Active principle ingredient

Another example of the gain in resolution quality from the complementary information among different images is seen in the analysis of a series of pills with different percentages of excipient and active principle ingredient (API) of 0, 20, 40, 60 and 80% [65]. The different proportions of compounds in the pills ensure a good recovery of the pure spectra, and also of the distribution maps of all compounds, even when one of them is present in only a small proportion. It should... 

The previously discussed experimental data have recently been extended to pharmaceutical formulations with organic co-solvent - active principle ingredient (API) + water + fert-butyl alcohol (TEA) - by Daoussi et al. (2009) who used an automatic microbalance placed inside the product chamber to determine the sublimation kinetics. The same shapes of sublimation kinetics curves were observed. 

API active principle ingredient BSA bovine serum albumin DSC differential scanning microscopy FTIR Fourier transform infra-red IR infra-red... 

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]. 

Mottling is defined as an uneven coloration of tablets or nonuniformity of color over the tablet surface. One of the possible causes of mottling may be the difference in color between the active principle and excipients, but sometimes it may be the result of degradation of the active ingredient which imparts spot zones over the surface of the tablets. 

The International Conference on Harmonization (ICH), representing FDA, EU, and Japanese regulatory authorities, produced guidance in 2000 on the manufacmre of active pharmaceutical ingredients (APIs) that included computer validation expectations. Not too surprisingly, essential principles were unchanged compared to computer vahdation for fiitished dmg products. The key topics covered were ... 

Gradual diffusion of an active ingredient through a permeable or soluble coating. Pelleted products such as fertilizers and medicinals are often covered with a layer of a substance that permits slow and uniform escape of the active principle. Sulfur is used to coat controlled-release fertilizers gelatin and similar materials serve the same purpose in pharmaceuticals. 

Guideline on General Principles of Process Validation, May 1987 Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients, March 1998 (Draft)... 

In its Notice on "Studies of Prolonged-Action Forms in Man" dated 1987 09) the EC introduces the term of active principle presented in "pharmaceutical forms." This concept may apply to prodrugs, but only indirectly because the substance contained as such in the pharmaceutical form is not exactly the active principle. Similarly, in the council recommendation of 1987 on Investigation on Bioavailability (20), the terms active drug ingredient or therapeutic moiety of a drug are used to define the chemical species that should be measured. Finally, in a newer definition of bioavailability, the term active substance is used (21). 

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