Abstract
One of the possible directions of the development of targeted substance delivery systems is the creation and introduction of biodegradable polymers into production. Their distinctive feature is that they are capable of spontaneously gradually degradation in the body due to natural biochemical processes. There is an increasing spread pharmaceutical form, which use similar excipients in their technology – medicinal ocular insert. Modified cellulose, gums and rare-cross-linked acrylic polymers are used to create a biodegradable matrix base. In terms of development approach, ocular inserts can be divided into two groups according to the principle of matrix biodegradation. In non-biodegradable composites, the effect of prolongation of the therapeutic effect is observed due to the release of the active substance from the non-decomposing matrix. This fact can be confirmed by both pharmacopoeial and non-pharmacopoeial methods. The classic tests regulated by the Pharmacopoeia of the XV edition include the "Dissolution" test (GPM.1.4.2.0014 "Dissolution of solid pharmaceutical dose forms"), and for non–pharmacopoeial ones – dialysis through a semipermeable membrane according to Kruvchinsky or using Franz's dialysis cells. The analysis of the kinetics of dissolution helps to determine and select the most suitable matrix-forming agent to be used in the composition with other substances in the composition of ocular insert. Ocular inserts with a biodegradable matrix have a second factor that affects the release of active substances – the formation of complexes or associates between parts of the matrix and the active ingredient molecules. These intermolecular compounds can indirectly prolong the effect of the drug. All features must be taken into account in the development of ocular inserts, since they, among other things, help to model fundamentally new ways of targeted delivery of substances. In this case, it is necessary to develop a test for the second modified release factor, which would reliably determine the presence of complexation processes within the selected ocular inserts model.
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