DEVELOPMENT AND STANDARDIZATION OF A SUBLINGUAL ALLERGEN-SPECIFIC IMMUNOTHERAPY TABLET BASED ON WORMWOOD (ARTEMISIA ABSINTHIUM) POLLEN
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Abstract:
This study presents the results of the development and standardization of a tablet dosage form intended for sublingual allergen-specific immunotherapy (SLIT) based on wormwood (Artemisia absinthium) pollen. The key quality attributes of the formulation were evaluated, including total nitrogen content as an indirect indicator of the protein fraction, solubility, dosage uniformity, and stability. The findings demonstrated that the total nitrogen content was 0.145%, confirming the presence of biologically active protein components. The tablets exhibited satisfactory solubility and met the requirements for dosage uniformity at a mass of 0.3 g. Stability studies showed that the main quality parameters remained unchanged throughout the observation period. The obtained results indicate the potential of the developed dosage form and support its further standardization.
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References:
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ICH Harmonised Tripartite Guideline. Stability testing of new drug substances and products Q1A(R2). 2003.

