*1 Patel Dimpalben Girishkumar, 2 Mr.K.H.Shah, 3 Rohit K Patel, 3Yatish Shukla, 3 Modi B, 3 Nilesh Patel
1 Dharmaj Degree Pharmacy College,
Dist- Anand, Dharmaj -388430, Gujarat
2 Professor, IPCPRC, Dharmaj, Gujarat
3 KAPTAB Pharmaceuticals
The aim of the current investigation is to design oral once daily modified release dosage forms of amoxicillin trihydrate for treatment of pharyngitis/tonsilitis, which release the drug for 24 hours and match with theoretical drug release profile. The tablets and capsules were prepared by the different method using different polymers in different concentrations. The interference of the polymers was ruled out by FT-IR spectroscopy studies. The powder-blends of tablets and drug were evaluated for their physical properties like angle of repose, bulk density, compressibility index, and Hausner ratio and found to be satisfactory. The manufactured tablets were evaluated for in process and finished product quality control tests including appearance, thickness, weight variation, hardness, friability, drug content, and in vitro drug release. All formulations showed appearance, thickness, weight variation, hardness, friability and drug content in specified limit. All formulations showed acceptable pharmacotechnical properties and complied with in-house specifications for tested parameters. The results of dissolution studies indicated that formulation containing 50% ethyl cellulose and 50% methocel was the most successful formulation which was evidenced by similarity (f2) and dissimilarity (f1) factors. The formulated amoxicillin trihydrate tablets followed zero order release kinetics and Higuchi diffusion was the dominant mechanism of drug release, resulting in regulated and complete release within 24 hours. Formulations were subjected to short term stability studies as per ICH guidelines and were found stable. Capsule formulations 16 were evaluated for weight uniformity, drug content and in vitro drug release. The results of dissolution studies indicated that drug release from capsule not extend up to 24hrs. All formulations of capsule failed in in-vitro drug release test. In comparison of tablet and capsule formulations, tablet found to be successful dosage form.