The powder flow and compact mechanical properties of sucrose and three high-intensity sweeteners used in chewable tablets.
The physical, flow, and mechanical properties of four common pharmaceutical sweeteners were measured to assess their relative manufacturability in solid dosage formulations. Sucrose, acesulfame potassium (Sunett), saccharin sodium, and aspartame were evaluated to determine significant differences in particle shape, size distribution, and true density. Powder flow and cohesivity as well as compact mechanical properties such as ductility, elasticity, and tensile strength were measured and found to be noticeably different. Among these sweeteners, sucrose and acesulfame potassium demonstrated excellent flowability and marginal mechanical property performance relative to over 100 commonly used pharmaceutical excipients evaluated in the authors' laboratory. Saccharin sodium and aspartame demonstrated poor flowability and superior compact strength relative to sucrose and acesulfame, despite their noticeably higher brittleness. These data suggest that careful selection of an appropriate sweetener is warranted in obtaining desirable process and tableting robustness, particularly if sweetener loading is high. Detailed descriptions of each material property and recommendations for sweetener selection in formulation development are included.
Mullarney
Matthew P
MP
Pfizer Inc., Eastern Point Road, Groton, CT 06340, USA. matthew_p_mullarney@groton.pfizer.com
Hancock
Bruno C
BC
Carlson
Glenn T
GT
Ladipo
Dauda D
DD
Langdon
Beth A
BA
D004548:Elasticity; D006244:Hardness; D008855:Microscopy, Electron, Scanning; D011208:Powders; D013395:Sucrose; D013549:Sweetening Agents; D013607:Tablets; D013678:Technology, Pharmaceutical; D013718:Tensile Strength
D011208:Powders; D013549:Sweetening Agents; D013607:Tablets; D013395:Sucrose