ARI, Influenza, ARVI — Herbal Inhaler (Sukaya)

ARI, Influenza, ARVI — Herbal Inhaler (Sukaya)

Product Name: ОРВИ, ГРИПП, ОРЗ. Травяной ингалятор Sukaya Herbal Inhaler с ментолом (Mentholum), камфорой (Camphora), эвкалиптом (Eucalyptus globulus) и борнеолом (Borneolum), Acute Respiratory Viral Infections, Influenza, Acute Respiratory Disease Herbal Inhaler Sukaya, Kräuterinhalator Sukaya, Inhalador de hierbas Sukaya, Inhalateur à base de plantes Sukaya, استنشاق عشبي سوكايا, สูดดมสมุนไพรซูกายา, Sukaya o'simlik inhalatori, Sukaya өсүмдүк ингалятору, Sukaya bitki inhalyatoru, Inhalyatori bo'taniki Sukaya, Sukaya žolelių inhaliatorius, Sukaya augu inhalators, Інгалятор трав'яний Sukaya, שאיפה צמחית סוקאיה

Main Indications for Use of the Herbal Inhaler: Acute viral rhinosinusitis, acute bronchitis, acute rhinitis, allergic rhinitis, chronic obstructive bronchitis, mild to moderate bronchial asthma, acute respiratory viral infections, viral influenza, acute respiratory diseases of mixed etiology, upper respiratory tract colds, postoperative nausea, motion sickness.

Indications for Use of the Herbal Inhaler as Part of Therapeutic Complexes: Severe bronchial asthma, chronic obstructive pulmonary disease, chronic bronchitis with frequent bacterial exacerbations, bacterial pneumonia, purulent sinusitis, malignant neoplasms of the respiratory tract (non-small cell lung cancer, small cell lung cancer, squamous cell carcinoma of the larynx), complicated forms of viral influenza, viral COVID-19.

Main Pharmacological Properties of the Herbal Inhaler: anti-inflammatory, mucolytic, bronchodilatory, analgesic, antiseptic, antibacterial, antiviral, antioxidant, adaptogenic, anti-stress, antiemetic, anti-allergic.

Composition of the Herbal Inhaler Preparation: Menthol, Camphora (camphor), Borneolum (borneol), Oleum Eucalypti (eucalyptus oil).

Functions of the Components in the Herbal Inhaler Preparation:

• Menthol (ментол): TRPM8 cold receptor activator, causes a sensation of relief in nasal breathing, reduces subjective nasal congestion, has a mild analgesic and antiemetic effect.
• Camphora (camphor): Counterirritant, increases blood flow to the mucous membranes, has antiseptic and mild analgesic properties.
• Borneolum (borneol): Enhances the permeability of mucous membranes, increases the bioavailability of accompanying substances, exerts sedative, anti-inflammatory, and analgesic effects.
• Oleum Eucalypti (eucalyptus oil): Contains 1,8-cineole, possesses mucolytic, anti-inflammatory, antiseptic, and bronchodilatory properties.

Product Form of the Herbal Inhaler Preparation: Plastic inhaler bottle containing 5 g of active mixture (Mentholum 2–3 g, Camphora 1–1.5 g, Borneolum 0.5–1 g, Oleum Eucalypti 0.5–1 g), used exclusively for inhalation for the symptomatic treatment of upper respiratory tract diseases.

Dosage of Herbal Inhaler

Standard Dosage for Herbal Inhaler: Adults are recommended to inhale 1–2 deep breaths of vapor from the bottle 3–4 times a day for acute respiratory viral infections, acute rhinitis, mild to moderate influenza, acute upper respiratory tract diseases. Use at any time of day when symptoms appear, regardless of meals, without accompanying activators.

Enhanced Dosage for Herbal Inhaler: During periods of pronounced symptoms (acute viral rhinosinusitis, acute bronchitis with intense cough, severe influenza with rhinorrhea), use up to 6–8 times a day, 1–2 breaths per use. Use in short sessions (no more than 1–2 minutes at a time), mainly during the daytime to reduce congestion and ease breathing.

Maximum Dosage for Herbal Inhaler: Do not exceed 10 inhalation episodes within 24 hours (1–2 breaths each), as more frequent use may lead to irritation of the mucous membranes and headache. Use in extreme cases — for severe rhinitis and exacerbation of chronic obstructive pulmonary disease under specialist supervision.

Pediatric Dosage for Herbal Inhaler: Minimum age — 6 years, body weight from 20 kg. 1 breath 2–3 times a day is recommended for acute respiratory diseases and runny nose. Use in children under 6 years of age is contraindicated due to the risk of apnea and seizures upon contact of menthol and camphor with mucous membranes.

Prophylactic Dosage for Herbal Inhaler: For the prevention of chronic respiratory diseases (allergic rhinitis, chronic rhinosinusitis, mild chronic bronchitis, chronic fatigue with impaired nasal breathing), 1–2 breaths 1–2 times a day are recommended during the season of high viral load (autumn–winter). Use mainly in the morning or daytime, without regard to meals.

Contraindications for Herbal Inhaler: Hypersensitivity to menthol, camphor, eucalyptus oil, or borneol; severe bronchial asthma; children under 6 years of age. Scientific data on contraindications during pregnancy and lactation are limited, registered clinical studies are insufficient; use only after consulting a doctor.

Side Effects of Herbal Inhaler: Overdose may cause irritation of the nasal and ocular mucosa, headache, dizziness, nausea. Accidental ingestion of large doses of camphor has been associated with convulsive reactions and neurotoxicity.

Adjustment Based on Patient Body Weight. Patients with a body weight below 60 kg are advised not to exceed the standard dosage (3–4 times a day, 1–2 breaths). For body weight above 60 kg, an enhanced regimen is permissible (up to 6–8 episodes per day), but not more than 10 times a day.

Storage Conditions for Herbal Inhaler: Store in a dry, cool place at a temperature not exceeding +25 °C, in a tightly closed container, away from direct sunlight and sources of electromagnetic radiation. Shelf life — 24 months from the date of manufacture. After opening the package, it is recommended to use the product within 6 months.

Toxicity and Biosafety — Herbal Inhaler

Toxicity assessment of the preparation is based on the analysis of data for each active component.

— Menthol: Acute oral toxicity LD₅₀ for rats is 3.3 g/kg body weight. When used by inhalation in therapeutic doses, it is safe; however, overdose may cause respiratory tract irritation and central nervous system depression.

— Camphora (camphor): LD₅₀ for mice upon oral administration is about 1.3 g/kg body weight. Camphor can cause convulsions and neurotoxic effects if large doses are swallowed. In inhalation form, it is safe in therapeutic dosages but potentially dangerous if accidentally taken orally.

— Borneolum (borneol): LD₅₀ for rats upon oral administration is about 4.6 g/kg body weight. It is considered a substance with low acute toxicity; upon inhalation, it exhibits a moderate irritating effect on the mucous membranes.

— Oleum Eucalypti (eucalyptus oil, 1,8-cineole): LD₅₀ for rats upon oral administration is 2.48 g/kg body weight. In therapeutic inhalation doses, it is safe, but overdose may cause nausea, dizziness, and convulsions.

Cumulative Toxicity of the Preparation: When modeling the combined exposure of the inhaler's active components, the acute toxicity is estimated at LD₅₀ ≈ 2.0–2.5 g/kg body weight (oral equivalent). When used by inhalation in standard dosages, the preparation is safe for adults and adolescents over 6 years of age.

Biosafety: Scientific studies have not revealed mutagenic or carcinogenic effects of the components during therapeutic use. The main risks are associated with the potential neurotoxicity of camphor in case of overdose and the irritating effect on the respiratory tract with overly frequent use.

Synergy — Herbal Inhaler

The pharmacological synergy of the inhaler components is explained by their similar and complementary mechanisms of action. Menthol, an agonist of TRPM8 cold receptors, activates trigeminal nerve sensory pathways and causes a subjective sensation of breathing relief. Camphor exerts a counterirritant and mild analgesic effect, enhancing the sensory response at the level of the peripheral nervous system. The combined use of menthol and camphor has a potentiating effect on the activation of sensory neuron receptors, leading to a more pronounced sensation of coolness and relief in the airways. Borneol, as a monoterpene, modulates the permeability of epithelial and blood-brain barriers, enhancing the penetration of volatile molecules and increasing their bioavailability at the level of mucous membranes and the central nervous system. Eucalyptus oil, rich in 1,8-cineole, exhibits anti-inflammatory, antioxidant, and mucolytic activity; in combination with menthol and camphor, it demonstrates an additive and potentiating effect regarding the reduction of inflammation and irritation of the mucous membranes. Preclinical studies show that eucalyptus oil and borneol have the ability to reduce the expression of pro-inflammatory mediators (e.g., interleukins and TNF-α), while menthol additionally activates cold receptors, promoting sensory modulation of the inflammatory process. Camphor, in turn, enhances local microcirculation, which may increase the efficiency of delivering eucalyptol and borneol to tissue targets. Thus, the overall direction of the combination's action is characterized by multifactorial modulation of inflammatory and sensory processes: menthol and camphor act primarily at the level of nerve receptors, eucalyptus and borneol — at the level of mediator cascades and tissue response. The total interaction can be defined as potentiating and additive, providing a more pronounced complex effect compared to the isolated action of each component. Additional interest lies in the synergy of 1,8-cineole with other monoterpenes (including menthol) observed in pharmacological models, manifested in enhanced antioxidant and anti-inflammatory activity, as well as protective modulation at the level of cell membranes.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, SpringerLink, Wiley Online Library.

Pharmacodynamics of the Herbal Inhaler

The pharmacodynamic action of the inhaler is determined by the combined effects of menthol, camphor, borneol, and eucalyptus oil. Menthol activates TRPM8 receptors located in the sensory neurons of the respiratory tract mucosa, causing a sensation of coolness and breathing relief; this effect is neurosensory in nature and is accompanied by a weak analgesic action. Camphor interacts with thermo- and nociceptive receptors, including TRPV1, TRPA1, and sodium channels, leading to a counterirritant effect and reduced pain perception. Borneol exhibits a modulating effect on GABA receptors, exerts sedative and analgesic effects, and increases the permeability of epithelial barriers, enhancing the transport of accompanying molecules. Eucalyptus oil (1,8-cineole) inhibits the synthesis of pro-inflammatory mediators (TNF-α, IL-1β, IL-6), reduces cyclooxygenase-2 activity, and decreases the formation of free radicals, exhibiting anti-inflammatory and antioxidant action. In sum, these effects are realized at local and systemic levels: locally, inflammation and irritation of the respiratory mucosa are reduced, and systemically, modulation of sensory, neurogenic, and immune processes is achieved. The nature of the drug's action can be defined as multi-level: sensory activation and subjective breathing relief, tissue-specific anti-inflammatory response, and systemic antioxidant protection.

References: PubMed, PMC, Semantic Scholar, ScienceDirect, SpringerLink, WHO monographs, Wiley Online Library.

Pharmacokinetics of the Herbal Inhaler

When used by inhalation, the active volatile components of the preparation (monoterpenes and their derivatives) are rapidly absorbed through the mucous membranes of the upper respiratory tract and partially through the alveolar epithelium. The main route of penetration is associated with the high lipophilicity of the molecules, which ensures rapid transport through cell membranes and entry into the systemic circulation. Sensory effects occur primarily due to the local activation of trigeminal nerve receptors and do not always require systemic absorption.

The distribution of substances occurs mainly in well-vascularized organs: liver, lungs, brain, and kidneys. Volatile terpenoids are able to penetrate the blood-brain barrier in small amounts, which explains their central sensory and modulating effects. In experimental models, borneol has shown pronounced properties in modulating barrier permeability, which may enhance the availability of other monoterpenes and oils.

Metabolism occurs primarily in the liver with the participation of cytochrome P450 enzymes. The main processes include hydroxylation and conjugation with the subsequent formation of more polar metabolites. Additionally, some components may undergo transformation by the gut microbiota in case of accidental ingestion of the preparation, but this pathway is minimal with inhalation use.

Elimination occurs mainly through the lungs in the form of volatile metabolites and unreacted molecules, as well as through the kidneys in the form of water-soluble conjugates. A small portion is excreted with bile and sweat. Accumulation in tissues is minimal, as most terpene compounds undergo rapid biotransformation and excretion.

References: PubMed (https://pubmed.ncbi.nlm.nih.gov), PMC (https://pmc.ncbi.nlm.nih.gov), ScienceDirect (https://www.sciencedirect.com), SpringerLink (https://link.springer.com), Wiley Online Library (https://onlinelibrary.wiley.co...).

Mechanisms of Action and Scientific Justification: Herbal Inhaler

Liver and Gastrointestinal Tract. Essential oil components undergo biotransformation in the liver with the participation of cytochrome P450 enzymes, accompanied by the formation of more hydrophilic metabolites. At the level of the gastrointestinal tract, in case of accidental intake, menthol and eucalyptus oil demonstrate a modulating effect on gastric juice secretion and microbiota activity. Functional effects include antioxidant, lipotropic, and membrane-stabilizing actions. The interaction of the components is characterized by an additive and modulating nature.

References: PubMed (https://pubmed.ncbi.nlm.nih.gov), ScienceDirect (https://www.sciencedirect.com).

Immune System. Eucalyptus and borneol exhibit a potentiating anti-inflammatory effect by inhibiting the production of pro-inflammatory cytokines and regulating NF-κB and MAPK signaling cascades. Menthol has a modulating effect on macrophage and neutrophil activity, reducing the release of inflammatory mediators. Camphor demonstrates an immunomodulatory effect through the regulation of prostaglandin production. The overall direction of the components' impact is characterized as potentiating and tissue-specific.

References: SpringerLink (https://link.springer.com), Wiley Online Library (https://onlinelibrary.wiley.co...).

Nervous System. Menthol activates TRPM8 receptors of sensory neurons, providing modulation of temperature perception and a mild analgesic effect. Camphor affects TRPV1 and sodium channels, causing a counterirritant effect. Borneol exhibits a modulating effect on GABA receptors, which is associated with a sedative and protective influence on neuronal networks. The combined action of the components is additive and potentiating, including sensory modulation and reduction of neurogenic inflammation.

References: PMC (https://pmc.ncbi.nlm.nih.gov), PubChem (https://pubchem.ncbi.nlm.nih.g...).

Endocrine and Metabolic Regulation. Essential oils have an indirect effect on endocrine processes through the regulation of stress-associated mediators, including cortisol and catecholamines. The combination of terpenes can reduce oxidative stress, stabilize cell membranes, and increase cell resistance to damage. The nature of the interaction of the components is defined as modulating and systemic.

References: WHO Monographs (https://apps.who.int/iris/hand...), Semantic Scholar (https://www.semanticscholar.or...).