Impact of micromeritic properties of an active pharmaceutical ingredient on its compaction behavior.
Physical characteristics of an active pharmaceutical ingredient (API) can have a significant impact on the processability of a high drug loading formulation. This paper provides an example where different micromeritic properties of an API were obtained by crystallization under different conditions, resulting in different tableting behavior. While the API form purity was maintained during the crystallization process change, significant changes were incurred in the surface geometry, porosity and surface area of the API. The batches consisting of particles with greater surface irregularity and porosity gave tablets of higher mechanical strength.
Bristol-Myers Squibb Company, Drug Product Science and Technology , New Brunswick, NJ , USA and.
Dilbir S
DS
Bindra
Sridhar
S
Desikan
D002152:Calorimetry, Differential Scanning; D019245:Compressive Strength; D003460:Crystallization; D005079:Excipients / Q000737:chemistry; D010316:Particle Size; D011799:Quinazolines / Q000737:chemistry; D013499:Surface Properties; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013818:Thermogravimetry; D014961:X-Ray Diffraction
C430648:DPC 083; D005079:Excipients; D011799:Quinazolines; D013607:Tablets
Compaction; crystallization; formulation; mechanical properties; morphology; polymorphism; pore volume; surface area