Ethanol is an excipient with known effect whose presence is regulated because it can cause adverse effects, notably a misuse. In order to raise awareness of this risk, this study searched all oral drugs with ethanol as an excipient from the Theriaque® database. All drugs marketed in France with a unit dose ethanol intake of 0.1g or more were identified and analyzed, according to the maximum unit and daily dosage recommended by the manufacturer. This research revealed 106 pharmaceutical specialties responsible for a unit intake of ethanol of 0.1g or more among the 8532 oral drugs containing ethanol (1.2 %): 2 at a daily dose >13g and the majority (57/106; 54 %) at a daily dose <1g. These are mainly oral solutions (97/106; 91 %) of phytotherapy (45/97; 46 %). The most frequently found therapeutic class was antitussive (12/106; 11 %). The majority of drugs are over-the-counter medication (56/106; 53 %). Overall, 106 drugs on the French market can be associated with a risk of misuse and cause adverse effects in vulnerable populations such as children and pregnant women. Vigilance and appropriate monitoring is required for these drugs (especially those over-the-counter ones), and their substitution should be preferred if possible.
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http://dx.doi.org/10.1016/j.therap.2022.05.003 | DOI Listing |
Asian J Pharm Sci
December 2024
NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, National Institutes for Food and Drug Control, Beijing 100050, China.
The structures of solid dosage forms determine their release behaviors and are critical attributes for the design and evaluation of the solid dosage forms. Here, the 3D structures of doxazosin mesylate sustained-release tablets were parallelly assessed by micro-computed tomography (micro-CT). There were no significant differences observed in the release profiles between the RLD and the generic formulation in the conventional dissolution, but the generic preparation released slightly faster in media with ethanol during an alcohol-induced dose-dumping test.
View Article and Find Full Text PDFAAPS PharmSciTech
December 2024
Formulation Research and Development, Sun Pharmaceutical Industries Ltd. , Tandalja, Vadodara, Gujarat, 390020, India.
The study aims to prepare and characterize a novel paclitaxel (PtX) preconcentrate formulation using polymer and lipid excipients that forms nanodispersion upon dilution. The goal was to understand the mechanism of nanodispersion formation and its properties. The water-insoluble PtX was dissolved in organic solvents containing ethanol, polyethylene glycol (PEG400), povidone (PVP), caprylic acid (CA), and sodium cholesterol sulfate (CS).
View Article and Find Full Text PDFMol Pharm
December 2024
Advanced Pharmaceutics and Drug Delivery Laboratory, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario M5S 3M2, Canada.
Alcohol-induced dose dumping (AIDD) remains a serious challenge in the controlled delivery of high potency drugs, such as opioids, which requires extensive investigation and innovative solutions. Current technologies rely on ethanol-insoluble excipients, such as guar gum and sodium alginate, to counteract the increased solubility of hydrophobic polymeric excipients in ethanol. However, these excipients pose several shortcomings, such as high viscosity of coating dispersion, high solution temperature, rapid gelation, and heterogeneity of resulted film.
View Article and Find Full Text PDFAAPS PharmSciTech
October 2024
Chongqing Key Laboratory of Digitalization of Pharmaceutical Processes, College of Traditional Chinese Medicine, Chongqing University of Chinese Medicine, Chongqing, 402076, China.
The granulation of traditional Chinese medicine (TCM) has attracted widespread attention, there is limited research on the high shear wet granulation (HSWG) and wetting mechanisms of sticky TCM powders, which profoundly impact the granule size distribution (GSD). Here we investigate the wetting mechanism of binders and the influence of various parameters on the GSD of HSWG and establish a GSD prediction model. Permeability and contact angle experiments combined with molecular dynamics (MD) simulations were used to explore the wetting mechanism of hydroalcoholic solutions with TCM powder.
View Article and Find Full Text PDFEur J Drug Metab Pharmacokinet
November 2024
College of Pharmacy, Hanyang University, 55 Hanyangdaehak-ro, Sangnok-gu, Ansan, 15588, South Korea.
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