Syntex (u.s.a.) Inc.

Deborah M Lidgate

Leo Gu

Philip L Felgner

William A Lee

Anthony C Allison

Noelene E Byars

Richard Maskiewicz

Cherng-Chyi R Fu

Cherng-chyi Fu

Victoria M Knepp

Roger F Cherng-Chyi

Linda C Foster

Sayee Gojanan Hegde

Bindu Joshi

Li-hua Wang-Kessler

Stable, aqueous pharmaceutical formulations of human nerve growth factor (NGF) in aqueous isotonic solutions, buffered to maintain the pH from about 4.5 to about 6.0, and optionally containing a carrier such as human serum albumin are provided. Also provided are aqueous NGF formulations suitable for lyophilization and subsequent reconstitution in which rhNGF is admixed with sugars, optionally HSA, and buffer. The formulations are useful for the treatment of Alzheimer's disease and other neuronal disorders.

Pharmaceutical formulations of nerve growth factor

High dose, dry granulations or powder blends and aqueous oral suspensions of mycophenolate mofetil or mycophenolic acid, contain: active compound (7.5-30%), suspending/viscosity agent, sweetener, flavor, buffer (to a pH of 5-7.5), and optionally contain flavor enhancer, wetting agent, antimicrobial agent and color.

Mycophenolate mofetil high dose oral suspensions

Stable, clear, antimicrobially effective, ophthalmic formulations are disclosed which provide an antimicrobially effective preservative. The formulations include an ophthalmologically effective amount of a drug, which is a --COOH group-containing non-steroidal anti-inflammatory drug (NSAID) alone or in combination with an antibiotic drug, and a preservative system formed of a quaternary ammonium preservative and a nonionic polyoxyethylated octylphenol surfactant, all in an aqueous vehicle. The preservative system can be used with other formulations which require the preservative to be ophthamologically acceptable and antimicrobially effective. These formulations are useful for treating diseases and/or conditions that are either caused by, associated with or accompanied by inflammatory processes, including, among others, glaucoma, cystoid macular edema, uveitis, diabetic retinopathy and conjunctivitis, or any trauma caused by eye surgery or eye injury. When the formulation is further comprised of an ophthalmologically acceptable antibiotic, the antibiotic is preferably tobramycin which has been found not to interfere with the rate of diffusion of the NSAID. The combination of the NSAID and antibiotic is particularly effective in simultaneously preventing and/or eliminating infection while preventing and/or eliminating inflammation.

Preservative system for ophthalmic formulations

This invention is directed to an adjuvant composition in the form of an emulsion which is comprised of an emulsion-forming amount of a non-toxic tetra-polyol or of a POP-POE block polymer and an immunopotentiating amount of a muramyldipeptide of the formula: ##STR1## or a pharmaceutically acceptable salt thereof, where R and R.sub.1 are each independently H or acyl of 1 to 22 carbon atoms, R.sub.2 is optionally substituted alkyl or optionally substituted aryl, R.sub.3 is H, alkyl, or aryl, R.sub.4 is H or lower alkyl, X is L-alanyl, L-.alpha.-aminobutyryl, L-arginyl, L-asparginyl, L-aspartyl, L-cysteinyl, L-glutaminyl, L-glutamyl, glycyl, L-histidyl, L-hydroxyprolyl, L-isoleucyl, L-leucyl, L-lysyl, L-methionyl, L-ornithinyl, L-phenylalanyl, L-prolyl, L-seryl, L-threonyl, L-tyrosyl, L-tryptophanyl, or L-valyl, and Y is D-glutamine, D-isoglutamine or D-isoasparagine. This invention is also directed to a vaccine containing an antigen and an adjuvant composition of the invention. This invention is also directed to a process of preparing an adjuvant composition and a vaccine of the invention. This invention is also directed to a kit for extemporaneous preparation of an adjuvant composition and a vaccine of the invention.

Vaccine adjuvant

Stable, clear, antimicrobially effective, ophthalmic formulations include an ophthalmologically effective amount of a drug, especially a --COOH group-containing drug or a NSAID, and a preservative system formed of a quaternary ammonium preservative and a nonionic surfactant, all in an aqueous vehicle. These formulations are useful for treating diseases that are either caused by, associated with or accompanied by inflammatory processes, including, among others, glaucoma, cystoid macular edema, uveitis, diabetic retinopathy and conjunctivitis, or any trauma caused by eye surgery or eye injury.

Ophthalmic NSAID formulations containing a quaternary ammonium

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Los Altos, CA, United States of America

Deborah M Lidgate