Background: Acamprosate is a generic drug used in the treatment of alcohol dependence. It is taken long-term (up to 12 months) after alcohol cessation to maintain abstinence. The poor oral bioavailability (~10%) and rapid elimination from the blood stream (half-life ~3 h) requires that acamprosate be administered orally at a relatively high dose (1.3 g/day) three times per day. The frequent dosing, along with behavioral issues associated with alcoholism, make non-compliance a serious concern. A controlled-release formulation that provides acamprosate at a constant rate for a prolonged time with a single parenteral injection could alleviate non-compliance.
Objective: The goals of the project are to investigate the feasibility of a controlled-release acamprosate formulation and design an appropriate delivery system. The delivery system must employ microspheres comprising PLGA 50/50 and should provide acamprosate at a near-constant rate of 130 mg/day for either 30, 60 or 90 days. Microspheres should be no less than 10 µm and no more than 80 µm in diameter.
The effective diffusivity of acamprosate in PLGA 50/50 is a function of polymer molecular weight according to the empirical power law: D(MW) = 5×10–11·MW-1.634
Deliverables: Your report will consist of two main components.
- Market analysis. Evaluate and define the potential market for a controlled-release acamprosate formulation. Possible components of your analysis include the market size and potential market share, market outlook, proposed pricing, possible competitors on the market, technological or intellectual property barriers, and regulatory concerns.