Reshmi Ramakrishnan1, Bharaniraja B1, Abi Santhosh Aprem2. 1. HLL Lifecare Ltd, Corporate R&D Centre, Trivandrum, Kerala, India 695017. 2. HLL Lifecare Ltd, Corporate R&D Centre, Trivandrum, Kerala, India 695017. Electronic address: abi@lifecarehll.com.
Abstract
BACKGROUND: The adverse effects of copper intrauterine devices (IUDs) such as abnormal bleeding, pain and cramps may be due in part to the burst release of copper ions during the first few months of usage. This study focuses on controlling the initial burst release of copper ions. STUDY DESIGN: This study evaluated in vitro release rates of copper for a period of 1 year from standard CuT380 IUDs (n=6) and from CuT380 IUDs coated with poly(dl-lactide-co-glycolide) (PLGA) films (n=6). This study characterized the coated device for its morphological changes during degradation of film by scanning electron microscopy (SEM). RESULTS: CuT380 IUDs coated with PLGA film with a thickness of 0.10±0.02 mm showed a reduced initial copper release (40-80 mcg/day) compared with uncoated CuT380 IUDs (150-200 mcg/day). Statistically significant (p<.05) results were obtained at different time intervals during the overall study period of 1 year. SEM images showed degradation of coating. CONCLUSION: Coating a CuT380 IUD with biodegradable polymer reduced the initial copper release without affecting release at 1 year. Clinical trials are required to determine whether this could reduce side effects such as bleeding and pain associated with copper containing IUDs.
BACKGROUND: The adverse effects of copper intrauterine devices (IUDs) such as abnormal bleeding, pain and cramps may be due in part to the burst release of copper ions during the first few months of usage. This study focuses on controlling the initial burst release of copper ions. STUDY DESIGN: This study evaluated in vitro release rates of copper for a period of 1 year from standard CuT380 IUDs (n=6) and from CuT380 IUDs coated with poly(dl-lactide-co-glycolide) (PLGA) films (n=6). This study characterized the coated device for its morphological changes during degradation of film by scanning electron microscopy (SEM). RESULTS: CuT380 IUDs coated with PLGA film with a thickness of 0.10±0.02 mm showed a reduced initial copper release (40-80 mcg/day) compared with uncoated CuT380 IUDs (150-200 mcg/day). Statistically significant (p<.05) results were obtained at different time intervals during the overall study period of 1 year. SEM images showed degradation of coating. CONCLUSION: Coating a CuT380 IUD with biodegradable polymer reduced the initial copper release without affecting release at 1 year. Clinical trials are required to determine whether this could reduce side effects such as bleeding and pain associated with copper containing IUDs.
Authors: Abhishek Kumar; Anu Sharma; Yi Chen; Megan M Jones; Stephen T Vanyo; Changning Li; Michelle B Visser; Supriya D Mahajan; Rakesh Kumar Sharma; Mark T Swihart Journal: Adv Funct Mater Date: 2020-12-13 Impact factor: 19.924