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Theobromine | CAS No: 83-67-0 | GMP-certified suppliers
A medication that provides vasodilation, diuretic, and mild cardiac stimulation, useful in managing fatigue, orthostatic hypotension, and respiratory conditions such as apnea of prematurity.
Therapeutic categories
Primary indications
- Theobromine is used as a vasodilator, a diuretic, and heart stimulant
- And similar to caffeine, it may be useful in management of fatigue and orthostatic hypotension
Product Snapshot
- Theobromine is an oral small molecule formulation
- It is primarily used as a vasodilator, diuretic, and cardiac stimulant, with potential applications in managing fatigue and orthostatic hypotension
- Theobromine currently holds investigational status without approved regulatory market authorization
Clinical Overview
Clinically, theobromine has been utilized for its vasodilatory, diuretic, and mild cardiac stimulant properties. Historically, it was applied in the management of angina pectoris and hypertension, as well as a diuretic agent. More recently, its clinical use is largely investigational, but it remains of interest for potential treatment of fatigue and orthostatic hypotension. Its bronchodilator activity is similar in nature to theophylline but is generally weaker, and it is used as a mild respiratory stimulant, including in neonates with apnea of prematurity.
Pharmacodynamically, theobromine acts as a central nervous system stimulant with weaker potency than caffeine, exhibiting mild diuretic and bronchodilator effects. Its mechanism of action involves antagonism of adenosine receptors (notably A1 and A2 subtypes) across various tissues. This antagonism promotes neurotransmitter release by blocking the inhibitory actions of endogenous adenosine, which leads to increased neuronal and cardiovascular activity. Additionally, theobromine was previously considered to increase intracellular cyclic AMP by phosphodiesterase inhibition; however, adenosine receptor antagonism is now considered the primary effect. The impact on medullary, vagal, and vasomotor centers results in increased respiratory rate, vasodilation, and bradycardia.
ADME characteristics include metabolism primarily mediated by cytochrome P450 enzymes such as CYP1A2 and CYP2E1. Theobromine exhibits moderate bioavailability and a half-life that supports its pharmacological effects without pronounced central nervous stimulation.
Safety considerations include its narrow therapeutic window when used as a stimulant or diuretic and known cardiovascular effects such as palpitations or arrhythmias, particularly at higher exposure levels. Theobromine's toxicity is notable in certain animal species, such as dogs, due to slower metabolic clearance.
When sourcing theobromine API, quality control must ensure compliance with pharmacopeial standards for purity, identity, and residual solvents, alongside batch-to-batch consistency. Suppliers should provide appropriate certificates of analysis and ensure manufacturing follows current Good Manufacturing Practices (cGMP) to support pharmaceutical development and regulatory submissions.
Identification & chemistry
| Generic name | Theobromine |
|---|---|
| Molecule type | Small molecule |
| CAS | 83-67-0 |
| UNII | OBD445WZ5P |
| DrugBank ID | DB01412 |
Pharmacology
| Summary | Theobromine acts primarily as a non-selective antagonist of adenosine A1 and A2a receptors, enhancing neurotransmitter release by inhibiting adenosine-mediated suppression. It also inhibits phosphodiesterase 4B, leading to increased intracellular cyclic AMP levels. These actions produce central nervous system stimulation, vasodilation, diuresis, and respiratory stimulation. |
|---|---|
| Mechanism of action | Theobromine stimulates medullary, vagal, vasomotor, and respiratory centers, promoting bradycardia, vasoconstriction, and increased respiratory rate. This action was previously believed to be due primarily to increased intracellular cyclic 3′,5′-adenosine monophosphate (cyclic AMP) following inhibition of phosphodiesterase, the enzyme that degrades cyclic AMP. It is now thought that xanthines such as caffeine and theobromine act as antagonist at adenosine-receptors within the plasma membrane of virtually every cell. As adenosine acts as an autocoid, inhibiting the release of neurotransmitters from presynaptic sites but augmenting the actions of norepinephrine or angiotensin, antagonism of adenosine receptors promotes neurotransmitter release. This explains the stimulatory effects of xanthine derivatives such as theobromine and caffeine. Blockade of the adenosine A1 receptor in the heart leads to the accelerated, pronounced "pounding" of the heart upon caffeine intake. |
| Pharmacodynamics | Theobromine, a xanthine derivative like caffeine and the bronchodilator theophylline, is used as a CNS stimulant, mild diuretic, and respiratory stimulant (in neonates with apnea of prematurity). |
Targets
| Target | Organism | Actions |
|---|---|---|
| Adenosine receptor A1 | Humans | antagonist |
| Adenosine receptor A2a | Humans | antagonist |
| cAMP-specific 3',5'-cyclic phosphodiesterase 4B | Humans | inhibitor |
Formulation & handling
- Theobromine is a small molecule xanthine derivative suitable for oral formulation due to its solid state and moderate water solubility.
- Low logP indicates a hydrophilic profile, which may influence absorption and formulation strategies.
- No specific peptide or biologic handling precautions are required; stability under standard storage conditions is expected.
Regulatory status
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Theobromine 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.
Theobromine (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.
Theobromine API manufacturers & distributors
Compare qualified Theobromine API suppliers worldwide. We currently have 3 companies offering Theobromine API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| BAJAJ HEALTHCARE LTD | Producer | India | India | CoA, GMP, WC | 8 products |
| Bakul Pharma Private Limi... | Producer | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 52 products |
| CSPC Innovation | Producer | China | China | CEP, CoA, FDA, GMP, KDMF | 3 products |
When sending a request, specify which Theobromine 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 Theobromine 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.
