Обґрунтування способу введення лізоциму гідрохлориду і аскорбінової кислоти у склад гумок жувальних лікувальних «Лізодент С»

Abstract

В останні роки широкого розповсюдження як системи доставки ліків отримали гумки жу- вальні лікувальні. На кафедрі заводської технології ліків НФаУ розробляються пресовані гумки жувальні під умовною назвою «Лізодент С» для профілактики та лікування стоматологічних захворювань, у яких як активні фармацевтичні інгредієнти використовуються аскорбінова кислота та лізоциму гідрохлорид, а як жувальна основа – композиція Health in Gum® марки PWD-01 (Cafosa, Іспанія).

In recent years, medicated chewing gums have been widely distributed as a drug delivery system. The Industrial Technology of Drugs Department of NUPh develops compressed chewing gums under the conventional name “Lysodent C” for the prevention and treatment of dental diseases, in which as active pharmaceutical ingredients ascorbic acid and lysozyme hydrochloride are used, and as a chewable base – composition Health in Gum ® of brand PWD-01 (Cafosa, Spain). Aim. To study the physico-chemical and pharmacotechnological properties of active pharmaceutical ingredients and chewable base for the purpose of establishing a method for the introduction of lysozyme hydrochloride and ascorbic acid into the composition of the compressed medicated chewing gums “Lysodent C”. Materials and methods. Research objects: lysozyme hydrochloride, ascorbic acid, Health in Gum ® of brand PWD-01 and mixture thereof. During the experiment, the physico-chemical (moisture absorption) and pharmacotechnological (optical microscopy, flowability, bulk density and tap-density, determination of granulometric composition by analytical sifting) of the substances’ powders methods were used in accordance with the requirements of SPU 2.0. Results and discussion. The crystallographic and sieve analysis showed the polydispersity and polymorphism of the particles of active pharmaceutical ingredients mixture and its combination with the chewing gum base, indicating a possible stratification of the samples under study in the process of a solid dosage form obtaining. Study of the sub - stances’ moisture absorption capacity has shown non-hygroscopicity of ascorbic acid and hygroscopicity of lysozyme hydrochloride and chewable base, which, in turn, indicates the need for the introduction of moisture absorbing agents to the composition of medicated chewing gums or maintenance of 40 % relative humidity of the environment in the pro - duction of the chewing gums. According to the results of pharmacotechnological studies, the substance of ascorbic acid has a satisfactory flowability, the composition of HiG brand PWD-01 has good flowability, and lysozyme hydrochloride – acceptable flowability, which accordingly provides for the adjustment of this indicator. Conclusions. Based on the studies conducted, it has been determined that the rational way of lysozyme hydrochloride ad - ministering to the composition of medicated chewing gums using pre-granulation technology, and ascorbic acid by premixing with lysozyme granulate and chewable base to avoid oxidation of the substance at contact with the moisturizer.