if nanoparticles enter cells, is there an effect on cellular functions quality of materialcharacterization as new toxicological risks that derive from prozac impotence novel materials and delivery systems are identified, new tests will be prozac impotence required to ascertain safety and efficacy industry and academia need to plan and conduct the research to identify potential risks and to develop adequate characterization methodologies what are the forms in which particles are presented to host, tissues, organs, organelles and cells what are prozac impotence the critical physical and chemical properties, including residual solvents, processing variables, impurities and excipients what are the standard tools used for this characterization what are the validated assays to detect and quantify nanoparticles in tissues, medical products, foods and processing equipment how do physical prozac impotence characteristics impact product quality and performance how do we determine long and shortterm stability of nanomaterials en vironmen tal considera hons can prozac impotence nanoparticles be released into the environment following human and animal use prozac impotence what methodologies would identify the nature and quantify the extent of nanoparticle release in the environment what might be the environmental impact on prozac impotence other species eg animals, fish, plants, microorganisms as the materials and prozac impotence the techniques used to manufacture the novel formulations may not have prozac impotence prior art to refer to as a standard, there is an additional burden on the pharmabiotech industry to carry out a detailed evaluation of the system to generate sufficient database for successful industrialization prozac impotence of the product some of the industrially relevant criteria include understanding prozac impotence the relationship between the physicochemical properties and product performance, effect of process and formulation variables on product characteristics, development of analytical tools prozac impotence and specifications to regulate product quality, accelerated stability testing as per standard protocols to propose a reliable shelflife, product scaleup to mass prozac impotence production and establishment of manufacturing standards and development of reference materialsstandards prozac impotence as guidelines for quality assurance development of validated testing methodsprotocols and establishment of reference standards through a thorough and logical process remains to be the major responsibility of the industry for convincing the fda prozac impotence to get product approval while considering the application of a polymeric nanoparticlesbased formulation, the fda may want the industry to include evidence for the parameters listed below particle size and size distribution surface area, surface chemistry, surface coating and porosity hydrophilicity and surface charge prozac impotence density purity and quality stability on shelf and upon administration manufacturing prozac impotence and controls drug release parameters and bioequivalence testing considerations conclusion and prozac impotence outlook under the light of current literature ie articles, books, patents prozac impotence and information posted on the nanotech company websites and the product pipelines of leading pharmabiotech companies, it is evident that we would be seeing many nanotechnologybased pharmaceutical products in this century table lists prozac impotence few of the important products in the drug delivery pipeline that prozac impotence are based on polymeric nanoparticles it is likely that the oral prozac impotence formulations would dominate this specialized segment of novel dosage forms the chemicalpolymer industry has been feeding the drug delivery scientists with a variety of biopolymers, having wide range of specialized properties nanoparticles made from the biopolymers are likely to dominate the novel drug delivery systems prozac impotence in the oral market because of the costtobenefit ratio, excellent stability, flexibility for industrial production and a voluminous database available, with respect prozac impotence to the regulatory issues addressed earlier polymeric nanoparticles are also being prozac impotence explored for topical applications and as sterile dosage forms for ophthalmic, nasal, subcutaneous and intravenous applications there are several other potential the health consequences of caffeine nanoparticles prozac impotence technologies which fall outside the coverage of this chapter, which are prozac impotence based on nanoparticles made from the drugs themselves they are termed as nanosuspensions, nanocrystals or insoluble drug delivery technologies essentially, all of them are colloidal dispersions of pure drug particles that are stabilized prozac impotence by polymers, surfactants or lipids they are synthesized either by physical eg size reduction by milling or chemical eg change in solubility prozac impotence induced by ph or solvent exchange means in the presence of stabilizing agents the striking advantage of these technologies is the high drug prozac impotence loading efficiency and the simplicity associated with its production these have prozac impotence been the first to roll out from the research and development scale to the industrial production scale under nanoparticle category rapamune� oral prozac impotence solution and tablets table product pipeline of polymeric nanoparticles source pharmaprojects technology bioactive compound company route of delivery france of amino acids bioalliance, france polyisohexyl doxorubicin intravenous cyanoacrylate nanoparticles munich biotech drug nanoparticles paclitaxel intravenous germany biosante, usa calcium phospahte insulin oral nanoparticles targesome, prozac impotence usa selfassembling lipid therapeutic intravenous nanospheres diagnostic american albumindrug paclitaxel intravenous bioscience, usa nanoparticles advectus life polybutylcyanoacrylate doxorubicin intravenous sciences, canada nanoparticles prozac impotence nanocarrier, japan micellar nanoparticles water insoluble drugs wyeth drug nanoparticles rapamycin prozac impotence oral novavax, usa flamel technologies micellar nanoparticles medusa� nanoparticles testosterone insulin interferon subcutaneous subcutaneous pharmaceuticals, usa containing sirolimus from wyeth and sangcya� prozac impotence oral solution from sangstat corporation containing cya if the science of pharmaceutical product development is undergoing a transformation from a traditional pharmaceutics to prozac impotence a more innovative molecular or nanopharmaceutics, the major credit would be prozac impotence taken by a combination of polymer based systems and nanoparticles it prozac impotence is more of a belief than a hope that the polymeric nanoparticles would address many of the therapeutic issues that are posing hurdles to a formulation scientist in this century 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