Reducing post-surgical adhesions utilizing a drug-enhanced device: sodium carboxymethylcellulose aqueous gel/poly(p-dioxanone) and Tranilast.
Post-surgical adhesion formation has numerous deleterious side effects in a wide variety of surgical settings. Physical barriers used together with laparoscopy were developed to reduce tissue trauma seen with open procedures. However, despite surgeons' meticulous techniques and the use of such barriers, adhesion formation remains a serious clinical problem, creating complications that cost the health care system over $1 billion annually. Our laboratories have combined a previously marketed drug, Tranilast, with a sodium carboxymethylcellulose (NaCMC) gel in a sustained release formulation using poly(p-dioxanone) (PDO) to provide a locally delivered medicated device that significantly reduces adhesions. This paper describes the preparation of the gel and the sustained release formulation, its key physical properties, and its sustained release kinetics. Pre-clinical data on inhibition of adhesion formation by the sustained release poly(p-dioxanone)/sodium carboxymethylcellulose/Tranilast drug enhanced device are also presented.
Cui
Helen
H
Center for Biomaterials and Advanced Technologies, Medical Devices Group, A Division of Ethicon, A Johnson & Johnson Company, Rt 22W, Somerville, NJ 08876, USA.
Gensini
Michel
M
Kataria
Ram
R
Twaddle
Tricia
T
Zhang
John
J
Wadsworth
Scott
S
Petrilli
Janel
J
Rodgers
Kathleen
K
diZerega
Gere
G
Cooper
Kevin
K
D000818:Animals; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000737:chemistry*; D004058:Diffusion; D004357:Drug Synergism; D006801:Humans; D011183:Postoperative Complications / Q000517:prevention & control*; D011817:Rabbits; D051381:Rats; D000267:Tissue Adhesions / Q000517:prevention & control*; D062367:ortho-Aminobenzoates / Q000008:administration & dosage* / Q000737:chemistry*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D062367:ortho-Aminobenzoates; C012293:tranilast