Integration of hydrogel forming microneedles with polyethylene glycol reservoir assisted clindamycin dermal delivery

Abstract

Diabetic ulcers (DU), commonly caused by impaired circulation and bacterial infection, remain a leading source of morbidity and mortality in patients with diabetes mellitus worldwide. Clindamycin (CLD) is recommended for mild to moderate DU infections, targeting Staphylococcus aureus and Streptococcus spp.; however, current CLD formulations still present several limitations. Therefore, the development of alternative dosage forms is essential to overcome these challenges. To develop a new strategy in delivering Clindamycin precisely to the target of action and controlled with a Hydrogel Forming Microneedle (HFM) system integrated with a PEG reservoir. Clindamycin will be made in the HFM system using the crosslink method of 2 types of polymers then Clindamycin will be formulated into a PEG reservoir with several types of PEG combinations from different MWs to optimize CLD loading, then physical and chemical characterization, ex vivo permeation and antibiofilm activity testing will be carried out. The HFM was successfully developed with desirable mechanical strength and reliable insertion performance (penetrate up to 72% of needle height). The results of the ex vivo permeation test showed that this formulation successfully delivered CLD through the dermal route with an efficiency of up to 85% (equivalent to 21.3 ± 1.57 mg/mL). The antibiofilm activity of all three HFM formulations was significantly different (p < 0.05) from that of the plain hydrogel. The development of Clindamycin in the form of HFM integrated with a PEG reservoir produces a Clindamycin preparation with good, safe and non-invasive characteristics.

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