The core reference innovator product for JUPOCIN® Indomethacin Sustained-Release Capsules is Indocin® (formerly known as Xiaoyantong in Chinese), developed by Merck & Co., Inc. (U.S.). As the world’s first marketed indole-based non-steroidal anti-inflammatory drug (NSAID), Indocin® was successfully synthesized by Merck’s R&D team in 1963 and officially approved for marketing by the U.S. Food and Drug Administration (FDA) in 1965. Clinically, it is mainly used for the treatment of inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis, and acute gout attacks.

To address the clinical pain points of the original innovator’s conventional formulations (e.g., capsules, tablets) — including short duration of drug effect, significant fluctuations in blood drug concentration due to multiple daily administrations, and poor patient compliance — our company launched a dedicated formulation R&D project.

With the core goal of “achieving stable 24-hour efficacy control”, the R&D team systematically conducted dosage gradient screening and sustained-release technology optimization studies, based on the pharmacokinetic characteristics of indomethacin (rapid absorption and fast metabolism after oral administration). Through in vitro dissolution tests, in vivo blood drug concentration monitoring, and clinical efficacy evaluation of different strengths (25mg, 50mg, 75mg, 100mg), it was found that when the formulation strength was set to 75mg, combined with an exclusive sustained-release formulation process, the drug could achieve slow and steady release in the body: effective blood drug concentration was reached 1–2 hours after administration, the peak concentration was stable without sudden increase, and the concentration required for treatment could be maintained continuously for 24 hours.

Finally, we confirmed 75mg as the optimal dosage and successfully developed JUPOCIN ® Indomethacin Sustained-Release Capsules that meet clinical needs. Since its production and launch in 1996, the product has passed the dual verification of clinical practice and patients with its stable efficacy, and gained a good reputation.