Description
Budesonide Inhalation Suspension (Respules) 0.5 mg / 1.0 mg
Healthy Inc is a specialized global supplier and exporter of advanced respiratory, neonatal, and critical care therapeutics. We provide ultra-high-purity, sterile Budesonide Respules, manufactured using Advanced Blow-Fill-Seal (BFS) Technology in a WHO–GMP certified facility. This “Nebulizing Glucocorticoid” is a critical strategic export to pediatric hospitals, emergency care centers, and international B2B distributors, serving as the globally preferred intervention for the acute and maintenance treatment of bronchial asthma in infants and children.
Product Overview
This formulation operates as a “Direct-to-Tissue Anti-Inflammatory.” It physically delivers a fine mist of medication to the smallest airways, providing relief where inflammation is most severe.
Mechanism 1 (Localized Corticosteroid Action): Budesonide physically binds to intracellular glucocorticoid receptors in the bronchial mucosa. This complex moves into the cell nucleus to chemically shut down the production of inflammatory mediators (cytokines/leukotrienes).
Mechanism 2 (Exudate Reduction): It physically reduces the “leaking” of fluid from micro-vessels in the lungs, chemically decreasing the tissue swelling (edema) that causes airway narrowing.
Mechanism 3 (Nebulization Advantage): Unlike inhalers, respules allow for Passive Inhalation. The medication is physically converted into a mist by a nebulizer, making it the only effective way to deliver steroids to infants or distressed patients who cannot physically coordinate a puff-and-breath maneuver.
Product Composition & Strength
We supply this product as a Sterile, Preservative-Free Aqueous Suspension in single-dose units.
| Active Ingredient | Strength (per 2 ml) | Primary Clinical Function |
| Budesonide IP/BP/USP | 0.5 mg / 1.0 mg | The Stabilizer: Reduces severe airway inflammation. |
| Excipients | Sodium Chloride / Polysorbate | The Vehicle: Ensures isotonicity and drug suspension. |
| Formulation | Sterile Aqueous Base | The Safety Standard: Preservative-free for neonatal safety. |
Technical & Logistics Specifications
HS Code: 3004.32.00 (Medicaments containing Adrenal Cortical Hormones)
CAS Number: 51333-22-3 (Budesonide)
Dosage Form: Inhalation Suspension (Nebulizer Liquid)
Packaging: 2 ml LDPE Respules (Single-dose units). Available in strips of 5, packed in nitrogen-flushed aluminum pouches to ensure 24-month stability in Zone IVb tropical climates.
Manufacturing Authority & Compliance
Blow-Fill-Seal (BFS) Technology: Our manufacturing process utilizes BFS Technology, where the container is formed, filled, and sealed in one continuous, automated, aseptic process. This physically eliminates human contact and ensures 100% sterility without the need for preservatives.
Particle Size Engineering: We ensure a physical Particle Size Distribution optimized for nebulization, ensuring the Budesonide particles are small enough to reach the deep alveolar sacs of a child’s lungs.
High First-Pass Metabolism: Like the inhaler version, any medication physically swallowed during nebulization is rapidly deactivated by the liver, chemically minimizing systemic side effects.
Primary Indications
Pediatrics: Maintenance and prophylactic treatment of Childhood Asthma.
Critical Care: Management of Croup (Laryngotracheobronchitis) in infants to reduce stridor and the need for intubation.
Respiratory: Maintenance of COPD (Chronic Obstructive Pulmonary Disease) in elderly patients who have difficulty using hand-held inhalers.
Dosage & Administration
Children (6 months – 12 years): Typically 0.5 mg to 1.0 mg daily, physically administered via a jet nebulizer connected to an air compressor.
Administration: The contents of one respule should physically be squeezed into the nebulizer cup. It should not be mixed with other medications unless specifically directed by a clinician.
Safety Protocol: It is physically critical to wash the child’s face and have them rinse their mouth after the session to prevent skin irritation or oral thrush.
Safety Warning: For Inhalation via Nebulizer Only. NOT for Injection. Acute Attack Note: This is NOT a rescue medication; for sudden shortness of breath, a fast-acting bronchodilator (e.g., Salbutamol respules) must physically be used. Contraindication: Do not use in patients with known hypersensitivity to Budesonide or as primary treatment for status asthmaticus.
Global Export & Contract Manufacturing
Healthy Inc is a premier Respiratory and BFS Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-volume Budesonide respules. Whether you are a National Pediatric Health Program in the CIS or a B2B Pharma Marketplace partner in Africa or SE Asia, we ensure secure, WHO-GMP compliant delivery.
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