The presence of a degradation product of alprazolam tablets that emerged throughout a short-stability assay has been determined and properly characterized. For this purpose an efficient methodology has been successfully applied, including SPE and HPLC methods for isolation and purification, respectively. LC/MS, MS/MS, 1H NMR, 13C NMR, UV and IR have been employed for structural elucidation conf...

www.pharmtech.com evelopment and validation of bioanalytical methods for pharmaceutical product analysis are common rate-limiting steps in biopharmaceutical product development. A rational, strategic approach to developing robust, automated, validated bioanalytical methods can reduce slowdowns and bottlenecks in drug development and contribute to synergistic, consistent, longterm performance. T...

pray-dried (SD) lactose was introduced to the pharmaceutical market in the 1960s as an excipient that enables direct compression of formulations in a simple manufacturing process (1). To this day, lactose remains one of the most popular excipients for active pharmaceutical ingredients (APIs) whose dose makes them suitable for direct compression. Several manufacturers make and sell SD lactose, a...

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Not surprisingly, the wide range of effective medicinal agents available today is one of the greatest scientific achievements. Regardless of the advancements in effectiveness and safety of the medicines embedded in dosage forms, the pharmaceutical concept of the latter is growing to be ever more eminent (Adibkia et al., 2011). Following on from recent advancements, in a time of increased consid...

Hydrochlorothiazide is a diuretic used to treat hypertension that belongs to class IV of the Biopharmaceutics Classification System. The drug was evaluated by quality control, thermal characterization tests, and pharmaceutical formulation compatibility studies. It was concluded that the generic drug, Lab 2, was not a pharmaceutical equivalent. The compounded drugs, Lab 5 and Lab 6, produced uns...

OBJECTIVES This study aims to examine the impact of external price referencing (EPR) on on-patent medicine prices, adjusting for other factors that may affect price levels such as sales volume, exchange rates, gross domestic product (GDP) per capita, total pharmaceutical expenditure (TPE), and size of the pharmaceutical industry. METHODS Price data of 14 on-patent products, in 14 European cou...

The price effects of the Swedish pharmaceutical substitution reform are analyzed using data for a panel of all pharmaceutical product sold in Sweden in 1997-2007. The price reduction due to the reform was estimated to average 10% and was found to be significantly larger for brand-name pharmaceuticals than for generics. The results also imply that the reform amplified the effect that generic ent...

This paper sheds light on the product cycle and neotechnology theories of trade in the context of generic pharmaceuticals. The paper studies the export performance of 177 Indian pharmaceutical firms for the post-liberalization period 1991-2004. The results indicate that technology proxied by foreign patent rights has a positive impact on exports. This suggests that developing countries with inn...