Anti-Asthmatic APIs
Premium Active Pharmaceutical Ingredients for Asthma and Respiratory Disease Management
About Anti-Asthmatic APIs
Holiness Pharmaceutical is a trusted manufacturer and global supplier of high-quality Anti-Asthmatic APIs used in the treatment of asthma, COPD, and other respiratory conditions. Our portfolio includes bronchodilators, leukotriene receptor antagonists, and inhaled corticosteroids manufactured under WHO-GMP standards. We supply pharmaceutical companies worldwide with APIs for developing life-improving respiratory medications.
Key Features
- WHO-GMP certified respiratory drug manufacturing
- Compliance with IP, BP, USP, and EP standards
- Multiple therapeutic classes for respiratory diseases
- Specialized particle size control for inhalation products
- Advanced micronization technology for optimal lung deposition
- Comprehensive stability studies under various conditions
- Complete regulatory documentation and DMF support
- Technical support for inhalation and oral formulations
Application Areas
Asthma Management
Bronchodilation and anti-inflammatory treatment for asthma control and prevention
COPD Treatment
Management of chronic obstructive pulmonary disease and bronchitis
Acute Bronchospasm
Quick relief during asthma attacks and acute respiratory distress
Exercise-Induced Bronchoconstriction
Prevention of breathing difficulties during physical activity
Allergic Respiratory Conditions
Management of allergic asthma and seasonal respiratory allergies
Quality Assurance
Our anti-asthmatic APIs undergo specialized quality testing including particle size distribution analysis for inhalation products, polymorphic form characterization, residual solvent testing, chiral purity assessment where applicable, aerodynamic particle size determination, and comprehensive microbiological evaluation. Each batch meets stringent specifications for respiratory drug applications.
Our Anti-Asthmatic APIs Products
| Product Name | CAS Number | Grade | Form | Actions |
|---|---|---|---|---|
Montelukast Sodium | 151767-02-1 | IP/BP/EP/USP | API Powder | View Product |
Pranlukast Sodium API | 1031177-37-3 | IP/BP/USP | API Powder | View Product |
Salbutamol Sulphate API | 51022-70-9 | IP/BP | API Powder | View Product |
Frequently Asked Questions
What are Anti-Asthmatic APIs?
Anti-Asthmatic APIs are active pharmaceutical ingredients used to prevent and treat asthma and respiratory conditions. They include bronchodilators (beta-2 agonists), anti-inflammatory agents (corticosteroids), leukotriene receptor antagonists, and combination products that work by relaxing airway muscles, reducing inflammation, and preventing bronchospasm.
Which anti-asthmatic APIs does Holiness Pharmaceutical manufacture?
We manufacture Salbutamol Sulphate (bronchodilator), Montelukast Sodium (leukotriene receptor antagonist), Budesonide (inhaled corticosteroid), and related respiratory APIs. All products are manufactured to international pharmacopeial standards suitable for oral, inhalation, and nebulizer formulations.
Why is particle size critical for inhalation APIs?
Particle size determines lung deposition and therapeutic efficacy. For optimal delivery to the lungs, respirable particles should be 1-5 microns. We provide micronized grades with controlled particle size distribution, typically D50 < 5 microns, ensuring effective drug delivery to the respiratory tract and maximum therapeutic benefit.
Do you provide different grades for inhalation versus oral formulations?
Yes, we manufacture specialized grades: micronized APIs with fine particle distribution for dry powder inhalers (DPI) and metered-dose inhalers (MDI), suspension grades for nebulizers with specific particle size ranges, and standard grades for oral tablets and syrups. Each grade is optimized for its intended route of administration.
How do you ensure stability of respiratory APIs?
We conduct comprehensive stability studies under ICH guidelines including long-term, accelerated, and stress conditions. Special attention is given to polymorphic stability, hygroscopicity, and photostability. Products are packaged in moisture-barrier containers with appropriate desiccants, and storage recommendations are provided based on stability data.
Can you provide technical support for inhalation formulation development?
Yes, our technical team provides comprehensive support including aerodynamic particle size distribution data, flowability characteristics, compatibility studies with lactose and other excipients, surface morphology analysis, electrostatic properties, and guidance on achieving optimal fine particle fraction for inhalation products.
What analytical methods do you use for anti-asthmatic APIs?
We employ HPLC for purity and related substances, laser diffraction for particle size distribution, cascade impactor for aerodynamic assessment, Karl Fischer for moisture content, XRD for polymorphic characterization, SEM for particle morphology, and specific methods for chirality where applicable. All methods are validated according to ICH guidelines.
Do you manufacture enantiomerically pure forms of chiral anti-asthmatic APIs?
Yes, for chiral molecules like Montelukast and Salbutamol, we manufacture the active enantiomeric forms with strict control over optical purity. We use chiral HPLC methods to ensure enantiomeric excess meets specifications, typically >99% for the active isomer, ensuring optimal therapeutic activity and reduced side effects.