A Biodegradable Copolyester, Poly(butylene succinate--ε-caprolactone), as a High Efficiency Matrix Former for Controlled Release of Drugs.

A biodegradable copolyester, poly(butylene succinate--ε-caprolactone) (PBS_CL), was used for first time as an excipient for pharmaceutical dosage forms using direct compression and hot processing techniques (ultrasound-assisted compression (USAC) and hot melt extrusion (HME)). Robust binary systems were achieved with hot processing techniques, allowing a controlled release of the drug. With only 12% / of PBS_CL, controlled release forms were obtained using USAC whereas in HME over 34% / of excipient is necessary.

Thermoplastic polyurethane as matrix forming excipient using direct and ultrasound-assisted compression.

Thermoplastic polyurethanes (TPU) are block copolymers utilized in a wide variety of applications due to their superior characteristics as resistance, flexibility and biocompatibility. However, the use of TPU as a matrix tablet forming excipient is more limited. For the first time, matrix tablets based on TPU have been developed by direct compression and ultrasound-assisted compression (USAC) allowing a comparison between these two methods.

Achieving High Excipient Efficiency with Elastic Thermoplastic Polyurethane by Ultrasound Assisted Direct Compression.

Ultrasound assisted compression (USAC) is a manufacturing technique which applies thermal and mechanical energy to the powder bed, producing tablets with improved characteristics compared to the direct compression process. This technology is ideal for thermoplastic materials, as polyurethanes, whose particles usually undergo a sintering process. Thermoplastic polyurethanes are widely used in sustained drug release systems but rarely seen in tablets due to their elastic properties.

First study of the evolution of the SeDeM expert system parameters based on percolation theory: Monitoring of their critical behavior.

The deep understanding of products and processes has become a requirement for pharmaceutical industries to follow the Quality by Design principles promoted by the regulatory authorities. With this aim, SeDeM expert system was developed as a useful preformulation tool to predict the likelihood to process drugs and excipients through direct compression. SeDeM system is a step forward in the rational development of a formulation, allowing the normalisation of the rheological parameters and the identification of the weaknesses and strengths of a powder or a powder blend.