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Loratadine Powder is a widely used second-generation antihistamine drug primarily used to alleviate symptoms caused by allergic reactions. It belongs to the tricyclic antihistamines, usually appearing as white or off white crystalline powder, odorless or slightly specific odor, slightly soluble in water, and easily soluble in organic solvents such as ethanol and acetone. Loratadine selectively blocks peripheral H1 receptors, inhibits the binding of histamine to receptors, and thus blocks histamine induced allergic reactions. Histamine is a key mediator in allergic reactions, which can cause capillary dilation, increased vascular permeability, smooth muscle contraction, and other symptoms such as nasal itching, sneezing, runny nose, and skin itching. It can also inhibit inflammatory cells (such as mast cells, eosinophils) from releasing inflammatory mediators (such as leukotrienes, prostaglandins, platelet activating factor). Regulating the release of cytokines (such as IL-4, IL-5, IL-13) to alleviate the inflammatory response in chronic allergic diseases.
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Additional information of chemical compound:
| Product Name | Loratadine Powder | Loratadine Tablets | Loratadine Capsules | Loratadine Spray | Loratadine Sirop |
| Product Type | Powder | Tablet | Capsules | Paste | liquid |
| Product Purity | ≥99% | ≥99% | ≥99% | ≥99% | ≥99% |
| Product Specifications | 100g/1kg/etc. | 5mg/10mg | 5mg/10mg | 10ml/5mg | 50ml/50mg |
| Product Form | Organic synthesis | Take Orally | Take Orally | External application | Take Orally |
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Loratadine COA
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Loratadine Powder, as a second-generation antihistamine drug, has become a core drug in the global anti allergic treatment field since its launch in 1993 due to its high efficacy, long-lasting effect, and low sedation advantages. Its powder form (Loratadine), as an active pharmaceutical ingredient, is the basis for drug formulation production, scientific research innovation, and industrial applications, and is widely used in various fields such as medicine, food, cosmetics, etc. The following is a detailed explanation of its purpose:
In clinical treatment: core drugs in the field of anti allergy
When allergens (such as pollen and dust mites) enter the body, the immune system recognizes and activates mast cells and eosinophils, releasing inflammatory mediators such as histamine. Histamine triggers downstream signaling pathways by binding to H1 receptors on the surface of target cells, such as nasal mucosal epithelial cells and vascular endothelial cells, leading to capillary dilation, increased vascular permeability, increased glandular secretion, and itching sensation at nerve endings. After oral absorption, loratadine powder rapidly distributes in peripheral tissues and binds with high affinity to H1 receptors, forming a drug receptor complex that blocks histamine receptor binding and inhibits the initiation of allergic reactions. Loratadine can stabilize mast cell membranes, reduce the release of inflammatory mediators such as histamine, leukotrienes, and prostaglandins, thereby reducing the intensity and duration of inflammatory reactions. For example, in patients with chronic urticaria, loratadine can significantly reduce serum leukotriene C4 (LTC4) levels, alleviate wheals and itching. It can also inhibit the secretion of cytokines such as IL-4 and IL-5 by Th2 cells, reduce IgE synthesis, and thus block the immune cascade reaction of allergic reactions. This role is particularly important in the long-term management of allergic rhinitis.
Molecular basis of low central sedative properties
Compared with first generation antihistamines such as diphenhydramine, loratadine has lower lipid solubility and is a substrate for P-glycoprotein, making it difficult to penetrate the blood-brain barrier and enter the central nervous system. Therefore, it hardly causes central side effects such as drowsiness and decreased attention. Loratadine is metabolized by CYP3A4 in the liver to produce desloratadine, which has a stronger H1 receptor antagonist effect and a longer half-life (about 27 hours), prolonging anti allergic efficacy while maintaining low sedative properties.
The clinical application of loratadine powder covers common allergic diseases such as allergic rhinitis, chronic urticaria, and allergic conjunctivitis, and is suitable for acute exacerbation and long-term maintenance treatment. Loratadine can significantly alleviate typical symptoms such as nasal itching, sneezing, runny nose, and nasal congestion in seasonal allergic rhinitis (SAR). A multicenter randomized controlled trial (RCT) involving 1200 SAR patients showed that after 7 days of daily treatment with 10mg loratadine, the total nasal symptom score (TNSS) of the patients decreased by 62% compared to the placebo group (P<0.001). Effective time: 1-3 hours after oral administration, peak effect occurs at 8-12 hours and lasts for 24 hours, supporting a once daily dosing regimen. Using loratadine 2-4 weeks before the pollen season can reduce the severity and frequency of symptoms. Loratadine can reduce inflammatory cell infiltration and epithelial cell damage in nasal mucosa, and improve nasal ventilation function in perennial allergic rhinitis (PAR). Combined use with nasal corticosteroids (such as mometasone furoate) can enhance therapeutic efficacy, especially for patients with moderate to severe PAR. Loratadine can quickly relieve nasal itching and sneezing, while nasal hormones can alleviate nasal congestion and mucosal edema.
Chronic Urticaria (CU)&Allergic Conjunctivitis (AC)
Loratadine can inhibit the formation of wheals and the degree of itching for wheals and itching. Loratadine can reduce sleep disorders and daily activity limitations caused by itching in patients. For recurrent CU, loratadine can be used as a maintenance therapy drug, which can maintain efficacy even after continuous use for more than 6 months. An open label extension study showed that patients who received continuous treatment for 12 months had a 60% lower recurrence rate compared to the placebo group. For refractory CU, the dose can be increased to 20mg/d or combined with other antihistamines (such as cetirizine), but attention should be paid to monitoring adverse reactions. Eye itching, tearing, and conjunctival congestion. Loratadine significantly improves ocular surface symptoms by reducing conjunctival vascular permeability and reducing the release of inflammatory mediators. Combined use with antihistamine eye drops (such as loratadine) or mast cell stabilizers (such as sodium succinate) can enhance efficacy, especially in patients with severe symptoms.
Loratadine can alleviate skin itching and erythema in AD patients with atopic dermatitis, especially suitable for pediatric patients. A study involving 200 children with AD showed that when combined with topical corticosteroid treatment, the itching score in the loratadine group decreased by 30% compared to the steroid group alone, and sleep quality significantly improved. For contact allergies caused by metals, cosmetics, etc., loratadine can shorten the course of the disease and accelerate the healing of skin lesions. A study on nickel allergy patients showed that the treatment group had a 3-day reduction in the time for skin lesions to disappear compared to the control group. Loratadine can inhibit histamine release at the bite site, alleviate local redness, swelling, and itching. Oral administration combined with local cold compress is a commonly used treatment plan.
Research application: the cornerstone of drug research and development
Construction of pharmacological models
Loratadine is a key tool for establishing animal models of allergies:
Passive Skin Allergy Test (PCA) in Mice: Sensitization was achieved by intravenous injection of anti ovalbumin (OVA) IgE antibody. After 24 hours, oral administration of Loratadine (1-10 mg/kg) significantly inhibited histamine induced local vascular permeability increase (ED50=3.2 mg/kg). This model was used to evaluate the potency intensity of other antihistamines, such as cetirizine with an ED50 of 0.8 mg/kg, demonstrating its efficacy four times that of Loratadine. Non human primate asthma model: In rhesus monkeys, continuous administration of Loratadine (5 mg/kg/d) for 14 days can reduce airway hyperresponsiveness (PC20 value increased by 2.1 times in acetylcholine challenge test), revealing the non classical role of H1 receptors in asthma and providing a basis for the development of new drug indications.
Pharmacokinetic (PK) and Toxicological (Tox) Studies
As a reference substance, Loratadine powder is irreplaceable in PK/Tox studies: bioavailability comparison: in beagle dogs, the absolute bioavailability of Loratadine tablets is 53%, while that of nanocrystalline suspension is 82%. By preparing different dosage forms through powder preparation, the administration route can be optimized. Metabolite identification: Human liver microsomal incubation experiments showed that Loratadine is mainly metabolized by CYP3A4 to decarbonethoxyloratadine (DCL), which has activity comparable to the original drug (IC50=1.2 nM vs 1.5 nM), but its half-life is extended to 36 hours, explaining its long-acting properties. Genetic toxicity evaluation: Ames test showed that Loratadine did not induce revertant mutations in TA98 and TA100 strains at a concentration of 5000 μ g/dish, and the mouse bone marrow micronucleus test was negative, demonstrating its genetic safety and providing a benchmark for preclinical studies.
Drug interaction research
Loratadine is a sensitive substrate for CYP3A4 and P-glycoprotein (P-gp), commonly used to explore the regulatory mechanisms of drug metabolizing enzymes and transporters
Enzyme induction/inhibition experiment: When rifampicin (CYP3A4 inducer) is combined with Loratadine (10 mg), the AUC of DCL decreases by 70%, while ketoconazole (CYP3A4 inhibitor) increases the Cmax of DCL by 3.2 times, providing dose adjustment basis for clinical drug combination.
P-gp substrate validation: In the Caco-2 cell model, the apparent permeability coefficient (Papp) of Loratadine was 1.2 × 10 ⁻⁶ cm/s, while after adding verapamil (P-gp inhibitor), the Papp increased to 8.5 × 10 ⁻⁶ cm/s, demonstrating its P-gp dependent transport and explaining individual differences in intestinal absorption.
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