if nanoparticles enter cells, is there an effect on cellular functions quality of materialcharacterization as new toxicological childrens motrin vs childrens tylenol risks that derive from new york penicillin molly oniell recipe novel materials and delivery systems are identified, new tests will be required to ascertain safety and efficacy industry and academia need to new york penicillin molly oniell recipe plan and conduct the research to identify potential risks and to develop adequate characterization methodologies what are the forms in which particles new york penicillin molly oniell recipe are presented to host, tissues, organs, organelles and cells what are new york penicillin molly oniell recipe 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 new york penicillin molly oniell recipe in tissues, medical products, foods and processing equipment how do physical new york penicillin molly oniell recipe characteristics impact product quality and performance how do we determine long new york penicillin molly oniell recipe and shortterm stability of nanomaterials en vironmen tal considera hons can nanoparticles be released into the environment following human and animal use new york penicillin molly oniell recipe what methodologies would identify the nature and quantify the extent of nanoparticle release in the environment what might be the environmental impact on new york penicillin molly oniell recipe other species eg animals, fish, plants, microorganisms as the materials and new york penicillin molly oniell recipe the techniques used to manufacture the novel formulations may not have prior art to refer to as a standard, there is an additional burden on the pharmabiotech industry to carry out a detailed new york penicillin molly oniell recipe evaluation of the system to generate sufficient database for successful industrialization of the product some of the industrially relevant criteria include understanding new york penicillin molly oniell recipe the relationship between the physicochemical properties and product performance, effect of process and formulation variables on product characteristics, development of analytical tools and specifications to regulate product quality, accelerated stability testing as per standard protocols to propose a reliable shelflife, product scaleup to mass production and establishment of manufacturing standards and development of reference materialsstandards as guidelines for quality assurance development of validated testing methodsprotocols and new york penicillin molly oniell recipe 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 new york penicillin molly oniell recipe 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 new york penicillin molly oniell recipe density purity and quality stability on shelf and upon administration manufacturing and controls drug release parameters and bioequivalence testing considerations conclusion and new york penicillin molly oniell recipe outlook under the light of current literature parlodel for decreased lactation ie articles, books, patents new york penicillin molly oniell recipe and information posted on the nanotech company websites and the product pipelines of leading pharmabiotech companies, it is evident that we would new york penicillin molly oniell recipe be seeing many nanotechnologybased pharmaceutical products in this century table lists new york penicillin molly oniell recipe few of the important products in the drug delivery pipeline that are based on polymeric nanoparticles it is likely that the oral 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 in the oral market because of the costtobenefit ratio, excellent stability, new york penicillin molly oniell recipe flexibility for industrial production and a voluminous database available, with respect to the regulatory issues addressed earlier polymeric nanoparticles are also being new york penicillin molly oniell recipe explored for topical applications and as sterile dosage forms for ophthalmic, nasal, subcutaneous and intravenous applications there are several other 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 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 new york penicillin molly oniell recipe induced by ph or solvent exchange means in the presence of stabilizing new york penicillin molly oniell recipe 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 scale to the industrial production scale under nanoparticle category rapamune� oral solution and tablets table product pipeline of polymeric nanoparticles source pharmaprojects new york penicillin molly oniell recipe technology bioactive compound company route of delivery france of amino acids new york penicillin molly oniell recipe bioalliance, france polyisohexyl doxorubicin intravenous cyanoacrylate nanoparticles munich biotech drug nanoparticles paclitaxel intravenous germany biosante, usa calcium phospahte insulin oral nanoparticles targesome, new york penicillin molly oniell recipe 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 oral novavax, usa flamel technologies micellar nanoparticles medusa� nanoparticles testosterone insulin interferon subcutaneous subcutaneous pharmaceuticals, usa containing sirolimus from wyeth and sangcya� oral solution from sangstat corporation containing cya if the science of pharmaceutical product development is undergoing a transformation from a traditional pharmaceutics to a more innovative molecular or nanopharmaceutics, the major credit would be new york penicillin molly oniell recipe taken by a combination of polymer based systems and nanoparticles it is more of a belief than a hope that the polymeric new york penicillin molly oniell recipe nanoparticles would address many of the therapeutic issues that are posing hurdles to a formulation scientist in this century references wilson � new york penicillin molly oniell recipe and waugh a anatomy and physiology in health and illness churchill livingstone new york tortora g and anagnostakos n principles of anatomy new york penicillin molly oniell recipe and physiology harper and row new york tate p, seeley r 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 new york penicillin molly oniell recipe john wiley and sons new york ganong w review of medical physiology appleton and lange norwalk, ct shojaei a buccal mucosa as a route for systemic drug delivery a review j pharm pharma sci zhang h, zhang j and streisand jb oral mucosal drug delivery new york penicillin molly oniell recipe clinical pharmacokinetics and therapeutic applications clin pharmacokinet collins l and dawes new york penicillin molly oniell recipe � 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 new york penicillin molly oniell recipe mucous membranes of the oral cavity, f pharm sci sakuma s, hayashi m and akashi m design of nanoparticles composed of graft new york penicillin molly oniell recipe copolymers for oral peptide delivery adv drug del rev gandhi rr, j oral cavity as a site for bioadhesive drug delivery adv drug del rev florence at particulate delivery the challenge of the oral route drugs pharm sci jung t, kamm w, breitenbach a, new york penicillin molly oniell recipe kaiserling e, xiao jx and kissel t biodegradable nanoparticles for oral delivery of peptides is there a role for polymers to affect mucosal uptake?