The investigation concluded that by adding Hyasis®, the Bacillus-derived Hyaluronic Acid (HA) used in the study formulated by Novozymes Biopharma, into a tablet containing tramadol hydrochloride for oral administration, the release of tramadol hydrochloride can be prolonged from 1.9 to 7.5 hours. A good correlation has been identified between the added amounts of HA and the drug release time, and this correlation gives excellent possibilities for developing specific drug release profiles for different oral drug applications.
“These results represent another step forward in meeting the emerging challenges in drug development, and we are delighted to be presenting our latest findings at the CRS annual meeting,” says Hans Ole Klingenberg, Global Marketing Director, Novozymes Biopharma. “We are committed to developing compliant formulation solutions that ensure improved stability, solubility and half-life of therapeutics and we are delighted to demonstrate how these innovative products can streamline the drug development process.”
Experimentally, the drug release was assessed by dissolution analysis using a closed loop system configuration (SOTAX CE7smart) and USP 4 dissolution method with 22.4mm dissolution cells. The tramadol was detected on-line with UV absorbance at 270nm.
Novozymes Biopharma’s Hyasis® is an ultra-pure material with exceptionally low amounts of nucleic acids, proteins, bacterial endotoxins and microbial contamination. With a reproducible molecular weight and narrow size distribution, it is well-tolerated, safe and biocompatible, allowing the sustained and controlled release of drugs in a HA concentration dependent manner.
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