title: Investigating the fundamental effects of binders on pharmaceutical tablet performance.
abstract: For solid dosage forms, a better understanding of the fundamental properties of the binders helps in developing better formulations and products. The objective of this study was to determine the effects of binder toughness and plastic flow on tablet hardness, friability, and capping. The characteristic of binder toughness was determined, and the correlation between the ejection force of the tablet and the toughness of the binder was established. Evaluation was conducted using acetaminophen tablets with different kinds of binders (i.e., hydroxypropylcellulose, methylcellulose [MC], povidone [PVP], starch, etc.). A rotary tablet press was used for tableting at three different speeds. The properties of binders and acetaminophen tablets were determined using a diametral compression test. The toughness was measured as the curve of the area under the load versus deflection. The microbehavior of these binders was also studied. The acetaminophen tablets with the binders were subjected to predetermined loads and then examined under a scanning electron microscope. The tablets that contained hydroxypropylcellulose as a binder showed the highest toughness and had the lowest ejection force. The ejection force of tablets decreased with increasing concentrations of hydroxypropylcellulose in the dosage forms. The tablets that contained other binders failed by capping and random cracking in the middle. These results show that hydroxypropylcellulose, a thermoplastic polymer, provides the best physical characteristics for the tablets. This effect could help in improving tablet manufacturing conditions (e.g., compression force and speed).
authors.affiliation: Hercules Incorporated, Wilmington, DE 19808-1599, USA.
authors.forename: S K
authors.initials: SK
authors.lastname: Joneja
authors.forename: W W
authors.initials: WW
authors.lastname: Harcum
authors.forename: G W
authors.initials: GW
authors.lastname: Skinner
authors.forename: P E
authors.initials: PE
authors.lastname: Barnum
authors.forename: J H
authors.initials: JH
authors.lastname: Guo
mesh_terms: D000082:Acetaminophen / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D019245:Compressive Strength; D005079:Excipients / Q000737:chemistry*; D006244:Hardness; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D008855:Microscopy, Electron, Scanning; D010969:Plastics / Q000737:chemistry; D011205:Povidone / Q000737:chemistry; D013213:Starch / Q000737:chemistry / Q000648:ultrastructure; D013607:Tablets / Q000737:chemistry*
chemical_list: D005079:Excipients; D010969:Plastics; D013607:Tablets; D000082:Acetaminophen; D008747:Methylcellulose; D013213:Starch; D011205:Povidone