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Benazepril | CAS No: 86541-75-5 | GMP-certified suppliers
A medication that treats hypertension by lowering blood pressure and supports cardiovascular and renal health, suitable for monotherapy or combination with thiazide diuretics.
Therapeutic categories
Primary indications
- Benazepril is indicated for the treatment of hypertension
- It may be used alone or in combination with thiazide diuretics
Product Snapshot
- Benazepril is available primarily as oral tablets and capsules, with some ophthalmic solution formulations
- It is used mainly for the treatment of hypertension, either as monotherapy or combined with thiazide diuretics
- The product is approved and marketed in the US and Canada, with additional investigational status in other indications
Clinical Overview
Benazepril and its active form belong to the class of dipeptides, characterized by two alpha-amino acids linked by a peptide bond. The primary mechanism of action involves competitive inhibition of ACE, preventing the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. Reduction of angiotensin II leads to decreased vasopressor activity, diminished aldosterone secretion, and lowered blood pressure. Additionally, by lowering angiotensin II levels, renin activity is modulated via feedback mechanisms, contributing to the antihypertensive effect.
Pharmacodynamically, benazepril is effective in reducing proteinuria and slowing progression of renal disease in patients with nephropathies. It also plays a role in reducing risks related to stroke, myocardial infarction, and cardiac mortality in high-risk patients. Its use may be monotherapy or in combination with thiazide diuretics.
Key absorption, distribution, metabolism, and excretion parameters include hepatic conversion to benazeprilat by esterases. The active metabolite inhibits ACE both in human subjects and animal models. Both benazepril and benazeprilat demonstrate a favorable pharmacokinetic profile consistent with once-daily dosing in clinical practice.
Safety considerations include the potential for angioedema, hyperkalemia, and inadvertent photosensitivity reactions. Monitoring of renal function and serum electrolytes is recommended during therapy. Benazepril is marketed under brand names such as Lotensin and is classified under multiple drug categories related to cardiovascular agents and enzyme inhibitors.
When sourcing benazepril API, ensuring compliance with regulatory standards including purity, potency, and absence of contaminants is critical. Manufacturers should demonstrate validated synthetic routes and analytical characterization consistent with pharmacopeial or regulatory guidelines to support quality and batch-to-batch consistency in pharmaceutical formulations.
Identification & chemistry
| Generic name | Benazepril |
|---|---|
| Molecule type | Small molecule |
| CAS | 86541-75-5 |
| UNII | UDM7Q7QWP8 |
| DrugBank ID | DB00542 |
Pharmacology
| Summary | Benazepril is an ACE inhibitor prodrug that is hydrolyzed to its active form, benazeprilat. It competitively inhibits angiotensin-converting enzyme, reducing the conversion of angiotensin I to angiotensin II, a vasoconstrictor involved in blood pressure regulation and aldosterone secretion. This mechanism leads to decreased vasopressor activity and lowered blood pressure, supporting its use in hypertension management. |
|---|---|
| Mechanism of action | Benazeprilat, the active metabolite of Benazepril, competes with angiotensin I for binding at the angiotensin-converting enzyme, blocking the conversion of angiotensin I to angiotensin II. Inhibition of ACE results in decreased plasma angiotensin II. As angiotensin II is a vasoconstrictor and a negative-feedback mediator for renin activity, lower concentrations result in a decrease in blood pressure and stimulation of baroreceptor reflex mechanisms, which leads to decreased vasopressor activity and to decreased aldosterone secretion. |
| Pharmacodynamics | Benazepril, an angiotensin-converting enzyme (ACE) inhibitor, is a prodrug which, when hydrolyzed by esterases to its active Benazeprilat, is used to treat hypertension and heart failure, to reduce proteinuria and renal disease in patients with nephropathies, and to prevent stroke, myocardial infarction, and cardiac death in high-risk patients. Benazepril and Benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Angiotensin-converting enzyme | Humans | inhibitor |
ADME / PK
| Absorption | Bioavailability of oral dosing is 3% to 4% in horses. In humans at least 37% of oral benazepril is absorbed and reaches peak plasma concentration in 0.5 hours to 1 hour. Other studies have shown a peak plasma concentration at a median of 1.5 hours. |
|---|---|
| Half-life | The half life of the prodrug benazepril is 2.7±8.5h. The half life of the active metabolite benazeprilat is 22.3±9.2h The accumulation half life of benazepril is 10 to 11 hours. |
| Protein binding | Benazepril is 96.7% protein bound while benazeprilat is 95.3% protein bound. |
| Metabolism | Cleavage of the ester group (primarily in the liver) converts benazepril to its active metabolite, benazeprilat. Benazepril and benazeprilat are conjugated to glucuronic acid prior to urinary excretion. |
| Route of elimination | Benazepril and benazeprilat are cleared predominantly by renal excretion in healthy subjects with normal renal function. Nonrenal (i.e., biliary) excretion accounts for approximately 11%-12% of benazeprilat excretion in healthy subjects. |
| Volume of distribution | The final population pharmacokinetic model in one study estimated the volume of distribution to be 203±69.9L. |
| Clearance | The final population pharmacokinetic model of one study estimates the clearance to be 129±30.0L. |
Formulation & handling
- Benazepril is a small molecule dipeptide primarily formulated for oral administration in tablet or capsule form. It has low water solubility and a moderate logP, indicating limited aqueous dissolution which may impact bioavailability. Food intake slows absorption rate but does not affect overall bioavailability; potassium-containing products should be avoided to reduce hyperkalemia risk.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patent expired in the United States in December 2017, allowing for generic market entry. The product is currently marketed in the US and Canada, reflecting a mature market phase. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Benazepril is manufactured by multiple originator and generic pharmaceutical companies with a significant presence in North American markets, particularly the US and Canada. The product is available in branded forms, primarily in the US and Canada, with multiple packaging partners supporting distribution. Given the patent expiration in December 2017 in the United States, there is existing generic competition in these markets. |
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Safety
| Toxicity | The most common adverse effects include headache, dizziness, fatigue, somnolence, postural dizziness, nausea, and cough[FDA Label,A839]. The most likely symptom of overdosage is severe hypotension. |
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- Handle with care to minimize exposure, as the compound may cause central nervous system effects including dizziness and somnolence
- Avoid inhalation and ingestion due to potential respiratory irritation and systemic toxicity
- In case of accidental overexposure, monitor for signs of hypotension and neurological symptoms
Benazepril is a type of ACE inhibitors
ACE inhibitors, or angiotensin-converting enzyme inhibitors, are a subcategory of pharmaceutical APIs (active pharmaceutical ingredients) commonly used in the treatment of various cardiovascular conditions. These medications work by inhibiting the activity of the angiotensin-converting enzyme, which plays a crucial role in the regulation of blood pressure and fluid balance.
By blocking the action of this enzyme, ACE inhibitors help relax and widen the blood vessels, reducing peripheral resistance and ultimately lowering blood pressure. This mechanism of action makes ACE inhibitors highly effective in treating hypertension (high blood pressure) and congestive heart failure.
Additionally, ACE inhibitors have been found to be beneficial for patients with certain kidney disorders and diabetic nephropathy. By dilating the renal blood vessels, they can help improve renal function and reduce proteinuria.
Some commonly prescribed ACE inhibitors include lisinopril, enalapril, and ramipril. These medications are typically administered orally and are available in various dosage forms, including tablets and capsules.
It's worth noting that ACE inhibitors may have certain side effects, such as dry cough, dizziness, and hyperkalemia (high potassium levels). However, these side effects are generally mild and well-tolerated by most patients.
In summary, ACE inhibitors are a vital subcategory of pharmaceutical APIs used in the management of hypertension, heart failure, and certain renal disorders. Their ability to lower blood pressure and improve renal function makes them an essential tool in the treatment of cardiovascular diseases.
Benazepril (ACE inhibitors), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Benazepril API manufacturers & distributors
Compare qualified Benazepril API suppliers worldwide. We currently have 7 companies offering Benazepril API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Albemarle | Producer | United States | United States | CoA, USDMF | 17 products |
| Amino Chemicals | Producer | Malta | Malta | CoA, JDMF, USDMF | 20 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Rolabo Outsourcing | Producer | Spain | Spain | CoA, JDMF | 11 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, WC | 219 products |
| Wisdom Pharma | Producer | China | China | CoA, USDMF | 12 products |
When sending a request, specify which Benazepril 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 Benazepril 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.
