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Dyphylline | CAS No: 479-18-5 | GMP-certified suppliers
A medication that provides bronchodilation for relief of acute bronchial asthma and reversible bronchospasm in chronic bronchitis and emphysema, supporting obstructive airway disease management.
Therapeutic categories
Primary indications
- For relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema
Product Snapshot
- Dyphylline is available in multiple formulation types including oral tablets, syrups, injectable solutions, and suppositories
- It is primarily indicated for relief of acute bronchial asthma and reversible bronchospasm in chronic bronchitis and emphysema
- Dyphylline holds regulatory approval for use in the US and Canadian markets
Clinical Overview
Pharmacodynamically, dyphylline acts as a bronchodilator with additional peripheral vasodilatory and smooth muscle relaxant effects. Its pharmacological profile is similar to other xanthines but is distinguished by a comparatively favorable safety and tolerability profile.
The mechanism of action involves competitive inhibition of phosphodiesterase enzymes, leading to increased intracellular cyclic adenosine monophosphate (cAMP) levels. Elevated cAMP causes relaxation of bronchial smooth muscle, thereby reducing airway resistance. Additionally, dyphylline antagonizes adenosine receptors, contributing to its bronchodilatory and vasodilatory effects.
Regarding absorption, distribution, metabolism, and excretion (ADME), dyphylline is predominantly eliminated via renal excretion. Due to its primary renal clearance, dose adjustments may be necessary in patients with impaired kidney function to avoid accumulation and potential toxicity.
From a safety perspective, dyphylline may exhibit typical xanthine-related adverse effects, including nervousness, gastrointestinal discomfort, and tachycardia at higher doses. Contraindications and precautions follow from its pharmacology and patient-specific risk factors. Vigilance regarding potential drug interactions, especially with other phosphodiesterase inhibitors or adenosine antagonists, is recommended.
Dyphylline is approved for use in multiple international markets and is classified under various pharmacologic classes including bronchodilator agents, cardiovascular agents, phosphodiesterase inhibitors, and respiratory system agents. Its application in clinical settings spans management of obstructive airway diseases and associated cardiovascular symptoms, such as cardiac dyspnea.
For API sourcing, emphasis should be placed on obtaining dyphylline from manufacturers adhering to Good Manufacturing Practices (GMP) with comprehensive impurity profiling and certification of analysis. Given the therapeutic context, consistent batch-to-batch quality and compliance with pharmacopeial standards are essential for safe formulation and reliable clinical performance.
Identification & chemistry
| Generic name | Dyphylline |
|---|---|
| Molecule type | Small molecule |
| CAS | 479-18-5 |
| UNII | 263T0E9RR9 |
| DrugBank ID | DB00651 |
Pharmacology
| Summary | Dyphylline is a xanthine derivative that acts as a bronchodilator by competitively inhibiting phosphodiesterase enzymes (PDE4 isoforms), leading to increased cyclic AMP levels and relaxation of bronchial smooth muscle. It also antagonizes adenosine A1 and A2a receptors, contributing to its bronchodilatory and smooth muscle relaxant effects. Therapeutically, dyphylline is used for the relief of acute bronchial asthma and reversible bronchospasm associated with chronic bronchitis and emphysema. |
|---|---|
| Mechanism of action | The bronchodilatory action of dyphylline, as with other xanthines, is thought to be mediated through competitive inhibition of phosphodiesterase with a resulting increase in cyclic AMP producing relaxation of bronchial smooth muscle as well as antagonism of adenosine receptors. |
| Pharmacodynamics | Dyphylline, a xanthine derivative, is a bronchodilator used for relief of acute bronchial asthma and for reversible bronchospasm associated with chronic bronchitis and emphysema. Dyphylline is a xanthine derivative with pharmacologic actions similar to theophylline and other members of this class of drugs. Its primary action is that of bronchodilation, but it also exhibits peripheral vasodilatory and other smooth muscle relaxant activity to a lesser degree. |
Targets
| Target | Organism | Actions |
|---|---|---|
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Humans | inhibitor |
| cAMP-specific 3',5'-cyclic phosphodiesterase 4A | Humans | inhibitor |
| cAMP-specific 3',5'-cyclic phosphodiesterase 4C | Humans | inhibitor |
ADME / PK
| Half-life | 2 hours (range 1.8 - 2.1 hours) |
|---|---|
| Protein binding | 84% |
| Metabolism | Hepatic |
| Route of elimination | Dyphylline exerts its bronchodilatory effects directly and, unlike theophylline, is excreted unchanged by the kidneys without being metabolized by the liver. Approximately 88% of a single oral dose can be recovered from the urine unchanged. |
Formulation & handling
- Dyphylline is a small molecule xanthine derivative suitable for oral, intramuscular, intravenous, and rectal administration.
- The API exhibits high water solubility and low lipophilicity (LogP -1.9), which supports formulation in aqueous solutions for injections and oral liquids.
- No peptide or biologic properties are present, indicating standard chemical stability and handling procedures for small molecule compounds apply.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently marketed in the US and Canada with patent protection expired or nearing expiration, indicating progression into a mature market phase with increased generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Dyphylline is produced by multiple manufacturers and packaged by various pharmaceutical companies, indicating a distributed manufacturing and supply network. Branded products are primarily marketed in the US and Canada, with no significant presence in the EU or other regions. The typical generic availability in these markets suggests that any initial patents have likely expired, enabling existing generic competition. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=1954 mg/kg (orally in mice) |
|---|
- Oral LD50 in mice is 1954 mg/kg, indicating moderate acute toxicity
- Use appropriate protective equipment to avoid inhalation or skin contact
- Handle in a well-ventilated area to minimize exposure risk
Dyphylline is a type of Xanthine derivates
Xanthine derivatives are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in the development of various medications. Xanthine derivatives are chemical compounds derived from xanthine, a purine base found in various biological systems.
These derivatives possess pharmacological properties that make them valuable for the treatment of numerous medical conditions. The most notable xanthine derivative is caffeine, a widely consumed psychoactive substance with stimulant effects on the central nervous system. Caffeine is commonly found in coffee, tea, and certain soft drinks.
Apart from caffeine, other xanthine derivatives, such as theophylline and theobromine, also exhibit distinct therapeutic properties. Theophylline is utilized for the treatment of respiratory disorders, including asthma and chronic obstructive pulmonary disease (COPD). It functions by relaxing the smooth muscles in the airways, thereby facilitating easier breathing. Theobromine, on the other hand, is found in cocoa products and is known for its mild diuretic effects.
Xanthine derivatives exert their pharmacological effects by competitively inhibiting the action of enzymes called phosphodiesterases. This inhibition leads to increased levels of cyclic adenosine monophosphate (cAMP), resulting in various physiological responses, including bronchodilation and increased heart rate.
In conclusion, xanthine derivatives, including caffeine, theophylline, and theobromine, are essential pharmaceutical ingredients with diverse applications in the medical field. Their unique properties and mechanisms of action make them valuable components in medications for respiratory disorders, cardiovascular conditions, and other therapeutic purposes.
Dyphylline (Xanthine derivates), classified under Respiratory Tract Agents
Respiratory Tract Agents are a vital category of pharmaceutical APIs (Active Pharmaceutical Ingredients) designed to treat respiratory conditions and diseases. These agents are specifically formulated to target the respiratory system, which includes the lungs, airways, and nasal passages. They play a crucial role in managing various respiratory disorders, such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
Respiratory Tract Agents encompass a wide range of medications, including bronchodilators, corticosteroids, antihistamines, and mucolytics. Bronchodilators are commonly used to relieve airway constriction and facilitate smooth breathing by relaxing the muscles in the airways. Corticosteroids help reduce inflammation in the respiratory system, alleviating symptoms and preventing exacerbations. Antihistamines work by blocking histamine receptors, thus mitigating allergic reactions that often impact the respiratory tract. Mucolytics aid in loosening and thinning mucus, making it easier to expel from the airways.
These APIs are developed through rigorous research and development processes, ensuring their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers rely on advanced technologies and stringent quality control measures to produce high-quality Respiratory Tract Agents. These APIs are subsequently incorporated into various dosage forms, including inhalers, nasal sprays, nebulizers, and oral medications.
Respiratory Tract Agents are essential in the management of respiratory conditions, providing relief from symptoms, improving lung function, and enhancing the overall quality of life for patients. They are prescribed by healthcare professionals and often used in combination therapies to achieve optimal results. As respiratory disorders continue to affect a significant portion of the global population, the development and availability of effective Respiratory Tract Agents play a vital role in addressing these health challenges and improving patient outcomes.
Dyphylline API manufacturers & distributors
Compare qualified Dyphylline API suppliers worldwide. We currently have 3 companies offering Dyphylline API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Bakul Pharma Private Limi... | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS | 52 products |
| Shanghai Wonder Pharma | Producer | China | China | CoA, JDMF, WC | 5 products |
| Shizuoka Coffein Co | Producer | Japan | Japan | CoA, JDMF | 8 products |
When sending a request, specify which Dyphylline API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dyphylline API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
