1. Mechanical Structural Properties of Paracetamol Ja’Kari Jackson, Darius Harris, Sheena M. Reeves   Prairie View A&M University/Department of Chemical Engineering 100 University Dr., Prairie View, TX, 77446, United States
2. Granulation and Analysis Methods
Initially, paracetamol powder was sieved at 600 µm to have uniform starting material. Powder bed contained 22.0 g (± 0.2g) of paracetamol. Fourteen cylindrical indentions were made in the bed. Equal number of drops placed in each hole. The bed allowed to dry for 24 hours. Excess powder was carefully removed using sieve trays. All granules in the batch were weighed and analyzed using imaging software. For surface impact testing, each granule was measured before and after dropping and the amount of attrition was recorded. Additionally, scanning electron microscopy (SEM) was performed on the granules investigated.
3. Results and Conclusions
The drop method is sufficient in developing granules for dissolution studies. Indentations aided in developing similarly shaped and sized granules. The number of binder drops was an important factor as too much binder created unwanted spreading in the bed. Five drops produced the most uniform granules with an average weight of 280 mg. A change in binder provided some change in the weight of the granules. Increasing the concentration of binder in water provided more stable granules. PVP, MC, and PEG had low levels of attrition from heights of 1 and 2 feet and are considered stable. SEM shows stronger binding with PVP.
Abstract
For dissolution testing, granules of similar size, shape, and weight were required for consistency. This project evaluated methods of producing these granules in a powder bed. An initial study was conducted to determine the number of binder drops required for a round, dense, and durable granule. As the number of drops varied, the size and weight of the granules varied. After formation, granules were weighed, sized, and mechanically tested with a goal around 300 mg. Image analysis was conducted using Image-Pro Premier software. Key parameters include aspect ratio, area, and roundness. Lastly, granules underwent surface impact testing. The surface impact method releases a granule to free fall onto a hard, elevated surface. The amount of attrition and fragmentation from the impact was measured.
1. Introduction
Paracetamol, or APAP, was the selected for examination. Wet granulation, the chosen method, is the cohesion of powder using a binder. The degree of cohesion is dependent on the properties of the binder. To prevent spreading and crating, indentions were made in the powder bed. In commercial medicine, 325 mg APAP is used. To determine the best binder for the granules, the durability must be tested. The surface impact test will eliminate the weaker binders by demonstrating the less durable granules crumbling at impact from free fall from a select height. The more cohesive binders will remain more intact as they are analyzed after pressure from the drop.
Fig. 2 Granulation Using Binder Drops
Fig. 1 Spreading and Crating During Granulation (Emady)
Drops
Volume
(mL)
Weight
Roundness
Aspect Ratio
(Major Axis/
Minor Axis)
AVG (mg)
DEV (mg)
AVG
DEV 3
0.12
140 14
1.33
0.15
1.20 4
0.16
237 54
1.49
0.22
1.30 5
0.20
268 23
1.52
0.14 6
0.24
345 30
1.66
0.25
0.13
Fig. 3 Average Granule Weight Based on Drops
Fig. 4 Granules Using Scanning Electron Microscopy
Fig. 5 Binder Comparison
Fig. 6 Initial Size and Weight Study
Fig. 7 PVP Surface Impact Results
Proceedings of the 2018 ASEE Gulf-Southwest Section Annual Conference The University of Texas at Austin
April 4-6, 2018