Fabrication and In VitroAssessment of Mucoadhesive Gels for Inner Ear Drug Delivery

Document Type : Original research articles

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Department of Pharmaceutices and Pharmaceutical Technology, Faculty of Pharmacy (Girls), Al- Azhar University, Cairo, Egypt

Abstract

The purpose of the current study was to fabricate and assess thermoreversible mucoadhesive in-situ otic gels of ofloxacin. This drug delivery technique may alleviate the drawbacks of conventional otic formulations like short residence time, leakage of medicaments from ear and repeated use. A variety of in situ otic gel formulations were fabricated using various mucoadhesive polymeric ratios of HPMC 100, HEC, carrageenan, chitosan and Carbopol 934. There was no drug-polymer interaction, according to the results of the FTIR and DSC analyses. In the solid state, all formulations appeared to be clear, with pH between (5.1 ± 0.08 and 7.1± 0.04) i.e., no irritation is expected after administration. The gelling temperature was ranged between (28.17± 0.56- 32.11±0.15°C). Mucoadhesive strength was ranged between (512.11±6.35- 3716±14.2 dyne/cm2) that insure prolonged adhesion. The drug content was complied with pharmacopeial range. Sol-gel transition was confirmed by the rheological study at physiological ear temperature. The in-situ gel that was created released the OFX up to 8 hours compared to the ear drops in the market which release the drug within 2 hours. Zero and Higuchi order kinetics were shown by the Kinetic evaluation of the release data. According to the greatest dissolution efficiency % (DE%), F1, F2, F4, F7 and F10 were chosen for short term accelerated test of stability at two different temperatures of 4 ± 2 and 25 ± 2 ºC/60 ± 5% relative humidity (RH). F1 containing poloxamer 407 (18% w/v) and hydroxypropyl methyl cellulose K100 (0.5% w/v) displayed the highest t90 value.

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