Tablets & Capsules

TC0917

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48 September 2017 Tablets & Capsules level greater than 11 percent in fish oil formulations sig- nificantly increased the risk of stickiness [8]. Research also shows that drying constraints and thermal history have a significant effect on achieving ideal moisture levels. Overcoming challenges Creating softgels is complex, and their development often presents multifaceted challenges. For instance, the bioavailability of active ingredients relies on the dissolu- tion of both the softgel shell and its fill, as well as the phar- macokinetic features of the API. During storage, however, the capsules may encounter excessive heat and moisture, which can degrade their stability and shelf-life [9]. To ensure stability and optimal API delivery, maintain mois- ture at the correct level, usually between 6 and 12 percent. A softgel's makeup can pose other challenges, includ- ing the migration of the product's components and the physical and chemical reactions between the shell and fill. In addition, external environmental influences can cause instability, brittleness, softness, or loss of shape. Any of those changes can affect how well the API is pro- tected against oxidation and/or cause recrystallization. Dynamic structures, such as polyethylene glycol-based (PEG) systems, are another example. They demonstrate a gradient in moisture level between the hydrophilic PEG fill and the shell, which can cause water to migrate after encapsulation. This leads to instability and reduces the product's effectiveness. Preventing these effects requires careful selection of the shell formulation and precise gelatin processing. An additional formulation challenge is the potential for extensive crosslinking, which occurs when strong chemical linkages form between gelatin chains. The result is a shell that becomes tough and rubbery, which Figure 1 Comparative analysis of foam capacity and foam stability of different gelatin types [7] Figure 3 Effect of different gelatin types on crosslinking behavior in the presence of aldehydes [10] Figure 2 Effect of final moisture level on the stickiness of fish oil softgels [9] Low reactivity Crosslink rectivity High reactivity Viscosity Normal 15% Normal 94% Sticky 6% Sticky 85% Moisture < 11% Moisture > 11% 160 140 120 100 80 60 40 20 0 50 100 150 200 250 300 Foam volume (cm 3 ) Time (s)

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