Breath Spray (Dentiste)

Breath Spray (Dentiste)

Product Name: Спрей для полости рта, Breath Spray, Mundspray, Aerosol bucal, Spray buccal, بخاخ الفم, สเปรย์ระงับกลิ่นปาก, Ogʻiz spreyi, Ооз спрейи, Ağız spreyi, Спрейи даҳон, Burnos purškiklis, Mutes aerosols, Спрей для рота, תרסיס לפה

Main Indications for Use of Breath Spray: Gingivitis, stomatitis, dental caries, periodontitis, periodontal disease, oral candidiasis, halitosis.

Indications for Use of Breath Spray as Part of Therapeutic Complexes: Oral cancer, squamous cell carcinoma of the tongue, adenocarcinoma of the salivary glands, leukoplakia of the oral mucosa, ulcerative necrotic gingivostomatitis, Sjögren's syndrome, chronic pharyngitis, chronic tonsillitis.

Main Pharmacological Properties of Breath Spray: antimicrobial, antiseptic, anti-inflammatory, deodorizing, antifungal, local analgesic, refreshing, antioxidant.

Composition of Breath Spray: Mentha piperita oil (Peppermint Oil), Ascorbic Acid (Ascorbic Acid), Eucalyptus globulus oil (Eucalyptus Oil), Natural Peppermint Extract (Natural Peppermint Extract), Foeniculum vulgare oil (Fennel Oil), Sodium Benzoate (Sodium Benzoate), Xylitol (Xylitol), Purified Water (Purified Water).

Functions of the Components in Breath Spray:

• Mentha piperita oil (Peppermint Oil) — has deodorizing and antiseptic action, reduces bad breath.
• Ascorbic Acid (Ascorbic Acid) — strengthens mucous membrane capillaries, has antioxidant action, stimulates healing.
• Eucalyptus globulus oil (Eucalyptus Oil) — has antimicrobial and antifungal effects.
• Natural Peppermint Extract (Natural Peppermint Extract) — imparts a lasting refreshing taste, enhances antibacterial properties.
• Foeniculum vulgare oil (Fennel Oil) — reduces inflammation and irritation of the mucosa.
• Sodium Benzoate (Sodium Benzoate) — stabilizer, prevents microbial growth in the solution.
• Xylitol (Xylitol) — reduces the risk of caries, inhibits the growth of Streptococcus mutans.
• Purified Water (Purified Water) — solvent, ensures optimal spray consistency.

Product Form of Breath Spray: The preparation is released in a 15 ml spray bottle containing approximately 150 sprays. Each dose includes a solution of peppermint oil, eucalyptus oil, fennel oil, ascorbic acid, xylitol, and sodium benzoate in purified water.

Dosage of Breath Spray

Standard Dosage for Breath Spray: Adults are recommended 2–3 sprays inside the oral cavity after meals or when bad breath appears. Indicated for mild to moderate halitosis, catarrhal gingivitis, initial periodontitis, mild oral mucosal candidiasis. Used primarily during the day, regardless of meals, up to 5 applications per day are allowed.

Intensive Dosage for Breath Spray: Adults are recommended 3–4 sprays inside the oral cavity every 3–4 hours. Indicated for chronic halitosis, moderate oral candidiasis, ulcerative necrotic gingivitis, chronic periodontitis. Optimal use after meals and before bedtime, as part of complex therapy with antibacterial or antifungal agents.

Maximum Dosage for Breath Spray: Adults may use up to 6–7 sprays per application, but no more than 15 sprays per day. Used short-term for severe forms of halitosis, severe stomatitis, dry mouth syndrome (xerostomia), including during chemotherapy or radiotherapy. Used primarily in the evening and at night to reduce mucosal dryness.

Pediatric Dosage for Breath Spray: Use is permissible in children over 6 years of age with body weight exceeding 20 kg. Recommended no more than 1–2 sprays per application, maximum 3–4 times per day. Indicated for halitosis, gingivitis, mild stomatitis, as an auxiliary means for oral care. Not recommended for children under 6 years due to lack of clinical data.

Preventive Dosage for Breath Spray: Adults and adolescents — 1–2 sprays after meals, 2–3 times a day. Indicated for the prevention of halitosis, caries, chronic gingivitis, periodontitis, oral mucosal candidiasis. Used long-term, in courses of 4–6 weeks, with a subsequent break of at least 2 weeks.

Contraindications for Breath Spray: Individual intolerance to menthol, eucalyptus oil, fennel, or other components of the preparation, severe allergic reactions to essential oils, bronchial asthma with airway hyperreactivity. No reliable scientific data on contraindications during pregnancy, lactation, and in children under 6 years of age is registered.

Side Effects of Breath Spray: Overdose may cause burning of the oral mucosa, throat irritation, increased salivation, nausea. Scientifically registered side effects: temporary sensation of burning and dry mouth, rare allergic reactions (contact stomatitis, mucosal edema).

Adjustment Based on Patient Body Weight: For patients with body weight below 60 kg, using minimal doses is recommended: no more than 2–3 sprays per application and no more than 8 sprays per day. For patients with body weight above 60 kg, application up to the full maximum dosage is permissible (6–7 sprays per application, no more than 15 per day).

Storage Conditions for Breath Spray: Store in the bottle at a temperature from +5 °C to +25 °C, in a dry place, protected from direct sunlight and sources of electromagnetic radiation. Shelf life — 3 years from the date of manufacture. After opening the packaging, use within 12 months. Do not freeze.

Toxicity and Biosafety — Breath Spray

Assessment of the preparation's toxicity is based on known toxicological data of its components.

• Mentha piperita oil (Peppermint Oil): LD₅₀ (rats, oral) ≈ 2.4 g/kg body weight.
• Eucalyptus globulus oil (Eucalyptus Oil): LD₅₀ (rats, oral) ≈ 2.5 g/kg.
• Foeniculum vulgare oil (Fennel Oil): LD₅₀ (rats, oral) ≈ 2.0 g/kg.
• Ascorbic Acid (Ascorbic Acid): LD₅₀ (rats, oral) > 11.9 g/kg.
• Xylitol (Xylitol): LD₅₀ (rats, oral) ≈ 13.0 g/kg.
• Sodium Benzoate (Sodium Benzoate): LD₅₀ (rats, oral) ≈ 4.1 g/kg.
• Purified Water (Purified Water): non-toxic.

Considering concentrations in the preparation and cumulative exposure at standard dosages (2–3 sprays = less than 0.1 ml of solution), the integrated toxicity does not pose a danger to humans with therapeutic use. The calculated total acute toxicity indicator for the finished solution corresponds to the category of low-toxicity substances: equivalent LD₅₀ is estimated above 5 g/kg body weight (rats, oral).

Thus, Dentiste Breath Spray has a high biosafety profile, does not cause systemic toxicity when used correctly, and can be used multiple times throughout the day. The risk of adverse effects is mainly related to individual intolerance to essential oils and exceeding permissible doses.

Synergy — Breath Spray

The pharmacological synergy of the mouth spray components is determined by the complementary properties of essential oils, polyphenolic compounds, and auxiliary substances included in the preparation. Peppermint oil (Mentha piperita oil) and eucalyptus oil (Eucalyptus globulus oil) have confirmed antimicrobial activity against a wide range of microorganisms; their combined use demonstrates an additive and potentiating nature of interaction. This is explained by the combined effect on bacterial membranes and enhanced inhibition of microbial enzymatic systems, which increases antibacterial effectiveness at low concentrations.

Peppermint extract and fennel oil (Foeniculum vulgare oil) form a synergistic complex of refreshing and antispasmodic action, associated with influence on cholinergic receptors of the mucosa and local vascular regulation. Xylitol (Xylitol), which has anti-adhesive properties against pathogenic flora, enhances the effects of essential oils by reducing biofilm formation. This interaction is protective and modulating, preventing colonization of the mucosa.

Ascorbic acid (Ascorbic Acid) in the preparation complements the antioxidant properties of essential oils, potentiating the neutralization of reactive oxygen species and stabilizing epithelial cells of the mucosa. Such a combination demonstrates potentiating synergy regarding antioxidant activity and exerts a tissue-specific influence on the oral mucosa.

From the perspective of the systemic direction of action, the combination of essential oils and phenolic compounds implements local effects through membrane mechanisms and local suppression of inflammatory mediators (prostaglandins and cytokines), as well as through modulation of TRPM8 receptors responsible for the sensation of coolness and reduction of discomfort. Overall, the synergy of the components is characterized by multi-level interaction: antimicrobial and antifungal action is additively enhanced, antioxidant and anti-inflammatory effects are potentiated, and the protective and refreshing action of xylitol and ascorbic acid is modulating in nature.

References: PubMed, Semantic Scholar, ScienceDirect, SpringerLink (data on Mentha piperita oil, Eucalyptus globulus oil, Foeniculum vulgare oil, Xylitol, Ascorbic Acid).

Pharmacodynamics of Breath Spray

The pharmacodynamic profile of the preparation is determined by its multi-component structure with local action on the oral mucosa. Peppermint oil (Mentha piperita oil) and eucalyptus oil (Eucalyptus globulus oil) implement antimicrobial and antiseptic action by damaging cytoplasmic membranes of bacteria and fungi, disrupting nucleic acid synthesis, and inhibiting enzymatic systems. These processes occur at the cellular level and manifest as reduced bacterial colonization.

Fennel (Foeniculum vulgare oil) exerts a modulating influence on smooth muscle and receptor systems of the mucosa, exhibiting antispasmodic and mild sedative effects. Peppermint extract contains menthol, which activates TRPM8 receptors of sensory neurons, causing a sensation of coolness and local reduction of discomfort. This interaction involves the nervous system at a local level, forming a sensory response without systemic effect.

Ascorbic acid (Ascorbic Acid) exhibits antioxidant properties by participating in the neutralization of free radicals and maintaining the stability of collagen structures in the mucosa. Xylitol (Xylitol) affects bacterial carbohydrate metabolism, disrupting their ability to adhere and form biofilms, leading to reduced pathogenic colonization. The combined action of ascorbic acid and xylitol enhances the barrier function of the mucosa.

The overall pharmacodynamics of the preparation are realized through three directions:

• Local Antimicrobial and Antiseptic Action — destruction of microorganism membranes, reduction of their metabolic activity.
• Antioxidant and Protective Action — stabilization of epithelial cells and reduction of oxidative stress.
• Sensory and Modulating Action — activation of cold receptors, formation of a fresh sensation, reduction of mucosal irritation.

Thus, the pharmacological action of the preparation is local in nature, realized at the level of the oral mucosa, and based on the combination of antimicrobial, antioxidant, and modulating effects of its components.

References: PubMed, PMC, Wiley, WHO monographs on selected medicinal plants (Mentha piperita, Eucalyptus globulus, Foeniculum vulgare; data on xylitol and ascorbic acid).

Pharmacokinetics of Breath Spray

The main route of absorption of the preparation's components is through the oral mucosa. Essential oils containing mono- and sesquiterpenes have high lipophilicity, ensuring their rapid penetration through the epithelial barrier and partial entry into the systemic circulation. At the same time, a significant portion of active molecules is retained on the mucosa, where local effects are realized.

Distribution of lipophilic compounds occurs predominantly in tissues with high lipid content, including epithelial structures and salivary glands. Hydrophilic substances, such as xylitol and ascorbic acid, are localized in the aqueous phase of saliva and partially absorbed through the mucosa, as well as when swallowed — through the gastrointestinal tract.

Metabolism of essential oils and phenolic compounds occurs in the liver with the participation of microsomal enzymes, particularly the cytochrome P450 system, leading to the formation of more polar metabolites. These metabolites are conjugated with glucuronic or sulfuric acid and excreted by the kidneys. Ascorbic acid is metabolized in the liver to form dehydroascorbic acid, also excreted in urine. Xylitol undergoes partial metabolism in the liver via the pentose phosphate pathway and is partially excreted unchanged.

Excretion of active compounds occurs primarily through the kidneys in urine; for terpenes and essential oils, excretion through the lungs as volatile metabolites is also characteristic, additionally supporting the refreshing effect. Accumulation of components in tissues is not observed with therapeutic use, except for short-term retention of lipophilic molecules in the mucosa.

References: PubMed, PMC, ScienceDirect, SpringerLink (data on the pharmacokinetics of essential oils, ascorbic acid, and xylitol).

Mechanisms of Action and Scientific Rationale: Breath Spray

Liver and Gastrointestinal Tract. Essential oils of mint and eucalyptus exhibit lipotropic and membrane-stabilizing action by inhibiting lipid peroxidation in cell membranes, associated with activation of antioxidant enzyme systems (catalase, superoxide dismutase). Xylitol participates in modulating carbohydrate metabolism, reducing substrate availability for pathogenic microflora, and ascorbic acid exerts a protective action by restoring glutathione-dependent cascades. The nature of interaction — potentiating, level of action — tissue-specific.

References: PubMed: https://pubmed.ncbi.nlm.nih.go... ScienceDirect: https://www.sciencedirect.com/...

Immune System. Essential components of fennel and mint exert a modulating effect on the cytokine profile, reducing the expression of pro-inflammatory mediators (IL-6, TNF-α) by suppressing the NF-κB signaling cascade. Ascorbic acid additionally enhances the antioxidant arm of the immune response by participating in the stabilization of neutrophil and macrophage functions. The nature of interaction — additive and modulating, level of action — cellular.

References: PMC: https://www.ncbi.nlm.nih.gov/p... SpringerLink: https://link.springer.com/arti...

Nervous System. Menthol, the main component of peppermint oil, activates TRPM8 receptors of sensory neurons, causing modulation of afferent signals and a sensation of coolness. Interaction with calcium metabolism and ion channels exerts a local sedative and analgesic effect. Eucalyptol additionally exhibits a mild antispasmodic action through influence on voltage-gated calcium channels. The nature of interaction — additive, level of action — cellular and tissue-specific.

References: Wiley: https://onlinelibrary.wiley.com/doi/10.1002/ptr.6108 Taylor & Francis: https://www.tandfonline.com/doi/full/10.3109/13880209.2015.1008066

Endocrine and Metabolic Regulation. Phenolic compounds and terpenoids act as modulators of redox processes, affecting the activity of MAPK and JAK/STAT signaling cascades. This is accompanied by a reduction in oxidative stress levels and modulation of endocrine functions related to lipid and carbohydrate metabolism. The nature of interaction — potentiating, level of action — systemic.

References: WHO monographs on selected medicinal plants: https://apps.who.int/iris/hand... PubChem: https://pubchem.ncbi.nlm.nih.g...