Issue link: https://www.e-digitaleditions.com/i/1199406
22 January 2020 Tablets & Capsules VSC outlook While the supply of gelatin-free soft capsules is still in its nascent stage, demand for vegetarian capsule shells, whether plant derived or synthetic, is growing. VSCs have the potential to reach a considerable market share in the future using the gelatin substitutes discussed in this article. Decreasing material costs and increasingly opti- mized processes also provide opportunity for growth in the number of VSC products on the market. Existing products have demon- strated the feasibility and consistency of VSC materials and manufacturing processes. While there are some chal- lenges associated with VSC manu- facturing, the products demonstrated physical stability at accelerated con- ditions. However, disintegration times were longer for VSCs at stability con- ditions compared to GSCs, which should be evaluated, as disintegration time is a critical quality attribute. T&C References 1. Bjor n Ve r g a u we n, " C r e at- ing the perfect capsule," Phar ma Focus Asia, Available at: www.pharmafocusasia.com/ research-development/creating-perfect-capsule. 2. FAO report. 3. Beroe analysis. 4. IMR International, Hydrocolloid Information Cen- ter, "Food Hydrocolloid Extracts 5, 10, or 15 Years," Avail- able at: www.hydrocolloid.com/summary_extracts.php. 5. Beroe interaction with supplier. 6. Katy Askew, "On the frontline of climate change: Cargill building 'resilience' into its red seaweed supply chain," Available at: www.foodnavigator.com/Article/ 2019/03/14/On-the-frontline-of-climate-change-Cargill- building-resilience-into-its-red-seaweed-supply-chain. 7. Beroe analysis based in secondary research. 8. MarketWatch, "EU Modified Starch Market: Ingre- dion Inc., Cargill Inc., Bunge Ltd.," Available at: www. marketwatch.com/press-release/eu-modified-starch-market- ingredion-inc-cargill-inc-bunge-ltd-2019-07-01. 9. Available at: www.optinutra.com/quality/. 10. Beroe analysis. Claudia Silva, PhD, is director of new pharmaceutical technol- ogies at Procaps (575 371 9000, www.softigel.com). Kirti Vatsa is principal analyst at Beroe (919 747 4818, www.beroeinc.com). The moisture content in fresh capsule shells may be about 20 percent, depending on the formulation, and drying time is comparable to GSCs. The filling volume should determine the proper die roll size, since overfill- ing affects the seal strength and the shells may contract during drying. Despite some particular processing requirements, for- mulations containing carrageenan are straightforward to encapsulate compared to modified starch because of their consistency batch to batch, robust film formation, elasticity, seal strength, and stabilit y at var ying moisture and temperature conditions. In-process controls include tem- peratures at different points in the encapsulation machine, film thick- ness, and weight variation. Physical testing of the capsules includes hard- ness, burst test, film and seal thick- ness, and shell moisture content. Stability of VSC products Fig ure 1 shows the results of a study comparing the hardness, burst test, seal percentage, shell moisture content, and disintegration time for several marketed VSC products at stability conditions. The study compared the properties of two Procaps VSC products (S1 and S2) and four commercial VSC products made from C-MS at 40°C, 75 percent RH at initial time (M0), 1 month (M1) and 3 months (M3). In general, VSC hardness has been reported to be as low as 2.0 newtons and not comparable to GSCs. Most VSCs are nutritional products containing either single oils or oily suspensions using only glycerol as a plasti- cizer. Hardness can be a reference for the final drying time, and low hardness values could compromise the products during bulk storage and transport. Burst test and percentage of the trailing seal are a measure of the seal quality, ranging roughly from 100 to 300 newtons and 50 to 87 percent, respectively, at the initial time, as shown in the figure. Percent seal values in VSCs can be as high as 80 percent depending on the die roll design. Disintegra- tion times were determined under USP conditions for rupture time of soft capsules (USP apparatus 2), con- sidering the total disintegration of the shell as final point for visual detection. At stability conditions, phys- ical properties tended to decrease but not to an unac- ceptable level, with the exception of the disintegration times, which in some cases, were observed to be longer than 30 minutes. While VSCs show a lag time in disso- lution due to the slow hydration of the shells, they are not prone to crosslinking, as gelatin is, so the cause of the increased disintegration times at stability condi- tions is unclear. While the supply of gelatin-free soft capsules is still in its nascent stage, demand for vegetarian capsule shells, whether plant derived or synthetic, is growing.