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Catalent, Acura Enter Clinical Manufacturing Pact

Catalent to scale-up manufacturing of LTX-03 for clinical testing

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Acura Pharmaceuticals has engaged Catalent Pharma Solutions to initiate manufacturing scale-up of LTX-03 (hydrocodone bitartrate and acetaminophen) tablets to ultimately be used in clinical testing. Formulation and manufacturing process optimization work being performed at a different laboratory is nearing completion.
 
LIMITx Technology is designed to retard the release of active drug ingredients when too many tablets are accidentally or purposefully ingested by neutralizing stomach acid with buffer ingredients, but to also deliver efficacious amounts of drug when taken as a single tablet with a nominal buffer dose. Acura has completed four clinical studies of various product formulations utilizing the LIMITx Technology, which have demonstrated proof-of-concept for the LIMITx Technology and have identified the key components of its formulation for advancement to formal clinical testing.

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