A fundamental step in your tablet development – MEDELPHARM brochure

Formulation development and technical transfer from lab to production can be challenging and requires a deep knowledge of your formulation.

The integrated and intuitive data analysis features drive formulators and scientists in their decision-making process with build-in graphs and reports to develop robust and scalable formulations. Knowledge management based on data leads to avoid tablet defects in production and guarantee high production output. This can be undertaken right from the development stage thanks to STYL’One compaction simulators

Tensile strength: a better way to express tablet breaking force.

Tablet breaking force as a function of compression force are useful to assess formulations and to determine the critical process parameters of production rotary tablet presses. However, according to the USP <1062> monograph, this plot also known as manufacturability profile should be replaced by the tabletability profile which normalizes data and minimizes the impact of tablet dimension and weight on tableting behavior. This plot expresses the tablet tensile trength as a function of compression pressure.

Working with compression pressure and tensile strength has several benefits. As the compression force is divided by the punch tip cross-section, it allows scientists to compare compression data from different tooling sizes and shapes.

Compression stress for an ideal direct-compression material goes from 20 MPa to 125 MPa and should not exceed 300 MPa with a shaped tooling. In case of limited amount of material available, a single point pressure can be quickly performed to compare different products. At MEDELPHARM Science Lab, a pressure of 200 MPa is considered as a standard pressure to study pharmaceutical blends.

Tensile strength is calculated automatically thanks to different equations that depends on tablet geometry. Tensile strength at around 1 MPa should suffice for small batches where tablets are not subjected to significant mechanical stresses. A tensile strength of 1.7 MPa will ensure that a tablet is mechanically strong enough to withstand commercial manufacture, and packaging. When dealing with short material supply, scientists can compare tablet tensile strengths at the same solid fraction, i.e., a solid fraction of 0.85.

Fast experiment setup with limited amount of material

In this study, excipients were used as placebo materials, but the concept remains the same with formulations. Four well-known excipients have been compared on a STYL’One Evo compaction simulator: microcrystalline cellulose grade 102 (MCC 102), maize starch, di-calcium phosphate (DCP), and mannitol grade 200 SD. A six-point compression profile was made from 5kN to 30kN, using a standard EU-B 11.28mm round flat tooling and a V-shape research compression profile (also known as saw-tooth profile). V- shape profile is often used for material characterization to ensure constant speed of the punch during the compaction process.

The STYL’One external lubrication box has been used with MgSt to assess the tableting behavior of neat material.

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Source: MEDELPHARM brochure “A fundamental step in your tablet developement”