RESUMO
Introduction: Posaconazole is a widely used antifungal drug, and its accurate quantification is essential for quality control and assessment of its pharmaceutical products. This study aimed to develop and validate a reverse-phase high-performance liquid chromatography (HPLC) analytical method for quantifying Posaconazole in bulk and dosage form. Methods: The HPLC method was developed and validated based on International Conference on Harmonisation (ICH) guidelines. The developed method was then applied to quantify Posaconazole in a marketed tablet formulation. The method's specificity, linearity, precision, accuracy, robustness, and stability were evaluated. Results: The developed HPLC method showed good linearity over a 2-20 µg/mL concentration range. The percentage recovery of Posaconazole from the bulk and marketed formulations was found to be 99.01% and 99.05%, respectively. The intra-day and inter-day precisions were less than 1%, and the method was stable under different conditions. The HPLC method was successfully applied to quantify Posaconazole in the marketed formulation. Conclusion: The developed and validated HPLC method is reliable and efficient for analyzing Posaconazole in bulk and dosage forms. The method's accuracy, precision, specificity, linearity, robustness, and stability demonstrate its effectiveness. The method can be used for the quality control and assessment of Posaconazole-containing pharmaceutical products.
Assuntos
Antifúngicos , Triazóis , Cromatografia Líquida de Alta Pressão/métodos , Comprimidos , Triazóis/análiseRESUMO
BACKGROUND: Globally, neonatal healthcare-associated infections (HAIs) are known to cause high mortality. HAIs is a preventable condition related to the healthcare environment. The current study explored the contributors to neonatal HAIs in one of the largest tertiary care referral hospitals in South India. METHODS: Neonates from December 2016 to June 2018 were observed for the occurrence of healthcare-associated infections and compared with the matched control group. Various observations on neonatal demography, maternal contributors, and medical procedures were made and recorded to explore and analyse the contributors to neonatal HAIs. Univariate and multivariate analysis was carried out to find the contributors. The Odds ratio with 95% CI was also computed and reported. RESULTS: Bloodstream infection (83%) was prevalent among neonates; the maternal contributor was only preterm labor (Odds ratio of 11.93; 95% CI; 6.47-21.98; p<.05) to acquire HAIs. On univariate analysis, mechanical ventilation for > 3days duration, NIV for > five days, and PICC line insertion procedure were significant (p<0.05) contributors to neonatal HAIs. IV cannulation for more than three times in four consecutive days was found in 100(85%) neonates considered being associated with neonatal HAIs. On multivariate analysis, NIV, PICC line, preterm labor, and low birth weight were significant (p<0.05) contributors to neonatal HAIs. CONCLUSION: The increased duration of invasive and non-invasive therapeutic devices and catheters contributes to neonatal HAIs. Neonates are acquiring bloodstream infections; low birth weight (LBW) neonates are more susceptible to acquiring HAIs.
Assuntos
Infecção Hospitalar , Trabalho de Parto Prematuro , Sepse , Infecção Hospitalar/epidemiologia , Infecção Hospitalar/prevenção & controle , Atenção à Saúde , Feminino , Humanos , Recém-Nascido , Unidades de Terapia Intensiva NeonatalRESUMO
Background: Asiatic acid (AA) is a naturally occurring triterpenoid derivative of Centella asiatica (CA) with neuroprotective effect. The study aimed to design an ideal oral drug delivery system to treat Alzheimer's disease (AD) and develop chitosan-embedded liposomes comprising an extract of CA (CLCAE) and compare them with the chitosan-coated liposomes of asiatic acid (CLAA) for oral delivery to treat the initial phases of AD. Methods: The solvent evaporation technique was used to develop CLCAE and CLAA, optimised with the experiment's design, and was further evaluated. Results: Nuclear magnetic resonance (NMR) studies confirmed coating with chitosan. Transmission electron microscopy (TEM) and atomic force microscopy (AFM) indicated the successful formation of CLCAE and CLAA. Differential scanning colorimetry (DSC) confirmed the drug-phospholipid complex. Furthermore, the rate of in vitro release of CLCAE and CLAA was found to be 69.43±0.3 % and 85.3±0.3 %, respectively, in 24 h. Ex vivo permeation of CLCAE and CLAA was found to be 48±0.3 % and 78±0.3 %, respectively. In the Alcl3-induced AD model in rats, disease progression was confirmed by Y-maze, the preliminary histopathology evaluation showed significantly higher efficacy of the prepared liposomes (CLCAE and CLAA) compared to the Centella asiatica extract (CAE) and they were found to have equivalent efficacy to the standard drug (rivastigmine tartrate). The considerable increase in pharmacodynamic parameters in terms of neuronal count in the CLAA group indicated the protective role against Alcl3 toxicity and was also confirmed by assessing acetylcholine (Ach) levels. The pharmacokinetic study, such as C max, T max, and area under curve (AUC) parameters, proved an increase in AA bioavailability in the form of CLAA compared to the pure AA and CLCAE forms. Conclusion: The preclinical study suggested that CLAA was found to have better stability and an ideal oral drug delivery system to treat AD.
Assuntos
Doença de Alzheimer , Quitosana , Triterpenos , Ratos , Animais , Doença de Alzheimer/tratamento farmacológico , Lipossomos , Cloreto de Alumínio , Triterpenos/farmacologia , Triterpenos/química , Triterpenos/uso terapêuticoRESUMO
Lymphatic system is the secondary circulation system of the human body after the systemic circulation. Various problems, including the first-pass metabolism through oral administration of medicines, can be resolved by lymphatic targeting. Lymphatic absorption has been explored in detail, and studies reveal the improved bioavailability of medicines. In the case of cancer, AIDS, and various other health problems, lymphatic targeting has been focused on due to the fact that lymph nodes are involved greatly in tumor metastasis. This article reviews lymphatic absorption and its exploration in the treatment of various health problems. The physiology of the lymphatic system, the mechanisms of absorption, and the various formulation systems suitable for lymphatic absorption have been discussed. Some recent novel approaches like hydrodynamically driven device (HDD) and carbon nanotubes for lymphatic delivery have also been appraised.