New Jersey Patent of the Month – July 2024
Park Therapeutics, Inc. and Enteris Biopharma, Inc. have secured a patent for a calcitonin formulation which is stable at room temperature.
Calcitonin is a hormone that plays a role in regulating the level of calcium in your blood by decreasing it. Injections of calcitonin are often used to treat conditions like Paget’s disease of the bone and to prevent bone loss in women. Park Therapeutics’ room stable calcitonin formulation can be administered orally, removing the need for injections entirely.
The formulation addresses longstanding challenges in peptide therapeutics. Traditionally administered via injection or nasal sprays due to instability in the gastrointestinal tract, calcitonin’s new tablet formulation marks a significant leap forward. The innovation lies in a meticulously designed tablet core, blending calcitonin with coated citric acid, crospovidone, copovidone, silicified microcrystalline cellulose, and magnesium stearate. This composition not only stabilizes the active ingredient but also enhances its bioavailability.
This approach not only enhances the tablet’s shelf-life at room temperature but also ensures consistent and predictable release profiles, meeting stringent regulatory standards for solid dosage forms. By minimizing water content to under 2.5%, the tablet remains stable without requiring refrigeration, marking a significant advancement in patient convenience and medication adherence.
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