The presented review article is a compilation of several foreign reviews and experimental papers, as well as several authority guidelines, which deal with the phenomenon of dose dumping of solid dosage forms with modified drug release. The aim of the publication is to present this often-neglected issue to a wider domestic audience. The work deals with two basic types of dose dumping, i.e., alcohol-induced dose dumping and food-induced dose dumping. It contains basic factors affecting this phenomenon as well as possible formulation solutions that can be used to eliminate it. Last but not least, the current requirements of the authorities are also mentioned, especially for testing newly introduced products with the presumed potential risk of dose dumping.
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Clin Pediatr Endocrinol
January 2025
Department of Pediatrics, The University of Tokyo, Tokyo, Japan.
Wieacker-Wolff syndrome (WRWF) is an X-linked genetic disorder characterized by neuromusculoskeletal abnormalities caused by loss-of-function variants of the gene. Here, we report the case of a male infant with WRWF manifesting as multiple joint contractures and congenital anomalies at birth. He underwent gastrostomy to treat the gastroesophageal reflux disease, which caused mixed apnea and transient bradycardia.
View Article and Find Full Text PDFAsian 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 PDFToxics
November 2024
División de Química, Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas (CIEMAT), Avda. Complutense 40, 28040 Madrid, Spain.
The state of Zacatecas (Mexico) is one of the places most affected by pollution from the mining industry. A total of 21 samples from two areas were collected (6 samples from zone A and 15 samples from zone B) to evaluate the level of radioactivity and the degree of contamination with heavy metals. The activity concentration for U and Th was within typical values but that of Ra exceeded the value of 60 Bq kg in both areas.
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 PDFJ Foot Ankle Surg
September 2024
Cali Biosciences US, LLC, 9675 Businesspark Avenue, San Diego, CA, 92131, USA.
CPL-01 (ropivacaine extended-release injection) is formulated to safely provide postoperative analgesia and reduce opioid use. Participants undergoing unilateral distal first metatarsal bunionectomy with osteotomy were randomized to receive either CPL-01 (200 mg in Cohort 1, 300 mg in Cohort 2), ropivacaine HCl (50 mg in Cohort 1, 75 mg in Cohort 2), or volume-matched placebo into the surgical site prior to closure. Participants remained in an inpatient setting for 72 h to assess efficacy (Numeric Rating Scale [NRS] scores for pain with activity adjusted for opioid usage, and rescue medication usage), safety and pharmacokinetics.
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