Terry Moore

ANALYSIS OF ELECTRONIC CIGARETTE CARTRIDGES, REFILL SOLUTIONS, AND SMOKE FOR NICOTINE AND NICOTINE RELATED IMPURITIES

The objective of this study was to determine nicotine and the nicotine related impurities, that is, cotinine, myosmine, anatabine, anabasine, and β-nicotyrine, in electronic cigarette cartridges, the liquid used to fill the cartridges, and from smoke generated using the electronic cigarette devices. An HPLC method was validated for the determination. Samples of nicotine containing products were purchased via the internet from NJOY, Smoking Everywhere, CIXI, and Johnson Creek. Electronic cigarette devices were purchased from NJOY, Smoking Everywhere, and CIXI. The results from the testing found that (1) the nicotine content labeling was not accurate with some manufacturers, (2) nicotine is present in the “smoke” from electronic cigarettes, and (3) nicotine related impurities contents in cartridges and refills were found to vary by electronic cigarette manufacturer.

Identification of amino-tadalafil and rimonabant in electronic cigarette products using high pressure liquid chromatography with diode array and tandem mass spectrometric detection.

A high-pressure liquid chromatography-diode array detection and multi-mode ionization tandem mass spectrometry (HPLC-DAD-MMI-MS/MS) method was used to identify amino-tadalafil and rimonabant in electronic cigarette (e-cigarette) cartridges. Amino-tadalafil is a drug analogue of the commercially approved Cialis™ (i.e. tadalafil). Rimonabant is a drug that was, at one time, approved for weight loss in Europe (although approval has been retracted), but not in the United States. In addition, poor quality control over the e-cigarette products analyzed here is shown by the presence of nicotine in products labeled as containing no nicotine or by the presence of significant amounts of rimonabant oxidative degradant in e-cigarette products containing rimonabant. Identification was accomplished by comparing the retention time of relevant peaks in the sample with those of standard compounds, in addition to comparison of the UV spectra, mass spectra and/or product ion mass spectra.

Stability, Dose Uniformity, and Palatability of Three Counterterrorism Drugs—Human Subject and Electronic Tongue Studies

PurposeThese studies evaluated the ability of common household food and drink products to mask the bitter taste of three selected anti-terrorism drugs.MethodsThree anti-terrorism drugs (doxycycline, ciprofloxacin hydrochloride, and potassium iodide) were mixed with a variety of common household food and drinks, and healthy adult volunteers evaluated the resulting taste and aftertaste. In parallel, the ASTREE Electronic Tongue was used to evaluate taste combinations. Stability of the mixtures over time was monitored, as was the dosage uniformity across preparations.ResultsFoods and drinks were identified that satisfactorily masked the bitter flavor of each drug. Dose uniformity and stability were also acceptable over the range studied, although some combinations were significantly less stable than others. The electronic tongue was able to differentiate between tastes, but ranked masking agents in a different order than human volunteers.ConclusionsDoxycycline, potassium iodide, and ciprofloxacin, which are stockpiled in solid tablet form, can conveniently be prepared into more palatable formulations, using common household foods and drinks. The electronic tongue can be used to perform an initial screening for palatability.

In vitro dissolution of oral modified-release tablets and capsules in ethanolic media

In 2005, Palladone, an extended-release capsule, was withdrawn from the market after clinical testing showed subjects who took the product with alcohol had increased levels of drug in their blood. To better understand this phenomenon, we studied the in vitro drug release of 27 oral modified-release products in alcohol-containing media. In 40% alcoholic medium, 9 of 10 capsules and 2 of 17 tablets show accelerated drug release. When a high percentage of the total dose is released in a short period of time, the extended-release product is then performing like an immediate release formulation. Products were also tested in 5% and 20% alcoholic media and in simulated gastric fluid (without enzyme) containing 20% alcohol. No tested capsules or tablets exhibited a significant increase in drug release in media containing only 5% alcohol. The current study indicates that in vitro dissolution may provide evidence regarding the ruggedness of formulations to ingested alcohol.

Generic omeprazole delayed-release capsules: in vitro performance evaluations

Background: After the patent on omeprazole delayed-release capsules expired, Food and Drug Administration (FDA) approved several generic omeprazole delayed-release capsule applications. FDA has received some complaints concerning a lack of therapeutic effect of the generic omeprazole delayed-release capsules. Aim: To investigate the quality of five different marketed generic omeprazole delayed-release capsules. Method: The dissolution characteristics of these generic omeprazole delayed-release capsules were determined according to the United States Pharmacopeia (USP). Additional dissolution studies under simulated in vivo physiological conditions were also conducted to determine whether generic omeprazole capsules would perform similarly under these conditions. Results: The experimental data show that all the generic omeprazole delayed-release capsules met the USP standards. The in vitro dissolution of generic drugs is similar to that of the brand omeprazole product. Conclusions: There is no scientific evidence to support the claims that the generic omeprazole delayed-release capsules perform differently from the brand omeprazole product in vitro.