DETERMINATION OF THE QUALITY ATTRIBUTES OF LEVODOPA-BASED NAZAL DROPS FOR THE TREATMENT OF PARKINSON'S DISEASE

Abstract

Relevance. Currently, nasal delivery of drugs is considered as a relevant alternative to oral administration and opens up new possibilities for the treatment of neurodegenerative diseases of the brain. During the pharmaceutical development of a new form of nasal delivery of levodopa, the target quality profile of the drug was determined. The aim of this study was to develop a target quality profile for nasal drops based on api L-DOPA for further study of the stability and standardization of the drug. Material and methods. Experimental series of nasal drops containing levodopa (3,4-dihydroxy-l-phenylalanine - l-dopa), which is an oily suspension of polymer particles with micronized levodopa, which were evaluated by quality indicators in accordance with the requirements of the state pharmaco-poeia of the Russian Federation and the pharmacopoeia EAEU: authenticity and quantification (for an active pharmaceutical substance), as well as par-ticle size, sedimentation stability, pH value characterizing the dosage form "Suspensions", testing for acid number, peroxide value and a universal indi-cator for assessing the quality of all non-sterile dosage forms – microbiological purity . The HPLC method was used to determine the authenticity and quantitative content of L-DOPA in nasal drops. Results. As a result of studies of experimental series of nasal drops based on the active pharmaceutical ingredient L-DOPA, in accordance with the pharmacopoeial requirements for the active pharmaceutical ingredient, excipients and dosage form, a target quality profile of nasal drops based on levodopa was developed. The expediency of including the "Uniformity of dosing" test for an oil suspension has been established, since when adminis-tered intranasally, the drug is oriented towards a resorptive effect, which dictates the need to comply with the dosing conditions. Based on the results of the conducted studies of experimental series of levodopa-based nasal drops, a draft specification was developed containing the substantiated con-tent of quality targets and analysis methods. Conclusions. The developed quality targets for nasal drops will be used to study the stability, standardization and subsequent quality control of the drug.