US 4,537,883 A · Lyophilized cyclophosphamide

Abstract

A lyophilized pharmaceutical solid composition containing cyclophosphamide for reconstitution with water to provide a solution for oral or parenteral administration. This lyophilized cyclophosphamide solid composition demonstrates improved stability, solubility characteristics and enhanced appearance compared with currently available dry powder pre-mix compositions of cyclophosphamide. The lyophilized solid composition contains about 20 parts by weight of cyclophosphamide, about 11/4-2 parts by weight of water and from about 10-85 parts by weight of excipient which is comprised mainly of mannitol. Processes for making the composition are disclosed.

Claims16

Dependent claims

A hydrated lyophilizate composition with improved stability, superior solubility characteristics and enhanced appearance comprising about 20 parts by weight of cyclophosphamide, taken as the anhydride, about 11/4-2 parts by weight of water and from about 10 to 85 parts by weight of mannitol.

Dependencies are inferred from the claim text.

Facts

Application

06/589,202Filed 13 Mar 1984 · continuation in part

Priority

12 Nov 1982

Granted

27 Aug 1985

Term ends

Not estimatedThe source records don’t support an estimate.

Classification5 codes

A61K 47/26
Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite: carbohydrates, e.g. sugar alcohols,…
A61K 9/0019
Galenical forms characterised by the site of application: injectable compositions; Intramuscular, intravenous, arterial, subcutaneous…
A61K 9/19
Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles: lyophilised , i.e.…
A61K 31/675
Phosphorus compounds: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate

Abstract

Facts

Application

06/589,202Filed 13 Mar 1984 · continuation in part

Priority

12 Nov 1982

Granted

27 Aug 1985

Term ends

Not estimatedThe source records don’t support an estimate.

Classification5 codes

A61K 47/26
Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite: carbohydrates, e.g. sugar alcohols,…
A61K 9/0019
Galenical forms characterised by the site of application: injectable compositions; Intramuscular, intravenous, arterial, subcutaneous…
A61K 9/19
Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles: lyophilised , i.e.…
A61K 31/675
Phosphorus compounds: having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate

Lyophilized cyclophosphamide

Life of this patent

Abstract

Claims16

Lyophilized cyclophosphamide

Life of this patent

Abstract

Claims16