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Dinoprost tromethamine | CAS No: 38562-01-5 | GMP-certified suppliers
A medication that facilitates second-trimester abortion, therapeutic abortion, labor induction at term, and serves as a vasodilator adjunct in angiographic procedures.
Therapeutic categories
Primary indications
- Used for aborting second-trimester pregnancy (between the twelfth to eighteenth week of gestation) and in incomplete abortion or for therapeutic abortion in cases of intrauterine fetal death and congenital abnormalities incompatible with life
- Also used at low-doses for medically indicated induction of labor at term
- Also injected intra-arterially for use as a vasodilator to assist in angiography
Product Snapshot
- Dinoprost tromethamine is formulated as a solution for intra-amniotic administration
- It is primarily indicated for second-trimester pregnancy termination, incomplete abortion management, therapeutic abortion in cases of fetal death or severe abnormalities, labor induction, and as an intra-arterial vasodilator in angiography
- This API is approved for use in Canada, including veterinary indications
Clinical Overview
Clinically, dinoprost tromethamine is indicated primarily for obstetric use. It is employed to induce abortion during the second trimester of pregnancy, specifically between the twelfth and eighteenth week of gestation. Additionally, it is used in cases of incomplete abortion and therapeutic abortion where fetal anomalies incompatible with life or intrauterine fetal death occur. At low doses, it is utilized for medically indicated labor induction at term. Beyond obstetrics, dinoprost tromethamine can be administered via intra-arterial injection as a vasodilator adjunct to angiographic procedures.
Pharmacodynamically, dinoprost tromethamine exerts its effects largely by stimulating myometrial contractions and promoting cervical relaxation. It inhibits steroidogenesis in the corpora lutea and may induce luteolysis. The mechanism of action involves binding to prostaglandin receptors on uterine smooth muscle cells, facilitating contractions akin to those during spontaneous labor. This uterotonic activity results in effective induction of uterine contractions sufficient to cause abortion or labor induction. Notably, uterine sensitivity to prostaglandins increases progressively throughout pregnancy.
Regarding absorption, distribution, metabolism, and excretion, dinoprost is rapidly metabolized primarily in the lungs and liver, leading to a short systemic half-life. These pharmacokinetic characteristics necessitate controlled dosing to minimize systemic exposure and adverse effects.
Safety considerations include its potent uterotonic effects, which can induce uterine hyperstimulation, fetal distress, or rupture if misused. Appropriate clinical monitoring is essential during administration. Adverse reactions may include gastrointestinal disturbance, fever, and allergic reactions.
From a sourcing and quality perspective, careful attention to the hygroscopic nature of dinoprost tromethamine is required to maintain API stability and potency. Compliance with pharmacopeial standards for prostaglandin purity and characterization is critical to ensure batch consistency and suitability for formulation into parenteral or other dosage forms.
Identification & chemistry
| Generic name | Dinoprost tromethamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 38562-01-5 |
| UNII | CT6BBQ5A68 |
| DrugBank ID | DB01160 |
Pharmacology
| Summary | Dinoprost tromethamine is a prostaglandin F2-alpha analog that primarily targets prostaglandin F2-alpha and prostacyclin receptors. It induces myometrial contractions and promotes cervical softening and dilation by stimulating uterine prostaglandin receptors. These effects facilitate termination of pregnancy and labor induction by mimicking physiological uterine contractions and modulating local reproductive tissue activity. |
|---|---|
| Mechanism of action | Dinoprost tromethamine appears to act directly on the myometrium, but this has not been completely established. Dinoprost stimulates myometrial contractions (via its interaction with the prostaglandin receptors) in the gravid uterus that are similar to the contractions that occur in the term uterus during labor. These contractions are usually sufficient to cause abortion. Uterine response to prostaglandins increases gradually throughout pregnancy. Dinoprost also facilitates cervical dilatation and softening. |
| Pharmacodynamics | Dinoprost tromethamine is the tromethamine (THAM) salt of the naturally occurring prostaglandin F2<sub>alpha</sub>. Prostaglandin F2<sub>alpha</sub> has several pharmacologic effects on the female reproductive system, including stimulation of myometrial activity, relaxation of the cervix, inhibition of steroidogenesis by corpora lutea, and can potentially lyse corpora lutea. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin F2-alpha receptor | Humans | agonist |
| Prostacyclin receptor | Humans | antagonist |
ADME / PK
| Absorption | Slowly absorbed from the amniotic fluid into systemic circulation. |
|---|---|
| Half-life | The half-life of dinoprost in amniotic fluid is 3 to 6 hours. The plasma half-life of dinoprost after intravenous administration is reported to be less than 1 minute. |
| Metabolism | Enzymatic dehydrogenation primarily in the maternal lungs and also in the liver. |
Formulation & handling
- Dinoprost tromethamine is formulated as an aqueous solution for intra-amniotic administration and is not intended for oral use.
- As a prostaglandin compound, it is a small molecule with moderate lipophilicity (LogP 2.61) and low aqueous solubility, requiring appropriate solvents for formulation.
- Handle under controlled conditions to maintain stability, as prostaglandin analogs can be sensitive to light and temperature.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently available in the Canadian market with patent protection expired, allowing for generic competition. The product is in a mature phase with established market presence. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Dinoprost tromethamine is supplied primarily by originator companies such as Pfizer Inc., with branded products present in markets including Canada. The branded product Prostin F2 Alpha indicates an established market presence, while lack of mention of multiple regions like the US or EU suggests a more limited global footprint. Patent expirations in this category typically allow for generic competition, indicating potential or existing availability of generic equivalents. |
|---|
Safety
| Toxicity | Although overdose by intra-amniotic administration of dinoprost has not been reported, exaggeration of the nausea, vomiting, and diarrhea that occur with normal doses would be expected. |
|---|
- Exposure may cause gastrointestinal irritation manifested by nausea, vomiting, and diarrhea
- Handle with appropriate protective equipment
- Potential fetal toxicity prohibits use outside controlled clinical settings
Dinoprost Tromethamine is a type of Prostaglandin Analogues
Prostaglandin analogues are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicine. These synthetic compounds mimic the effects of natural prostaglandins, which are hormone-like substances found in the body.
Prostaglandin analogues have gained significant attention in medical research due to their diverse therapeutic applications. They exhibit a wide range of physiological activities, such as regulating inflammation, blood flow, and hormone levels. These compounds are commonly used in the treatment of various conditions, including glaucoma, ocular hypertension, and certain types of cancer.
One notable application of prostaglandin analogues is in ophthalmology. These compounds effectively reduce intraocular pressure by increasing the outflow of aqueous humor, providing an effective treatment for glaucoma patients. Moreover, prostaglandin analogues offer the advantage of once-daily dosing, enhancing patient compliance and convenience.
In the field of oncology, prostaglandin analogues have shown promise as anticancer agents. They exert anti-proliferative effects on cancer cells and can induce apoptosis, making them valuable in the treatment of certain malignancies.
Overall, prostaglandin analogues represent a significant class of pharmaceutical APIs with diverse therapeutic applications. Continued research and development in this area hold great potential for the advancement of medicine and the improvement of patient care.
Dinoprost Tromethamine (Prostaglandin Analogues), classified under Anti-inflammatory Agents
Anti-inflammatory agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat various inflammatory conditions. These agents play a vital role in alleviating pain, reducing swelling, and controlling inflammation in the body. They are widely employed in the management of diverse medical conditions, including arthritis, autoimmune disorders, asthma, and skin conditions like dermatitis.
Anti-inflammatory APIs primarily function by inhibiting the production of specific enzymes called cyclooxygenases (COX) and lipoxygenases (LOX). These enzymes are responsible for the synthesis of pro-inflammatory molecules known as prostaglandins and leukotrienes, respectively. By suppressing the activity of COX and LOX, anti-inflammatory agents effectively curtail the production of these inflammatory mediators, thereby mitigating inflammation.
Common examples of anti-inflammatory APIs include non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, aspirin, and naproxen. These agents exhibit analgesic, antipyretic, and anti-inflammatory properties. Another group of anti-inflammatory APIs includes corticosteroids, such as prednisone and dexamethasone, which are synthetic hormones that modulate the body's immune response to control inflammation.
In conclusion, anti-inflammatory agents are a vital category of pharmaceutical APIs widely used to manage inflammation-related disorders. They target enzymes involved in the synthesis of pro-inflammatory molecules, effectively reducing pain and swelling. NSAIDs and corticosteroids are commonly prescribed anti-inflammatory APIs due to their efficacy in controlling inflammation.
Dinoprost Tromethamine API manufacturers & distributors
Compare qualified Dinoprost Tromethamine API suppliers worldwide. We currently have 6 companies offering Dinoprost Tromethamine API, with manufacturing taking place in 4 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, CoA, GMP, USDMF | 229 products |
| Chinoin | Producer | Hungary | Hungary | CoA, GMP | 21 products |
| Chirogate International | Producer | Taiwan | Taiwan | CoA, FDA, GMP | 17 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| Pharmacia & Upjohn | Producer | United States | United States | CoA, USDMF | 30 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
When sending a request, specify which Dinoprost Tromethamine 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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