Pharmaceutical Innovation

In the pharmaceutical industry, costs attributed to manufacturing are a major part of a company’s total expenses. In this paper, trends in various expense and income categories of pharmaceutical companies have been analyzed with particular emphasis on manufacturing costs to gain an insight into their relationships and how they may differ among types of pharmaceutical companies such as brand name, generics, and biotechs. The study includes data published in the annual reports of leading pharmaceutical companies from 1994 to 2005. Twenty-two pharmaceutical companies were selected based on the annual revenues. The set was further divided into three groups: brand names, generics, and biotechs. The analysis shows that, between 1994 and 2005, manufacturing costs (as a percentage of total sales) are different for the three groups of companies listed above. Additionally, each group of companies differs in how savings are leveraged strategically. The data on brand-name pharmaceutical companies also indicate that there is a strong correlation between the reduction of the cost of goods sold (COGS) and the increase in R&D expenditure. This suggests the validity of Vernon’s theory that for brand-name companies, a reduction in COGS will likely have a positive impact on investments in R&D, presumably resulting in much needed innovations and future health benefits for the society.

In the pharmaceutical industry, systems for improving operational effectiveness and efficiency are becoming more and more popular. In this paper, developments in the industry’s improvements in operational effectiveness and efficiency have been analyzed. A holistic model is presented which builds the basis for the presented study results. The study includes data gathered from pharmaceutical production sites in surveys in 2004 and 2009. The analysis is divided according to the four sub-systems: Total Productive Maintenance, Total Quality Management, Just-in-Time, and the Management System. For each sub-system, key performance indicators and associated elements (practices and instruments) from 2004 to 2009 are investigated. The data indicates that the industry did make continuous steps towards “Excellence in Operations” between 2004 and 2009. Pharmaceutical companies took control over their former low asset utilization and managed to improve the efficiency of their quality systems; however, they are still far away from having any kind of “continuous flow”, smooth production scheduling or make-to-order manufacturing. It can be said that most of the companies are still working on the effectiveness side rather than focusing on the efficiency side.

It is not commonly understood that one of the largest components of the overall cost of bringing a new drug to the market is the cost of product development. Cost of product development can account for as much as 30% to 35% of the total cost of bringing a new drug to the market. Quality of product development also affects time to market and the quality of manufacturing and therefore cost of manufacturing. Investment in basic research in the science of product development and manufacturing will pay for itself through savings achievable in the cost of new drug development and in the cost of goods sold (COGS) of pharmaceutical products. In order for us to arrive at good estimates of the saving potential, one first needs to have credible estimates of the cost of new drug development and the overall COGS for pharmaceutical products.

A laser-induced breakdown spectroscopy-based analytical methodology is developed to study tablet coating variability in pharmaceutical tablets. The method quantifies the amount of coating on a tablet by assigning an average coating thickness score to it. When tested using samples with different amounts of coating, the coating thickness scores showed direct correlation to the weight gain of the tablet, hence validating the analytical method. The relative significance of the processing parameters and the components of variability were computed using statistical techniques. The sampling frequency of laser shots was found to have no significant effect. The effect of the position of the laser pulse on the tablet surface was found to be significant; however, it was determined that this effect was due to the tablet curvature, which resulted in the laser optical path to intersect the coating diagonally. The variability between batches (lots) manufactured under the same processing conditions was not significant. The largest avoidable source of variability was the tablet-to-tablet component, possibly indicating the inadequate mixing performance of the coating device.

Abstract Understanding mass transfer effects (eg, condensation and absorption) of hydrogen peroxide is essential for clean room decontamination technology. For example, absorption of hydrogen peroxide in polymers often causes unwanted effects in the final aeration ...

In this study, a quality by design approach was applied to the design and scale-up of a batch mixing process. Mixtures of acetaminophen and lactose were sampled at different mixing times using a groove sampler. Samples were subsequently analyzed using NIR reflection spectroscopy. The effects of four processing parameters on the empirical mixing rate in a bin blender were examined. Blender rotation rate (two levels), powder fill level (two levels), powder cohesion (two levels), and blender size (three levels) represent the four parameters studied. Blender geometry and blender loading method were treated as constant parameters. Statistical analysis was used to assess the impact each parameter had on the mixing rate. Blender size (p = 0.02), powder cohesion (p = 0.05), and rotation rate (p = 0.07) all significantly affected the mixing rate. The least significant parameter was the vessel fill level (p = 0.18), indicating mixing performance is not strongly affected by fill level, given the range studied.

To understand the communication of new pharmaceutical drugs, promotion strategy could be divided in three main pathways : public relation to physicians, targeted communication in health care (as patients association) and advertisement to consumers.

In this study, a quality by design approach was applied to the design and scale-up of a batch mixing process. Mixtures of acetaminophen and lactose were sampled at different mixing times using a groove sampler. Samples were subsequently analyzed using NIR reflection spectroscopy. The effects of four processing parameters on the empirical mixing rate in a bin blender were examined. Blender rotation rate (two levels), powder fill level (two levels), powder cohesion (two levels), and blender size (three levels) represent the four parameters studied. Blender geometry and blender loading method were treated as constant parameters. Statistical analysis was used to assess the impact each parameter had on the mixing rate. Blender size (p = 0.02), powder cohesion (p = 0.05), and rotation rate (p = 0.07) all significantly affected the mixing rate. The least significant parameter was the vessel fill level (p = 0.18), indicating mixing performance is not strongly affected by fill level, given the range studied.

It is not commonly understood that one of the largest components of the overall cost of bringing a new drug to the market is the cost of product development. Cost of product development can account for as much as 30% to 35% of the total cost of bringing a new drug to the market. Quality of product development also affects time to market and the quality of manufacturing and therefore cost of manufacturing. Investment in basic research in the science of product development and manufacturing will pay for itself through savings achievable in the cost of new drug development and in the cost of goods sold (COGS) of pharmaceutical products. In order for us to arrive at good estimates of the saving potential, one first needs to have credible estimates of the cost of new drug development and the overall COGS for pharmaceutical products.

Raman spectroscopy was used to design and monitor a lysozyme protein batch crystallization process in a lab scale study to facilitate the design of a pharmaceutical protein manufacturing process. A D-optimal design that consisted of 18 experiments was performed to elucidate the effect of temperature, concentration of the precipitating agent, time of crystallization, and possible interactions between these three factors on the Raman scattering changes. A polynomial mathematical model was calculated relating the scattering of the lysozyme solutions measured at individual Raman shifts to the significant factors obtained in the previous crystallization experiment. The 2,940-cm−1 band provided the highest correlation values indicative of small prediction errors and good predictive ability for the crystallization model. Raman scattering signals obtained during the experiments were used as input to obtain a response surface for the factors studied and elucidate the relationship between the crystallization process conditions and the crystals obtained. The main factors affecting the crystallization process were the sodium chloride concentration and temperature.

Ezetimibe (EZE), a water insoluble drug, depicts variable bioavailability. The objective of the present investigation was to improve dissolution characteristics of EZE, which might offer improved bioavailability. The solid dispersions were prepared using poloxamer 407 (L 127) and polyvinyl pyrrolidone by melt and solvent method, respectively. Phase solubility studies indicated linear relationship between drug solubility and carrier concentration. In vitro