Gelation Factors of Pectin for Development of a Dry Jelly, as a Novel Dosage Form
Jellies for oral administration are dosage forms that contain water, as stipulated in the Japanese Pharmacopeia, and heat is generally applied to the jellies during the manufacturing process. Therefore, it is difficult to formulate drugs that may be affected adversely by water and/or heat. To solve this problem, we tried to develop a powder form of gel as a novel dosage form (dry jelly: jelly medicine extemporaneously prepared) that is converted to jelly after addition of water at the time of administration. For this purpose, a basic gel formulation consisting of pectin, glucono-δ-lactone, dibasic calcium phosphate hydrate, and sucrose was investigated to evaluate the critical factors affecting gelation phenomena. The gel form was developed by adjusting the amount of each component of the formulation and of water added. Gelation occurred even with hard water containing metal ions (hardness of approximately 304 mg/L), and no changes in gel hardness occurred. The desired gel hardness could be controlled by adjusting the amount of water. The gel hardness changed over time after the addition of water, but this change did not affect the dissolution behavior of drugs formulated in the dry jelly.
The goal of this study was to develop a novel dry jelly dosage form that did not contain water when stored and that could become a jelly for oral administration by the addition of water at the time of administration. Pectin was used as the gel base, and the influences of various related factors on gelation were studied. The concentration and DM of pectin and control of the dissolution of DCPH by GDL were important factors that affected the gelation of the dry jelly. When pectin is used as the gel base, metal ions contained in the water sometimes can inhibit gelation; however, when the optimum formulation was used, gelation occurred even with hard water (hardness of approximately 304 mg/L), and there were no changes in gel hardness. In addition, the desired gel hardness could be achieved by adjusting the amount of water. Furthermore, changes in the physical properties over time were observed after the addition of water; however, the changes did not affect the dissolution behavior of the test drug.
In this study, the physical properties and functionality of a formulation in which the raw materials were simply combined were evaluated. In the future, we will continue to study the conversion of dry jellies into granules and easily disintegrating tablets with improved physical properties that have good stability and are easily ingestible. We are considering different dry jellies using a variety of gel substrates other than pectin.