EVALUATION OF A CO-PROCESSED EXCIPIENT FROM COW BONE POWDER AND GELATIN FOR USE IN DIRECT COMPRESSION TABLETING
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ABSTRACT
The objective of the study was to develop an excipient consisting of cow bone powder and gelatin by the co-processing method and to evaluate its use in direct compression tablet formulation. Co-processing is based on the novel concept of two or more excipients interacting at the sub particle level, the objective of which is to provide a synergy of functionality improvement as well as masking the undesirable properties of individual excipients. Fresh cow femur and tibia bones were collected and cut into pieces using an axe and boiled to about 100 °C to remove all traces of fat, meat and bone marrow and was subsequently washed with hot water. The bones were then dried and subjected to heating to produce the cow bone powder in an industrial furnace at about 600 °C to 800 °C for 6 h and then pulverized. Gelatin was dissolved in a beaker with 20 ml of water using gallenkamp regulator hot plate at a temperature of about 100 °C and incorporated into wet activated bone powder in the ratio of 90 : 10, 95 : 5 and 97.5 : 2.5 respectively. The resultant materials were dried and crushed using an electrical blending machine and thereafter, moisture content and pH were determined using standard methods. The coprocessed excipient was physically characterized for flow rate, bulk density, tapped density, angle of repose, carr's index, hausner ratio and moisture content of 12.3(0.06), 1.16(0.02), 1.35(0.02), 21(0.09), 14.1, 1.16 and 4.20 respectively using standard methods. There was no much difference between activated bone powder (ABP) and co-processed in term of flow rate but there was improved mechanical compressibility with co-processed excipient. Fourier Transform Infrared (FTIR) and Differencial Scanning Calorimetry (DSC) spectra data were taken to find out the chemical stability of the excipient. The DSC was performed on all the samples using Perkin Elmer model Pyris-6, USA. The results of FTIR and DSC spectra of pure bone powder, gelatin powder and co-processed excipient indicated that there was no chemical interaction and vii only physical changes occurred, since no observable changes in spectra were observed. In the formulation studies, ascorbic acid and metronidazole powders were chosen as model drugs in a binary mix of 30:70 and 40:60 respectively. Tablets of Ascorbic acid and Metronidazole that was prepared by direct compression method employing Activated cow bone powder and gelatin (ABPG95) in ratio 95:5 were made co-processed excipient using punch die set at 8 mm and 12 mm respectively. Good quality tablets were produced with regard to weight uniformity, crushing strength, disintegration time and friability test of 333(0.2), 7.5(0.4), 5.37(0.5) and 1.00 for Ascorbic acid and 501(0.1), 7.6(0.27), 10.0(0.5) and 1.02 for Metronidazole respectively. The drug dissolution test results indicated that there was high release observed within the range of 30-40 minutes for the formulations. The present study concluded that co-processed cow bone powder and gelatin can be used as a direct compression excipient.
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