STUDIES IN PROSPECTIVE PROCESS VALIDATION OF MULTI COMPONENT ANTI-RETRO VIRAL TABLET DOSAGE FORMULATION
Check the weight of all ingredient. Lamivudine, Zidovudineand PVPK-90were sifted through quadro co mill, sifted materials were collected in a double lined polybag and labelled as SIFT-A. Sodium starch gllycolate and Eudragit were sifted through quadro co-mill, sifted material were collected in a double lined polybag and labelled as SIFT-B. Dispensed Pectin was sifted through quadro mill. Sifted material was collected in double lined polybag and labelled as SIFT-C. Blending of SIFT-A and SIFT-B was done for 30 minutes at 14 rpm in 300L blender. After this, lubricant (SIFT-C) was added to the above blended material and blended again for 5 mins. After this sampling was done, 3 sets of 10 samples were taken from ten different locations of the blender for blend uniformity analysis and 150g of the sample was taken for bulk density, tap density and particle size distribution analysis.To calculate the Compressibility index and Hausner ratio. Compression was done by 26 stations compression machine, using tooling: Sifted material i.eLamivudine + Zidovudine + PVPK-90 and Sodium starch gllycolate + Eudragitwere loaded into V-blender and blended for 30 min at 14 rpm. Sifted magnesium stearate was then added to V-blender and was mixed for 5 min at 14 rpm. 3 sets of 6 samples were withdrawn from six different location of the v-blender to check the bulk uniformity along sample up to 150g Sampling was done after 30+5min of lubrication. The final blended material was loaded into double lined polybags and was marked as ready for compression. Accurately weighed and transferred about 70mg of Lamivudine working standard and 140mg of Zidovudine working standard into 50ml volumetric flask, add about 10ml of methanol and Sonicate to dissolve, make up the volume with dissolution medium and mix, further dilute 3ml to 25ml with dissolution medium and mix, flteredthrough 0.45um nylon filter.The raw dissolution data was calculated for calculating the amount of drug released and percentage cumulative drug released at different time intervals.
KEY WORDS: Tablet, Lamivudine, Eudragit,starch gllycolate,Zidovudine,PVPK-90.