Tablet manufacture active ingredients

Compressed Tablets. This popular type of dosage form offers convenience, stabiUty, accuracy and precision, and good bioavadabihty of active ingredients. After the best formulation has been estabflshed, compressed tablets can be manufactured at high rates of speed on advanced equipment. Tablets can be made to achieve rapid dmg release or to produce delayed, repeat, or prolonged therapeutic action (Controlled release technology, pharmaceutical). ... 

Selection of the most suitable chemical form of the active principle for a tablet, while not strictly within our terms of reference here, must be considered. For example, some chloramphenicol esters produce little clinical response [13], There is also a significant difference in the bioavailability of anhydrous and hydrated forms of ampicillin [14], Furthermore, different polymorphic forms, and even crystal habits, may have a pronounced influence on the bioavailability of some drugs due to the different dissolution rates they exhibit. Such changes can also give rise to manufacturing problems. Polymorphism is, of course, not restricted to active ingredients, as shown, for example, in an evaluation of the tableting characteristics of five forms or sorbitol [15]. 

If data are produced which are not fit for their intended purpose, there is both the financial penalty and the possible legal penalty to be considered. For instance, if a manufacturer of pharmaceuticals produces a pharmaceutical tablet containing the incorrect amount of active ingredient, the consequences could be disastrous, causing, in the worst circumstances, loss of life. 

As stated in Chapter 1, a laboratory analysis is almost always meant to give a result that is indicative of a concentration in a large system. For example, a farmer wants an analysis result to represent fertilizer needs in an entire 40-acre field. A pharmaceutical manufacturer wants an analysis result to represent the concentration of an active ingredient in each tablet in 80 cases of its product, each case containing three dozen bottles of 100 tablets each. A governmental environmental control agency wants a single laboratory analysis to represent the concentration of a toxic chemical in every cubic inch of soil within 5 miles of a hazardous waste dump site. 

The concentrations of the active ingredients as reported from the manufacturer s label are 37% acetaminophen, 37% aspirin, and 10 % caffeine. The remainder of the tablet mass represents the excipient (binder, disintegrant, and lubricant) materials. Pure acetaminophen, aspirin and caffeine samples are obtained in either tablet form or powder compact and used to obtain reference specua of pure components. 

Ensuring homogeneous mixing of the components (APIs and excipients) of a pharmaceutical preparation is a crucial prerequisite for obtaining proper solid dosages (tablets and capsules). Pharmaceutical manufacturers invest much time, labor and material resources in this process. Blending is intended to ensure uniform distribution of all components in the end products,so that each dose wiU contain the correct amount of the active ingredient. 

Manufacturing materials can and often are a source of contamination. Various materials, such as filtering aids and charcoal, are used especially in chemical synthesis of active ingredients. These materials can carry over to the finishedproduct and can represent a significant source of contamination. For many years, companies would occasionally see tiny black spots on white tablets. Often those black spots could be traced using very sensitive analytical techniques back to the active ingredient and positively identified... 

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