Predictive model for tensile strength of pharmaceutical tablets based on local hardness measurements

Abstract

In the pharmaceutical field, tablets are the most common dosage forms for oral administration. During the manufacture of tablets, measures are taken to assure that they possess a suitable mechanical strength to avoid crumbling or breaking when handling while ensuring disintegration after administration. Accordingly, the tensile strength is an essential parameter to consider. In the present study, microscopic hardness and macroscopic tensile strength of binary tablets made from microcrystalline cellulose and caffeine in various proportions were measured. A relationship between these two mechanical properties was found for binary mixture. The proposed model was based on two physical measurements easily reachable: hardness and tablet density. Constants were determined from the two extreme compositions of this given system. This model was validated with experimental results, and a comparison was made with the one developed by Wu et al. (2005). Both models are relevant for this studied system. Nonetheless, with this model, the tablet tensile strength can be connected with a tablet characteristic at microscopic scale in which porosity is not needed.

Experimental study of tensile strength of pharmaceutical tablets: effect of the diluent nature and compression pressure

“…The active pharmaceutical ingredient (API) used in this work is the anhydrous caffeine form I (CFI) obtained by using the same method as [14] from commercial anhydrous caffeine Form II (Cooper). To study the effect of the diluent nature, two different powders were used: microcrystalline cellulose (MCC) Avicel R…”

“…Standard Euro D tools with flatfaces of diameter 11.28 mm were fitted on the simulator. Refer to [14] for a complete description of this single station press. Tablets were made without lubricant using one main compression, driven by force.…”

“…One can cite the studies based on the percolation theory [18][19][20][21] (which also requires several unknown parameters such as critical relative density) and the studies based on the Ryskewitch-Duckworth equation [22,23]. However, recently a model between the tablet tensile strength and the surface hardness of tablet was also proposed [14]. For more details about these models refer to [14].…”

“…However, recently a model between the tablet tensile strength and the surface hardness of tablet was also proposed [14]. For more details about these models refer to [14]. In order to test the efficiency of the model proposed in this study, we compared results obtained by equation 2 with values predicted by Wu et al's model [22] and Juban et al's model [14].…”

From Black-Box to Transparent Computational Intelligence Models: A Pharmaceutical Case Study

“…A solid dosage form must be of a minimum hardness to be able to withstand stress during processing and packaging, and at the same time be able to disintegrate in a given time, crucial to obtain expected bioperformance [1]. Different excepients and process conditions influence the tensile strength of a tablet drastically -maintaining a tighter control over the system is imperative owing to consistency and quality concerns of pharmaceutical products.…”