Levocetirizine + Montelukast Syrup

Belonging to the Syrups category, this formulation is a pharmacologically rational combination for managing severe pediatric allergies:

• Levocetirizine (H1 Antihistamine): The active R-enantiomer of cetirizine. It selectively blocks histamine receptors with minimal CNS penetration, providing low-sedating relief from sneezing, itching, and rhinorrhea.
• Montelukast (Leukotriene Antagonist): Blocks cysteinyl leukotrienes released by mast cells. This directly halts mucosal edema and bronchoconstriction—symptoms that standard antihistamines cannot control.

Together, they address the full allergic cascade, making this combination vastly superior to monotherapy for patients with co-existing rhinitis and asthma. Manufactured at our WHO-GMP facility in Baddi.

Contract manufacturing a Montelukast suspension presents extreme palatability and stability challenges. Our formulation resolves these definitively:

• Zero-Bitterness Taste-Masking: Montelukast Sodium is intensely bitter. We utilize advanced layered sweeteners and premium fruit flavors to ensure 100% acceptance among the 2–5 year pediatric demographic.
• Photostability Matrix: Montelukast degrades rapidly under UV light. We use antioxidant stabilizers and high-barrier amber PET/glass bottles to prevent photodegradation and maintain full API potency.
• Dual-pH Compatibility: Levocetirizine and Montelukast have different stability pH optima. Our chemists have engineered a precisely buffered base that sustains both actives simultaneously without phase separation.
• Automated Fill Consistency: High-speed twin-head fillers ensure accurate 30 ml and 60 ml volumes per bottle, minimizing batch wastage and ensuring correct patient dosing.

This DCGI-approved Schedule H formulation is heavily prescribed by pediatricians for:

• Seasonal & Perennial Allergic Rhinitis: Complete relief from seasonal pollen or year-round dust mite allergies. Montelukast specifically targets severe nasal congestion.
• Paediatric Bronchial Asthma: Adjunctive therapy for mild-to-moderate asthma, particularly effectively preventing early morning bronchoconstriction.
• Allergic Urticaria: Fast-acting relief for chronic hives and IgE-mediated skin reactions.

Dual Synergy Mechanism

• Histamine Pathway: Levocetirizine acts as an inverse agonist at H1 receptors. By pre-occupying these receptors, it prevents histamine-induced vascular leakage and sensory nerve stimulation (itching/sneezing).
• Leukotriene Pathway: Allergen exposure also triggers the 5-lipoxygenase pathway to release leukotrienes. Montelukast competitively blocks CysLT1 receptors in bronchial smooth muscle, physically preventing airway inflammation and remodeling.
• The Result: Blocking both distinct pathways simultaneously produces disproportionate, synergistic symptom relief.

B2B Manufacturing Integrity

• Oxidation Prevention: Our manufacturing utilizes nitrogen-purged mixing vessels and light-controlled filling environments to prevent oxidative degradation of Montelukast.
• Epimerization Control: Our strict pH-controlled base prevents Levocetirizine from converting to its inactive S-enantiomer, guaranteeing maximum H1-selective potency throughout its 24-month shelf life.

Both molecules possess pharmacokinetic profiles that allow for highly convenient once-daily evening dosing:

• Rapid Absorption: Levocetirizine achieves peak plasma concentration (Cmax) within 1 hour. Its high receptor affinity provides 24-hour symptom control from a single 2.5 mg dose.
• Consistent Bioavailability: Montelukast reaches Cmax in 3–4 hours. Our liquid formulation delivers bioavailability perfectly matched to standard granule protocols.
• Evening Dosing Rationale: Bedtime administration is optimal because Montelukast effectively combats nocturnal asthma, while evening Levocetirizine administration minimizes daytime somnolence for school-aged children.
• Commercial Pack Logic: The 30 ml format provides exactly a 30-day supply (at 5 ml/day), simplifying pharmacy inventory and ensuring straightforward prescription refills.

Saar Biotech offers specialized Third-Party Manufacturing services from our high-capacity facility in Baddi:

• Facility: Automated liquid lines with nitrogen-purge mixing and amber bottle capability.
• Capacity: Pilot batches of 5,000 units up to massive commercial runs of 100,000+ units.
• Quality Lab: GLP-certified QC with validated dual-API HPLC assay capability.
• Turnaround: 30–45 working days for new private-label orders; 20–25 days for repeats.
• Packaging: 30 ml and 60 ml amber bottles with measuring cups and Schedule M-compliant mono-cartons.
• MOQ: Starting at 5,000–10,000 units.

1. Light Protection is Mandatory: Store below 30°C in the original amber bottle. Exposure to direct sunlight will permanently degrade Montelukast Sodium.
2. Cold-Chain Exemption: Does not require refrigeration. Sub-zero temperatures can alter dose uniformity.
3. In-Use Safety: Once opened, keep tightly capped. Ensure the measuring cup is washed after every use to prevent microbial growth.

Every batch is quarantined and released only after exhaustive analytical testing in our GLP-certified laboratories:

• Dual-API HPLC Assay: Simultaneous quantification of both actives to confirm 98–102% label claim accuracy.
• Related Substances Testing: Targeted tracking of Montelukast photodegradation impurities to guarantee ICH Q3B compliance.
• pH & MLT Testing: Ensuring baseline stability and absolute microbiological purity for pediatric safety.

• Common: Mild somnolence (Levocetirizine), mild fatigue, or nausea.
• Neuropsychiatric Advisory: Montelukast has a rare but noted association with behavioral changes or sleep disturbances (insomnia/abnormal dreams). Caregivers should monitor and report these symptoms.
• Contraindications: Severe renal impairment or hypersensitivity to either active. Avoid concurrent use with strong CNS depressants.

For high-volume contract manufacturing or to request pricing for Levocetirizine + Montelukast Syrup, please use the B2B enquiry form below.