Formulation of valnemulin
AssigneeNovartis AG
InventorsKurt Koller, Franz Schwarz
Life of this patent
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Abstract
The preparation of an improved galenic delivery form of valnemulin, which is notable for its good tolerance and stability in storage, is described. The new delivery form in question is a non-aqueous or oily injection formulation, which is obtainable by means of in-situ preparation and subsequent stabilisation of the free, relatively unstable base of the active ingredient. A further aspect of the present invention concerns the usage of such an injection formulation in a method of treating infectious diseases in productive livestock or domestic animals.
Claims11
A method of producing a non-aqueous composition comprising a free valnemulin base;
- wherein the free valnemulin base is produced in situ by contacting a salt of valnemulin with a physiologically acceptable non-aqueous solvent or solvent mixture (i) and is stabilized by adding a further solvent (ii).
A method of producing a non-aqueous composition comprising a free valnemulin base;
- wherein the free valnemulin base is produced in situ by contacting a salt of valnemulin with a physiologically acceptable non-aqueous solvent or solvent mixture (i) and optionally stabilizing the composition by adding a further solvent (ii).
The method of producing a non-aqueous composition comprising suspending a salt of valnemulin in a physiologically acceptable non-aqueous solvent or solvent mixture (i), adding an alkaline compound to the suspension while stirring and heating in a temperature range of about 50° C. to about 80° C. in order to effect in situ release of the valnemulin base in solvent (i), separating the aqueous phase and the non-aqueous phase at a temperature of about 50 to about 80°C.;
- washing the valnemulin free base-containing non-aqueous phase with water at room temperature to yield a fresh phase separation at a temperature of about 50 to 80° C.;
- drying the non-aqueous phase and removing volatile components, and mixing the dried non-aqueous phase with a stabilizing solvent or solvent mixture (ii).
Dependencies are inferred from the claim text.