Elemental impurities in pharmaceutical products adding fuel to the fire.

The pharmaceuticals may generate impurities at various stages of development, transportation and storage which make them risky to be administered. Thus, it is essential that these impurities must be detected and quantified. However, their presence as impurities in finished products is virtually unavoidable, even under GMP conditions. Control of elemental impurities in pharmaceutical materials is currently undergoing a transition from control based on concentrations in components of drug products to control based on permitted daily exposures in drug products. Within the pharmaceutical community, there is uncertainty regarding the impact of these changes on manufactures of drug products. This uncertainty is fueled due to lack of publicly available information on elemental impurity levels in common pharmaceutical excipients. The present compilation gives an account of updated information about elemental impurities and reviews the regulatory aspects for such impurities in active pharmaceutical ingredients/drug formulations. In addition, the aim of this article is to review and discuss the currently used quantitative analytical method, which is used for quality control of elemental impurities in pharmaceutical products.

Assessment of compliance level of ICH guidelines for organic volatile impurities in common ayurvedic hepatic formulations.

Background Herbal medicines have been used in the treatment of liver diseases for a long time. In recent years, the use of herbal medicines for protection from other strong antibiotics as well as drugs that can damage the liver during their metabolism in liver and for treatment of liver diseases has increased all over the world. It is important to mention that a number of organic solvents are used at different stages of extraction/formulation development for these traditional preparations in industries/pharmacies. In addition, some of these solvents possess established carcinogenic properties and may enter the formulation as residual solvents. Hence as per ICH guidelines it is mandatory to keep the level of these solvents up to permissible limits. There has been a lot of hue and cry that ayurvedic formulations available in the market are not properly standardized for their quality due to lack of stringent regulations and standards from regulatory authorities. Therefore the aim of present work was to assess the compliance of ICH guidelines for level of organic volatile impurities in common marketed ayurvedic hepatic formulations. Methods In this study, 25 ayurvedic herbal formulations available as OTC product have been assessed for presence of residual solvents using gas chromatography with flame ionization detector. Results This study on 25 fast moving hepatic formulations in the market reflects that no residual solvents were detected in any of the formulations however if present were within prescribed permissible limits of ICH guidelines. The data was also subjected to statistical analysis (F-test and t-test at 95% confidence level). Conclusions Results indicate the safety of these hepatic formulations with respect to residual solvents. In addition presents a simple, linear, specific, accurate, precise and rugged gas chromatographic method for estimation of residual solvents.

Clinico-Hematological Features and Management Outcome in Neonatal Malaria: A Nine Years Analysis from North India.

BACKGROUND: Malaria is an important cause of death and illness in children worldwide. Most cases of neonatal malaria are misdiagnosed because of lack of specific symptoms and general lack of awareness. Nothing much is known in literature about the hematological changes during malaria infection and outcome of disease in neonates. Neonatal malaria is an underdiagnosed entity. So this hospital based observational study aims to assess diagnostic features of neonatal malaria. METHODS: From August 2004 to August 2013, information of all slide positive for malaria cases aged 0 to 28 days admitted to our pediatric hospital was collected and analysed. RESULTS: 28 slide positive cases of neonatal malaria were studied, four out of them were congenital malaria. Fever (93%) was the most common symptom followed by pallor (72%) and diarrhoea (50%). We also found respiratory distress in four (14%) cases. Apart from anemia and atypical lymphocytosis, We also found thrombocytopenia and low hematocrit, MCV and RBC count. Two cases with bleeding manifestations expired during course of treatment. DISCUSSION: Malaria in the first few months of life can simulate transplacentally or postnatally acquired infection such as TORCH, syphilis, neonatal hepatitis and septicemia all having an important symptom complex of fever jaundice, hepatosplenomegaly and anemia. Although in our cases clinical presentation has been similar to septicemia but culture of blood, CSF and urine were sterile. The dilemma of distinguishing neonatal malaria alone versus neonatal sepsis or both existing does not seem to be easily resolved by the use of clinical features alone. The laboratory diagnosis of parasitemia in neonates require special attention in Giemsa staining as well as the technical skill involved in malaria microscopy because parasite densities are low. So high degree of suspicion is needed to diagnose malaria in newborns presenting with fever and anemia.

Congenital malaria due to chloroquine-resistant Plasmodium vivax: a case report.

The clinical manifestation of malaria in neonates and young infants is non-specific and differs from that of adults and older children. So a high index of suspicion is needed to diagnose malaria in early infancy. Chloroquine is the first-line treatment for Plasmodium vivax malaria in most parts of the world. This case report details a case of chloroquine-resistant malaria due to P. vivax by transplacental transmission from mother with mixed infection of P. falciparum and P. vivax in a 26-day-old young infant who presented with moderate grade fever and reviews the literature of malaria in infantile and neonatal age groups. And we concluded that high suspicion of malaria is needed to diagnose congenital malaria. Primigravida women with placental malaria pose high risk for congenital infection in baby and emerging chloroquine-resistant P. vivax in congenital malaria.