A case study demonstrating the migration of diethyl phthalate from an ancillary component to the drug product

Publication date: Available online 13 November 2018Source: Journal of Pharmaceutical and Biomedical AnalysisAuthor(s): Gagandeep Singh, Ramarao Gollapalli, Alejandro Blinder, Felix Gallo, Milan PatelAbstractPhthalates are chemical compounds employed as plasticizers in the plastic industry and have been reported to migrate into drug products. The extent of their migration into the drug product depends upon various factors including the chemical nature of the migrant and the permeability of its packaging container. Migration of semi-volatile phthalates such as Diethyl phthalate (DEP) into drug products is often related to the primary and secondary packaging but due to its chemical nature, it could also migrate from an ancillary component. Therefore, it is not only important to screen the primary and secondary components, but also the ancillary materials that are used during the handling of drug products. In our study, we discovered an ancillary material (scotch tape) to be the source of DEP found in an ophthalmic drug product using orthogonal mass spectroscopy techniques (GC-MS and LC-MS). It is evident from our data that DEP migrated from the scotch tape into the drug product crossing the physical barriers provided by the primary (LDPE container closure system) and secondary packaging (carton and label). The tape was used as an ancillary material to wrap the packaged drug product units together for storage in the stability chamber. The primary and the secondary packaging of th...
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research

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This study aims to examine the effectiveness of the postural treatment of the Mézières method on elite rhythmic gymnastics athletes with low back pain. DESIGN: Double-blind, randomized, controlled trial. SETTING: The sports hall of "Puente Tocinos," Murcia, Spain. PARTICIPANTS: Ninety gymnastics athletes were randomized into 2 parallel groups (intervention: n = 39; control: n = 51), of whom 98.9% were women (women = 89; man = 1). INTERVENTION: The Mézières method postural therapy was implemented. It lasted about 60 minutes in repeated sessions of 2 to 3 meetings per wee...
Source: Journal of Sport Rehabilitation - Category: Sports Medicine Tags: J Sport Rehabil Source Type: research
CONCLUSIONS: Delayed activation of the VM registered in females determines an increase in anterior shear force, which is an important risk factor for incurring an ACL injury. This testing protocol becomes adequate for the screening of high-risk athletes and for targeting interventions to specific imbalances that may increase injury risk. PMID: 31711040 [PubMed - as supplied by publisher]
Source: Journal of Sport Rehabilitation - Category: Sports Medicine Tags: J Sport Rehabil Source Type: research
Authors: Fyock M, Cortes N, Hulse A, Martin J Abstract Clinical Scenario: Patellofemoral pain (PFP) is a common knee injury in recreational adult runners, possibly caused by faulty mechanics. One possible approach to reduce this pain is to retrain the runner's gait. Current research suggests that no definitive gold standard treatment for PFP exists. Gait retraining utilizing visual feedback may reduce PFP in both the short and long term. Clinical Question: In adult runners diagnosed with PFP, does gait retraining with real-time visual feedback lead to a decrease in pain? Summary of Key Findings: A literature search...
Source: Journal of Sport Rehabilitation - Category: Sports Medicine Tags: J Sport Rehabil Source Type: research
Publication date: Available online 13 November 2019Source: Materials Today CommunicationsAuthor(s): Dian Putri Hastuti, Wardah Amalia, Zakiah Priska, Pekik Nurwantoro, SholihunAbstractStabilities and atomic geometries in germanene multivacancies has been studied. We carry out eight configurations, mono-, di-, tri-, tetra-, penta-, hexa-, hepta-, and octavacancies by using the density-functional-theory calculations (DFT). We calculate formation and dissociation energies to analyze the stability by finding the magic numbers. Magic numbers are the number of vacancy belonging to stable configurations. We find that di-, tetra-,...
Source: Materials Today Communications - Category: Materials Science Source Type: research
Publication date: Available online 12 November 2019Source: Materials Today CommunicationsAuthor(s): Manorama Tripathi, Surekha Parthasarathy, Prasun Kumar RoyAbstractThis paper deals with the fabrication of non-woven polyurea nanofibers through an electrospinning process and evaluation of their mechanical properties under dynamic conditions. Polyurea is finding increasing applications for protection against dynamic loads like blast and ballistics. Processing polyurea into nanofibers can further improve their properties, especially with respect to mechanical properties and high surface areas, expanding their field of applic...
Source: Materials Today Communications - Category: Materials Science Source Type: research
Conclusion: HTX-019 administered by 2-minute injection has a tolerable safety profile in patients with cancer, representing a viable method of HTX-019 administration for CINV prevention. PMID: 31709853 [PubMed - as supplied by publisher]
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
Authors: Gabella G Abstract All the cells of rat detrusor muscle fall into one of five ultrastructural types: muscle cells, fibroblasts, axons and glia, and vascular cells (endothelial cells and pericytes). The tissue is ~79% cellular and 21% non-cellular. Muscle cells occupy 72%, nerves ~4% (1/3 axons, 2/3 glia), and fibroblast>3% of space. Muscle cells (up to 6 µm across and ~600 µm long, packed to almost 100,000 per mm2) have surface-to-volume ratio of 2.4 µm2/µm3 ~93% of cell volume is contractile apparatus, 3.1% mitochondria and 2.5% nucleus. Cell profiles are irregular but section...
Source: Journal of Smooth Muscle Research - Category: Research Tags: J Smooth Muscle Res Source Type: research
Source: Autonomic Neuroscience: Basic and Clinical - Category: Neuroscience Source Type: research
Journal Name: Clinical Chemistry and Laboratory Medicine (CCLM) Issue: Ahead of print
Source: Clinical Chemistry and Laboratory Medicine - Category: Laboratory Medicine Source Type: research
Journal Name: Clinical Chemistry and Laboratory Medicine (CCLM) Issue: Ahead of print
Source: Clinical Chemistry and Laboratory Medicine - Category: Laboratory Medicine Source Type: research
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