POROUS PLASTIC MATRIX TABLETS OF LEVETIRACETAM FOR ZERO-ORDER CONTROLLED RELEASE: DEVELOPMENT AND FORMULATION OPTIMIZATION

Objective: The prior objective of the current research work was to develop once-daily levetiracetam extended/controlled-release tablets having zero-order release kinetics with the plastic matrix as the release retarding element. For a high water-soluble drug, the formulation of a dosage form so as to have an extended drug release has always been a difficult task. Methods: In the current work, levetiracetam which is a highly soluble drug was taken as the model drug for which extended-release matrix tablets were developed using varied plastic polymers like Polyvinyl acetate (PVAc), Polyvinyl chloride (PVC), Eudragit RSPO and Eudragit RLPO. PVP was considered as a pore-forming agent and PEG 6000 was taken as a water regulating agent. The porous plastic matrix tablets were prepared by embedding the drug in solvent-activated polymer dispersion followed by drying, sieving, mixing with other excipients and finally compressed. Including physical characterization studies and drug release studies, the tablets were subjected to SEM studies before and after the dissolution studies to analyze the effect of the pore former. Results: Pre-compression mixtures exhibited good packageability of 81-92% and hence the compressed tablets were strong enough with good tensile strength in the range of 0.78–0.90 N/mm2. Drug release study results showed that the drug release was controlled for a period of 12–24h. PVAc had shown better controlled-release among all the plastic polymers taken. PEG 6000 in combination with PVP produced the desired zero-order drug release. Conclusion: The levetiracetam porous plastic matrix tablets were developed with zero-order drug release that was effectively controlled for 24hr

Analytical Method Development and Validation of Iron, Arsenic, Cadmium, Mercury and Lead Content in Sunset Yellow by Inductively Coupled Plasma Mass Spectrometry (Icp-Ms)

A method for determining the iron, arsenic, cadmium, mercury, and lead content in Sunset Yellow by ICP-MS was developed, verified, and implemented for routine ICP-MS analysis. Inductively coupled plasma mass spectrometry (ICP-MS) is a good instrument for determining the basic composition of numerous substances. Iron, arsenic, cadmium, mercury, and lead metal as defined in USP (233) linearity, method precision, accuracy, robustness, and ruggedness factors were taken into account and analysed for method validation in this work. The recovery rates of iron, arsenic, cadmium, mercury, and lead metals ranged between 92.0% and 101.4%. The detection limits of all elements investigated demonstrated the procedure's suitability for routine analyses. To summarize, the provided analytical processes can be used to measure the mass fractions of iron, arsenic, cadmium, mercury, and lead components in Sunset Yellow samples

Microstructural and texture development in direct laser fabricated IN718

Microstructural characterisation was performed for IN718 thin-walled builds, produced using direct laser fabrication (DLF), to understand the influence of the variations in the deposition path and the laser power on the microtexture, grain structures and intermetallic particle morphology development. Considerable differences were observed, with the high laser power input generating a columnar grain structure, with a strong < 001 > fibre texture along the build height, compared to a mixture of fine uniform and large columnar grains in the low power builds, with a near random texture. The influence of different DLF conditions on the formation of Laves and of δ phase was also found to be significant, with the Laves phase precipitates being larger in the high laser power sample. Carbides and δ were also present in the high power build, but were not observed in the low power samples regardless of the deposition path

Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants

ObjectiveTo compare in-hospital outcomes after umbilical cord milking vs delayed cord clamping among infants <29 weeks of gestation.Study designMulticenter retrospective study of infants born <29 weeks of gestation from 2016 to 2018 without congenital anomalies who received active treatment at delivery and were exposed to umbilical cord milking or delayed cord clamping. The primary outcome was mortality or severe (grade III or IV) intraventricular hemorrhage (IVH) by 36 weeks of postmenstrual age (PMA). Secondary outcomes assessed at 36 weeks of PMA were mortality, severe IVH, any IVH or mortality, and a composite of mortality or major morbidity. Outcomes were assessed using multivariable regression, incorporating mortality risk factors identified a priori, confounders, and center. A prespecified, exploratory analysis evaluated severe IVH in 2 gestational age strata, 22-246/7 and 25-286/7 weeks.ResultsAmong 1834 infants, 23.6% were exposed to umbilical cord milking and 76.4% to delayed cord clamping. The primary outcome, mortality or severe IVH, occurred in 21.1% of infants: 28.3% exposed to umbilical cord milking and 19.1% exposed to delayed cord clamping, with an aOR that was similar between groups (aOR 1.45, 95% CI 0.93, 2.26). Infants exposed to umbilical cord milking had higher odds of severe IVH (19.8% umbilical cord milking vs 11.8% delayed cord clamping, aOR 1.70 95% CI 1.20, 2.43), as did the 25-286/7 week stratum (14.8% umbilical cord milking vs 7.4% delayed cord clamping, aOR 1.89 95% CI 1.22, 2.95). Other secondary outcomes were similar between groups.ConclusionsThis analysis of extremely preterm infants suggests that delayed cord clamping is the preferred practice for placental transfusion, as umbilical cord milking exposure was associated with an increase in the adverse outcome of severe IVH.Trial registrationClinicalTrials.gov: NCT00063063