Metformin Hydrochloride Lab Report
Feasibility trails were carried out by melt granulation method.
Method: Drug was passed from 40# sieve. Weigh accurately drug, polymer and other excipients. Wax was melted at 60-65°C. After that drug and other ingredient were added to wax and mixing of drug and wax was done. Prepared lump was passed from 10# sieve. Granules were dried at 40°C. Lubricant was added to granules. Granules were compressed to prepare tablets. Table 4.6: composition of trail F1 and F2
Ingredients F1 F2
Metformin Hydrochloride IP2010 500 mg 500 mg
Yellow Bees Wax IP2010 500 mg 250 mg
Paraffin Wax IP2010 - 250 mg
Lactose IP2010 250 mg 250 mg
Magnesium Stearate IP2010 2 mg 2 mg
Talc IP210 2 mg 2 mg
Total weight 1.254 gm 1.254 gm
4.4.2.2. Feasibility Trail F3, F4 and F5
Feasibility trails F3, F4 …show more content…
Flow properties of Metformin HCl
Table 5.6: Flow properties of Metformin HCl
Test Result
Bulk density 0.468 gm/ml
Tap density 0.686 gm/ml
Compressibility index 31.77%
Hausner’s ratio 1.44
Result: It was concluded that Metformin Hydrochloride API has poor flow properties.
Table 5.7: Standards for compressibility index and Hausner’s ratio
Flow property C.I (%) Hausner ratio
Excellent ≤ 10 1.00 – 1.11
Good 11 – 15 1.12 – 1.18
Fair 16 – 20 1.19 – 1.25
Passable 21 – 25 1.26 – 1.34
Poor 26 – 31 1.35 – 1.45
Very poor 32 – 37 1.46 – 1.59
Very, very poor > 38 > 1.60
5.1.4 Standard curve for Metformin HCl
Table 5.8: Standard curve for Metformin HCl
Concentration (ppm) Absorbance 1 2 3 4 Average
0 0 0 0 0 0
2 0.16977 0.16613 0.16977 0.16653
Method: Drug was passed from 40# sieve. Weigh accurately drug, polymer and other excipients. Wax was melted at 60-65°C. After that drug and other ingredient were added to wax and mixing of drug and wax was done. Prepared lump was passed from 10# sieve. Granules were dried at 40°C. Lubricant was added to granules. Granules were compressed to prepare tablets. Table 4.6: composition of trail F1 and F2
Ingredients F1 F2
Metformin Hydrochloride IP2010 500 mg 500 mg
Yellow Bees Wax IP2010 500 mg 250 mg
Paraffin Wax IP2010 - 250 mg
Lactose IP2010 250 mg 250 mg
Magnesium Stearate IP2010 2 mg 2 mg
Talc IP210 2 mg 2 mg
Total weight 1.254 gm 1.254 gm
4.4.2.2. Feasibility Trail F3, F4 and F5
Feasibility trails F3, F4 …show more content…
Flow properties of Metformin HCl
Table 5.6: Flow properties of Metformin HCl
Test Result
Bulk density 0.468 gm/ml
Tap density 0.686 gm/ml
Compressibility index 31.77%
Hausner’s ratio 1.44
Result: It was concluded that Metformin Hydrochloride API has poor flow properties.
Table 5.7: Standards for compressibility index and Hausner’s ratio
Flow property C.I (%) Hausner ratio
Excellent ≤ 10 1.00 – 1.11
Good 11 – 15 1.12 – 1.18
Fair 16 – 20 1.19 – 1.25
Passable 21 – 25 1.26 – 1.34
Poor 26 – 31 1.35 – 1.45
Very poor 32 – 37 1.46 – 1.59
Very, very poor > 38 > 1.60
5.1.4 Standard curve for Metformin HCl
Table 5.8: Standard curve for Metformin HCl
Concentration (ppm) Absorbance 1 2 3 4 Average
0 0 0 0 0 0
2 0.16977 0.16613 0.16977 0.16653