Evaluation of TRI-726 as a drug delivery matrix

Abstract

Background: The TRI-726 polymeric drug delivery matrix is a newly-developed biocompatible hydrogel exhibiting in situ reverse-thermal gelling, mucoadhesivity, and sustained-erosion properties.

Methods: Using two model drugs, clindamycin hydrochloride and acetaminophen, we determined the gelling temperatures, in vitro release profiles, kinetics of matrix erosion, rheological properties, mucoadhesive strength, microbiological activity of released clindamycin, and biocompatibility when in contact with cells.

Results: It was demonstrated that none of the excipients contained in the TRI-726 polymer matrix caused any loss in clindamycin’s antimicrobial activity following incorporation into the polymer matrix. Thus, the new patent pending TRI-726 drug delivery matrix was both inert and non-reactive toward the incorporated clindamycin in terms of chemical degradation (<10% degradation under accelerated conditions over 6 months) and antimicrobial activity.

Conclusions: This new drug delivery matrix is capable of releasing a wide variety of water-soluble drug compounds over an approximate 10-day period, due primarily to protracted dissolution/erosion of the three-dimensional polymer matrix in an aqueous-based biophase. Additionally, TRI-726 exhibits excellent mucoadhesive properties that would allow a candidate drug/TRI-726 formulation to adhere and remain at a potential application site for an extended period of time. Lastly, the biocompatibility tests affirmed the non-toxic and biocompatible nature of TRI-726 when in contact with cells, which suggests its suitability and versatility as a drug delivery matrix for the targeted administration of a wide range of pharmaceutical compounds where in situ gelation, protracted release of the active, and mucoadhesion of the formulation are desired.

Keywords::

• Hydrogel
• reverse-thermal gel
• mucoadhesive
• biocompatible
• sustained-release

Acknowledgements

The authors wish to acknowledge the expert assistance of Mr. Tim L. Quinn with all of the microbiological testing conducted in this investigation. The authors also wish to acknowledge the expert assistance of Dr. Betty Herndon for the use of her microbiological facilities and for providing us with the particular strain of Staphylococcus aureus we used in this investigation.

Declaration of interest

The corresponding author (T.P.J.) acts in the capacity of a consultant to Trilogic Pharma, LLC. Furthermore, the work presented herein was financed by Trilogic Pharma, LLC with a contract to the Johnston Laboratory. Dr. P.M. is a post-doctoral fellow in the Johnston laboratory and is paid from funding supplied by Trilogic Phama, LLC to the Johnston Laboratory. Dr. H.A. is the Vice-President and Chief Scientific Officer of Trilogic Pharma, LLC.