High-Purity Budesonide API

Budesonide (molecular formula: C25H34O6) is a glucocorticoid with potent topical anti-inflammatory activity. It enhances the stability of endothelial cell membranes, smooth muscle cell membranes, and lysosomal membranes; suppresses immune responses and reduces antibody synthesis; thereby decreasing the release and activity of histamine and other allergic mediators. It also attenuates enzymatic processes triggered by antigen–antibody interactions and inhibits the synthesis and release of bronchoconstrictive substances, thereby reducing smooth muscle contraction.

Clinically, budesonide is used in patients with glucocorticoid-dependent or glucocorticoid-independent bronchial asthma and asthmatic chronic bronchitis.

Following inhalation, budesonide exerts its effects primarily in the airways and lung tissues through the combined mechanisms described above. It inhibits the production of inflammatory and allergic mediators, cytokines, and other biologically active substances; promotes the constriction of dilated mucosal blood vessels; and enhances the sensitivity of bronchial smooth muscle and inflammatory cells to β2-agonists. These effects provide effective therapeutic benefits in both extrinsic and intrinsic asthma.

In addition to relieving clinical symptoms such as asthma and dyspnea and improving pulmonary ventilation, budesonide offers a particularly significant advantage over many other asthma medications through its anti-inflammatory activity.

A long-term clinical study involving patients treated with budesonide found, through pre- and post-treatment bronchoscopic examinations and histological analysis of tissue specimens, that budesonide could alleviate or partially reverse airway inflammatory remodeling in patients with chronic asthma. These pathological changes included airway mucosal edema and basement membrane thickening associated with subepithelial collagen deposition.

The anti-inflammatory potency of budesonide is approximately 500 times that of dexamethasone. Consequently, when administered by low-dose inhalation to achieve the aforementioned local therapeutic effects, even the fraction absorbed through the respiratory tract or swallowed (with a bioavailability of only 11%) is unlikely to cause significant systemic glucocorticoid-related adverse effects.

1. Potent Anti-Inflammatory Activity: Inhibits inflammatory responses in the airways and mucous membranes, reducing redness, swelling, and exudation.

2. Anti-Allergic Activity: Reduces allergic responses and alleviates allergy-related symptoms such as coughing, wheezing, nasal itching, and rhinorrhea.

3. Suppression of Excessive Immune Responses: Reduces the release of inflammatory mediators, helping prevent airway hyperresponsiveness and asthma exacerbations.

1. Respiratory Formulations: Used in the manufacture of nebuliser suspensions, dry powder inhalers (DPIs), and metered-dose inhalers (MDIs) for the prevention and treatment of bronchial asthma, chronic bronchitis, and inflammatory conditions associated with airway hyperresponsiveness.

2. Nasal Formulations: Used in the production of nasal sprays for the symptomatic treatment of allergic rhinitis, non-allergic rhinitis, and nasal polyps, as well as for preventing postoperative recurrence.

3. Gastrointestinal and Intestinal Inflammatory Formulations: Used in the development of enteric-coated capsules, oral suspensions, and rectal formulations for the treatment of gastrointestinal inflammatory disorders, including Crohn's disease, ulcerative colitis, and eosinophilic esophagitis. It is also used in the development of formulations related to IgA nephropathy.

Packaging: Sealed in double-layer inner polyethylene (PE) bags, with an outer aluminium canister or fibreboard drum.

Standard packaging options:

1 kg / aluminium canister

5 kg / aluminium canister

25 kg / fibreboard drum

Customised small packaging options are available upon request. Labels include the batch number, Certificate of Analysis (COA), expiry date, and CAS number.

Storage Requirements: Store in a tightly sealed container, protected from light, in a cool, dry place. Protect from moisture and avoid exposure to intense light and high temperatures.

Transportation: Available for sea, air, and land transportation. Classified as an ordinary pharmaceutical chemical raw material and is not classified as a dangerous good. Protect the product from rain and moisture throughout transportation and avoid prolonged exposure to direct sunlight.

Shelf Life: 5 years under sealed storage conditions.

1. Delivery Follow-Up: Logistics and shipment tracking information is provided upon dispatch. After delivery, customers are contacted to confirm receipt and verify that the packaging, quantities, and complete set of shipping and quality documentation are in order.

2. Quality Complaint Handling: In the event of specification deviations or packaging damage, customers may provide supporting evidence, such as test reports and photographs. We will promptly investigate the issue and negotiate an appropriate solution in accordance with the contract, including replacement, supplementary shipment, or refund.

3. Ongoing Technical Support: Technical assistance is available for formulation development, analytical testing, and process optimisation. We also provide consultation on technical documentation required for customer registration and regulatory submissions.

4. Batch Record Retention: Batch-specific COAs and original analytical test records are retained for long-term reference. Historical batch documentation can be retrieved at any time to support repeat orders.

5. Regulatory Compliance Advisory: Customers are advised of the applicable storage conditions, shelf life, and regulatory requirements. This product is a steroid hormone active pharmaceutical ingredient (API) and is intended exclusively for use in the manufacture of pharmaceutical formulations.

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