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Published on: October 20, 2018
Hydrolysis profiling: an in vitro methodology to predict in vivo absorption time
Benjamin D Fitz1, Dennis D Jamiolkowski
1Research and Development, Ethicon Inc. (A Johnson & Johnson Company), US Route 22 West, Somerville, New Jersey, USA. bfitz@its.jnj.com
Summary
A new in vitro method estimates the degradation time of synthetic bioresorbable sutures. This hydrolysis profiling technique can accelerate product development and reduce animal testing for medical devices.
Area of Science:
- Biomaterials Science
- Polymer Chemistry
- Medical Device Development
Background:
- Synthetic bioresorbable polyesters are widely used in medical sutures.
- Accurate prediction of in vivo degradation time is crucial for clinical performance and safety.
- Current methods for assessing suture degradation can be time-consuming and require animal testing.
Purpose of the Study:
- To develop and validate an in vitro method for estimating the in vivo degradation time of synthetic bioresorbable sutures.
- To establish the applicability of hydrolysis profile methodology using model compounds and commercial suture products.
- To investigate the influence of suture size and chemical composition on degradation behavior.
Main Methods:
- Development of an in vitro hydrolysis profiling technique.
- Testing of model compounds and commercially available bioresorbable sutures.
- Determination of hydrolysis profiles as a function of suture size and chemical composition.
Main Results:
- A reliable in vitro method for estimating suture degradation was established.
- Hydrolysis profiles varied based on suture size and chemical composition.
- The method demonstrated applicability to commercial bioresorbable suture products.
Conclusions:
- The developed in vitro hydrolysis profiling method provides a valuable tool for predicting suture degradation.
- This accelerated absorption testing can significantly shorten product development timelines.
- The methodology offers potential insights into the mechanical property loss of sutures over time, reducing reliance on animal testing.
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