Process Simulation and Analysis of Pharmaceutical Tablet Printing and Disintegration
Implementing Organization
Indian Institute Of Technology Madras
Principal Investigator
Dr. Vvsd Ratnakumar Annabattula
Indian Institute Of Technology Madras, Tamil Nadu
ratna@iitm.ac.in
CO-Principal Investigator
Dr. Murugaiyan Amirthalingam
Indian Institute Of Technology Madras, I.I.T. Post Office,Tamil Nadu,Chennai-600036
Project Overview
This project aims to develop a numerical framework to analyze 3D tablet printing of a polypill and disintegration processes with experimental investigations and validations. Polypills are typically used for the treatment and prevention of multiple medical conditions. In producing polypills, the pharmaceutical industries have to address two significant challenges. Firstly, select the proper tablet-making process that provides higher production rates with the consistency of medicine dose and high patient compliance. Secondly, controlled drug release performance in the body with complex Active Pharmaceutical Ingredients (APIs). A detailed understanding of the process attributes of the tablet-making process and its direct effect on drug release is of utmost importance. Computational simulations with experimental investigations can provide sensitive insights to optimize the parameters for effective drug production and release performance. 3D printing (3DP) of pharmaceutical pills helps us to achieve patient-centered polypills. Selective Laser Sintering (SLS) printing technology is one of the many 3D technologies that allow the customization of medicine based on the medical condition and intended therapeutic outcome suitable for the patient. The pharmaceutical powder is spread into thin, dense powder layers in SLS, selectively sintering the particles using a laser. The dose can be controlled in SLS by calculating material consumption, location of printing and the number of printed layers. Drug absorption and efficacy depend highly on the pharmaceutical tablet disintegration and drug release performance. Pharmaceutical tablet disintegration is a crucial parameter that impacts drug dissolution, bioavailability, delivery, safety, and efficacy. Therefore, it is a critical factor that must be carefully considered during the formulation and manufacturing of oral solid dosage forms. SLS tablet printing can enable the creation of tablets with unique drug delivery properties, such as immediate-release, sustained-release, and extended-release formulations, that can improve the effectiveness of the medication. To simulate the realistic behavior of the powder spreading and sintering process, the primary step is to characterize the pharmaceutical powder for ease of modelling. The powders are characterized to obtain the material and cohesion properties. Discrete element modeling (DEM) is the numerical tool used to model the discrete nature of the powder particles. DEM study of the dynamic behavior of the powder spreading and powder sintering gives insights into the process parameter to obtain a dense and homogeneous powder layer. Computational simulation of tablet integration help to determine parameters that relate the tablet making and disintegration. Thereby desired performance of drug release is achieved. Finally, a customized DEM model would be developed that can provide significant benefits and minimize the computational cost associated with model development.