Influence of Formulation Factors on Tablet Formulations with Liquid Permeation Enhancer Using Factorial Design


Bejugam, N. K., Parish, H. J., & Shankar, G. N. (2009). Influence of formulation factors on tablet formulations with liquid permeation enhancer using factorial design. AAPS PharmSciTech, 10(4), 1437-1443.


For a drug with low bioavailability, a matrix tablet with liquid permeation enhancer (LabrasolĀ®) was formulated. Factorial design was used to evaluate the effect of three formulation factors: drug percentage, polymer type (MethocelĀ® K100M or EudragitĀ® L 100-55), and tablet binder percentage (PlasdoneĀ® S-630) on tablet characteristics. Tablets were prepared by direct compression and characterized. Compressibility index values ranged between 15.90% and 29.87% and tablet hardness values from 7.8 to 29.78Ā Kp. EudragitĀ®-containing formulations had better compressibility index values with higher tablet hardness. Time for 75% of drug release (TĀ 75) was calculated, and formulations containing EudragitĀ® L 100-55 had faster release rates than tablet formulations with MethocelĀ® K100M. Formulations with MethocelĀ® K100M fit well in the Higuchi model as indicated by theirĀ RĀ 2Ā values (>0.98). Among all the formulation factors studied, polymer type displayed the highest and statistically significant effect on compressibility index, tablet hardness, and dissolution rate. Statistical design helped in better understanding the effect of formulation factors on tablet characteristics important for designing formulations with desired characteristics.

Keywords: Eudragit L 100-55, factorial design, Labrasol, Methocel K100M

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