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01. March 2017
Abstract The purpose of the present study was to develop a near-infrared spectroscopy (NIRS) method to quickly, accurately, and precisely evaluate and control the coating process of the low dose drug, glimepiride on tablet. For this purpose, a calibration set for the drug was quantified using a partial least-squares regression method with a high-performance liquid chromatography (HPLC) as the reference method. The correlation coefficient (R2) between the NIRS method and the HPLC method in the...
18. January 2017
What is Process Validation? Validation for ExcipientsThe concept of validating pharmaceutical processes or, in FDA’s definition, “the establishment of scientific evidence that a process is capable of consistently delivering quality product across its lifecycle”, was first introduced to the FDA in the 1970s. The idea behind pharmaceutical validation was to build quality into pharmaceutical products by ensuring that processes are robust and will routinely meet specification and customer...
14. December 2016
Purpose: To validate a new and simple method for cleaning a manufacturing line for creams and ointments. Methods: The worst case product of the line chosen was a cream containing three practically insoluble ingredients: betamethasone, tolnaftate and cliquinol. The cleaning method utilized hot water and a commercial detergent, followed by rinsing. Validation methods included the visual inspection of the machine surface, swab sampling, microbial bioburden determination and testing the final rinse...
08. August 2016
Abstract Previously, it was shown in Phase I clinical trials that solubility-limited oral absorption of docetaxel and paclitaxel can be drastically improved with a freeze dried solid dispersion (fdSD). These formulations, however, are unfavorable for further clinical research because of limitations in amorphicity of SD and scalability of the production process. To resolve this, a spray drying method for an SD (spSD) containing docetaxel or paclitaxel and subsequently drug products were...