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 required to ascertain safety and efficacy industry and academia need to how much will simvastatin lower cholesterol 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 the critical physical and chemical properties, including residual solvents, processing variables, how much will simvastatin lower cholesterol impurities and excipients what are the standard tools used for this how much will simvastatin lower cholesterol 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 how much will simvastatin lower cholesterol nanoparticles be released into the environment following human and animal use how much will simvastatin lower cholesterol what methodologies lithium cr2 battery specifications would identify the nature and quantify the extent of nanoparticle how much will simvastatin lower cholesterol release in the environment what might be the environmental impact on how much will simvastatin lower cholesterol other species eg animals, fish, plants, microorganisms as the materials and 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 evaluation of the system to generate sufficient database for successful industrialization how much will simvastatin lower cholesterol of the product some of the industrially relevant criteria include understanding how much will simvastatin lower cholesterol the relationship between the physicochemical properties and product performance, effect of how much will simvastatin lower cholesterol process and formulation variables on product characteristics, development of analytical tools how much will simvastatin lower cholesterol 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 establishment of reference standards through a thorough and logical process remains to how much will simvastatin lower cholesterol be the major responsibility of the industry for convincing the fda how much will simvastatin lower cholesterol to get product approval while considering the application of a polymeric nanoparticlesbased formulation, the fda may want the industry to include evidence how much will simvastatin lower cholesterol for the parameters listed below particle size and size distribution surface area, surface chemistry, surface coating and porosity hydrophilicity and surface charge how much will simvastatin lower cholesterol density purity and quality stability on shelf and upon administration manufacturing and controls drug release parameters and bioequivalence testing considerations conclusion and outlook under the light of current literature ie articles, books, patents and information posted on the nanotech company websites and the product pipelines of leading pharmabiotech companies, it is evident that we would how much will simvastatin lower cholesterol be seeing many nanotechnologybased pharmaceutical products in this century table lists 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 how much will simvastatin lower cholesterol the biopolymers are likely to dominate the novel drug delivery systems in the oral market because of the costtobenefit ratio, excellent stability, how much will simvastatin lower cholesterol flexibility for industrial production and a voluminous database available, with respect to the regulatory issues addressed earlier polymeric nanoparticles are also being explored for topical applications and as sterile dosage forms for ophthalmic, nasal, subcutaneous and intravenous applications there are several other potential nanoparticles how much will simvastatin lower cholesterol 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 how much will simvastatin lower cholesterol them are colloidal dispersions of pure drug particles that are stabilized how much will simvastatin lower cholesterol 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 how much will simvastatin lower cholesterol 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 how much will simvastatin lower cholesterol solution and tablets table product pipeline of polymeric nanoparticles source pharmaprojects technology bioactive compound company route of delivery france of amino acids how much will simvastatin lower cholesterol bioalliance, france polyisohexyl doxorubicin intravenous cyanoacrylate nanoparticles munich biotech drug nanoparticles how much will simvastatin lower cholesterol 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 oral novavax, usa flamel technologies micellar nanoparticles medusa� nanoparticles testosterone insulin how much will simvastatin lower cholesterol 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 taken by a combination of polymer based systems and nanoparticles it how much will simvastatin lower cholesterol is more of a belief than a hope that the polymeric how much will simvastatin lower cholesterol nanoparticles would address many of the therapeutic issues that are posing how much will simvastatin lower cholesterol hurdles to a formulation scientist in this century references wilson � and waugh a anatomy and physiology in health and illness churchill livingstone new york tortora g and anagnostakos n principles of anatomy how much will simvastatin lower cholesterol and physiology harper and row new york tate p, seeley r how much will simvastatin lower cholesterol and stephens t understanding the human body mosby st louis solomon e introduction to human anatomy and physiology w b saunders company, how much will simvastatin lower cholesterol philadelphia mcclintic jr basic anatomy and physiology of the human body how much will simvastatin lower cholesterol 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 how much will simvastatin lower cholesterol clinical pharmacokinetics and therapeutic applications clin pharmacokinet collins l and dawes how much will simvastatin lower cholesterol � 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 how much will simvastatin lower cholesterol 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 aleve tablet of the oral route drugs pharm sci jung t, kamm w, breitenbach a, how much will simvastatin lower cholesterol kaiserling e, xiao jx and kissel t biodegradable nanoparticles for oral how much will simvastatin lower cholesterol delivery of peptides is there a role for polymers to affect mucosal uptake?