Measurements: the liquids in the pharmaceutical manufacturing as a PAT tool of refractive index
Health is crucial to the social and economic assets, while the development of effective drugs is closely related to modern human beings and the development of the society.We will be able to cure, prevent and respond to more than ever before.However, in the face of emerging medical conditions and diseases, pharmaceutical researchers are still unswervingly, devoted to the development of new drugs.
Drugs made up of two parts:Active pharmaceutical ingredients(API) (they are the main components of the disease) and the corresponding chemical inert materials (they are drug delivery to the medium of human or animal body).Pharmaceutical research and development and a focus of attention in product engineering is to explore new API, so that the development of innovative drugs, and the possible development of personalized medicine in the future.
The complexity of the pharmaceutical
The development of new drugs is a high risk, high cost and long process.For reference only, according to Taft drug development research center, estimates, a drug on the market cost more than $2 billion;And according to the journal of pharmaceutical sciences, every 10 drugs clinical stage, finally only one can be put on the market.In addition, the development of a drug will cost about 10 to 15 years of time, and in drugs available for sale, may only 10 years to recover the high cost.In order to balance the cost of new drug development process, many pharmaceutical companies are manufacturing generic drugs, pay attention to the patent expired products or just a little modification on the patent.
Manufacturing company of the other challenge is related to drug manufacturing strict laws and regulations, and the resulting increase in operating costs.Required by the drug manufacturing system to ensure that the final product meet predetermined specifications.The traditional methods by separate step intermittent production of drugs, its characteristic is long storage time, and each stage will be offline after quality inspection.Batch production may even require that the intermediate product from a facility transfer to another facility, in order to perform the follow-up production steps.This method ensures the compliance and the high quality products, but also led to several drawbacks, including causing major bottleneck in the process and low efficiency, prolong the overall processing time, and greatly increased the cost of production.
These will affect the pharmaceutical company's financial performance, and finally the product cost to patients and society.At the same time, reduce drugs price pressure is also growing, as a result, pharmaceutical companies are looking for new ways of working to relieve the pressure.The industry's many companies have invested heavily in research and development, strive to explore technical solutions, which can shorten the time required for drug development, improve the benefit of the cost of the process.
Realizing continuous production
The mission of the United States and the food and drug administration (FDA) is to support the innovation of the pharmaceutical industry and modernization, in order to fulfill its commitment to protect and promote public health.On this basis, the FDA analysis technique (PAT) launched a process plan and issued guidance framework, in order to support the use of measurement and analysis tools in time, thus providing used to get enough information to deepen understanding of the process approach.The PAT strategy also is in the pharmaceutical and biopharmaceutical manufacturing shift from intermittent production to the continuity of production to point the right direction.
In order to realize the continuous production, need to fully understand the process to create a control strategy, in order to minimize the incoming changes.Must define key quality characteristics and the impact on these features will become due, so as to set the acceptable deviation tolerance and definition of right PAT tool for monitoring.From the early stages of drug discovery is executed real-time measurement, helps to collect a large amount of data needed for acquiring scientific knowledge, which can reduce the risk of associated with drug development, and is designed to provide stable quality products and reliable technology.
As a PAT tool of refractive index
PAT is not only involved the use of traditional process control sensors (such as pressure, temperature and pH sensors), also involves the use of new technology of on-line analyser.Is a new technology of refractive index, which is a direct measurement method based on light refraction principle of liquid concentration.For decades, the refractive index measurement has been adopted by other industries (for example, in pulping and papermaking industry, is used to measure the solid content of black liquor;When in the sugar industry, for sugarSugar measurement), but in PAT plan to start with, in the field of pharmaceutical remains to be development and utilization of this technology.
Refractive index of a big advantage is that can be online through online refractometer measurement, and strong support system to continuous production in current medicine industry trends.On-line refractometer is mainly used for measuring, monitoring and control of liquid concentration.These measurements are also important in the manufacturing process, because of many process steps are performed in liquid medium.But online refractometer in more unconventional applications also puts glorious greatly;In these applications, the refractive index measurement provide many opportunities for drug development and production.
Refractive index measurement for product identification proved to be a precise, even more than density and electrical conductivity measurement is reliable, because each chemicals have different refractive index values.This particular characteristics show that the refractive index as the potential of the PAT analysis tools in other applications, such as different solvents or between the interface between the solvent and product testing, and the refractive index value of mixture reaction monitoring of changes with the reactants into products.Online for the refractive index measurement technology has opened a window, and provides the traditional off-line test lab without access to information.
Understand the refractive index on the basis of process has considerable potential
A large pharmaceutical company in Europe was conducted in the several years ago a study to determine the single refractive index in the API measuring 11 potential applications.Scientists concluded that the online real-time measuring the refractive index, specific to the process map, it can be used as a lean production development and process scale of reference, and ultimately to sharply reduce drug development work and time.
The advantage of the refractive index measurement is not confined to API production.Refractive index measurement has been widely used in biomedical technology processing, and refractometer now used to monitor a variety of applications, such as fermentation, cell culture, vaccine, protein, the plasma and enzyme production.
Refractive index is becoming understanding process innovative methods.In addition, it is in the cost-effective processes needed for the stability of the process control design process is also useful in the chemical and dynamic interaction, it can reduce the product difference.Shown above is just a few examples, but there is no doubt that opportunities will be more and more, because drug companies begin to focus on the future development, and embrace the potential of the refractive index measurement in pharmaceutical process.
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