![]() The method exploits the fact that terahertz radiation can penetrate deep into pharmaceutical powder compacts due to the transparency of excipients at terahertz frequencies as well as the fact that there is a significant difference in the refractive index between dry polymer and dissolution medium.Ĭharacterisation of Microstructural Changes during Disintegration Using this method it is possible to simultaneously measure the amount of overall swelling of the tablet as well as the position of the liquid front within the tablet. The terahertz measurement is a non-contact and non-invasive method that is performed at the centre of flat faced tablets with a time resolution of less than 1 s per sampling point. We recently developed a flow cell that can be used for measuring the one-dimensional liquid ingress during disintegration of immediate release tablets by TPI. ![]() Fast and Non-destructive Imaging of Disintegration Using this technique it is possible to measure the liquid transport into the dosage form in detail and extract quantitative data that can be used to design mathematical models forming the basis for rational formulation design for immediate release tablets. Here we introduce a fundamentally new approach based on terahertz pulsed imaging (TPI) to investigate the penetration of dissolution medium into the porous matrix of immediate release formulations. One reason for this situation could be due to the lack of sufficiently fast and accurate measurement techniques to quantify the changes in microstructure that occur during the interaction of the dosage form and the dissolution medium. The development of immediate release formulations is still dominated by a largely empirical approach. Apart from establishing the conformity with such official guidelines the disintegration test yields little additional information and is not very useful to guide rational formulation design. Based on the results of the disintegration test it is judged whether or not the dosage form meets the specification required by the respective pharmacopoeia e.g. In traditional disintegration testing it is difficult to establish any detailed insights into the mechanism of tablet disintegration as the test is merely designed to indicate the time it takes for a tablet or capsule to disintegrate completely, and this is defined as the state "in which any residue of the unit is a soft mass having no palpably firm core". Characterisation of Disintegration of Pharmaceutical Solid Dosage FormsĮven though the majority of solid dosage forms on the market and in development are immediate release tablets, surprisingly little is known about the disintegration process.
0 Comments
Leave a Reply. |