Topical amlodipine salts for the treatment of anorectal diseases

A method for treating an anorectal disease selected from the group consisting of hemorrhoids, anal fissure (acute or chronic), painful conditions after anorectal surgery, prolapsed thrombosed piles, perianal haematoma, or proctalgia fugax, comprising topically applying a stable topical pharmaceutical gel composition of amlodipine besylate to a skin surface of a patient in need thereof, wherein the stable topical pharmaceutical gel composition comprises:

• about 0.01-1% w/w of amlodipine besylate, as measured as the free base, wherein said amlodipine besylate is present in a dissolved state in said gel, and wherein the degradation impurities of said amlodipine besylate is less than about 2.5% for a storage period of at least 24 months at a temperature of about 2-8° C.;
• about 5-75% w/w of at least one glycol solvent;
• about 0.1-10% w/w of hydroxyethyl cellulose;
• about 30-50% w/w of glycerin;
• about 5-15% w/w of ethanol;
• and
• about 15-35% w/w of water.