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Terpin hydrate | CAS No: 2451-01-6 | GMP-certified suppliers
A medication that acts as an expectorant to support mucus clearance and relieve respiratory conditions such as bronchitis, pneumonia, bronchiectasis, and COPD.
Therapeutic categories
Primary indications
- Terpin hydrate is used in the treatment of acute and chronic bronchitis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease, infectious and inflammatory diseases of the upper respiratory tract
Product Snapshot
- Terpin hydrate is available as oral dosage forms including tablets, lozenges, elixirs, and capsules
- It is indicated for respiratory conditions such as acute and chronic bronchitis, pneumonia, bronchiectasis, COPD, and infectious or inflammatory diseases of the upper respiratory tract
- Terpin hydrate holds approved and experimental status in the Canadian pharmaceutical market
Clinical Overview
Clinically, terpin hydrate is indicated for the treatment of acute and chronic bronchitis, pneumonia, bronchiectasis, chronic obstructive pulmonary disease (COPD), and other infectious or inflammatory diseases affecting the upper respiratory tract. Its therapeutic objective is to facilitate mucus clearance and alleviate bronchial congestion.
Pharmacodynamically, terpin hydrate acts by modulating the viscosity and consistency of bronchial secretions, thereby making expectoration more efficient. This expectorant effect supports the removal of mucus accumulated within the respiratory tract, which may otherwise exacerbate symptoms and hinder airflow. The mechanism of action involves direct stimulation of bronchial secretory cells in the lower respiratory tract, promoting the liquefaction of secretions. Additionally, terpin hydrate is postulated to exert a mild antiseptic effect on pulmonary tissue, potentially reducing microbial load locally. The compound increases the fluid content of the respiratory lining, enhancing mucociliary clearance and reducing mucus thickness.
Key absorption, distribution, metabolism, and excretion (ADME) data for terpin hydrate are limited in the literature, reflecting its historical status and regulatory considerations. Terpin hydrate was commonly derived from natural sources such as turpentine, oregano, thyme, and eucalyptus. It was widely used in the United States during the late 19th century through the mid-20th century but was removed from marketed formulations in the 1990s following the U.S. Food and Drug Administration’s determination that available evidence was insufficient to establish general recognition of safety and effectiveness.
Despite its removal from commercial products, terpin hydrate remains available as a prescription item prepared by specialty compounding pharmacies in certain jurisdictions, often formulated as an elixir. Safety considerations include the need for careful dosing due to the alcohol content and potential irritation. There is limited contemporary clinical safety data, and its use should be guided by current regulatory frameworks and clinical judgment.
Given the compound’s extraction from botanical sources and variable purity profiles, API procurement requires rigorous quality control measures. This includes verification of identity, assay, impurity profiling, and compliance with pharmacopeial standards, if applicable. Sourcing from reliable suppliers who provide full documentation ensures compliance with regulatory requirements and the reproducibility of formulation quality.
Identification & chemistry
| Generic name | Terpin hydrate |
|---|---|
| Molecule type | Small molecule |
| CAS | 2451-01-6 |
| UNII | S3V868548T |
| DrugBank ID | DB13163 |
Pharmacology
| Summary | Terpin hydrate acts as an expectorant by targeting bronchial secretory cells to liquefy mucus and enhance mucociliary clearance in the lower respiratory tract. It increases airway fluid volume, reducing mucus viscosity and facilitating the removal of secretions. Additionally, it exhibits mild antiseptic effects on pulmonary tissue, supporting its role in managing mucus-related respiratory conditions. |
|---|---|
| Mechanism of action | Terpin hydrate improves mucociliary function by working directly on the bronchial secretory cells in the lower respiratory tract to liquify and facilitate the elimination of bronchial secretionsas well as exerting a weak antiseptic effect on the pulmonary parenchyma. It is thought to increase the amount of fluid in the respiratory tract, which increases the flow and clearance of local irritants and as well as reducing the viscosity of mucus . |
| Pharmacodynamics | It acts to facilitate the removal of mucus from the respiratory tract. It prevents the exacerbation of excessive mucus production and secretion due to airway bacterial or viral infections, asthma or chronic bronchitis. Expectorants like terpin hydrate change mucus consistency and make coughing more productive. |
Formulation & handling
- Terpin hydrate is a small molecule suitable for oral administration in various formulations including tablets, capsules, lozenges, and elixirs.
- It exhibits moderate water solubility and a logP of 1.19, indicating balanced hydrophilic and lipophilic properties relevant for formulation design.
- No specific stability or handling precautions are noted, suggesting standard conditions for solid oral dosage forms are applicable.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in Canada with patent protection recently expired, resulting in increased availability of generic alternatives and a mature market landscape. |
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| Markets | Canada |
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Supply Chain
| Supply chain summary | Terpin hydrate is marketed primarily in Canada with multiple branded products including various formulations of Valda Pastilles and Terpin Hydrate Codeine Elixir. The presence of several originator brands indicates an established manufacturing base. Given the current product landscape and lack of notable patent protections, generic competition is likely established or imminent. |
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Safety
| Toxicity | Overdose can cause nausea, vomiting and abdominal pain. |
|---|
- Handle terpin hydrate with appropriate protective equipment to avoid ingestion and minimize exposure risk
- In case of overdose, be aware of potential acute toxicity manifesting as gastrointestinal symptoms including nausea, vomiting, and abdominal pain
- Store in a controlled environment to prevent degradation and ensure chemical stability
Terpin Hydrate is a type of Cough suppressants
Cough suppressants, a subcategory of pharmaceutical active pharmaceutical ingredients (APIs), are commonly used to alleviate coughing symptoms. These medications act on the central nervous system to reduce the urge to cough, providing temporary relief and improving patient comfort. Cough suppressants are widely employed in the treatment of various respiratory conditions, including colds, flu, bronchitis, and allergies.
The primary mechanism of action for cough suppressants involves targeting the cough reflex arc. This reflex arc comprises sensory nerve fibers in the respiratory tract that detect irritants, sending signals to the brainstem to initiate coughing. Cough suppressants work by suppressing this reflex at different points, depending on the specific drug.
One widely used class of cough suppressants is opioid derivatives, such as codeine and hydrocodone. These substances act by binding to opioid receptors in the brain, decreasing the sensitivity of the cough reflex. Another class includes non-opioid agents, such as dextromethorphan, which functions by affecting receptors in the brain called NMDA receptors.
Cough suppressants are available in various formulations, including oral syrups, tablets, and capsules. They are often combined with other active ingredients, such as expectorants or antihistamines, to provide a more comprehensive treatment approach.
While cough suppressants can provide symptomatic relief, it is crucial to use them under proper medical guidance. Certain individuals, such as those with respiratory conditions like chronic obstructive pulmonary disease (COPD) or asthma, may require cautious use or alternative treatment options due to potential side effects or drug interactions.
In conclusion, cough suppressants are an essential subcategory of pharmaceutical APIs utilized to manage coughing symptoms. These medications work by targeting the cough reflex arc in the central nervous system, providing temporary relief from coughing. Careful consideration should be given to appropriate usage and potential contraindications, ensuring safe and effective treatment.
Terpin Hydrate (Cough suppressants), 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.
Terpin Hydrate API manufacturers & distributors
Compare qualified Terpin Hydrate API suppliers worldwide. We currently have 1 companies offering Terpin Hydrate API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Cambrex | Producer | Italy | United States | CoA, GMP | 104 products |
When sending a request, specify which Terpin Hydrate 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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