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Journal of Bioactive and Compatible Polymers
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In Vitro Evaluation of Drug Solubility and Gamma Irradiation on the Release of Betamethasone under Simulated In Vivo Conditions

Mohammad Rafienia

Biomedical Engineering Department, Amirkabir University of Technology, Tehran 15875-4413, Iran

Hamid Mirzadeh

Biomedical Engineering Department, Amirkabir University of Technology, Tehran 15875-4413, Iran, h.mirzadeh{at}ippi.ac.ir

Hamid Mirzadeh

Iran Polymer and Petrochemical Institute, NDDS Research Department, Tehran 14965-115, Iran

Hamid Mobedi

Iran Polymer and Petrochemical Institute, NDDS Research Department, Tehran 14965-115, Iran

Ahmad Jamshidi

Iran Polymer and Petrochemical Institute, NDDS Research Department, Tehran 14965-115, Iran

In situ—forming biodegradable polymeric systems loaded with betamethasone (BTM) and betamethasone acetate (BTMA) (5, 7, and 10% (w/w)) were prepared using poly(DL-lactide-co-glycolide) (33% (w/w)), ethyl heptanoate (5% (w/w)), and N-methyl-2-pyrrolidone as biodegradable material, additive, and solvent, respectively. The effects of gamma irradiation, drug loading, and solvent removal on release profiles were evaluated. The drug release in phosphate-buffered solution (pH = 7.4, 37°C) was measured using high-performance liquid chromatography. The release profiles of irradiated and nonirradiated formulations based on BTMA showed a three-phase release pattern, whereas the pattern for BTM was biphasic. Gamma irradiation had no significant effect on the BTMA release profiles ( p>0.05). Unexpectedly, irradiation had a significant effect on release behavior of BTM ( p<0.05); also, the rate of BTM release was decreased with an increase in drug loading up to 10%. The amount of BTM that was released in the burst phase decreased by about 1.4 and 1.5 times for 7 and 10% BTM loading, respectively. The duration of BTM release was more than that of BTMA. Changes in hydrophobicity and hydrogen bonding had a strong effect on the release behavior of the two forms of BTM from the in situ—forming systems.

Key Words: in situ—forming systems • betamethasone • gamma irradiation • PLGA • drug release • controlled release • drug implant.

Journal of Bioactive and Compatible Polymers, Vol. 22, No. 4, 443-459 (2007)
DOI: 10.1177/0883911507080110
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