药品中粘度检测方案(粘度计)

RheoSense Simply Precise" High Throughput Rheological Characterization of Small VolumeFarBiopharmaceutical Formulations David Nieto Simavilla， Ivan Akhremitchev and Seong-gi Baek-RheoSense Inc.，2420 Camino Ramon STE 240 San Ramon， CA 94583 Abstract During the drug discovery process， biopharmaceuticalindustries produce a large number of formulations withsmall recipe variations. One important aspect in thedevelopment of novel drugs is the characterization oftheir viscosity fingerprint (i.e. viscosity dependence onshear rate， temperature...). Viscosity is a good indicatorofssmall changesin concentration and molecularstructure that play a key role in the efficacy and stabilityof the final product. Challenges In the early stages of drug development， availablesample volume for testing is very limited. Conventionalrheometers often require large sample volumes (~1 mLor higher). Microfluidic based rheometers offer extensiverheological characterization at a fraction of the volume. Figure1. A viscosity measurement can0 No Solvent Evaporationbe performed with just a few uL!. Another advantage of microfluidic-based rheometers isthat， due to their small size， they can achieve muchhigher shear rates than conventional rheometerswithout inducing flow instabilities [1]. This enables thestudy of high shear applications such as injectability ofnon-Newtonian protein therapeutics. VROC@ Technology VROCQ (Viscometer/Rheometer On a Chip) is a hybrid ofmicrofluidic and MEMs technologies. Experimental BSA and lgG solutions up to 200 mg/mL in PBS(Phosphate Buffer Saline) and water were tested atseveral shear rates.VROC@ technology's high accuracyand repeatability allows for the characterization of thesesolutionsSaas afunction of concentration， pH，buffer，...These samples were also tested for intrinsicviscosity. MethocelTM water solutions were also testedto demonstrate the importance of shear rate andtemperature for injectability. Highly monodispersePS/Toluene solutions were used to validate intrinsicviscosity measurements. The following set of results demonstrate VROC@ capabilities forviscosity fingerprinting of samples relevant to biopharmaceuticalindustries. Protein Therapeutics. Bovine Serum Albumin (BSA) and Immunoglobulin (igG) are goodexamples of protein systems that are found in biological applications. BSA in Water BSA in PBS 6 1IgG in PBS Hard Sphere Model 4 0 0 50 100 150 200 Shear Rate [1/s] Concentration [mg/mL] Figure2.Viscosity as a function of shear rate for different concentrations of BSA inPBS(left). Viscosity as a function of concentration of BSA and IgG solutions (right)[2] Injectability. Less frequent dosing have lead pharmaceutical companies toincrease the concentration of their protein therapeutics. Figure 3. Viscosity as a function of shear rate for MethocelTM solutions in water. Intrinsic Viscosity VROC@ superior repeatability enables indirect measurement ofmolecular size and structure.nsp Automated CharacterizationPowered by VROC@ technology， VROC@initium is the firstfully automatic viscometer/rheometer for Vviscosityfingerprinting. Key specifications include： Additionally， VROC initium features continuous testing viasample retrieval12allowing shear and temperature stabilitystudies as well as sample recovery. Automatic Viscosity Fingerprinting Summary & Applications VROC@ powered viscometers/rheometers take advantage ofthe small scale of microfluidic devices and the highresolution of MEMs technology to enable the accuratemeasurements with) smallsample volumes required forapplications such as： High Throughput Screening with Viscosity Injectability of Protein Therapeutics Stability of Protein Therapeutics Kinetics of Chemical Reaction and Degradation Solubility Intrinsic Viscosity Hydrodynamic Radius Thanks to automation VROCe initium will make yourmeasurements of viscosity Simply Precise TM! References 1234 Makosco. Rheology： Principles and Applications， Wiley 1994 Kawahara et al. J. Biological Chemistry 1966 Brandrup. Polymer Handbook 2001 Lee et al. Analytical Chemistry 2005 For more information： info@RheoSense.com925-866-3808 用户可自动设置剪切速率和扫描温度 样品自动清洗和干燥 最小进样量：10uL 40个1.2 mL 样品位，也可选择小样品位 标准96孔板 剪切速率范围：1-1600,000 1/S 温控范围：4-70℃，内置帕尔贴温控系统 测试粘度范围：0.2-100，000 mPa-S 精度：2%（读数） 重复性：0.5%（全量程）