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Ipratropium | CAS No: 60205-81-4 | GMP-certified suppliers
A medication that provides bronchodilation for COPD maintenance, supports management of severe asthma exacerbations, and relieves rhinorrhea symptoms in respiratory conditions.
Therapeutic categories
Primary indications
- Inhaled ipratropium is indicated in combination with inhaled beta-agonist systemic corticosteroids for the management of severe exacerbations of asthma flares requiring treatment
- Asthma exacerbations are characterized by a progressive increase in one or more of asthma symptoms accompanied by a decrease in expiratory flow
Product Snapshot
- Ipratropium is available primarily as inhalation aerosols and solutions for respiratory administration, with additional nasal spray and topical formulations
- It is indicated for the management of asthma exacerbations, chronic obstructive pulmonary disease (COPD), and symptomatic relief of rhinorrhea associated with common cold or allergic rhinitis
- Ipratropium is FDA-approved in the United States and approved for use in Canada, with some experimental applications under investigation
Clinical Overview
Clinically, ipratropium is indicated for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. It is also used in combination with inhaled beta-agonists and systemic corticosteroids for managing severe asthma exacerbations requiring acute intervention. Additionally, ipratropium nasal spray is approved for symptomatic relief of rhinorrhea in patients aged five years and older, particularly in the context of common cold or seasonal allergic rhinitis, although it does not alleviate nasal congestion or sneezing. Investigational uses include treatment of sialorrhea associated with neurological disorders.
Pharmacodynamically, ipratropium inhibits parasympathetic nervous system activity by competitively antagonizing muscarinic receptors in bronchial smooth muscle and secretory glands. This results in reduced bronchoconstriction and mucus secretion, thereby improving airway patency and reducing respiratory symptoms. Onset of action typically occurs within one to two hours, with effects lasting approximately four to six hours.
Pharmacokinetic data indicate limited systemic absorption after inhalation due to its quaternary ammonium structure, which restricts penetration across lipid membranes. This contributes to a favorable safety profile with minimal systemic anticholinergic adverse effects. Common safety considerations include potential for dry mouth, cough, and, rarely, paradoxical bronchospasm. Due to its antimuscarinic activity, caution is advised in patients with glaucoma or urinary retention.
Initially developed by Boehringer Ingelheim, ipratropium received FDA approval as monotherapy in 1986 and subsequently in combination with albuterol in 1996. The drug is categorized under bronchodilator agents, anticholinergics, and respiratory system agents, among other pharmacologic classes.
For sourcing and quality assurance, procurement of ipratropium API requires adherence to stringent purity criteria and validation of residual solvents, given its inhalation administration. Manufacturers should ensure compliance with pharmacopeial standards and regulatory guidelines to guarantee consistent efficacy and safety in finished dosage forms.
Identification & chemistry
| Generic name | Ipratropium |
|---|---|
| Molecule type | Small molecule |
| CAS | 60205-81-4 |
| UNII | GR88G0I6UL |
| DrugBank ID | DB00332 |
Pharmacology
| Summary | Ipratropium is a short-acting muscarinic acetylcholine receptor antagonist targeting M1, M2, and M3 subtypes to inhibit parasympathetic nervous system activity in the airways. This inhibition reduces bronchial smooth muscle contraction and secretions, leading to bronchodilation and decreased airway obstruction. It is primarily used to manage bronchospasm in conditions such as asthma exacerbations and chronic obstructive pulmonary disease. |
|---|---|
| Mechanism of action | Ipratropium acts as an antagonist of the muscarinic acetylcholine receptor. This effect produces the inhibition of the parasympathetic nervous system in the airways and hence, inhibit their function. The function of the parasympathetic system in the airway is to generate bronchial secretions and constriction and hence, the inhibition of this action can lead to bronchodilation and fewer secretions. At the cellular level, the diameter of the airways is controlled by the release of acetylcholine into the muscle cells causing them to contract and producing a narrow airway. Thus administration of ipratropium stops the activity of acetylcholine in the smooth muscle preventing the contraction and producing relaxed airways. |
| Pharmacodynamics | Ipratropium is a short-acting agent that inhibits the parasympathetic nervous system at the level of the airway which then produces bronchodilatation. The effect of this agent starts after 1-2 hours and it is known to last only from 4 to 6 hours. As part of the effect, ipratropium relaxes the bronchial airways which reverse the narrowing that accounts for wheezy breathing, chest tightness, cough and abnormal gas exchange. In clinical trials where ipratropium was used in the initial management of status asthmaticus, it was demonstrated a clear benefit in pulmonary function in children and adults. However, the continuous use of ipratropium after an acute asthmatic attack is not proven to be significantly advantageous nor the prophylactic administration of this agent. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Muscarinic acetylcholine receptor M3 | Humans | antagonist |
| Muscarinic acetylcholine receptor M1 | Humans | antagonist |
| Muscarinic acetylcholine receptor M2 | Humans | antagonist |
ADME / PK
| Absorption | Ipratropium is a topically active but poorly absorbed agent. The lack of absorption potential in the mucosal surfaces is associated with the presence of a charge in the 5-valent nitrogen. The molecule itself presents very large topic effectiveness however, it does not produce detectable blood levels nor systemic effects. Serum levels of ipratropium after oral or inhaled administration are very low, corresponding to only 1-2% of the administered dose. These low levels peak after 1-2 hours and it presents a low bioavailability of 2%. |
|---|---|
| Half-life | Ipratropium presents a short half-life of about 1.6 hours. |
| Protein binding | The protein binding of ipratropium is very low as the level of circulating ipratropium is very minimal. The bound state represents only from 0-9% of the administered dose. |
| Metabolism | Ipratropium is metabolized in the gastrointestinal tract by the activity of the cytochrome P-450 isoenzymes. From the orally administered dose, about 90% of the dose is excreted unchanged. The absorbed portion is partially metabolized by ester hydrolysis to inactive metabolites, tropic acid and tropane. |
| Route of elimination | About 80-100% of the administered dose of ipratropium is excreted in the urine leaving less than 20% of the dose to be eliminated through the feces. From the urine eliminated portion, almost all the drug is found unchanged. However, when ipratropium is orally administered, due to its low absorption, most of the dose is recovered in the feces with a very minimal amount found in the urine. |
| Volume of distribution | Ipratropium has a volume of distributions of 4.6 L/kg and hence, it is known to be highly distributed in the tissues. |
| Clearance | The average clearance rate of ipratropium is of 2.3 L/min with a renal clearance of 0.9 L/min. |
Formulation & handling
- Ipratropium is a small molecule primarily formulated for respiratory routes including inhalation and nasal delivery, as well as buccal administration.
- Due to its low water solubility and use in aerosol and solution forms, careful consideration is needed for formulation stability and particle size for effective delivery.
- Ipratropium is not a peptide or biologic; it does not exhibit sensitivity to food and requires standard handling conditions typical for small molecule inhalation drugs.
Regulatory status
| Lifecycle | The API's primary patents in the United States expired between 2009 and 2021, with an additional patent extending protection until 2030; in Canada, key patent protection ended in 2013. Products containing this API are marketed in both the US and Canadian markets, reflecting a transition from patent exclusivity to increased generic competition. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ipratropium is supplied by multiple manufacturers, including both originator and generic companies, indicating a diversified manufacturing landscape. Branded products such as Atrovent have presence primarily in the US and Canadian markets. Patent expiration dates ranging from 2009 to 2030 suggest that while some patents have expired enabling generic competition, others remain active, supporting ongoing proprietary protection in certain formulations. |
|---|
Safety
| Toxicity | The reported LD50 in mice after oral administration of ipratropium is 1500 mg/kg.[MSDS] However, overdosage is not very likely due to the poor absorption of ipratropium. Ipratropium was not shown to present carcinogenesis, teratogenesis not mutagenesis potential and it did not present effects on fertility. The only effect after high administration of ipratropium was a reduction in the conception rate. |
|---|
- Ipratropium exhibits low oral toxicity with an LD50 of 1500 mg/kg in mice
- Systemic toxicity risk is limited due to poor absorption
- No evidence of carcinogenicity, mutagenicity, or teratogenicity has been reported
Ipratropium Bromide is a type of Anticholinergics/Parasympathemimetics
Anticholinergics/Parasympathomimetics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These compounds exhibit specific pharmacological actions by targeting the cholinergic system in the body.
Anticholinergics are drugs that block the action of acetylcholine, a neurotransmitter that regulates various bodily functions. By inhibiting the activity of acetylcholine, anticholinergics can have diverse therapeutic effects, including reducing muscle spasms, decreasing gastrointestinal motility, and alleviating symptoms associated with certain respiratory conditions.
On the other hand, parasympathomimetics, also known as cholinomimetics, mimic the action of acetylcholine by stimulating cholinergic receptors. These compounds enhance the parasympathetic nervous system, which is responsible for the "rest and digest" functions of the body. Parasympathomimetics are commonly used to treat conditions such as glaucoma, urinary retention, and Alzheimer's disease.
The use of anticholinergics/parasympathomimetics requires careful consideration and medical supervision due to their potential side effects, which can include dry mouth, blurred vision, urinary retention, constipation, and cognitive impairment. These medications are available in various forms, including tablets, capsules, patches, and inhalers, and their dosage is determined by the specific medical condition being treated.
Overall, anticholinergics/parasympathomimetics play a vital role in modern medicine, providing targeted therapeutic effects by modulating the cholinergic system. Their usage has significantly improved patient outcomes in various medical conditions and continues to be an important category of pharmaceutical APIs.
Ipratropium Bromide (Anticholinergics/Parasympathemimetics), classified under Autonomic Nervous System Agents
Autonomic Nervous System Agents are a crucial category of pharmaceutical active ingredients (APIs) that target the autonomic nervous system (ANS). The ANS plays a vital role in regulating essential bodily functions such as heart rate, blood pressure, digestion, and respiratory rate. This category of pharmaceutical APIs encompasses a wide range of drugs designed to modulate the activity of the ANS.
One subcategory within Autonomic Nervous System Agents is the Sympathomimetic agents, which mimic the effects of the sympathetic nervous system. These drugs are often used to treat conditions such as asthma, nasal congestion, and hypotension by stimulating specific adrenergic receptors.
Conversely, Sympatholytic agents act to inhibit or block the sympathetic nervous system. They are employed to treat hypertension, anxiety, and certain cardiac conditions by reducing sympathetic activity.
Another subcategory is Parasympathomimetic agents, which mimic the effects of the parasympathetic nervous system. These drugs are commonly used to treat glaucoma, urinary retention, and certain gastrointestinal disorders by stimulating cholinergic receptors.
Parasympatholytic agents, on the other hand, act to block the parasympathetic nervous system. They find applications in the treatment of conditions such as overactive bladder and irritable bowel syndrome by inhibiting cholinergic receptors.
The Autonomic Nervous System Agents API category includes various drugs with distinct mechanisms of action that enable healthcare professionals to fine-tune the balance of the autonomic nervous system. By targeting specific receptors and pathways, these pharmaceutical APIs provide valuable therapeutic options for managing a wide range of medical conditions related to autonomic dysfunction.
Ipratropium Bromide API manufacturers & distributors
Compare qualified Ipratropium Bromide API suppliers worldwide. We currently have 9 companies offering Ipratropium Bromide API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, cDMF, CoA, GMP, MSDS | 229 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Boehringer Ingelheim | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 35 products |
| Cipla | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF | 164 products |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP | 18 products |
| Lusochimica | Producer | Italy | Italy | CEP, CoA, FDA, GMP, KDMF, USDMF | 23 products |
| Miat | Producer | Italy | Italy | CoA | 10 products |
| Resonance Labs. | Producer | India | India | CoA, GMP, WHO-GMP | 34 products |
| Vamsi Labs | Producer | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC, WHO-GMP | 29 products |
When sending a request, specify which Ipratropium Bromide 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.).
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