Pharmaceutical Quality Control of phenobarbital

Introduction

Pharmaceutical quality control of phenobarbital is crucial for ensuring its efficacy and safety, particularly in clinical settings where it is used to manage seizures. This synthesis examines the current research on the quality control measures and methodologies for phenobarbital, focusing on its therapeutic monitoring, detection methods, and efficacy in treatment.

Key Insights

Therapeutic Monitoring and Efficacy:
- Sequentially administered IV phenobarbital effectively controls seizures in both term and preterm newborns, with a therapeutic effect that plateaus at a serum concentration of 40 micrograms/mL. Higher concentrations may require a second antiepileptic agent for unresponsive patients.
- Proficiency testing has significantly improved the routine monitoring of phenobarbital concentrations in laboratories, enhancing the accuracy and reliability of therapeutic drug monitoring.
Detection Methods:
- A method using liquid phase microextraction (LPME) and gas chromatography-mass spectrometry (GC-MS) has been developed for the identification and quantification of phenobarbital in hair samples. This method is highly sensitive and precise, with a limit of detection (LOD) of 0.1 ng/mg and a limit of quantification (LOQ) of 0.25 ng/mg.

Conclusion

The research highlights the importance of precise therapeutic monitoring and advanced detection methods in the quality control of phenobarbital. Effective seizure control in newborns is achievable with carefully monitored serum concentrations, and proficiency testing has improved laboratory performance in drug assays. Additionally, innovative detection techniques like LPME and GC-MS offer reliable and sensitive methods for phenobarbital quantification, ensuring accurate monitoring and compliance in clinical treatments.

Pharmaceutical Quality Control of phenobarbital

Summary

Introduction

Key Insights

Conclusion

Sources and full results

Rapid sequential phenobarbital treatment of neonatal seizures.

Sequential intravenous phenobarbital effectively controls seizures in both term and preterm newborns (77%), with optimal therapeutic effect at a serum concentration of 40 micrograms/mL.

Proficiency Testing in Determinations of Antiepileptic Drugs

Antiepileptic drug monitoring in laboratories, with 88% performing satisfactory phenytoln assays and significant improvement in phenobarbital, carbamazeplne, and ethosuximide assays.

Determination of phenobarbital in hair matrix by liquid phase microextraction (LPME) and gas chromatography-mass spectrometry (GC-MS).

The LPME and GC-MS method effectively detects and quantifies phenobarbital in hair samples, making it suitable for various purposes.

Phenobarbital dosage for control of neonatal seizures

The initial phenobarbital dose for neonatal seizures should be 16 to 23 mg per kilogram, with blood levels proportional to dosage per kilogram and seizure control requiring blood concentrations above 16.9 pg per milliliter.

Quantitative analysis of phenobarbital in biological fluids: Analyte enrichment by an electrically-assisted microextraction technique

Electrically-assisted microextraction technique effectively enriches phenobarbital in biological fluids, providing a reliable method for quantitative analysis of this drug.

Availability and Costs of Antiepileptic Drugs and Quality of Phenobarbital in Vientiane Municipality, Lao PDR

Phenobarbital availability in Lao PDR is limited, but the quality of available phenobarbital is satisfactory, despite high drug costs for people with epilepsy.

Automation of diphenylhydantoin and phenobarbital measurements using the ABA-100 with emit reagents.

The automated EMIT-AED procedure for diphenylhydantoin and phenobarbital measurements on the ABA-100 provides a two-thirds savings in reagents, with less than 8% coefficient of variation across the concentration range tested.

Quality Control of Drug Assays

A suitable intralaboratory quality control scheme using serum pools at 3 concentrations can maximize the benefits of participating in external quality assessment schemes for drug assays.

A Clinical Trial Assessing the Efficacy and Safety of a New Injectable Formula of Sodium Phenobarbital Containing No Additives for the Treatment of Neonatal Seizures

NOBELBAR® is an effective and safe new injectable phenobarbital formula for neonatal seizures, with plasma drug concentrations maintained within the therapeutic range.

High-dose phenobarbital therapy in term newborn infants with severe perinatal asphyxia: a randomized, prospective study with three-year follow-up.

Phenobarbital at 40 mg/kg intravenously over 1 hour in term, severely asphyxiated newborn infants is safe and significantly reduces seizures and improves neurologic outcome at 3 years of age.

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