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COLD CHAIN


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tInternational Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Quality Risk Management. Q9. Current Step 4 Version, November 9, 2005.


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International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Pharmaceutical Development. Q10. Current Step 4 Version, June 4, 2008.


7. Jenke D, Rivera C, Mortensen T, et al. A compilation of metals and trace elements extracted from materials relevant to pharmaceutical applications such as packaging systems and devices. PDA J Pharm Sci Technol. 2013;67(4):354-375.


8. Jenke DR, Stults CLM, Paskiet DM, Ball DJ., Nagao LM. Materials in manufacturing and packaging systems as sources of elemental impurities in packaged drug products: a literature review. PDA J Pharm Sci Technol. 2015;69(1):1-48.


9. Desai NR, Shah SM, Koczone J, Vencyl-Joncic M, Sisto C, Ludwig SA. Zinc content of commercial diluents used in drug admixtures prepared for intravenous infusion. Int J Pharm Compounding. 2007;11(5):426-432.


10. Padovese P, Gallieni M, Brancaccio D, et al. Trace elements in dialysis fluids and assessment of the exposure on patients on regular hemodialysis, hemofiltration and continuous ambulatory peritioneal dialysis. Nephron. 1992;61:442-448.


11. McHalsky ML, Rabinow BE, Ericson SP, Weltzer JA, Ayd SW. Reduction of aluminum levels in dialysis fluids through the development and use of accurate and sensitive analytical a methodology. J Parenteral Sci Technol. 1987;41(2):67-75.


12. Hayes P, Martin TP, Pybus J. Aluminum content of intravenous solutions, additives and equipment used to prepare parenteral nutrition mixtures. Aust J Hosp Pharm. 1992;22(5):353-357.


13. Toxicological Profile for Aluminum. U.S. Department of Health and Human Services; Agency for Toxic Substances and Disease Registry. Atlanta, GA; September, 2008.


CN Perspective


Pharmaceutical Outsourcing is one of several outstanding publications available from CompareNetworks, Inc. Here is a look at the insightful content our readers may enjoy from our sister publications: American Pharmaceutical Review and American Laboratory.


Evaluating Active Ingredients in Pharmaceutical Hot Melt Extrusion Products with Raman Imaging


Hot melt extrusion is a relatively new method being developed as an attractive alternative to traditional processing methods for producing products such as tablets, granules, pellets, and even transdermal films. The lack of solvents in HME processing saves money and eliminates steps such as drying. Hot melt extrusion products can be evaluated with Raman spectroscopy to gain information about molecular structure and orientation. Polymorphs and solvates can be differentiated as well as the physical properties of materials such as stress or degree of crystallinity.


In this article, Robert Heintz of Thermo Fisher Scientific illustrates how Raman imaging identifies molecules, verifies drug components, and provides visual representations of spatial distributions.


http://www.americanpharmaceuticalreview.com/Featured-Articles/170904-Evaluating-Active-Ingredients-in-Pharmaceutical-Hot-Melt- Extrusion-Products-with-Raman-Imaging/


Dr. Dennis Jenke is a Baxter Distinguished Scientist at Baxter Healthcare Corporation, where he works to establish the suitability for use of packaging systems, manufacturing systems, and administration devices for pharmaceutical products (for example, leachables/extractables and drug binding). He has published extensively in analytical chemistry, environmental science, and material/solution compatibility and serves as an expert reviewer for numerous pharmaceutical and analytical journals. He is the author of Compatibility of Pharmaceutical Solutions and Contact Materials; Safety Considerations Associated with Extractables and Leachables and is a contributing author to the Leachables and Extractables Handbook. Dr. Jenke is a member of several professional organizations that establish best demonstrated practices in the area of material/solution compatibility and is a frequently invited speaker on that subject.


Dr. Barrett E. Rabinow is Baxter Distinguished Scientist at Baxter Healthcare Corporation. Dr. Rabinow received his PhD in Chemistry from the University of Chicago and joined Baxter in 1977 where he headed chemistry and related functions, supporting the parenterals solutions business. He has engaged in collaborative studies with PDA, AdvaMed, AAMI, ISO, USP, FDA, and NIH. Dr. Rabinow holds numerous patents and authored 4 book chapters and over 40 articles in physical-organic chemistry, clinical and analytical chemistry, biomaterials, packaging, pharmaceutical science, drug delivery, pharmacokinetics, pharmacology, and drug targeting.


Molly Chacko is a Research Scientist in the Analytical Center of Excellence at Baxter Healthcare Corporation. Molly is an expert in trace element analysis, including Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Inductively Coupled Plasma Optical Emission Spectrometry (ICP-OES), and Flame and Graphite Furnace Atomic Absorption Spectrometry. She was a member of the USP <231> Heavy Metals (GC) Ad hoc Advisory Panel from 2006 to 2009 and has co-authored several publications in her field of expertise.


High-Throughput Tools for Optimizing Drug Nanosuspensions


Drug nanoparticle suspensions are an attractive formulation option. Due to their small particle size, they are amenable to a variety of administration routes, including oral delivery and direct systemic delivery via parenteral action or inhalation. This approach can facilitate the use of nanosuspension formulations to support early studies in drug discovery and to address challenges with new drug candidates.


In this article, Dennis Leung and colleagues from Merck and Co. explain the purpose, design, and facilitation of a high-throughput screening procedure for drug nanoparticle suspensions.


http://www.americanlaboratory.com/914-Application-Notes/171598-High-Throughput-Tools-for-Optimizing-Drug-Nanosuspensions/ pharmoutsourcing.com | 35 | March/April 2015


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