Physical properties and compact analysis of commonly used direct compression binders.
This study investigated the basic physico-chemical property and binding functionality of commonly used commercial direct compression binders/fillers. The compressibility of these materials was also analyzed using compression parameters derived from the Heckel, Kawakita, and Cooper-Eaton equations. Five classes of excipients were evaluated, including microcrystalline cellulose (MCC), starch, lactose, dicalcium phosphate (DCP), and sugar. In general, the starch category exhibited the highest moisture content followed by MCC, DCP, lactose, and finally sugar; DCP displayed the highest density, followed by sugar, lactose, starch, and MCC; the material particle size is highly processing dependent. The data also demonstrated that MCC had moderate flowability, excellent compressibility, and extremely good compact hardness; with some exceptions, starch, lactose, and sugar generally exhibited moderate flowability, compressibility, and hardness; DCP had excellent flowability, but poor compressibility and hardness. This research additionally confirmed the binding mechanism that had been well documented: MCC performs as binder because of its plastic deformation under pressure; fragmentation is the predominant mechanism in the case of lactose and DCP; starch and sugar perform by both mechanisms.
Zhang
Yeli
Y
Health Care Department, National Starch and Chemical Company, 10 Finderne Avenue, Bridgewater, NJ 08807, USA. yeli.zhang@nstarch.com
Law
Yuet
Y
Chakrabarti
Sibu
S
D002482:Cellulose / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D007785:Lactose / Q000737:chemistry*; D010316:Particle Size; D016062:Porosity; D011208:Powders; D011312:Pressure; D013213:Starch / Q000737:chemistry*
D005079:Excipients; D011208:Powders; D002482:Cellulose; D013213:Starch; D007785:Lactose; C109691:microcrystalline cellulose