The role of formulation excipients in the development of lyophilised fast-disintegrating tablets

Rahul Chandrasekhar, Zahra Hassan, Farhan AlHusban, Alan M. Smith, Afzal R. Mohammed

Research output: Contribution to journalArticlepeer-review

79 Citations (Scopus)

Abstract

Despite recent success, many fast-disintegrating tablets (FDTs) still face problems of low mechanical strength, poor mouth-feel and higher disintegration times. This study aimed to optimise FDTs using a progressive three-stage approach. A series of hardness, fracturability and disintegration time tests were performed on the formulations at each stage. During Stage I, tablets were prepared in concentrations between 2% and 5% w/w, and were formulated at each concentration as single and combination bloom strength gelatin (BSG) using 75 and 225 BSGs. Analysis revealed that both hardness and disintegration time increased with an increase in gelatin concentration. A combination (5% gelatin) FDT comprising a 50:50 ratio of 75:225 BSGs (hardness: 13.7 ± 0.9 N and disintegration time: 24.1 ± 0.6 s) was judged the most ideal, and was carried forward to Stage II: the addition of the saccharides sorbitol, mannitol and sucrose in concentrations between 10% and 80% w/w. The best properties were exhibited by mannitol-containing formulations (50%-hardness: 30.9 ± 2.8 N and disintegration time: 13.3 ± 2.1 s), which were carried forward to the next stage: the addition of viscosity-modifying polymers to improve mouth-feel and aid pre-gastric retention. Addition of carbopol 974P-NF resulted in the enhancement of viscosity with a compromise of the hardness of the tablet, whereas Pluronic F127 (6%) showed an increase in disintegration time and viscosity with retention of mechanical properties.

Original languageEnglish
Pages (from-to)119-129
Number of pages11
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Volume72
Issue number1
Early online date3 Dec 2008
DOIs
Publication statusPublished - May 2009
Externally publishedYes

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