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The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.
Acura Pharmaceuticals announced it has initiated a manufacturing scale-up of LTX-03 (hydrocodone bitartrate and acetaminophen) tablets for clinical testing with Catalent Pharma Solutions.
According to a Sept. 9, 2019 press release, the tablets use LIMITx Technology, which is designed to obstruct the release of active drug ingredients when too many tablets are ingested by neutralizing stomach acid with buffer ingredients. The technology also delivers efficacious amounts of the drug when taken as a single tablet with a nominal buffer dose.
Four clinical studies of formulations using the technology have already been completed and showed proof-of-concept and have identified the key components of its formulation for advancement to formal clinical testing.
The formulation and manufacturing process optimization process for LTX-03 tablets is currently nearing completion.
Source: Acura Pharmaceuticals