Tablets & Capsules

TC0420

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Tablets & Capsules April 2020 25 Finally, we took a sample for immediate evaluation and packed another sample into 3 HDPE bottles with non- vented caps for a one-month stability study. We then repeated the procedure using MCT oil, mineral oil with 1 percent lecithin, and MCT oil with 1 percent lecithin. An internal sensory panel evaluated all the cleaned ini- tial samples and one-month stability samples in terms of luster, smell, taste, and surface residue. Results and discussion The evaluation results for all cleaned initial samples and cleaned one-month stability samples are summarized in Table 1 and Table 2, respectively. The results indicate that MCT oil alone is most efficient at cleaning residue from softgel capsules. Figure 1 shows the appearance of the one-month stability capsules. Unlike ethanol, mineral and MCT oils are non-volatile liquids and do not negatively impact the environment or human health and safety. Softgel encapsulation machines typically use mineral or MCT oil to lubricate the gelatin ribbons during operation. Mineral oil and MCT oil are also used to clean both hard and soft solid surfaces [2]. Using mineral or MCT oil to clean softgel capsules may overcome the shortcomings of using ethanol. Lecithin is an excellent emulsifier in food systems. Moreover, formulators usually add lecithin to a softgel's liquid fill suspension to improve its viscosity during encapsulation. Because of these characteristics, adding lecithin to mineral or MCT oil may improve the oil's abil- ity to clean leaked material from softgel surfaces. Study method In this study, we used mineral oil, MCT oil, mineral oil with 1 percent lecithin, and MCT oil with 1 percent lecithin to clean a multivitamin-mineral-fish oil softgel product in a pilot-scale Technophar drying basket. We then evaluated samples under initial conditions and under one-month stability conditions (40°C and 75 percent relative humidity) to determine which cleaning agent was most efficient at removing residue from the softgels. For the lecithin-containing cleaning agents, we added 5 grams of lecithin oil into a beaker containing 495 grams of mineral oil and mixed well to obtain a mineral oil with 1 percent lecithin. We also added 5 grams of lecithin oil into a beaker containing 495 grams of MCT oil and mixed well to obtain an MCT oil with 1 percent lecithin. To prepare the softgels for the study, we preweighed 7.0 kilograms of softgels and placed them into the Tech- nophar drying basket. We broke 15 additional softgels and added the contents to the basket of capsules, then tumbled the basket for 30 minutes at 20 rpm. Next, we poured 500 milliliters of mineral oil into a plastic bag, placed 4 oil-ab- sorption paper towels into the bag, shook the bag to sat- urate the towels, and squeezed the residue oil out of each towel. We then placed the towels into the basket with the softgels and tumbled the basket for 90 minutes. Then we removed the oiled towels, added 4 dry oil-absorption tow- els into the basket, and tumbled for another 90 minutes. Cleaning agent Luster Smell Taste Surface residue Mineral oil 2 3 2 No MCT oil 4 4 4 No Mineral oil + lecithin 4 3 2 Yes MCT oil + lecithin 4 3 1 Yes Table 1 Appearance, smell, and taste of cleaned initial samples (1 = Worst, 5 = Best) Cleaning agent Luster Smell Taste Surface residue Mineral oil 1 3 2 No MCT oil 4 3 3 No Mineral oil + lecithin 2 2 1 Yes MCT oil + lecithin 5 2 1 Yes Table 2 Appearance, smell, and taste of cleaned one- month stability samples (1 = Worst, 5 = Best) Figure 1 Appearance of one-month stability capsules a. Capsules cleaned using mineral oil b. Capsules cleaned using MCT oil c. Capsules cleaned using mineral oil with 1 percent lecithin d. Capsules cleaned using MCT oil with 1 percent lecithin

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