Simulating drug-packaging conditions can save up to six months in development time.
For pharmaceutical companies, time is money: Those who get to market first with a new product will often capture the largest customer share and maximize profits.Innovators of new drugs commit considerable resources to developing and seeking approval for breakthrough products. The sooner they can market a new product, the sooner they can begin to see returns on their investment. Time is of the essence for manufacturers of generic drugs, too, since they often have a suite of drug applications pending and vie with competitors to be the first to commercialize their products for the 180-day period of marketing exclusivity. For these reasons, technologies and services that streamline drug development can provide important competitive advantages to drug manufacturers.Sophisticated packaging simulation modeling can help formulation chemists and packaging engineers identify the right conditions in which to ensure the stability and potency of drugs. This mechanism, referred to as ‘pseudo-empirical’ modeling, can be performed early in the development process, guiding production decisions and helping to avoid costly errors that could prove to be roadblocks to production.Pseudo-empirical modeling is a technique that uses empirically derived data measurements from the packaging materials, including moisture vapor transmission rate MVTR through the bottle, surface area of the bottle, sorbent adsorption isotherms, and drug product adsorption/desorption isotherms. Linking these variables together mathematically will pseudo-empirically predict the relative humidity of a pharmaceutical package’s headspace and drug product hydration level over time. This resulting information will ultimately determine the means by which manufacturers can maintain a drug’s chemical and physical characteristics over time.
via Healthcare Packaging.
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