It is the patient compliance and stability in
combination with controlled drug delivery and biocompatibility that
forms the core feature in present research and development of
sustained biodegradable patch formulation intended for wound
healing. The aim was to impart sustained degradation, sterile
formulation, significant folding endurance, elasticity,
biodegradability, bio-acceptability and strength. The optimized
formulation comprised of polymers including Hydroxypropyl methyl
cellulose, Ethylcellulose, and Gelatin, and Citric Acid PEG Citric
acid (CPEGC) triblock dendrimers and active Curcumin. Polymeric
mixture dissolved in geometric order in suitable medium through
continuous stirring under ambient conditions. With continued stirring
Curcumin was added with aid of DCM and Methanol in optimized
ratio to get homogenous dispersion. The dispersion was sonicated
with optimum frequency and for given time and later casted to form a
patch form. All steps were carried out under strict aseptic conditions.
The formulations obtained in the acceptable working range were
decided based on thickness, uniformity of drug content, smooth
texture and flexibility and brittleness. The patch kept on stability
using butter paper in sterile pack displayed folding endurance in
range of 20 to 23 times without any evidence of crack in an
optimized formulation at room temperature (RT) (24 ± 2°C). The
patch displayed acceptable parameters after stability study conducted
in refrigerated conditions (8±0.2°C) and at RT (24 ± 2°C) up to 90
days. Further, no significant changes were observed in critical
parameters such as elasticity, biodegradability, drug release and drug
content during stability study conducted at RT 24±2°C for 45 and 90
days. The drug content was in range 95 to 102%, moisture content
didn’t exceeded 19.2% and patch passed the content uniformity test.
Percentage cumulative drug release was found to be 80% in 12h and
matched the biodegradation rate as drug release with correlation
factor R2>0.9. The biodegradable patch based formulation developed
shows promising results in terms of stability and release profiles.
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