PharmaTher Develops 3D Printed Tablets for Targeted Colon Drug Delivery
Written with artificial intelligence.
PharmaTher Holdings is advancing a series of 3D printed peptide tablets aimed at treating gastrointestinal conditions. These tablets, KPV and BPC-157, are designed to release their active ingredients in the colon, aligning with new U.S. compounding regulations that enable pharmacies to prepare these medications.
Overview of PharmaTher's New Approach
PharmaTher Holdings is spearheading the development of a line of 3D printed peptide products, specifically targeting gastrointestinal conditions through a new U.S. compounding pathway. The initial products are oral tablets containing KPV and BPC-157, both engineered to release their active ingredients directly in the colon. This initiative coincides with a policy by the U.S. Department of Health and Human Services (HHS) that allows Section 503A pharmacies to compound specific peptides.
Key Details of the Compounding Policy
The HHS Enforcement Discretion Policy regarding 503A compounding is set to be published on October 30, 2026. It allows the compounding of six peptides, including BPC-157 and KPV, under strict conditions:
- Peptides must be sourced from an FDA-registered manufacturer.
- Each prescription must be for an individual patient.
- Serious adverse events must be documented.
- Oral formulations must demonstrate adequate human absorption.
Although neither KPV nor BPC-157 is FDA-approved, they can now be prescribed and compounded for oral use under these regulations.
Innovative Drug Delivery Technology
PharmaTher utilizes its M3DICINES platform and a novel technology called CORR3CT (COntRollable Release in 3D printed Colonic Targeting), developed by Craft Health, to create these tablets. The design features a core that delivers the peptide after surviving stomach conditions, aiming to improve treatment outcomes for conditions like left-sided ulcerative colitis. In lab studies, tablets using this technology have shown promising results, delivering significant doses directly to the colon while minimizing pre-release in the stomach.
Commercial Strategy and Future Plans
PharmaTher's strategy involves partnering with established healthcare companies and pharmacies, rather than directly selling to consumers. This approach allows healthcare providers to offer specialized peptide formulations without investing in their own 3D printing capabilities. Future developments may include additional peptide products and colon-targeted formulations of existing gastrointestinal medications, emphasizing the importance of precise drug delivery in treatment efficacy.