Investigation of magnesium aluminometasilicate (Neusilin US2) based surface solid dispersion of sorafenib tosylate using QbD approach: and pharmacokinetic study.

Background And Purpose: Sorafenib tosylate (SFN), a potent multikinase inhibitor, is used for the treatment of various cancers. However, it shows limited therapeutic applications due to its poor biopharmaceutical properties. The aim of the present investigation is to develop surface solid dispersion (SSD) of SFN using adsorbent to improve its solubility, bioavailability and therapeutic efficacy.

Correlation of Quality Metrics of Acute Stroke Care with Clinical Outcomes in an Indian Tertiary-care University Hospital: A Prospective Evidence-based Study.

Aim: To characterize the impact of adherence to quality metrics of stroke care on the clinical outcomes of ischemic stroke (IS) and intracerebral hemorrhage (ICH) admissions.

Methods: Consecutive patients with acute stroke were prospectively followed up for their demographic and clinical characteristics, acute stroke management, and associated clinical outcomes at discharge. Stroke quality metrics [adopted from the American Heart Association (AHA)/American Stroke Association's Get with The Guidelines (GWTG)] with a specific interest in an association between acute reperfusion therapies and functional recovery in stroke patients are analyzed and presented.

Antitubercular therapy causing drug reaction with eosinophilia and systemic symptoms manifesting multi-organ dysfunction syndrome and death in an elderly patient: A case report with review of literature.

We present the case of a drug reaction with eosinophilia and systemic symptoms (DRESS) manifesting multi-organ dysfunction syndrome (MODS) that led to death in an elderly patient during the intensive phase of antitubercular therapy (ATT). A 74-year-old male developed skin rash (morbilliform), patchy erythematous macules, pustular-purpuric nonblanching spots, fever, lymphadenopathy, liver dysfunction, leukocytosis, and eosinophilia during intensive phase of ATT (ATT: day 45). Laboratory tests revealed hypereosinophilia (eosinophils; 10500/μL), hyperacute fulminant hepatic failure (aspartate transaminase/alanine transaminase; 1444/1375 IU/L, total bilirubin; 11.

Adverse events associated with Pegaspargase biosimilar in pediatric patients with acute lymphoblastic leukemia: A prospective single-center study.

Background: While Pegaspargase is an essential component of the treatment of acute lymphoid leukemia (ALL) in children, it causes adverse events (AEs) that sometimes make full use impossible.

Objective: The objective was to investigate the safety of Pegaspargase biosimilar in pediatric ALL patients undergoing treatment according to ICiCLe ALL-14 protocol.

Method And Materials: A prospective study was carried out in a university teaching hospital located in the state of Maharashtra, India.

Melatonin and Triclofos Sodium to Execute Sleep Electroencephalography in Pediatric Patients: A Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial.

Objectives: To evaluate cost-effectiveness between oral sedatives melatonin and triclofos sodium used to perform sleep electroencephalography (EEG) in pediatric patients and develop a criterion for resource allocation by the institution.

Methods: This prospective study was conducted alongside the randomized controlled trial conducted at a tertiary care hospital, wherein pediatric patients arriving for sleep EEG were randomized to receive melatonin dosed at 0.3 mg/kg (< 10 kg), 3 mg (10-15 kg), and 6 mg (> 15 kg) and triclofos at 50 mg/kg (maximum dose 1 g, 6 mo to 11 y; 2 g, 11 to 18 y) after due consent.

A Case of Cerebral Toxoplasmosis and Cryptococcosis Preferred Therapy Associated Adverse Drug Reactions in a Patient Newly Co-diagnosed with Acquired Immune Deficiency Syndrome.

Purpose: The simultaneous occurrence of cerebral toxoplasmosis and cryptococcosis is rare. The infections continue to be treated with sulfadiazine and amphotericin-B-based regimens (preferred therapy), respectively. Both these drugs are linked to some serious adverse drug reactions (ADRs).

Plasma drug concentrations of 4-drug fixed-dose combination regimen and its efficacy for treatment of pulmonary tuberculosis under National Tuberculosis Elimination Programme: A prospective pilot study.

Background: The thrice weekly dosing regimen of DOTS has shown low rifampicin plasma concentrations as an independent risk factor for unfavourable tuberculosis (TB) outcome. With introduction of daily regimen using fixed dose combinations (FDC) under National Tuberculosis Elimination Programme (NTEP) the existence of suboptimal plasma levels of first-line antitubercular drugs and its clinical significance remain poorly understood.

Method: We included a prospective cohort of newly diagnosed pulmonary tuberculosis (PTB) patients receiving 4-FDC daily regimen under NTEP.

Time Elapsed from Onset of Pediatric Convulsive Status Epilepticus to Antiepileptic Administration-An Experience of Single Institute.

Data regarding time elapsed from the onset of pediatric convulsive status epilepticus (CSE) to antiepileptic (AED) administration remains scarce after the adoption of standard treatment-guidelines in Indian healthcare settings. A prospective observational analysis was performed on 52 children presenting to an urban, academic tertiary care teaching hospital diagnosed with CSE and evolving to refractory CSE (RCSE). Time frames of AED administration were compared to the adopted 'Status Epilepticus Management Protocol'.

Efficacy and tolerability of Melatonin vs Triclofos to achieve sleep for pediatric electroencephalography: A single blinded randomized controlled trial.

Purpose: To compare Melatonin with Triclofos for efficacy (proportion of successful EEG, need of augmentation, sleep onset latency (SOL), yield of discharges, duration of sleep, presence and grade of artifacts) and tolerability (adverse effect profile).

Methods: A randomized trial was performed (block randomization). All children were advised regarding sleep deprivation, EEG technician administered the drug.

Compliance with status epilepticus management protocol and effect on clinical outcomes in children with status epilepticus.

Background: Guidelines for the management of status epilepticus (SE) aid in rationalising the treatment for a better clinical outcome; however, published literature regarding the use of antiepileptics and compliance is limited, even after the availability of a consensus guideline.

Objectives: To evaluate the use of antiepileptics in children with SE and to analyse the effect of compliance with the Status Epilepticus Management Protocol on clinical outcomes.

Methods: An open-label non-randomised prospective observational study was conducted in children with SE aged 1 month to 14 years for 8 months in a tertiary care teaching hospital.

A simple and reliable analytical method for simultaneous quantification of first line antitubercular drugs in human plasma by LCMS/MS.

The present study describes the optimization of a simple and reliable method for the determination of four first line antitubercular drugs in human plasma. The studied analytes were isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) in fixed dose combination recommended to patients under the Revised National Tuberculosis Control Programme (RNTCP, India). The analytes were extracted from the human plasma (150 μL) using the single step liquid-liquid extraction approach and were analyzed by liquid chromatography (LC) coupled to tandem mass spectrometry (MS/MS).