Bausch + Lomb
Senior Research Fellow and Group Leader
Pfizer Mar 2004 - Jan 2006
Research Fellow and Group Leader
Pfizer Jan 2002 - Mar 2004
Senior Research Advisor and Fellow
Pfizer 1992 - 1996
Senior Research Scientist and Group Leader
Pfizer 1986 - 1992
Senior Research Scientist
Education:
Colorado State University 1985 - 1985
Doctorates, Doctor of Philosophy, Chemistry
Bates College 1978 - 1978
Bachelors, Bachelor of Science, Chemistry
Skills:
Analytical Chemistry Validation Pharmaceutical Industry Hplc Chemistry Technology Transfer Fda Capa Gmp Quality Assurance Glp R&D Drug Development Drug Delivery Clinical Development Characterization Lc Ms Chromatography Drug Discovery Clinical Trials Regulatory Affairs Commercialization Life Sciences Product Development Quality By Design Piping V&V Cross Functional Team Leadership Lifesciences Team Building Process Simulation Hands on Technical Leadership Root Cause Problem Solving
Interests:
Mechanochemistry Plan B Strategic Planning Bagpiping
An article of manufacture is provided comprising a vial having (a) a first chamber that is substantially filled with an injectable pharmaceutical formulation; (b) a second chamber that is substantially empty but for a gaseous medium; (c) a septum, impermeable to the gaseous medium, separating the first and second chambers; and (d) actuating means effective to bring the formulation and the gaseous medium into contact by breach of the septum such that the gaseous medium acts as an effective headspace for agitation of the formulation. The formulation comprises an aqueous medium, a drug in solid particulate form in a therapeutically effective amount suspended in the medium, and one or more wetting and/or suspending agents in an amount effective to provide controlled flocculation of the drug, at least one ingredient of the formulation being susceptible to oxidative degradation.
Stabilized Injectable Suspension Of A Steroidal Drug
Steven MacLeod - Portage MI, US Lloyd Fox - Richland MI, US Neal Adams - Kalamazoo MI, US David Salvat - Marcellus MI, US
International Classification:
A61K031/56 A61K031/57 A61K009/14
US Classification:
514/177000, 514/182000, 424/489000
Abstract:
A parenterally deliverable composition is provided, comprising an aqueous medium having dispersed therein, in solid particulate form, a steroidal drug in a therapeutically effective amount. The aqueous medium comprises one or more wetting and/or suspending agents in an amount effective to provide controlled flocculation of the drug, at least one of the wetting and/or suspending agents being susceptible to oxidative degradation. The composition further comprises, as a component thereof or as an adjunct thereto, means for protecting the oxidative degradation susceptible agent from oxidative degradation.
Ophthalmic Compositions Comprising A Carboxyl-Modified Fructan Or A Salt Thereof
Ophthalmic composition including a carboxyl-modified fructan or a salt thereof. The ophthalmic composition can be used in an eye care product or a contact lens care product such as a contact lens packaging solution or contact lens disinfecting solution.
The invention is directed to an ophthalmic composition comprising a disuccinate of formula I or a corresponding salt thereof;wherein Ris selected from hydrogen, alkyl or —C(O)alkyl, the alkyl having one to twelve carbons and optionally one or more oxygen atoms, A is a methylene group or an oxyalkylene group, and n is from 2 to 8. The ophthalmic composition also includes a cationic antimicrobial component and a tonicity agent, wherein the tonicity agent provides for an osmolality of the composition from 200 mOs/kg to 420 mOsm/kg.
Pharmaceutical Formulations Comprising Stabilized Polysaccharides And Source Of Hydrogen Peroxide
Erning Xia - Penfield NY, US Michael E. Allen - Webster NY, US Steven K. MacLeod - Henrietta NY, US Tammy J. Kleiber - Rochester NY, US Graig M. Cody - Scottsville NY, US
International Classification:
A61K 33/40 A61K 33/22 C11D 3/04
US Classification:
424616, 424613, 510115
Abstract:
A pharmaceutical formulation that is effective in adversely affecting the viability of microorganisms or in inhibiting their growth and that provides better safety and/or comfort to the users comprises a polysaccharide, a source of hydrogen peroxide, and an anti-oxidant. The formulation can further comprise a chelating agent and/or an ophthalmically active agent for treating or controlling a disease or disorder of the eye. The formulation may be used to treat, clean, disinfect, store, wet, or rewet contact lenses.
Method For Preparing Suspensions Of Low-Solubility Materials
Steven K. MacLeod - Henrietta NY, US Daniel J. Stein - Rochester NY, US James Donald Hayes - Tampa FL, US Donald L. Herber - Tampa FL, US
International Classification:
A61K 9/50 A61K 47/30
US Classification:
424501, 5147721
Abstract:
A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient (“API”) having low solubility, the process comprises: (a) preparing a first solution comprising a carboxy-containing vinyl polymer and a solvent; and (b) adding a compound of the API to said first solution under conditions of high-shear mixing for a time from about 5 minutes to about 5 hours, said compound being soluble in said solvent, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer; wherein a concentration of said API in said suspension is higher than a solubility of said API in said solvent. The present invention also provides a suspension produced by such process.
Method For Preparing Suspensions Of Low-Solubility Materials
A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient (“API”) having low solubility, the process comprises: (a) preparing a first solution comprising a carboxy-containing vinyl polymer and a solvent; and (b) adding a compound of the API to said first solution under conditions of high-shear mixing for a time from about 5 minutes to about 5 hours, said compound being soluble in said solvent, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer; wherein a concentration of said API in said suspension is higher than a solubility of said API in said solvent. The present invention also provides a suspension produced by such process.