Non-destructive dose verification of two drugs within 3D printed polyprintlets

Publication date: Available online 23 January 2020Source: International Journal of PharmaceuticsAuthor(s): Sarah J Trenfield, Hui Xian Tan, Alvaro Goyanes, David Wilsdon, Martin Rowland, Simon Gaisford, Abdul W BasitAbstractThree-dimensional printing (3DP) is a revolutionary technology in pharmaceuticals, enabling the personalisation of flexible-dose drug products and 3D printed polypills (polyprintlets). A major barrier to entry of this technology is the lack of non-destructive quality control methods capable of verifying the dosage of multiple drugs in polyprintlets at the point of dispensing. In the present study, 3D printed films and cylindrical polyprintlets were loaded with flexible, therapeutic dosages of two distinct drugs (amlodipine and lisinopril) across concentration ranges of 1-5% w/w and 2-10% w/w, respectively. The polyprintlets were non-destructively analysed for dose content using a portable near infrared (NIR) spectrometer and validated calibration models were developed using partial least squares (PLS) regression, which showed excellent linearity (R2 Pred = 0.997, 0.991), accuracy (RMSEP= 0.24%, 0.24%) and specificity (LV1= 82.77%, 79.55%) for amlodipine and lisinopril, respectively. X-ray powder diffraction (XRPD) and thermogravimetric analysis (TGA) showed that sintering partially transformed the phase of both drugs from the crystalline to amorphous forms. For the first time, we report a non-destructive, RTR quality control of two separate active ingredie...
Source: International Journal of Pharmaceutics - Category: Drugs & Pharmacology Source Type: research