Marketing drug products

It is expected that the potency, purity, and quality of the drug substance be maintained over time. The chemical, physical, enzymatic, and microbiological quality, as appropriate, should be retained through to the claimed life of the drug substance and also through the life of the formulated drug substance, that is, the marketed drug product. 

Marketed Drug Product Intendedfor Room Temperature Storage Conditions The... 

Marketed Drug Product Intended for Room Temperature Storage Conditions ... 

Marketed Drug Product Packaged in Semipermeable Containers ... 

Table 2 Preclinical Studies for Recent Excipients Under Development or Used in Marketed Drug Products... 

Beyond lead optimization, the cost savings for final marketed drug production may be dramatic if the final compound is accessible via MCR methodology, as opposed to a multi-step route. Indeed multi-step chemical process development is often a bottleneck in drug discovery. An excellent example is the HIV protease inhibitor Crixivan , which will be discussed in due course [6]. 

Monolithic non-gas-generating systems are matrix tablets consisting of hydrocolloids that form an external gel layer when hydrated. The internal tablet core remains dry with an overall density lower than that of the gastric fluid. Hydroxypropylmethycellulose (HPMC) is the most commonly used hydrocolloid. This approach has been developed into marketed drug products as the Hydrodynamically Balanced System (HBS) invented by Sheth and Tossounian.93 Gastric retention and flotation times up to 6 hours were achieved. Valrelease (diazepam) and Madopar (levodopa and benserazide) were two marketed products developed using this approach. 

Manufacturing The stage of drug development responsible for the manufacture of marketed drug products. 

Already marketed drug product—duplication by new manufacturer... 

Already marketed drug product without previously approved NDA... 

The total number of marketed drug products known to exhibit a significant bioavailability problem is relatively small. Thus, one point of view is that the bioavailability has been overemphasized and that for most drug products, it is not a matter of concern. Another point of view is that those products that exhibit a bioavailability deficiency in a carefully controlled study provide ample evidence of the potential for many drug products that have not yet been studied to present a bioavailability problem. 

On October 3, 1996, President Clinton signed into law the Comprehensive Methamphetamine Control Act of 1996 (MCA). The MCA broadens controls on listed chemicals used in the production of methamphetamine, increases penalties for the trafficking and manufacture of methamphetamine and listed chemicals, and expands controls to include the distribution of lawfully marketed drug products which contain the listed chemicals ephedrine, pseudoephedrine and phenyl-propanolamine (PPA). 

Finished and marketed drug products (formulations) may contain active ingredients at vastly different levels, from almost entirely pure drug substance to parts-per-million (ppm) levels. Therefore the characterization of drug product impurities in formulations is always a challenging project. Before any characterization technique is chosen, the amount available for analysis... 

Pharmaceutical analytical data are the foundation and backbone for development and marketing of new drugs. These data are acquired and reported in various ways to demonstrate quality, purity, and stability of an investigational or marketed drug product. The data also serve to bridge changes that occur in synthesis, formulation, and manufacture of a pharmaceutical product from the initial concept through development and postapproval modifications. 

In aqueous solutions CDs are able to solubilize many hydrophobic drugs by taking up some lipophilic moiety of the drug into the cavity, through formation of water-soluble inclusion complexes [13]. Cyclodextrins can be found in just over 30 marketed drug products worldwide [58]. In aqueous solutions free drug and CD molecules are in dynamic equilibrium with the complexes and every complex unit is generally assumed to be free and independent of other complexes as well as of other excipients found in the solution. 

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