EVOLUTION OF THE NOMENCLATURE OF EXCIPIENTS IN THE TECHNOLOGY OF SUPPOSITORIES

Suppositories are a traditional segment of the Russian pharmaceutical market due to certain benefits and historical traditions. In the 1930s, the State Pharmacopoeia (SP), 7th edition, recommended suppository bases, regardless of the physicochemical properties of the pharmaceutical substance, which limited the use of suppositories due to occurring incompatibilities. The subsequent (9th to 13th) editions of SP expanded the range of bases through their inclusion in the list of the excipients: preservatives, antioxidants, emulsifiers, and stabilizers. The expansion of the range of available pharmaceutical ingredients currently allows the suppositories to include the following classes of excipients, which improve the structural and mechanical properties of additives, stabilizers, solvents, solubilizers, penetrants, release modifiers, and mucoadhesive components. The SP of the Russian Federation, 13th edition, contains a list of 3 groups of suppository bases: hydrophilic, lipophilic, and diphilic. This allows incorporation of active ingredients of almost any nature and concentration in the suppositories. The suppository segment of the Russian pharmaceutical market has currently reached maturity and continues to develop. The state register of medicines has included 230 brand name suppositories from 43 pharmacotherapeutic groups. Due to the success of pharmaceutical ingredients industry, the currently available suppository bases are universal and represented by brands with different physicochemical and technological characteristics. The development of the suppository segment determines the need to expand the range of excipients and to enhance requirements for their quality.