Daniel E Francis

US Patent:

47973889, Jan 10, 1989

Filed:

Jun 26, 1986

Appl. No.:

6/879143

Inventors:

Daniel L. Francis - Ravenna OH

Assignee:

Cetus Corporation - Emeryville CA

International Classification:

A61K 3166
A61K 3170
A61K 4700

US Classification:

514 23

Abstract:

An improved pharmaceutical composition contains galactitol as carrier for the therapeutic agent. One example is a lyophilized composition of about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 5 to 21 parts by weight of galactitol as excipient, and about 1. 4 to 3 parts by weight of water. Preferably, the amount of galactitol is 15-21 parts by weight. The galactitol enhances the chemical and physical stability of the drug and allows faster reconstitution of the formulation in water than mannitol.

US Patent:

46596992, Apr 21, 1987

Filed:

May 21, 1984

Appl. No.:

6/612626

Inventors:

Daniel L. Francis - Ravenna OH

Assignee:

Cetus-Ben Venue Therapeutics - Emeryville CA

International Classification:

A61K 3170
C07H 100

US Classification:

514 53

Abstract:

A two-stage process for freeze-drying an aqueous solution of a dosage amount of cyclophosphamide to yield a hydrate of cyclophosphamide (referred to as "CPA" for brevity), comprises, in a first stage, freeze-drying a solution of CPA in combination with an excipient until the moisture content of the freeze-dried material is less than 2% by wt, based on the amount of anhydrous CPA present; and, in a second stage, rehydrating the freeze-dried material until the moisture content of the product is in the critical range of from about 2% to 7% by wt, based on the net wt of CPA product, it being essential for stability of the product that at least one sugar excipient be present. The process requires that a major amount by weight of the excipient(s) or all of it, be mannitol, optionally with an additional sugar and/or a carboxylic acid, and/or a buffer salt; and, the mannitol is present in an amount at least one-half (0. 5 times) as mush as the CPA (anhyd) present. To produce a dosage form of a `plug` or `cake` which is free of flakes and granules, or bubbles on its surface, and/or voids within the product (or "plug"), any of which are individually no greater than 2 mm in equivalent diameter ("equiv. dia.

US Patent:

49238760, May 8, 1990

Filed:

Jun 9, 1988

Appl. No.:

7/204391

Inventors:

Daniel L. Francis - Albuquerque NM
Robert Kasubick - Auora OH

Assignee:

Cetus Corporation - Emeryville CA

International Classification:

A61K 3144

US Classification:

514283

Abstract:

Disclosed herein are ready-to-use solutions comprising pharmaceutical compositions suitable for intravenous injection which are stable at room temperature. Pharmaceutical formulations of this invention comprise aqueous compositions of a pharmaceutically-acceptable vinca dimer salt, a citrate buffer and a preservative, wherein the composition pH is between 3. 0 and 5.