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next decade, reaching $316.6 billion by 2025 [3]. This growth stems from several factors, including the increase in consumption of pharmaceuticals and supplements, technological advances, and the expansion of investment opportunities [4, 5]. Softgels' ability to encapsulate liquid or semi-solid formulations of hydrophobic medications is another important growth factor. Softgels also allow rapid dissolution in the digestive tract, which enhances the absorption and bioavailability of otherwise poorly water-soluble active ingredients. In addition to the multiple advantages softgels offer formulators and manufacturers, they increasingly appeal to consumers over other dosage forms because they are easier to swallow and because their airtight seal masks unpleasant odors and tastes. Furthermore, as the "clean" and "clear" label trend continues to gain mainstream appeal, gelatin capsules are well placed to help companies meet growing demand. That is because gelatin, the main excipient in softgels, is a naturally sourced ingredient. It is a fully digestible protein obtained through the partial hydrolysis of colla- gen found in the skin, bones, and connective tissues of animals. A clean-label ingredient, gelatin contains 18 dif- ferent amino acids, including eight of the nine essential amino acids that the human body requires. From raw material selection to production, gelatin undergoes strict and continuous testing and control to ensure maximum traceability, quality, and safety before it is used in softgels. Optimizing API delivery Because gelatin is non-allergenic, gelatin capsules are fully compatible with the human body and can be com- pletely metabolized. In addition, they melt at body tem- perature within 15 minutes, ensuring complete dissolu- tion and an ideally timed release of the active. Gelatin's neutral organoleptic properties and masking capabilities also help R&D specialists to deliver challenging concepts without affecting the finished product's taste or odor. Choosing the correct high-quality gelatin—one with the right functional characteristics—is critical for efficient softgel development, production, and API delivery. To protect the fill from the damaging effects of oxygen and light, for example, the gelatin shell can include opacifiers. Manufacturers are continuously innovating and many of them use tailored gelatin to streamline manufacturing by increasing encapsulation efficiency and optimizing delivery of the active ingredient(s). The right gelatin also helps manufacturers produce high-quality, effective soft- gels consistently, meeting both consumer demands and stringent regulatory requirements. (Gelatin is also used in a number of other pharmaceutical applications.) In addi- tion, gelatin has gelling and film-forming functionalities, thermo-reversible properties, and a unique mechanical resilience, all of which allow formulators to achieve the desired texture and mechanical stability in softgel cap- sules. And again, because gelatin softgels accept liquid compounds, they can improve the bioavailability of poorly soluble actives. Protective barrier Softgels are sealed airtight and provide a protective barrier that shields active ingredients from environmental contamination and oxidation. The seal also prevents ingredients from leaking before their intended release. Tests on lecithin-based softgel formulations have shown that several factors, including gelatin type and processing conditions, have a significant impact on the shell's risk of leakage in critical conditions. Gelatin that is too viscous, for instance, prevents the formation of an effective seal, which leads to misshapen capsules prone to leak. The results of one study showed that using a gelatin engi- neered to a suitable molecular weight, coupled with an optimized wedge during manufacture, decreased the rate of leaking capsules from 2 percent to almost zero. Those two modifications also boosted encapsulation yields [6]. Effective softgel production The three main steps of softgel production are perfect- ing the gel mass, optimizing the ribbon, and drying the capsules properly. To minimize manufacturing costs and create state-of-the art products, it is essential to prepare a gel mass that performs consistently and is not prone to foaming during production. Excessive foam can impair the performance of the vacuum and add costs because it prolongs the manufacturing process. To avoid those problems, conduct comparative analyses of the intrinsic foaming characteristics of various gelatin types. If the product requires a gelatin that foams, adjust the stirring conditions and vacuum to limit foam in the gel mass. The three curves in Figure 1 represent three gelatin variations [7]. Type 1 (red) comes with a high foam func- tion and high stability; type 2 (blue) has a high foam function and low stability; and type 3 (green) has less foam function and less stability. Each curve shows two phases. The first phase corresponds to the increasing amount of foam following the injection of an inert gas, and in the second phase, the amount of foam decreases over time. With this knowledge, it is possible to predict behavior and adjust the settings to prevent defects and maximize operational effectiveness. The second step is perfecting the ribbon. This requires a gelatin that is soluble and versatile, with good mechani- cal strength. Formation of the ribbon—essentially a thick film—requires monitoring and controlling, temperature, seam width, and fill quantity. It is essential that these para- meters be set correctly, because they have a significant impact on gelatin viscosity, and therefore the gelatin's film- forming capabilities. Other critical factors include the pro- cessing speed, gelling proximity, setting temperature, and thermo-reversibility characteristics. All have an effect on encapsulation. Choosing a gelatin with the optimal mechanical strength and elasticity will enable it to stretch during filling and ensure sufficient production speed. The third step is drying, which ensures that the soft- gels reach and maintain a moisture level that prolongs their shelf-life. An adequate moisture level also prevents stickiness. See Figure 2, which illustrates that a moisture Tablets & Capsules September 2017 47