Ginger Rothrock

Nasal Dry Powder Vaccine Delivery Technology

Nasal delivery of vaccines occurred over a millennium ago in China, where ground scabs from small pox lesions, presumably containing live virus, were sniffed. This practice was the basis for early vaccination with live virus in Europe in the eighteenth century. In the past decade, a number of reports have focused on new antigens, adjuvants, and delivery systems, but few approaches have entered development as a clinical candidate. This chapter outlines the critical steps needed to create a comprehensive integrated strategy adopting an antigen, with candidate physical and biochemical adjuvants, in a delivery system. There is a need to define unique formulation and device performance properties, evaluate dose sparing achieved through novel construction and adjuvancy, and develop rapid screening methods to identify toxic formulations.

A moldable sustained release bupivacaine formulation for tailored treatment of postoperative dental pain

A moldable and biodegradable dental material was designed for customized placement and sustained delivery of bupivacaine (BP) within an extraction cavity. Microparticles comprising poly(lactic-co-glycolic acid) (PLGA) containing BP were generated via solvent-evaporation and combined with absorbable hemostat Gelfoam®. Kinetics of drug release were evaluated by in vitro dialysis assays, showing higher release within the first 24 hours, with subsequent tapering of release kinetics. Formulations of Gelfoam® and BP-PLGA microparticles (GelBP), with three targeted dosing profiles (0.25, 0.5, and 1 mg/kg/day), were evaluated alongside acute subcutaneous BP injections (2 mg/kg) to determine analgesic efficacy in a rat model of tooth extraction pain. Molar extraction resulted in mechanical and thermal cold hyperalgesia in male and female rats. GelBP outperformed acute BP in blocking post-surgical dental pain, with the 0.25 mg/kg GelBP dose preventing hypersensitivity to mechanical (p < 0.01) and thermal cold stimuli (p = 0.05). Molar extraction also resulted in decreased food consumption and weight. Males receiving acute BP and 0.25 mg/kg GelBP maintained normal food consumption (p < 0.002) and weight (p < 0.0001) throughout 7 days. Females, receiving 0.25 mg/kg GelBP maintained weight on days 5–7 (p < 0.04). Customized, sustained release formulation of anesthetic within a tooth extraction cavity holds potential to eliminate post-operative dental pain over several days.

Methods for assessing the adherence to medical devices

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