ОСОБЕННОСТИ ИСПОЛЬЗОВАНИЯ ТАБЛЕТОК И КАПСУЛ ДЛЯ ИЗГОТОВЛЕНИЯ ЭКСТЕМПОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ В РЕСПУБЛИКЕ БЕЛАРУСЬ И ЗА РУБЕЖОМ

УДК 615.453.6:615.453.4(476)
DOI: https://doi.org/10.52540/2074-9457.2023.3.39
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Е. Н. Тарасова, В. В. Кугач

ОСОБЕННОСТИ ИСПОЛЬЗОВАНИЯ ТАБЛЕТОК И КАПСУЛ ДЛЯ ИЗГОТОВЛЕНИЯ ЭКСТЕМПОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ В РЕСПУБЛИКЕ БЕЛАРУСЬ И ЗА РУБЕЖОМ

Витебский государственный ордена Дружбы народов медицинский университет, г. Витебск, Республика Беларусь

В статье представлены результаты анализа нормативных правовых актов, руководств и научных публикаций Республики Беларусь и зарубежных стран по использованию готовых лекарственных форм (таблеток и капсул) в качестве активного фармацевтического ингредиента для получения экстемпоральных лекарственных средств. Показано, что в Республике Беларусь из таблеток и капсул изготавливают порошки, суспензии для наружного применения и мягкие лекарственные формы. За рубежом с использованием таблеток и капсул готовят порошки для внутреннего применения, жидкие лекарственные формы для внутреннего и наружного применения (растворы, суспензии), мягкие лекарственные формы, суппозитории. Особое внимание в зарубежных странах уделено получению суспензий для внутреннего применения. При изготовлении лекарственных средств с использованием готовых лекарственных форм следует учитывать наличие вспомогательных веществ в их составе. Необходимо рассчитывать не только массу действующих веществ, но и общую массу используемых таблеток и капсул. При применении дробного их количества разрезать таблетки на части не рекомендуется. В случае необходимости изготовления жидкой лекарственной формы целесообразно получать суспензии, несмотря на растворимость активного фармацевтического ингредиента в воде. Следует проводить анализ совместимости всех ингредиентов, входящих в состав получаемого экстемпорального лекарственного средства, включая вспомогательные вещества таблеток или капсул. Экстемпоральные лекарственные средства не подлежат обязательному исследованию стабильности. При ее оценке могут учитываться физические характеристики изготовленной лекарственной формы и может проводиться количественный анализ. Получение другой лекарственной формы может изменять биодоступность лекарственного препарата, поэтому рекомендуется тщательный мониторинг нежелательных реакций при оказании медицинской и фармацевтической помощи с применением экстемпоральных лекарственных средств.

Ключевые слова: аптечное изготовление, экстемпоральное лекарственное средство, готовая лекарственная форма.

SUMMARY 

E. N. Tarasova, V. V. Kuhach

FEATURES OF USING TABLETS AND CAPSULES FOR MANUFACTURING COMPOUNDED DRUG PRODUCTS IN THE REPUBLIC OF BELARUS AND ABROAD

The article presents the results of normative legal acts analysis, guidelines and scientific publications of the Republic of Belarus and foreign countries on the use of finished dosage forms (tablets and capsules) as an active pharmaceutical ingredient for obtaining compounded drug products. Powders, suspensions for external use and soft dosage forms are shown to be made from tablets and capsules in the Republic of Belarus. In foreign countries powders for internal use, liquid dosage forms for internal and external use (solutions, suspensions), soft dosage forms and suppositories are made using tablets and capsules. Particular attention in foreign countries is given to manufacturing suspensions for internal use. Presence of excipients in their composition should be taken into account while manufacturing medicines using finished dosage forms. It is necessary to calculate not only the weight of active ingredients, but also total weight of tablets and capsules used. When using fractional amount it is not recommended to cut the tablets into parts. If it is necessary to make liquid dosage form it is advisable to obtain suspensions despite their active pharmaceutical ingredient solubility in water. A compatibility analysis for all ingredients making up the resulting compounded drug product including excipients of tablets or capsules should be carried out. Compounded drug products are not subject to mandatory stability studies. When evaluating it, physical characteristics of the manufactured dosage form can be taken into account and an assay can be carried out. Obtaining another dosage form can change the drug bioavailability, therefore, careful monitoring of adverse reactions is recommended when providing medical and pharmaceutical care using compounded drug products.

Keywords: pharmacy manufacture, compounded drug product, finished dosage form.

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Адрес для корреспонденции:

210009, Республика Беларусь,

г. Витебск, пр. Фрунзе, 27,

УО «Витебский государственный ордена

Дружбы народов медицинский университет»,

кафедра фармацевтической технологии,

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Тарасова Е. Н.

Поступила 29.04.2023 г.