Pharmaceutical product development figure

While amorphous water as such may not figure in freeze-drying technology, the opposite is true for many of the other components that make up the finished pharmaceutical preparation. In fact, the realisation of the importance of amorphism in pharmaceutical product development has led to the birth of a new scientific discipline pharmaceutical materials science. Successful freeze-drying is firmly based on the same... 

With over 1300 bibliographic citation, figures, tables, and equations. Physical Characterization of Pharmaceutical Solids is an incomparable resource for industrial and product development pharmacists and pharmaceutical scientist spectrosoopials physical, surface, and colloid chemists and upper-level undergraduate and graduate students in these disciplines. 

The evaporation of citrus juices at temperatures up to 328 K, or of pharmaceutical products at even lower temperatures, has led to the development of an evaporator incorporating a heat-pump cycle using a separate working fluid. The use of the heat pump cycle, with ammonia as the working fluid is shown in Figure 14.13. In this arrangement, ammonia... 

Chiral sulfoxides have emerged as versatile building blocks and chiral auxiliaries in the asymmetric synthesis of pharmaceutical products. The asymmetric oxidation of prochiral sulfides with chiral metal complexes has become one of the most effective routes to obtain these chiral sulfoxides.We have recently developed a new heterogeneous catalytic system (WO3-30% H2O2) which efficiently catalyzes both the asymmetric oxidation of a variety of thioethers (1) and the kinetic resolution of racemic sulfoxides (3), when used in the presence of cinchona alkaloids such as hydroquinidine 2,5-diphenyl-4,6-pyrimidinediyl diether [(DHQD)2-PYR], Optically active sulfoxides (2) are produced in high yields and with good enantioselectivities (Figure 9.3). ... 

The path which must be followed in the development of a material from lab bench to consumer is long, torturous and expensive. As stated before it takes about twelve years and over 200 million to bring an entity to the point of being marketed. Part of that timeline is understandable considering the laws governing safety and efficacy. Outlined in Figure 1 are the major steps on the way to a pharmaceutical product. 

The pilot-production phase may be carried out either as a shared responsibility between the development laboratories and its appropriate manufacturing counterpart or as a process demonstration by a separate, designated pilot-plant or process-development function. The two organization piloting options are presented separately in Figure 1. The creation of a separate pilot-plant or process-development unit has been favored in recent years because it is ideally suited to carry out process scale-up and/or validation assignments in a timely manner. On the other hand, the joint pilot-operation option provides direct communication between the development laboratory and pharmaceutical production. 

Virtual companies are based on the premise that core competencies within chemical and pharmaceutical companies he in discovery research and not in development. There are many contract research and manufacturing companies who do have the necessary skills for the product development process and the job of the virtual company is to access these skills and then utilise them in an efficient way. The hub in which such a virtual pharmaceutical company operates is illustrated in Figure B9. 

Comparable figures with reasonable validity for animal health products are not available. Veterinary product development cost are definitely lower, but the revenues are also much lower. Due to rising registration demands, influenced by both the pharmaceutical and the agricultural sector, veterinary product development cost follow the same trend as human health products. 

Analysing the sales data by species (Figure 2) reveals that the cattle and companion animal sectors account for nearly 75% of pharmaceutical sales. Of these two, companion animal sales are growing fast. The limited commercial opportunities in the poultry and sheep markets will strongly influence future product development for these sectors. 

Figure 74 shows another example of evaluation in 254-nm UV light from the area of pharmaceutical process development. Here, starting materials, in-process control, mother Uquor, wash water and the end product are monitored by TLC. With in-process control, TLC gives rapid and reliable results with an accuracy that is quite adequate for the chemical production process. 

The product mandate for this project required that the active pharmaceutical ingredient (API) needed to be a single isomer. Methodology reported in the literature, for the general class of which cefovecin is a member, provided an epimeric diastereoisomer mixture of 3 (which became cefovecin sodium) and 4 (UK-287076 sodium). Both compounds are potent, but the (S) absolute configuration at the tetrahydrofuran (THF) C-2 center was selected for commercial development (Figure 11.1). 

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