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• W3025148966 abstract "Despite their widespread use for anesthesia and sedation, propofol emulsions have several unresolved issues, including pain on injection, stability concerns, and propensity to support bacterial growth. Pain accompanying a propofol injection has been attributed to the amount of free as opposed to emulsified propofol in the blood, which can differ with the formulation. Emulsions are inherently unstable and subject to several types of destabilization, but the actual mechanism may vary between formulations or batches. Free drug concentration and emulsion stability have not been widely studied between batches of propofol emulsions. Verifying whether batch-to-batch variability is a contributing factor to pain on injection or emulsion destabilization will help us better assess the causes and guide the design of future propofol formulations.Several samples of generic 1% propofol emulsion from various batches were compared. Free drug concentration was measured using an equilibrium dialysis method. Emulsion stability was evaluated by visible observation and by measuring droplet size distribution and polydispersity during shelf storage for up to 21 months.Small differences in free drug concentration were observed between samples (10.6-16.7 μg/mL), but these differences were not statistically significant (p > 0.05). Emulsion droplet size (235.4-221.1 nm) and polydispersity (0.115-0.095) did not differ statistically over 21 months of storage. All batches were resistant to creaming and other destabilization mechanisms.Batch-to-batch variability does not significantly alter the free drug concentration or stability of propofol formulations. If pain on injection of propofol is in fact related to the free propofol drug concentration, then it is unlikely that batch-to-batch variability causes any changes in pain on propofol injection.În ciuda largii lor utilizări pentru sedare şi anestezie, emulsiile de propofol au câteva inconveniente nerezolvate, care includ durerea la injectare, probleme legate de stabilitate şi de susceptibilitatea de a favoriza dezvoltarea bacteriană.Durerea pe care o provoacă injectarea de propofol a fost atribuită concentraţiei libere de propofol din sânge, care poate fi diferită de la un preparat la altul. Emulsiile sunt prin definiţie forme chimice instabile şi sunt predispuse la diverse forme de destabilizare, însă mecanismul acestei destabilizări poate fi variabil, în funcţie de forma farmaceutică şi/sau lotul de fabricaţie. Concentraţia liberă de propofol şi stabilitatea emulsiei în loturi diferite de emulsii de propofol nu a fost larg studiată până la această dată. Verificarea faptului că variabilitatea de la un lot la altul a emulsiei de propofol poate reprezenta un factor care contribuie la determinarea durerii la injectare sau a instabilităţii emulsiei ne va ajuta să apreciem mai corect cauzele şi va ghida spre eventuale noi formule de preparare a propofolului.Au fost comparate câteva mostre de emulsie de propofol 1% din diferite loturi de fabricaţie. Concentraţia liberă de propofol a fost determinată utilizând o metodă de echilibrare de tip dializă. Stabilitatea emulsiei a fost evaluată prin observaţie macroscopică, măsurând distribuţia picăturilor şi polidispersia de-a lungul depozitării, pe o perioadă de 21 de luni.Au fost observate mici diferenţe de concentraţie a propofolului între mostrele analizate (10,6–16,7 μg/ml), dar aceste diferenţe nu au fost semnificative statistic (p > 0,05). Dimensiunile picăturilor emulsiei şi polidispersia (0,115–0,095) nu au fost diferite din punct de vedere statistic de-a lungul celor 21 de luni de depozitare. Toate loturile s-au dovedit rezistente la decantare sau la alte mecanisme de destabilizare.De la un lot la altul, variabilitatea produsului nu a afectat semnificativ concentraţia liberă de propofol sau stabilitatea preparatelor. Dacă durerea de injectare la propofol este legată de fapt de concentraţia liberă de propofol, atunci este puţin probabil ca variabilitatea loturilor să determine modificări în durerea determinată de injectarea de propofol." @default.
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• W3025148966 date "2016-04-01" @default.
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• W3025148966 title "Propofol emulsion-free drug concentration is similar between batches and stable over time" @default.
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• W3025148966 doi "https://doi.org/10.21454/rjaic.7518.231.emf" @default.
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