Search results for "Drug Packaging"
showing 6 items of 6 documents
Physico-chemical stability of eribulin mesylate containing concentrate and ready-to-administer solutions.
2013
Objectives The aim of this study was to determine the stability of commercially available eribulin mesylate containing injection solution as well as diluted ready-to-administer solutions stored under refrigeration or at room temperature. Methods Stability was studied by a novel developed stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) assay with ultraviolet detection (detection wavelength 200 nm). Triplicate test solutions of eribulin mesylate containing injection concentrate (0.5 mg/mL) and with 0.9% sodium chloride solution diluted ready-to-administer preparations (0.205 mg/mL eribulin mesylate in polypropylene (PP) syringes, 0.020 mg/mL eribulin mesyl…
Implementation and microbiological stability of dose-banded ganciclovir infusion bags prepared in series by a robotic system.
2018
Objectives The implementation of dose-banding (DB) in centralised, pharmacy-based cytotoxic drug preparation units allows the preparation of standardised doses in series. The aim of this study was to evaluate the feasibility of DB for the prescribing of ganciclovir (GV) infusion solutions and to investigate the microbiological stability of dose-banded, automatically prepared ready-to-administer GV infusion bags by media-fill simulation tests and sterility tests. Methods The frequency of prescription of GV doses was retrospectively analysed before and after implementing the DB scheme. Four dose-ranges or ‘bands’ and the corresponding standard doses (250, 300, 350, 400 mg) were identified. Th…
In-use physicochemical and microbiological stability of biological parenteral products
2015
Pharmaceutical scientists in the biotechnology industry have traditionally focused on achieving acceptable shelf lives of drug products in their original, unopened product unit configuration (e.g., two years stored at 2–8 °C). However, it is now clear that stability considerations extend beyond
Comparison of quantitative analysis techniques for the determination of heat seal lacquer layers on aluminum blister foils
2010
For decades a gravimetric method has been common standard for the determination of heat seal lacquers on aluminum blister foils. With the availability of appropriate techniques such as interferometric, infrared reflection absorption spectroscopic (IRRAS), beta backscatter, impedance spectroscopic and eddy current techniques respectively, more efficient determinations can be foreseen which are subject of the present communication. The different methods were compared to each other regarding parameters required for validation of analytical procedures according to the ICH guidelines Q2 (R1) such as linearity, precision, accuracy, robustness and quantitation limits. The interferometric, IRRAS an…
Influences of heat seal lacquer thickness on the quality of blister packages.
2011
A sealability of aluminium lidding foils against formable polymer materials of blister packages is usually achieved by a coating of aluminium with certain grammages of heat seal lacquers. To investigate influences of their thickness on quality of blister packages, lidding foils with different grammages of two lacquer types were manufactured. Sealing experiments (variation of temperature, pressure and sealing time) were performed. Sealed seam strengths were determined with mechanical tensile tests, tightness of cold form blisters were analysed by means of helium leakage tests. Time-dependent moisture uptake of stored blisters was monitored with micro-gas chromatography. By means of a simple …
Plasticizer extraction of Taxol infusion solution from various infusion devices.
1996
Taxol solution extracts the plasticizer DEHP (di(2-ethylhexyl)phthalate) from polyvinyl chloride (PVC) materials. In order to minimize patient exposure to DEHP, Taxol solutions should be prepared and administered in PVC-free materials. Particulate matter may form in Taxol infusion solution over time, so that in-line filtration with microporous membranes not greater than 0.22 microns is advisable. The purpose of this study was to evaluate the suitability of various administration- and in-line filter-sets for Taxol application. The extent of leached DEHP was determined using a Reversed Phase HPLC assay specific for DEHP. The four tested administration-sets, labeled as PVC-free, were all found…