FIELD: pharmaceutics.
SUBSTANCE: group of inventions concerns pharmaceutical compositions for rectal foam, methods for obtaining such compositions, foam made of such compositions, and therapeutic methods with their use. The anhydrous pharmaceutical composition of rectal foam contains a drug based on aminosalicylate or its pharmaceutically acceptable salt or ester; a waxy/lipid component containing vaseline and caprylic/caprine triglycerides (CCT); a solvent/carrier; an emulsifying component/surfactant; gum/resinous component and a propellant. The pharmaceutical composition of rectal foam in the form of oil-in-water emulsion contains a drug based on aminosalicylate or its pharmaceutically acceptable salt or ester, a solvent/carrier containing water, an emulsifying component/surfactant, a waxy/lipid component, gum/resinous component and a propellant, while the waxy/lipid component contains vaseline, cetyl alcohol and optionally stearic acid. Methods for obtaining compositions include mixing the above-mentioned components in a certain sequence; adding a drug based on aminosalicylate to obtain a final mixture; combining the final mixture with a propellant. A method for injecting the drug and a method for treating inflammatory bowel disease (in particular, ulcerative colitis or Crohn’s disease), including rectal injection of any of the specified compositions or foam obtained from them, are also proposed.
EFFECT: combinations of components of the above-mentioned compositions give foam with required properties, namely, foam that expands gradually, expands to large total volume and/or demonstrates good preservation time, does not break down immediately after dosing and is stable in terms of destruction, separation, gelation or inversion of the emulsion during storage.
25 cl, 2 tbl, 5 ex, 1 dwg
