FIELD: pharmaceuticals.
SUBSTANCE: group of inventions relates to the field of chemistry and pharmaceuticals. Object 1 constitutes a medicinal immunotropic product with anti-inflammatory, immunomodulatory and antioxidant properties in the form of enteric-coated tablets, containing as an active substance aminodihydrophthalazinedione sodium and excipients in the following ratios: aminodihydrophthalazinedione sodium 100 mg; lactose Lactopress SD 250 124.28 mg; microcrystalline cellulose MCC 102 52.92 mg; sodium stearyl fumarate 2.8 mg; white film shell consisting of Acryl-eze 28.0 mg; wherein the mass of the tablet with a film shell is 308.0 mg. Object 2 is a method for producing a medicinal product, including the production of tablet cores on a tableting press by direct compression, application of an enteric-soluble white Acryl-eze shell to the tablet cores, resulting in a tablet.
EFFECT: production of an enteric-coated form of the medicinal product based on aminodihydrophthalazinedione sodium, providing the possibility of applying the technology of direct compression, manufacturability, retained activity and physical properties of the product, stability in storage, strength of the tablet and effectiveness of release of the medicinal substance from the product.
2 cl, 7 tbl, 2 ex, 1 dwg
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Authors
Dates
2022-06-21—Published
2020-12-29—Filed