PROSPECTS FOR THE PHARMACEUTICAL DEVELOPMENT OF AN INTRANASAL SPRAY BASED ON BIOTECHNOLOGICALLY DERIVED RAW MATERIALS

Abstract

ABSTRACT

Intranasal dosage forms improve the bioavailability and absorption of active pharmaceutical ingredients, particularly those of plant origin, enhancing their anti-inflammatory, antioxidant, neuroprotective, and anti-allergic effects. However, the poor solubility and stability of some plant-derived components are challenges that can be mitigated through the use of nanocarriers, liposomes, and other advanced drug delivery systems. The combination of nasal drug delivery with plant-derived components is a promising strategy for the treatment of nasal diseases, central nervous system disorders, and chronic diseases, potentially increasing clinical efficacy and expanding the therapeutic possibilities of these dosage forms.

The aim of the study is to determine the profile of an intranasal biopreparation with plant-derived components based on an analysis of the range of medicinal products available on the pharmaceutical market of Ukraine, as well as the results of a survey of healthcare professionals and patients, and to justify the feasibility of pharmaceutical development of intranasal drug products based on biotechnologically derived raw materials.

Materials and Methods. The study is based on an analysis of scientific literature, instructions for medical use of intranasal drugs, data from the State Register of Medicinal Products of Ukraine, the Compendium information resource, as well as the results of a sociological survey of respondents (physicians and pharmacists). Systemic-analytical and mathematical-statistical methods were applied.

Results and Discussion. In recent years, nasal drug administration as a non-invasive route of drug delivery has attracted considerable attention. Traditional methods of drug administration – oral and injectable – despite their widespread use in clinical practice, have certain disadvantages, particularly regarding the rate of drug absorption, duration of action, and associated adverse effects. Oral drug administration is influenced by digestion and absorption processes in the gastrointestinal tract, moreover, some active ingredients undergo first-pass hepatic metabolism, which reduces their therapeutic efficacy. Injectable administration, although bypassing the gastrointestinal tract, is associated with pain, risk of infection, and reduced patient adherence to treatment. In contrast, the nasal cavity, which serves as a direct pathway to the brain and systemic circulation, facilitates rapid and efficient drug absorption, making it particularly suitable for the treatment of neurological and respiratory diseases.

We have established that as of April 1, 2026, the pharmaceutical market of Ukraine includes 187 trade names of medicinal products belonging to group R01 «Nasal preparations». An analysis of the range of nasal drugs available on the Ukrainian pharmaceutical market showed that only five drugs contain plant-derived components. In the majority of products, these components are combined with decongestants (vasoconstrictors) or serve an auxiliary function. The analysis of the composition of drugs in group R01 revealed that the most common plant-derived components are menthol (levomenthol), camphor, eucalyptol, lavender essential oil, and thymol.

This justifies the existence of a therapeutic niche and the feasibility of pharmaceutical development of new combination drugs that combine active pharmaceutical ingredients of synthetic and plant origin. Furthermore, the possibility of creating accessible domestic raw materials through biotechnological methods of obtaining phytosubstances has been analyzed, which allows overcoming the problem of import dependence for this valuable medicinal raw material.

In order to determine the profile of an intranasal biopreparation, we conducted an anonymous survey of 100 healthcare professionals from healthcare facilities of various ownership forms. The questionnaire contained 15 questions concerning the prescription of intranasal drugs of different dosage forms, common diagnoses, pharmacotherapeutic groups, criteria for choosing products, side effects, and expected properties of a combination-action spray.

Professionals reported that patients most frequently present with acute respiratory viral infection (30%) and allergic rhinitis (25%). According to the survey results, in consulting and prescribing practice, preference is given to vasoconstrictor or combination drugs. The main criteria for choosing an intranasal drug, according to the survey, are speed of onset of effect (33%), duration of action (14%), and convenience of the dosage form (13%). The most common patient complaint is addiction to decongestants (vasoconstrictors) with long-term use (55.3%). It was found that professionals most often recommend nasal sprays (44%) and drops (17%). Despite the wide range of medicinal products in group R01, the needs of professionals and patients regarding the expected properties of intranasal drugs, as identified in the survey, remain unmet.

Conclusions. Diseases of the upper respiratory tract create a consistently high demand for intranasal drugs. Both patients (43%) and specialists (44%) prefer nasal sprays due to their convenience and dosing accuracy. This substantiates the existence of a therapeutic niche and the feasibility of the pharmaceutical development of new combined medicinal products that integrate synthetic and plant-derived active pharmaceutical ingredients. The possibility of creating accessible domestic raw materials through biotechnological methods for obtaining phytosubstances has been analyzed, allowing for the mitigation of import dependence regarding valuable medicinal raw materials.