Drug product special additives

Behind the relatively straightforward compositional nature of ophthalmic solutions, suspensions, and ointments, however, lie many of the same physicochemical parameters that affect drug stability, safety, and efficacy, as they do for most other drug products. But additionally, specialized dosage forms present the ophthalmic product designer with some extraordinary compositional and manufacturing challenges. These... 

Precise information on the synthesis of the polymer and descriptions of the monomers used in the polymerization, the solvents used in the synthesis, and the special additives that have been added during material production as well as knowledge of degradation products that may be released into the drug product are also important. 

Secondary packaging components are not intended to make contact with the dosage form. Examples are cartons, which are generally constructed of paper or plastic, and overwraps, fabricated from a single layer of plastic or from a laminate made of metal foil, plastic, and/or paper. In special cases, secondary packaging components provide some additional measure of protection to the drug product. In such cases it could be considered a potential source of contamination and the safety of the raw materials should be taken into consideration. 

One of the more common differences between products is the closure system. Closure systems are selected for compatibility with the formulation, and in some cases differences in formulation may be create differences in handling difficulty. A stopper that is more prone to clumping or jamming in the tracks of the stopper bowl will necessitate additional interventions not present with other stoppers of similar size and thus would be considered worst case situations. There are a number of specialized closure systems designed to facilitate the delivery of an aseptically filled product. As these systems have sealed interstitial spaces where product contact can occur during administration of the drug product, the simulation procedure for these... 

In addition to the universal tests described earlier, specific tests and acceptance criteria should be included for particular new drug products. The guideline does not include in its scope all conceivable dosage forms, largely because of limitations of time and the need to recruit expertise in some of the more specialized dosage forms such as inhalation products and transdermal... 

The new chemical industry will have two main types of companies. The molecule providers will focus on delivering commodity and fine chemicals at the lowest cost. These will require all the traditional skills associated with chemical engineering with a particular emphasis on supply chain and logistics optimisation, plant efficiency and reliability. The problem solvers will provide customised effects. Whether these are speciality additives or personalised drug systems, the customer is more concerned with the efficacy of the product than with specification of the composition of the product. 

Stress Testing—Drug Product [ICH Q1A] — Light testing should be an integral part of stress testing. Special test conditions for specific products (e.g., metered dose inhalations and creams and emulsions) may require additional stress studies. 

The applications given here have been chosen in order to describe typical areas of use of GC-MS, such as air, water, soil, foodstuffs, the environment, waste materials, drugs or pharmaceutical products. Special emphasis has been placed on current and reproducible examples which give successful templates for routine laboratories. The selection cannot be totally representative of the use of modern GC-MS, but shows the main areas into which the methodology has spread and will continue to do so. In addition, in special areas of application, such as the analysis of isotope-specific measuring procedures and the isotope dilution method for dioxin analysis are described. 

The formation of ordered two- and three-dimensional microstructuies in dispersions and in liquid systems has an influence on a broad range of products and processes. For example, microcapsules, vesicles, and liposomes can be used for controlled drug dehvery, for the contaimnent of inks and adhesives, and for the isolation of toxic wastes. In addition, surfactants continue to be important for enhanced oil recovery, ore beneficiation, and lubrication. Ceramic processing and sol-gel techniques for the fabrication of amorphous or ordered materials with special properties involve a rich variety of colloidal phenomena, ranging from the production of monodispersed particles with controlled surface chemistry to the thermodynamics and dynamics of formation of aggregates and microciystallites. 

In addition to food- or nutrient-based interactions in the metabolism of drugs, it has become quite clear in recent years that so-called dietary supplements including botanicals have the potential to participate in such interactions. The latter observation has special relevance because of the extensive use of such products worldwide ( 12 billion per year in the United States alone), their easy commercial availability (no prescription required), and their common use with prescribed drugs. Furthermore, many people consider such natural products to be safe and free of any bad effects (it should be pretty easy to recall many poisons... 

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