Innovative pharmaceutical form: Technology of chewable gel tablets

Abstract

Background. Among gel-based products, chewable gel tablets are one of the fastestgrowing categories in the pharmaceutical industry. The pharmaceutical form with a gel base resembles gummies, but it can have an active substance, a pharmacological effect, or nutritional value [1]. These tablets have a soft, elastic texture influenced by their ingredients. One of the main excipients in the production of chewable gel tablets are gelling agents such as gelatin, pectin or starch. Due to its ability to easily form gel structures, gelatin is mostly used to make chewable gel tablets. Gelatin is natural, colorless or slightly yellowish substance, and is obtained from collagen, a protein that is found in connective tissues [2,3]. Having a melting point close to human physiological temperature, gelatin gels dissolve rapidly in the gastrointestinal tract, which is important for achieving optimal and constant bioavailability of pharmaceutical chewable gel tablets [4,5]. In chewable gel tablets, the amount of gelatin can vary from 5% to 12% depending on the hardness of the final product and the excipients included [6]. Purpose. The purpose of this study was to evaluate the dependence of the hardness and stickiness of chewable gel tablets on the amount of gelatin. Methodology. Three series (B1, B2, B3) of chewable gel tablets with different gelatin amount (6%-10% of gelatin) were prepared by using silicones forms and were stored at room temperature 20±5°C in open and closed containers for one week. Texture properties such as hardness and stickiness were evaluated by texture analyzer TA.XT.plus. Measuring were repeated 3 times and an average with a standard deviation is presented. Also, mass variation of gel tablets after one week were measured (n=10). Chewable gel tablets base was made from gelatin, water and glycerol. The amount of base was melted and honey was added. A citric acid solution (2%) as a preservative was added. A chewable gel tablets example and changes during storage is presented in Figure 1. Results. Chewable gel tablets’ hardness and stickiness (Figure 2) after preparation were 363,68±37,41-638,15±22,56 g and 14,14±0,98-21,65±3,59 g (tablets with the least gelatin amount 47 had the smallest values of hardness and stickiness, while those with the most gelatin amount were the hardest and stickiest). After a week, chewable gel tablets that were stored in a closed container became moldy. The chewable gel tablets that have been stored in an open environment became even more hardened after a week (5.7 times more compared to just made tablets), and the stickiness of all of them decreased 2.7 times, p<0.05). Masses of gel tablets after preparation were 2,512±0,037 g, 2,529±0,015 g and 2,573±0,038 g (respectively, 6%, 8% and 10% of gelatin). After a week, mass decreased about 63%, p<0.05 (opened container). This high weight loss was due to the low amount of sweetener in the chewable gel tablets and the high amount of water. For these reasons, weight was statistically significantly reduced when tablets were kept open in container. Conclusions. A just made chewable gel tablets had the best texture compared with samples after one week. Gelatin content directly affects how hard gel tablets are; the more gelatin, the harder the tablets. In freshly made chewable gel tablets, stickiness was highest where the gelatin content was highest. After a week, stickiness was highest where the amount of gelatin was lowest. Chewable gel tablets were produced using 20% honey, this amount of sweetener is too low, so the chewable gel tablets went moldy after a week. Future research will be conducted to find an optimal composition that would remain stable for a long time.