Assessment of Tablet Surface Hardness by Laser Ablation and Its Correlation With the Erosion Tendency of Core Tablets.
Surface erosion of uncoated tablets results in processing problems such as dusting and defects during coating and is governed by the strength of particle bonding on tablet surface. In this study, the correlation between dusting tendency of tablets in a coating pan with friability and laser ablation surface hardness was assessed using tablets containing different concentrations of magnesium stearate and tartaric acid. Surface erosion propensity of different batches was evaluated by assessing their dusting tendency in the coating pan. In addition, all tablets were analyzed for crushing strength, friability, modified friability test using baffles in the friability apparatus, and weight loss after laser ablation. Tablets with similar crushing strength showed differences in their surface erosion and dusting tendency when rotated in a coating pan. These differences did not correlate well with tablet crushing strength or friability but did show reasonably good correlation with mass loss after laser ablation. These results suggest that tablet surface mass loss by laser ablation can be used as a minipiloting (small-scale) tool to assess tablet surface properties during early stages of drug product development to assess the risk of potential large-scale manufacturing issues.
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903. Electronic address: Narang.Ajit@Gene.com.
Ajit S
AS
Narang
Analytical and Bioanalytical Development, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Lydia
L
Breckenridge
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Hang
H
Guo
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Jennifer
J
Wang
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Abraham Avi
AA
Wolf
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Divyakant
D
Desai
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Sailesh
S
Varia
Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick, New Jersey 08903.
Sherif
S
Badawy
D002626:Chemistry, Pharmaceutical / Q000379:methods; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D007834:Lasers; D013229:Stearic Acids / Q000737:chemistry*; D013499:Surface Properties; D013607:Tablets / Q000737:chemistry*; D013644:Tartrates / Q000737:chemistry*
D005079:Excipients; D013229:Stearic Acids; D013607:Tablets; D013644:Tartrates; C031183:stearic acid; C029768:tartaric acid
LIBS; analysis; crushing strength; friability; hardness; magnesium stearate; spectroscopy; surface; tablet; tartaric acid