if nanoparticles enter cells, is there an effect on cellular functions quality of materialcharacterization as new toxicological risks that derive from novel materials and delivery systems are identified, new tests will be caffeine sotas required to ascertain safety and efficacy industry and academia need to plan and conduct the research to identify potential risks and to caffeine sotas develop adequate characterization methodologies what are the forms in which particles are presented to host, tissues, organs, organelles and cells what are the critical physical and chemical properties, including residual solvents, processing variables, caffeine sotas 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 characteristics impact product quality and performance how do we determine long and shortterm stability of nanomaterials en vironmen tal considera hons can caffeine sotas nanoparticles be released into the environment following human and animal use caffeine sotas what methodologies would identify the nature and quantify the extent of nanoparticle caffeine sotas release in the environment what might be the environmental impact on other species eg animals, fish, plants, microorganisms as the materials and caffeine sotas the techniques used to manufacture the novel formulations may not have prior art to refer to as a standard, there is an caffeine sotas additional burden on the pharmabiotech industry to carry out a detailed evaluation of the system to generate sufficient database for successful industrialization of the product some of the industrially relevant criteria include understanding caffeine sotas the relationship between the physicochemical properties and product performance, effect of process and formulation variables on product characteristics, development of analytical tools caffeine sotas and specifications to regulate product quality, accelerated stability testing as per standard protocols to propose a reliable shelflife, product scaleup to mass caffeine sotas production and establishment of manufacturing standards and development of reference materialsstandards 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 to get product approval while considering the application of a polymeric nanoparticlesbased formulation, the fda may want the industry to include evidence caffeine sotas for the parameters listed below particle size and size distribution surface area, surface chemistry, surface coating and porosity hydrophilicity and surface charge density purity and quality stability on shelf and upon administration manufacturing caffeine sotas and controls drug release parameters and bioequivalence testing considerations conclusion and caffeine sotas outlook under the light of current literature ie articles, books, patents caffeine sotas and information posted on the nanotech company websites and the product caffeine sotas pipelines of leading pharmabiotech companies, it is evident that we would be seeing many nanotechnologybased pharmaceutical products in this century table lists caffeine sotas few of the important products in the drug delivery pipeline that caffeine sotas are based on polymeric nanoparticles it is likely that the oral caffeine sotas formulations would dominate this specialized segment of novel dosage forms the chemicalpolymer caffeine sotas industry has been feeding the drug delivery scientists with a variety caffeine sotas of biopolymers, having wide range of specialized properties nanoparticles made from the biopolymers are likely to dominate the novel drug delivery systems in the oral market because of the costtobenefit ratio, excellent stability, caffeine sotas flexibility for industrial production and a voluminous database available, with respect to the regulatory issues addressed earlier polymeric nanoparticles are also being caffeine sotas explored for topical applications and as sterile dosage forms for ophthalmic, caffeine sotas nasal, subcutaneous and intravenous applications there are several other 17 estradiol pill potential nanoparticles technologies which fall outside the coverage of this chapter, which are based on nanoparticles made from the drugs themselves they are termed as nanosuspensions, nanocrystals or insoluble drug delivery technologies essentially, all of caffeine sotas them are colloidal dispersions of pure drug particles that are stabilized by polymers, surfactants or lipids they are synthesized either by physical eg size reduction by milling or chemical eg change in solubility induced by ph or solvent exchange means in the presence of stabilizing agents the striking advantage of these technologies is the high drug loading efficiency and the simplicity associated with its production these have been the first to roll out from the research and development caffeine sotas scale to the industrial production scale under nanoparticle category rapamune� oral caffeine sotas 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 caffeine sotas paclitaxel intravenous germany biosante, usa calcium phospahte insulin oral nanoparticles targesome, usa selfassembling lipid therapeutic intravenous nanospheres diagnostic american albumindrug paclitaxel intravenous bioscience, usa nanoparticles advectus life polybutylcyanoacrylate doxorubicin intravenous sciences, canada nanoparticles nanocarrier, japan micellar nanoparticles water insoluble drugs wyeth drug nanoparticles rapamycin caffeine sotas oral novavax, usa flamel technologies micellar nanoparticles medusa� nanoparticles testosterone insulin caffeine sotas interferon subcutaneous subcutaneous pharmaceuticals, usa containing sirolimus from wyeth and sangcya� oral solution from sangstat corporation containing cya if the science of pharmaceutical caffeine sotas product development is undergoing a transformation from a traditional pharmaceutics to a more innovative molecular or nanopharmaceutics, the major credit would be taken by a combination of polymer based systems and nanoparticles it caffeine sotas is more of a belief than a hope that the polymeric nanoparticles would address many of the therapeutic issues that are posing caffeine sotas hurdles to a formulation scientist in this century references wilson � caffeine sotas and waugh a anatomy tetracycline pneumonia and physiology in health and illness churchill livingstone new york tortora g and anagnostakos n principles of anatomy and physiology harper and row new york tate p, seeley r caffeine sotas and stephens t understanding the human body mosby st louis solomon e introduction to human anatomy and physiology w b saunders company, philadelphia mcclintic jr basic anatomy and physiology of the human body john wiley and sons new york ganong w review of medical physiology appleton and lange norwalk, ct shojaei a buccal mucosa as a caffeine sotas route for systemic drug delivery a review j pharm pharma sci caffeine sotas zhang h, zhang j and streisand jb oral mucosal drug delivery caffeine sotas clinical pharmacokinetics and therapeutic applications clin pharmacokinet collins l and dawes � the surface area of the adult human mouth and thichness of the salivary film covering the teeth and oral mucosa } dent res harris d and robinson j drug delivery via the mucous membranes of the oral cavity, f pharm sci sakuma s, hayashi m and akashi m design of nanoparticles composed of graft copolymers for oral peptide delivery adv drug del rev gandhi rr, j oral cavity as a site for bioadhesive drug delivery adv caffeine sotas drug del rev florence at particulate delivery the challenge of the caffeine sotas oral route drugs pharm sci jung t, kamm w, breitenbach a, kaiserling e, xiao jx and kissel t biodegradable nanoparticles for oral caffeine sotas delivery of peptides is there a role for polymers to affect mucosal uptake?