Compatibility study of tobramycin and pharmaceutical excipients using differential scanning calorimetry, FTIR, DRX, and HPLC

A Comprehensive Approach to Compatibility Testing Using Chromatographic, Thermal and Spectroscopic Techniques: Evaluation of Potential for a Monolayer Fixed-Dose Combination of 6-Mercaptopurine and Folic Acid

“…As previously mentioned, isothermal stress testing is often used in assessing the compatibility of drug substances with other substances and excipients potentially used in the formulation [ 16 , 18 ]. When coupled with a technique such as chromatography, its advantages are its high accuracy and precision, as well as ability to detect and identify possible interaction products present in small amounts.…”

“…In the case of incompatibility, technological solutions such as bilayer tablets should be considered. On the other hand, a number of techniques such as thermogravimetric analysis, differential scanning calorimetry (DSC), isothermal stress testing (IST) followed by Fourier-transform infrared spectroscopy (FTIR) or high-performance liquid chromatography (HPLC) assay, X-ray diffraction, dissolution testing and others are used to screen and assess the compatibility of the active substances and planned excipients but, also, of the two or more active substances [ 15 , 16 , 17 , 18 ]. Therefore, the aim of this work was to investigate the compatibility of FA and 6-mercaptopurine (6MP) ( Figure 1 ), a drug from the thiopurine class, as a prerequisite for FDC development.…”

Formulation and evaluation of ocular drops containing solid dispersion of tobramycin

“…Samples of 1ml were withdrawn at specified time intervals and analysed spectrophotometrically at 204 nm using Shimadzu-1700 UV-visible spectrophotometer; the samples withdrawn were replaced by fresh buffer solutions. Each preparation was tested in triplicate and then means values were calculated (Miller et al, 2017;Rosasco et al, 2018).…”

Implementation of Experimental Design Methodology in the Compatibility Study of Hydrocortisone With Selected Excipients Used in Solid Dosage Forms

“…The research articles describe the approach using binary mixtures consisting of an active pharmaceutical ingredient and a studied excipient in a 1:1 weight ratio or in a non-equilibrium ratio. Increasingly, in compatibility studies of pharmaceutical ingredients, multi-component mixtures are prepared in order to reflect in a higher manner the real composition of the target drug product [3,10,14,19]. The regulatory agencies (United States Food and Drug Administration, European Medicines Agency) recommend the implementation of so-called Quality by Design (QbD) concept at the drug product development stage [8].…”