The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient...

BACKGROUND Online drug information compendia (ODIC) are valuable tools that health care professionals (HCPs) and consumers use to educate themselves on pharmaceutical products. Research suggests that these resources, although informative and easily accessible, may contain misinformation, posing risk for product misuse and patient harm. OBJECTIVE Evaluate drug summaries within ODIC for accurac...

Recently sustained release dosage forms has become standards in the modern pharmaceutical design and intensive research has been undertaken in achieving much better drug product effectiveness. The sustained release product will optimize therapeutic effect and safety of a drug at the same time improving patient convenience and compliance. Prior to the development of these major dosage forms, it ...

Thorough knowledge and control of impurities is an expectation for the registration of pharmaceuticals. Actual and potential impurity investigations are phased during drug development to acquire the appropriate information necessary to ensure drug safety from the standpoint of patient exposure to impurities. Regulatory expectations and common practices for the timing of impurity investigations ...

High-throughput biology has contributed a wealth of data on chemicals, including natural products (NPs). Recently, attention was drawn to certain, predominantly synthetic, compounds that are responsible for disproportionate percentages of hits but are false actives. Spurious bioassay interference led to their designation as pan-assay interference compounds (PAINS). NPs lack comparable scrutiny,...

Although traditionally natural products have played an important role in drug discovery, in the past few years most Big Pharma companies have either terminated or considerably scaled down their natural product operations. This is despite a significant number of natural product-derived drugs being ranked in the top 35 worldwide selling ethical drugs in 2000, 2001, and 2002. There were 15 new nat...

Probiotics are living microorganisms that, when consumed, have the potential to confer a beneficial health effect. Unfortunately for purveyors of probiotic products, the system of regulation delineated in the Food, Drug, and Cosmetic Act is anything but "one size fits all." How a probiotic product is used or is intended to be used will govern the regulatory category or categories that the US Fo...

To overcome the well-established drawbacks of conventional organic solvents (toxicity, non-biodegradability, flammability, accumulation in the atmosphere) remarkable research efforts have been recently devoted to the replacement of traditional organic reaction media by the so-called Green Solvents. In this sense, the choice of a safe, non-toxic, biorenewable and cheap reaction media is a crucia...

1 Department of Pharmacognosy, Faculty of Pharmacy and Biochemistry, University of Buenos Aires, 1113 Buenos Aires, Argentina 2Unitat de Farmacologia i Farmacognòsia, Facultat de Farmàcia, Universitat de Barcelona, 08028 Barcelona, Spain 3 Universidade do Vale do Itajaı́, Núcleo De Investigações Quı́mico-Farmacêuticas (NIQFAR), CCS, Brazil 4Department of Chemistry, University of Alabama in Huntsv...

The transfer of information between the drug product development and manufacturing organizations is fundamental to drug product commercialization. This information is used to characterize the productprocess interaction and ensure manufacturability, and to set operating ranges at fill/finish sites. Amgen has successfully commercialized drug products for years, yet opportunities exist to improve ...