MAGNETIC TABLET DISINTEGRATION: COMPARISON OF BIOSUSCEPTOMETRY, WATER UPTAKE AND DISINTEGRATION FORCE.

TF15

Evangelista,GS, Fonseca,PR, Melo, CS, Corá,LA , Miranda,JRA

Depto de Física e Biofísica - IBB - UNESP – Botucatu – SP – Brasil

Introduction: Despite increasing interest on modified release systems, conventional tablets are still the most popular solid dosage forms due to ease of manufacture, convenience of dosing and stability. Disintegration of compressed tablets is an important parameter and is influenced by the properties of the excipients, such as particle size distributions and compression force. In experimental determination of tablet disintegration an official in vitro apparatus is used, however it does not describe satisfactorily the disintegration properties. Alternate Current Biosusceptometry (ACB) has become an alternative method for pharmaceutical research and has demonstrated the capability to be used as a tool in quality control for pharmaceutical products. The aim of this study was to quantify the tablet disintegration process by Biosusceptometry AC associated with an apparatus to measure water uptake (WU) and disintegration force (DF). Materials and Methods: ACB bases its functioning on induction coils for recording the magnetic flux variation obtained from the response of a magnetic material when an alternating magnetic field is applied; the data is processed to generate images which are segmented to quantify the disintegration. The apparatus for WU and DF measurements consists in a precision balance coupled to a force transducer which registers the amount of water that leaves a recipient placed on the balance and the DF produced due the water penetration. Tablets (0.5g ferrite and 0.375g excipients) were produced by direct compression (10, 20, 30, 40 and 50 kN) on a single punch tablet machine. To investigate the relationship among the data, the graphic profiles from ACB images, DF and WU were analyzed  using a modified Weibull distribution to evaluate the curve shape (b) and the time needed to reach 63.2% of the maximal value (t_63,2%)_. Results and Discussion: Compression force plays an important role for tablet manufacturing process and it is a well-known parameter that influences the disintegration time. The preliminary results showed that the disintegration time is highly influenced by the compression force, which results on a time delay on the evaluated parameters as the compression force arises. Conclusion: All the data presented a high level of correlation among the three techniques, i.e., the evaluation of the disintegration process using ACB has an advantage of  being radiation-free and low cost. Besides, this preliminary study demonstrated that ACB has enough sensibility to perform quality control of solid dosage forms. This methodology might be able to assess in vivo studies for pharmaceutical parameters. (The authors thank the financial support from CAPES and  FAPESP. Samples were a gift from Blanver Farmoquímica Ltda).