Non-aqueous topical solution of diclofenac and process for preparing the same
A non-aqueous topical solution composition of pharmaceutically acceptable salt of diclofenac is disclosed. The non-aqueous topical solution composition comprises therapeutically effective amount of pharmaceutically acceptable salt of diclofenac, solublizer, penetration enhancer and solvent, and optionally a humectant, counter irritant, additional penetration enhancer and anti-oxidants and a process for preparing the same.
1. A novel composition comprising:
an effective amount of pharmaceutically acceptable salt of diclofenac in the range of 1.16% to 5% w/v;
a penetration enhancer and solubilizer in the range of 10 to 20% v/v of a lower chain alcohol;
a solvent in an amount greater than 75% and selected from propylene glycol, glycofurol and mixtures thereof; and
an additional penetration enhancer in the range of 1 to 5% w/v, and selected from the group consisting of
oleic acid,
N-methyl-pyrrolidone (NMP),
2-methyl-pyrrolidone, and
1-methyl-pyrrolidone;
wherein the composition is a non-aqueous topical solution.
2. The composition according to claim 1 , consisting essentially of the pharmaceutically acceptable salt of diclofenac, the additional penetration enhancer and solubilizer, the solvent, and the additional penetration enhancer.
3. The composition according to claim 1 , wherein the solvent is greater than or equal to 60%.