PH1) MF59: A potent oil emulsion adjuvant formulation for human subunit vaccines, Van Nest, G., Walker, C., Ott, G., Barchfeld, G., Burke, R.L, and Steimer, K. Vaccines: New Technology & Applications. Organized by Cambridge Healthtech Institute. (1993). Abstract: A potent emulsion adjuvant formulation for human subunit vaccines. PH2) Hydrolysis of cellulose acetate and cellulose acetate butyrate pseudolatexes prepared by a solvent evaporation Microfluidization method. Bodmeier, R. and Chen, H. Drug Development and Industrial Pharmacy, 19:#5 pp521 (1993). Subject: Dispersion coatings, using a method called solvent evaporation. Objective: "to prepare pseudolatexes of the pharmaceutically acceptable cellulose ester, by a microfluidization solvent evaporation method and to follow chemical and physical degradation as a function of storage time and temperature." PH3) Effect of solvent system on microfluidization-induced mechanical degradation, CenciaRohan, L. and Silvestri, S., Intern'l J. of Pharmaceutics 95:pp23 (1993). Subject: Microfluidizer®-induced mechanical degradation of polymers (tragacanth). PH4) The use of muramyl peptides as vaccine adjuvants. Ott, G. VanNest, G. and Burke, R.L., Vaccine Research and Developments, Vol 1 1992, published by Marcel Dekker, Inc. Subject: Vaccine development using Microfluidizer® equipment to prepare small-droplet emulsions (200-500 nm). PH5) Sterile filtration of a parenteral emulsion, Lidgate, D.M., Trattner, T., Shulz, R.M.,Maskiewicz, R. Pharmaceutical Research, 9:#7 (1992). Subject: Parenteral emulsions. Conclusions: "equipment was capable of reducing the average dispersed oil droplet size to approx 160 nm. Operating at pressure greater than 16K psi, the resulting emulsion has a narrow droplet size range distribution with the largest droplets being small enough to enable sterile filtration. The emulsion becomes easily filtered through a 0.22 um cartridge filter, thus yielding a sterile end product. This is the first published example of emulsion sterilization being achieved by terminal filtration." PH6) Induction of antigen-specific class I restricted cytotoxic T cells by soluble proteins in vivo, Raychaudhuri, S., Tonks, M., Carbone, F., Ryskamp, T., Morrow, J.W., Hanna, N. Proc. Natl Acad Sci, 89:pp8308 Sept (1992). Subject: Antigen formulation (vaccine).
Successfully prepared a stable homogeneous emulsion with a mean particle size ranging from 250-300nm. PH7) Native but not denatured recombinant human immunodeficiency virus type 1 gp120 generates broad spectrum neutralizing antibodies in baboons. Haigwood, N.L., Nara, P.L., Brooks, E., Van Nest, G.A., Ott, G., Higgins, K.W., Dunlop, N., Scandella, C.J., Eichberg, J.W., and Steimer, K.S. J. of Virology Jan (1992). Subject: Emulsion (MF59) for subunit vaccine against AIDS, prepared using Microfluidizer® equipment. PH8) Advanced adjuvant formulations for use with recombinant subunit vaccines, Van Nest, G.A., Steimer, K.S., Haigwood, N.L., Burke, R.L., Ott, G. Vaccines, Cold Springs Harbor Laboratory Press (1992). Subject: Emulsion droplets reduced for increased stability using Microfluidizer® equipment. PH9) Effect of terminal block on the microfluidization induced degradation of model ABA block copolymer, Silvestri, S., Gabrielson, G. and Wu, L.L., Intn'l J. of Pharmaceutics, 71:pp65 (1991). Subject: Mechanical degradation of copolymers (ABA block). The older of two papers on degradation by Silvestri, et.al. PH10) Emulsion and emulsification, Lidgate, Debra M., Land of Lakes Conference, June 1991. Subject: Emulsions using MFZ processing as one (of four) methods.
Good, comprehensive study on mixing. Data: Includes charts showing emulsion characteristics, effects on biological efficacy, etc. PH11) The Microfluidizer® a process advancement in biotechnology, Oza, K.P., Innovations in Pharmaceutical Sciences & Technology, Oct (1990). Subject: General information Quotes: "Presently pharmaceutical companies are using the Microfluidizer for the manufacture of analgesic, antacids, antiarthritic, medication, anti-inflammatory, cardiac arrhythmia, anti-infective, anti-cancer, vaccines, adjuvants and blood substitutes. PH12) Production of disperse drug delivery system, Tabibi, S.E. Specialized drug delivery systems: manufacturing and Production Technology, ed, Praveen Tyle, Marcel Dekker, Inc. (1990). Subject: Compares the various methods of mixing. PH13) Formulation of vaccine adjuvant muramyldipeptides, 3. processing optimization, characterization, and bioactivity of an emulsion vehicle, Lidgate, D., Fu, R.C., Byars, N.E., Foster, L.C. and Fleitman, J.S. Pharmaceutical Research , Vol 6 #9 (1989). Conclusions: "The Microfluidizer® produced a homogeneous, elegant emulsion displaying little or no creaming." "New vaccine adjuvants must be safe, efficacious, and easy to use. By producing an elegant and stable emulsion in a rapid and reproducible fashion, the Microfluidizer® meets all these requirements". Data: Includes charts PH14) Using a Microfluidizer® to manufacture parenteral emulsions, Lidgate, D., Fu, R.C. and Fleitman, J.S. Biopharm October, 1989. Conclusions: "The Microfluidizer® produces emulsions characterized by small particle size. The emulsions appear physically consistent and are easily manufactured with a high degree of reproducibility. These attributes make the equipment commercially viable for manufacturing parenteral emulsions." PH15) Theoretical evaluation of dispersed droplet radii in submicron oil-in-water emulsions, Silvestri, S.L., and Lostritto, R.T., International J. of Pharmaceutics, 50 pp141-146, (1989). PH16) The production of parenteral feeding emulsions by Microfluidizer®, Washington, C., and Davis, S.S., International J. of Pharmaceutics, 44 pp169-176, (1988). Subject: General information about the Microfluidizer® technology and its capabilities for producing superior parenteral emulsions PH17) Use of Microfluidizer® Processing for Preparation of Pharmaceutical Suspensions, Illig, Kathleen J., Mueller, Ronald L., Ostrander, Kevin D., Swanson, Jon R., Pharmaceutical Technology, Oct (1996) Subject: Use of Microfluidizer® Processing for Preparation of Pharmaceutical Suspensions Conclusions: "Minimal contamination and linear scaleup of formulation are two distinct advantages of Microfluidizer® processing over conventional milling processes." PH18) Helping Cancer Patients Take Their Medicine. Subject: Clinical study at Johns Hopkins Oncology Center to determine if a new method for delivering a cytotoxic drug can be administered intravenously. PH19) New Intravenous Drug Therapies Possible Due to Microfluidizer® Processing. Subject: New kinds of drugs can now be administered by injection thanks to the Microfluidizer® Processor's particles size reduction capabilities. PH20) Genetic Researchers Score a Bargain: Free Delivery of DNA. Subject: Liposomes are used to carry DNA piggyback style into cells.
Researcher at the University of Pittsburgh has found a way to deliver
virtually any amount of DNA for the treatment of any disease. PH21) DNA Delivery, Sorgi, Frank L., Huang, Leaf., Genetic Engineering News, August (1997). Subject: A new way to deliver DNA for treating diseases without using viruses as a delivery vehicle. Liposomes are used to carry DNA piggyback style into cells. PH22) Sizing It Up, Philips, Christopher P., Pharmaceutical & Cosmetic Quality (1997). Subject: Spartaject™, injectable suspension PH23) Microfluidizer® Processor Helps Increase The Odds of Drug Discovery at Tularik, (1998) Subject: Disruption of E. coli. E. coli used as hosts to grow recombinant protiens that are naturally used by pathogenic viruses to reproduce. PH24) Genzyme Harvests Recombinant Enzymes Using Microfluidizer® Processor, (1998) Subject: Easy harvesting of protiens from E. coli. PH25) Large Scale Screening of Animals for Disease Made Possible with Microfluidizer® Processor, (1998) Subject: Preparing antigens and vaccines for the diagnosis of blood parasites. PH26) Aqueous-based Polymeric Dispersion:Preparation and Characterization of Cellulose Acetate Pseudolatex, Sastry, Wilber, Reddy, Khan, International Journal of Pharmaceutics (1998). Subject: Preparing CA pseudolatex as a semipermeable membrane provider for atenolol gastrointestinal therapeutic systems. PH27)Helping Cancer Patients Take Their Medicine, Pharmaceutical Laboratory, (1998). Subject: Mixing "uncombinable" compounds in suspensions that allow for intravenous administration with a high level of tolerance.