Feb 19, 2024

Alkaloid AD Skopje Makes a Groundbreaking Achievement in Treating Reflux Esophagitis and GERD with the World's First Patent for Liquid Omeprazole

In recent years, Alkaloid has embarked on a process of redesigning existing generic pharmaceutical products for new indications. The goal was to develop drugs with added value that address the treatment and fulfill the needs of individual or specific patient groups. Strategic investments aimed at modernizing the product portfolio resulted in the successful development of Alkaloid's first patented value-added drug. This drug is primarily designed to treat reflux esophagitis and gastroesophageal reflux disease (GERD) in young children unable to swallow tablets, as well as in adult patients who have difficulty swallowing (dysphagia patients) and those with an inability to swallow (gastric feeding tube patients and/or geriatric patients).

These conditions are some of the most common in gastroenterohepatology, manifested by the return of gastric acid into the esophagus, leading to discomfort and possible long-term complications. Proton pump inhibitors, including Omeprazole, are the preferred medications for treating reflux esophagitis and GERD. These medications are typically available in the form of gastro-resistant tablets and capsules, as well as powder for dissolution. In a groundbreaking discovery, Alkaloid has developed ready-to-use liquid Omeprazole for the first time in history.

The novelty of this Alkaloid product lies in enclosing two separate solutions in a dual-chamber package.  Upon opening, these solutions automatically mix to provide ready-to-use liquid Omeprazole. The product has a pleasant lemon and menthol flavor and is free from sugar, sorbitol, and artificial coloring. To accommodate the specific requirements of this drug’s manufacturing process, the company invested in a custom-built machine tailored to this innovative product, ensuring an efficient and sustainable global supply chain.

Alkaloid obtained the first international value-added medicine (VAM) patent for the Omeprazole peroral solution. The first marketing authorizations for this groundbreaking medication have been granted for both the Macedonian and UK markets. Registration processes are underway for European countries and European Union markets, with the anticipation of obtaining marketing authorizations and subsequent product launch.

This product underscores Alkaloid's dedication to excellence in the pharmaceutical industry, marking a milestone in generic drug manufacturing through innovation, market differentiation and catering to specific patient groups. At present, the company's development laboratories are actively working on several other innovative formulations.