PH1) MF59: A potent oilemulsion adjuvant formulation for human subunit vaccines,Van Nest, G., Walker, C., Ott, G., Barchfeld, G., Burke, R.L, andSteimer, K. Vaccines: New Technology & Applications.Organized by Cambridge Healthtech Institute. (1993).
Abstract: A potent emulsion adjuvantformulation for human subunit vaccines.
PH2) Hydrolysis ofcellulose acetate and cellulose acetate butyrate pseudolatexesprepared by a solvent evaporation Microfluidization method.Bodmeier, R. and Chen, H. Drug Development and IndustrialPharmacy, 19:#5 pp521 (1993).
Subject:
Objective: "toprepare pseudolatexes of the pharmaceutically acceptable celluloseester, by a microfluidization solvent evaporation method and tofollow chemical and physical degradation as a function of storagetime and temperature."Dispersion coatings, using amethod called solvent evaporation.
PH3) Effect of solventsystem on microfluidization-induced mechanical degradation,CenciaRohan, L. and Silvestri, S., Intern'l J. ofPharmaceutics 95:pp23 (1993).
Subject:Microfluidizer®-inducedmechanical degradation of polymers (tragacanth).
PH4) The use of muramylpeptides as vaccine adjuvants. Ott, G. VanNest, G. andBurke, R.L., Vaccine Research and Developments, Vol 1 1992,published by Marcel Dekker, Inc.
Subject:Vaccine development usingMicrofluidizer® equipment to prepare small-droplet emulsions(200-500 nm).
PH5) Sterile filtration ofa parenteral emulsion, Lidgate, D.M., Trattner, T., Shulz,R.M.,Maskiewicz, R. Pharmaceutical Research, 9:#7(1992).
Subject:
Conclusions:"equipment was capable of reducing the average dispersed oildroplet size to approx 160 nm. Operating at pressure greater than16K psi, the resulting emulsion has a narrow droplet size rangedistribution with the largest droplets being small enough to enablesterile filtration. The emulsion becomes easily filtered through a0.22 um cartridge filter, thus yielding a sterile end product. Thisis the first published example of emulsion sterilization beingachieved by terminal filtration."Parenteralemulsions.
PH6) Induction ofantigen-specific class I restricted cytotoxic T cells by solubleproteins in vivo, Raychaudhuri, S., Tonks, M., Carbone, F.,Ryskamp, T., Morrow, J.W., Hanna, N. Proc. Natl Acad Sci,89:pp8308 Sept (1992).
Subject:
Successfully prepared a stable homogeneous emulsion with amean particle size ranging from 250-300nm.Antigenformulation (vaccine).
PH7) Native but not denatured recombinant humanimmunodeficiency virus type 1 gp120 generates broad spectrumneutralizing 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 subunitvaccine against AIDS, prepared using Microfluidizer®equipment.
PH8) Advanced adjuvantformulations for use with recombinant subunit vaccines, VanNest, G.A., Steimer, K.S., Haigwood, N.L., Burke, R.L., Ott, G.Vaccines, Cold Springs Harbor Laboratory Press (1992).
Subject:Emulsion droplets reduced forincreased stability using Microfluidizer® equipment.
PH9) Effect of terminalblock on the microfluidization induced degradation of model ABAblock copolymer, Silvestri, S., Gabrielson, G. and Wu, L.L.,Intn'l J. of Pharmaceutics, 71:pp65 (1991).
Subject: Mechanical degradation ofcopolymers (ABA block). The older of two papers on degradation bySilvestri, et.al.
PH10) Emulsion andemulsification, Lidgate, Debra M., Land of Lakes Conference,June 1991.
Subject:
Good, comprehensive study on mixing.
Data: Includes chartsshowing emulsion characteristics, effects on biological efficacy,etc.Emulsions using MFZ processing as one (of four)methods.
PH11) The Microfluidizer®a process advancement in biotechnology, Oza, K.P.,Innovations in Pharmaceutical Sciences & Technology, Oct(1990).
Subject:
Quotes:"Presently pharmaceuticalcompanies are using the Microfluidizer for the manufacture ofanalgesic, antacids, antiarthritic, medication, anti-inflammatory,cardiac arrhythmia, anti-infective, anti-cancer, vaccines,adjuvants and blood substitutes.Generalinformation
PH12) Production ofdisperse drug delivery system, Tabibi, S.E. Specializeddrug delivery systems: manufacturing and Production Technology,ed, Praveen Tyle, Marcel Dekker, Inc. (1990).
Subject: Compares the various methodsof mixing.
PH13) Formulation ofvaccine 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:
Data: Includescharts "The Microfluidizer® produced a homogeneous,elegant emulsion displaying little or no creaming." "New vaccineadjuvants must be safe, efficacious, and easy to use. By producingan elegant and stable emulsion in a rapid and reproducible fashion,the Microfluidizer® meets all these requirements".
PH14) Using aMicrofluidizer® 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. Theemulsions appear physically consistent and are easily manufacturedwith a high degree of reproducibility. These attributes make theequipment commercially viable for manufacturing parenteralemulsions."
PH15) Theoreticalevaluation of dispersed droplet radii in submicron oil-in-wateremulsions, Silvestri, S.L., and Lostritto, R.T.,International J. of Pharmaceutics, 50 pp141-146,(1989).
PH16) The production ofparenteral feeding emulsions by Microfluidizer®, Washington,C., and Davis, S.S., International J. of Pharmaceutics, 44pp169-176, (1988).
Subject: General information about theMicrofluidizer® technology and its capabilities for producingsuperior parenteral emulsions
PH17) Use ofMicrofluidizer® Processing for Preparation of PharmaceuticalSuspensions, Illig, Kathleen J., Mueller, Ronald L.,Ostrander, Kevin D., Swanson, Jon R., PharmaceuticalTechnology, Oct (1996)
Subject:
Conclusions:"Minimal contamination and linear scaleup of formulation are twodistinct advantages of Microfluidizer® processing over conventionalmilling processes."Use of Microfluidizer® Processingfor Preparation of Pharmaceutical Suspensions
PH18) Helping CancerPatients Take Their Medicine.
Subject: Clinical study at JohnsHopkins Oncology Center to determine if a new method for deliveringa cytotoxic drug can be administered intravenously.
PH19) New Intravenous DrugTherapies Possible Due to Microfluidizer® Processing.
Subject:New kinds of drugs can now beadministered by injection thanks to the Microfluidizer® Processor'sparticles size reduction capabilities.
PH20) Genetic Researchers Score a Bargain: FreeDelivery of DNA.
Subject:
Researcher at the University of Pittsburgh has found a way todeliver
virtually any amount of DNA for the treatment of anydisease. Liposomes are used to carry DNA piggybackstyle into cells.
PH21) DNA Delivery, Sorgi, Frank L.,Huang, Leaf., Genetic Engineering News, August(1997).
Subject: A new way to deliver DNA fortreating 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™, injectablesuspension
PH23) Microfluidizer® Processor Helps Increase TheOdds of Drug Discovery at Tularik,(1998)
Subject: Disruption of E. coli. E.coli used as hosts to grow recombinant protiens that are naturallyused by pathogenic viruses to reproduce.
PH24) Genzyme Harvests Recombinant Enzymes UsingMicrofluidizer® Processor, (1998)
Subject: Easy harvesting of protiensfrom E. coli.
PH25) Large Scale Screening of Animals for DiseaseMade Possible with Microfluidizer® Processor,(1998)
Subject: Preparing antigens andvaccines for the diagnosis of blood parasites.
PH26)Aqueousbased PolymericDispersion:Preparation and Characterization ofCellulose Acetate Pseudolatex, Sastry, Wilber,Reddy, Khan, International Journal of Pharmaceutics(1998). -
Subject: Preparing CA pseudolatex as asemipermeable membrane provider for atenolol gastrointestinaltherapeutic systems.
PH27) Helping CancerPatients Take Their Medicine, PharmaceuticalLaboratory, (1998).
Subject: Mixing "uncombinable"compounds in suspensions that allow for intravenous administrationwith a high level of tolerance.