Determination of the quality attributes of levodopa-based nazal drops for the treatment of Parkinson's disease

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 pharmacopoeia of the Russian Federation and the pharmacopoeia EAEU: authenticity and quantification (for an active pharmaceutical substance), as well as particle size, sedimentation stability, pH value characterizing the dosage form "Suspensions", testing for acid number, peroxide value and a universal indicator 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 administered 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 content 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.