MODULE 4: PRACTICUM ON PHARMACEUTICAL TECHNOLOGY SOLIDA PREPARATIONS GRANULES EVALUATION Medicinal products or raw materials, excipients included in the scope of the Pharmacopoeia must meet the requirements in the Pharmacopoeia. For this reason, tests are needed on the granules before the printing process is carried out. TOOLS AND MATERIALS 1. Mix the Inner Phase and Outer Phase granules before printing. 2. Funnel 3. 100 ml Measuring Cup 4. Pycnometer 5. Glycerin 6. infrared moisture balance. TESTING PROCEDURE 1. Organoleptic Observation of shape, smell, color and taste is carried out visually. 2. Water content Measuring the water content is done using a toolinfrared moisture balance. Method: weigh 5 grams of granules and place them on the left side of the weighing plate and positionThe lamp is placed at a height of 6 cm so that it can reach a temperature of 105°C. Pay attention to the scalethe water level is at zero, then the light is turned on. Pay attention if the granules start to dry out,the equilibrium scale will change. With the help of the indicator knob, the balance scale can bemoved to achieve equilibrium again. When the equilibrium indicator has returned,then the granules are completely dry and the scale can be read. Or the dry granules are weighed andWater content is calculated using the formula: Water content = W1-W2/W1 x 100 % W2 = Weight of dry granules (grams) 3. Flow speed Weigh 30 grams of granules and put them in the bottom funnelclosed. At the same time the lid is opened and the stopwatch is turned on. Note the timeit takes the granules to flow completely from the funnel and the flow rate is calculated usingformula : Flow rate = Granule Weight(grams)/time(seconds) Table 1 Relationship between Flow Speed and Powder Flow Properties. Flow Rate (g/sec) Nature of Flow > 10 Very good 4-10 Good 1.6-4 Hard <1.6 Very difficult 4. Angle of rest Weigh 30 grams of granules and put them in a funnel with the bottom closed.Then the lid is opened and the granules are allowed to flow completely from the funnel where the granules are accommodated using graph paper. Then measure the diameter of the granule base and the height of the cone formed with a ruler. Then measure the angle of repose using the formula: Tg α = h/r Where: α = angle of repose h = height of granule pile r = radius Table 2. Relationship between angle of rest and flow characteristics Angle of repose (Tg α) Flow properties <25 Very good 25-30 Good 30-40 Enough > 40 Very bad 5. Real specific gravity Weigh 30 grams of granules (Wo), put them in a 100 mL measuring cup. and observedvolume (Vo). Real Bj is calculated using the formula: Real Bj =Wo/Vo 6. Compressible specific gravity Weigh 30 grams of granules (Wo), put them in a 100 mL measuring cup and measurevolume (Vt). Then put it on the tooltap density testerwith as many taps as possible 1250 times and the volume was recorded (Vt1). If the difference between Vt and Vt1no more than 2 mL, thenVt is used. Compressible specific gravity is calculated using the formula: Blocked bj =Wo/ Vt 7. Correct specific gravity Using a pycnometer and paraffin solvent. Method: weigh the empty pycnometer (a) pycnometer added with paraffin until full (b). Empty pycnometer plus 2 gramsgranules, (c), then added paraffin until full and weighed again (d). Specific gravitycorrectly calculated by the formula: Bj solvent ( ) =ba/v pycnometer Bj correct =ca/ (ca)+(bd) x Bj Solvent 8. Compressibility Compressibility = Compressed Bj-Real Compressed Bj/ Compressed Bj x 100% Table 3. Relationship between compressibility and powder flow properties (Aulton, 1988) Compressibility (%) Nature of Flow 5-15 Very good 12-17 Good 18-22 Enough 23-33 Not enough 34-38 Very less > 38 Very bad 9. Porosity Porosity is inversely proportional to disintegration time, so if the porosity is small, thenthe disintegration time is slow, and is directly proportional to the hardness of the tablet, if the porosity is small,the tablet is not hard enough. Requirements: 37-40% Porosity = 1 - Compressed Bj/ True Bj x 100% 10. Hausner Factor Hausner Factor = Compressed Bj/ Real Bj Hausner Factor: < 1.25 Good flow > 1.5 Poor flow 11. Percentagefines/fine powder Done using the sieving method. Method: 30 grams of granules are placed on top sieve and sift. The remaining granules are sieved and weighed. The percentage of fines is calculatedwith the formula: %Fines=Weight of fine powder obtained/ Initial Granule Weight DISCUSSION AND CONCLUSIONS Discuss the results of testing the granules and what conclusions can be drawn from these tests.