RAPID-Pharma

An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance. A variety of sophisticated softwares, such as RAPID-Pharma (2) are now available to consolidate many functions required to manage the initiatives related to PAT. 

The applicant should provide justification for using the racemate. Where the interconversion of the enantiomers in vivo is more rapid than the distribution and elimination rates, then use of the racemate is justified. In cases where there is no such interconversion or it is slow, then differential pharmacological effects and fate of the enantiomers may be apparent. Use of the racemate may also be justified if any toxicity is associated with the pharmacological action and the therapeutic index is the same for both isomers. For preclinical assessment, pharmacodynamic, pharmacokinetic (using enantiospecific analytical methods) and appropriate toxicological studies of the individual enantiomers and the racemate will be needed. Clinical studies on human pharmacodynamics and tolerance, human pharmacokinetics and pharma-cotherapeutics will be required for the racemate and for the enantiomers as appropriate. 

The rate of biotech discoveries reaching the market needs to increase rapidly if the overall pharmaceutical pipeline is to grow. At the very least, however, the advent of the biotech Industry has greatly changed the face of pharmaceuticals worldwide, and may yet become - as has been touted for decades - the creative force that saves the pharma industry. 

Although no biopharmaceutical product delivered to the bloodstream via the pulmonary route has been approved to date, several companies continue to pursue active research and development programmes in the area. Amongst the leading product candidates is Exubera , an inhalable dry powder insulin formulation currently being evaluated by Pfizer and Aventis Pharma in Phase III clinical studies. The inhaled insulin is actually more rapidly absorbed than if administered subcutaneously and appears to achieve equivalent glycaemic control. While promising, final approval or otherwise of this product also depends upon additional safety studies which are currently under way. 

A limited competition and substantial unmet needs would describe a favorable working environment for business development. For custom manufacturing, neither is the case nowadays. The number of fine-chemical companies and the global GMP fine-chemical production capacity have increased more rapidly than demand since 2000. Also, the reluctance of pharma to outsource has increased (see Chapter 10). 

Rapidly expanding market—growth rate 10-15% per annum (pharma overall 9%). One-quarter of development drugs are biopharmaceuticals. 

Carbohydrate system, made from compendial ingredients Pharmaburst SPI Pharma , Inc., New Castle, U.S.A. High compactibility, high loading in small tablets, smooth mouth feel, rapid disintegration... 

Sila-chlorphenoxamine (LD50 = 411.6 mg/kg) exhibits only 25% of acute toxicity (white mice, i.p.) of its carbon analogue (LD50 = 108.6 mg/kg)112). This observation could easily be explained by a rapid hydrolytic detoxication of the sila-pharma-con. 

The truth is that despite the common education of scientists who are active in life sciences in academia and the Pharma industry, the values and work forms diverge very rapidly. And if academic scientists understood the industry a little bit better, things would be easier to comprehend and to accept. Increased understanding of the drug discovery process improves scientists efficiency in translating scientific results into therapies. 

Pfizer compound file Large pharma collection. Outsourced from ArQule, ChemRx, ChemBridge, and Tripos. > 2 X 10 U.S. 1 billion file enrichment program to expand diversity, dmg likeness, synthetic tractability, and rapid analog access. 15... 

Dissolution Rate While not directly related to solubility, the ability to rapidly reach the therapeutic concentration may be useful for fast-acting therapeutic agents, and may compensate for drugs that may have sufficient solubility but are metabolized/excreted too quickly to reach the desired concentration. An example of a method to enhance dissolution is the WOWTAB technology developed by Yamanouchi Pharma.13... 

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