Since the introduction of aspirin in 1899, and more particularly since the advent of antibiotic "wonder drugs" in the 1940s, society has come to rely on the widespread availability of therapeutic drugs at reasonable prices. It was a tremendous challenge to bring penicillin to market and could not have been done without the simultaneous development of both product and process under the inspired leadership of Howard Florey over a 10 year period starting in the early 1930s, much has changed in drug development, but the timelines remain long, and the obstacles to success remain high.
For drugs delivered to patients in crystalline form, the physical properties of the pharmaceutical intermediates or active pharmaceutical ingredient (API) including crystal form, size and shape have the potential to impact bioperformance, particularly for low-solubility compounds, where the rate-limiting-step in drug uptake may be the dissolution of the API in the gut. These physical properties of the API are often controlled in the final API crystallization step. Because most small molecule drugs (.90%) are delivered in crystalline form, and currently about 90% of new API's being pursued are classified as having low solubility in water, a well-controlled crystallization of the API is often a vitally important operation in pharmaceutical manufacturing.
Moreover, it is a difficult operation because of uncertainty in the crystal forms that will appear, and because of the many challenges associated with scaling-up crystallizations from laboratory to manufacturing scale. Although great emphasis is placed on the therapeutic and chemical discovery aspects of new APIs, it must be emphasized that the successful entities will eventually need to be manufactured. Most companies seek to minimize manufacturing costs and maximize process portability by applying the simplest manufacturing process capable of producing their drugproduct with desired attributes. Because only 10% of the compounds in development survive the efficacy and safety hurdles in the clinic and become marketed drugs, there is also great value in minimizing R&D costs (including clinical trials), which are estimated to be about $1 billion per launch, with a remaining life protected on-patent of typically only 6–10 years.
Another application for intermediates is in Pesticide. Pesticide intermediates are used to manufacture agriculture and other industrial products. These are used in the synthesis of the active ingredient or in the production of pesticide products. Pesticides and pesticides intermediates are raw materials used for the manufacture of technical grade of active ingredient by chemical reactions or purification. It can be obtained from other sources or can be manufactured on similar site as that of the final pesticide product. Environmental Protection Agency (EPA) requires information regarding any environmental or toxic qualities of pesticide that may be harmful and these pesticides are thoroughly tested for effectiveness. These intermediate substances are also subject to regulation under the toxic substances control act (TSCA).
These are the vital substances used for the production of active ingredient used in the formulation of pesticide. Thus, extensive demand for agricultural products drives the global pesticide intermediate market. Further, increase in global population and food demand boosts the market growth. However, stringent regulations associated with the production and usage of pesticide intermediate restrain the market growth during the forecast period. Moreover, manufacturers of pesticide intermediate products emphasize more on the production of organic products to ensure its friendliness with crops, humans, and the environment.
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