Alivio Therapeutics, Inc.

Derek G Van Der Poll

Gregory T Zugates

Dominick J Blasioli

A non-injectable formulation or formulation for instillation, including self-assembling hydrogels formed of gelators such as the Food and Drug Administration's Generally Regarded as Safe (GRAS) compounds like ascorbyl palmitate, in the form of capsules, tablets, oral suspensions, enemas, and rectal or vaginal suppositories or inserts have been developed. In a preferred embodiment, the formulation contains anti-inflammatories, anti-infectives, or other therapeutic, prophylactic, or diagnostic agents that can be administered orally, especially when lower blood levels relative to tissue levels of agent are preferred. In the most preferred formulation, the composition contains tacrolimus-loaded ascorbyl palmitate gel microfibers containing nanostructures ('hydrogels').

Non-injectable hydrogel formulations for smart release

A gel formulation has been developed which provides high loading, e.g., between about 5% and about 50% wt/wt agent/total gel weight, of a wide range of agents, especially amine-containing compounds such as local anesthetic agents that are known to be difficult to encapsulate, and which adhere to charged surfaces. Examples of pharmaceutically important amines include anesthetics, such as lidocaine. Tuning the ionic strength of an aqueous medium during preparation, suspension, and dialysis purification of the hydrogel composition allows for retention and/or control of agent loading contents, as well as a high capacity for adhesion to charged surfaces mimicking inflamed tissue. In some instances, the rheological properties of the gel can be tuned such as to impart thixotropic properties to the gels formed.

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Medford, MA, United States of America

Derek G Van Der Poll