, CG and the other tablet excipients showed no physicochemical incompatibilities as observed in the FTIR and DTA analyses. There was no significant difference in drug release between the innovator product and formulation F6 when the HPMC concentration was modified in low percentage while increasing CG concentration besides satisfying FDA and compendia requirements for the f1 and f2 limits and amounts of drug released for each of the prescribed sampling time. Applying kinetic equation models, the mechanism of release of the drug from formulation F6 was found to follow Higuchi model, as the plots showed high linearity, with correlation coefficient (r) value of 0.95. In the bioequivalence studies, all the pharmacokinetic parameters obtained with formulation F and the innovator product were not significantly different and were found to be bioequivalent. Conclusion: The resulting formulation tablet produced complied within the specified technical limits as to content uniformity, weight variation, thickness, friability, disintegration and hardness. A positive correlation existed between the in vivo bioavailability and in vitro dissolution tests. Results of the present study indicated the suitability of CG in the preparation of sustained release formulation of clarithromycin.
Keywords: Cashew Gum, Clarithromycin, Sustained-Release Tablet, Bioequivalence, In vitro – In vivo Correlational