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Scopolamine | CAS No: 51-34-3 | GMP-certified suppliers
A medication that helps prevent nausea and vomiting related to motion sickness and postoperative recovery, supporting reliable supply needs for perioperative and travel‑related care.
Therapeutic categories
AdjuvantsAdjuvants, AnesthesiaAgents producing tachycardiaAlimentary Tract and MetabolismAlkaloidsAnticholinergic Agents
Generic name
Scopolamine
Molecule type
small molecule
CAS number
51-34-3
DrugBank ID
DB00747
Approval status
Approved drug, Investigational drug
ATC code
N05CM05
Primary indications
- Scopolamine is indicated in adult patients for the prevention of nausea and vomiting associated with motion sickness and for the prevention of postoperative nausea and vomiting (PONV) associated with anesthesia or opiate analgesia
Product Snapshot
- Scopolamine is a small‑molecule anticholinergic available in multiple formulations including oral forms, injectables, ophthalmic solutions, and extended‑release transdermal systems
- It is used for prevention of motion‑induced nausea and vomiting and for postoperative nausea and vomiting in adults
- It is approved in the US and Canada, with certain presentations also noted as investigational
Clinical Overview
Scopolamine (CAS 51-34-3) is a tropane alkaloid extracted primarily from Solanaceae plants. It is structurally related to atropine and hyoscyamine and functions as a non‑selective antagonist of muscarinic acetylcholine receptors. Clinically, it is indicated for the prevention of nausea and vomiting associated with motion sickness and for reducing postoperative nausea and vomiting linked to anesthesia or opioid analgesia. Regulatory approvals include long‑standing FDA authorization for oral formulations and a transdermal system introduced to provide controlled exposure.
Scopolamine’s pharmacology reflects broad inhibition of M1 to M5 muscarinic receptors in the central and peripheral nervous systems. This antagonism disrupts normal parasympathetic signaling, influencing smooth muscle tone, glandular secretion, cardiac activity, and neurological pathways relevant to emesis. Its therapeutic effect in motion‑related and postoperative nausea is attributed to suppression of cholinergic transmission in CNS regions involved in vestibular signaling and vomiting reflex pathways.
The transdermal system delivers continuous drug release for up to three days, with urinary excretion detectable for more than 100 hours after application. Systemic anticholinergic effects include decreased secretions, mydriasis, tachycardia, and reduced gastrointestinal motility. Central effects may include sedation, cognitive impairment, and, in susceptible individuals, agitation or psychosis. Scopolamine is contraindicated in angle‑closure glaucoma and requires caution in open‑angle glaucoma, urinary retention, and gastrointestinal obstruction. It may provoke withdrawal symptoms after extended use, and patches must be removed before MRI procedures due to potential skin heating.
Metabolism involves hepatic pathways, including CYP3A4, though quantitative pharmacokinetic parameters vary by formulation. Elimination occurs mainly via renal excretion of metabolites.
Common usage contexts include branded and generic transdermal patches such as Scopoderm TTS and oral formulations used in perioperative settings.
For API procurement, sourcing should prioritize plant‑derived or semi‑synthetic material with well‑controlled impurity profiles, validated tropane alkaloid quantification, and compliance with relevant pharmacopeial and controlled‑substance handling requirements.
Scopolamine’s pharmacology reflects broad inhibition of M1 to M5 muscarinic receptors in the central and peripheral nervous systems. This antagonism disrupts normal parasympathetic signaling, influencing smooth muscle tone, glandular secretion, cardiac activity, and neurological pathways relevant to emesis. Its therapeutic effect in motion‑related and postoperative nausea is attributed to suppression of cholinergic transmission in CNS regions involved in vestibular signaling and vomiting reflex pathways.
The transdermal system delivers continuous drug release for up to three days, with urinary excretion detectable for more than 100 hours after application. Systemic anticholinergic effects include decreased secretions, mydriasis, tachycardia, and reduced gastrointestinal motility. Central effects may include sedation, cognitive impairment, and, in susceptible individuals, agitation or psychosis. Scopolamine is contraindicated in angle‑closure glaucoma and requires caution in open‑angle glaucoma, urinary retention, and gastrointestinal obstruction. It may provoke withdrawal symptoms after extended use, and patches must be removed before MRI procedures due to potential skin heating.
Metabolism involves hepatic pathways, including CYP3A4, though quantitative pharmacokinetic parameters vary by formulation. Elimination occurs mainly via renal excretion of metabolites.
Common usage contexts include branded and generic transdermal patches such as Scopoderm TTS and oral formulations used in perioperative settings.
For API procurement, sourcing should prioritize plant‑derived or semi‑synthetic material with well‑controlled impurity profiles, validated tropane alkaloid quantification, and compliance with relevant pharmacopeial and controlled‑substance handling requirements.
Identification & chemistry
| Generic name | Scopolamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 51-34-3 |
| UNII | DL48G20X8X |
| DrugBank ID | DB00747 |
Pharmacology
| Summary | Scopolamine is a non‑selective competitive antagonist of muscarinic M1–M5 receptors, dampening central and peripheral acetylcholine signaling. This blockade modulates neural pathways involved in motion‑ and anesthesia‑related emesis, with additional effects linked to altered neurotransmitter release in cortical and limbic circuits. Its pharmacodynamic profile reflects broad anticholinergic activity across autonomic and CNS targets. |
|---|---|
| Mechanism of action | [Acetylcholine] (ACh) is a neurotransmitter that can signal through ligand-gated cation channels (nicotinic receptors) and G-protein-coupled muscarinic receptors (mAChRs). ACh signalling via mAChRs located in the central nervous system (CNS) and periphery can regulate smooth muscle contraction, glandular secretions, heart rate, and various neurological phenomena such as learning and memory.mAChRs can be divided into five subtypes, M1-M5, expressed at various levels throughout the brain.Also, M2 receptors are found in the heart and M3 receptors in smooth muscles, mediating effects apart from the direct modulation of the parasympathetic nervous system.While M1, M3, and M5 mAChRs primarily couple to G<sub>q</sub> proteins to activate phospholipase C, M2 and M4 mainly couple to G<sub>i/o</sub> proteins to inhibit adenylyl cyclase and modulate cellular ion flow.This system, in part, helps to control physiological responses such as nausea and vomiting. Scopolamine acts as a non-selective competitive inhibitor of M1-M5 mAChRs, albeit with weaker M5 inhibition; as such, scopolamine is an anticholinergic with various dose-dependent therapeutic and adverse effects.The exact mechanism(s) of action of scopolamine remains poorly understood. Recent evidence suggests that M1 (and possibly M2) mAChR antagonism at interneurons acts through inhibition of downstream neurotransmitter release and subsequent pyramidal neuron activation to mediate neurological responses associated with stress and depression.Similar antagonism of M4 and M5 receptors is associated with potential therapeutic benefits in neurological conditions such as schizophrenia and substance abuse disorders.The significance of these observations to scopolamine's current therapeutic indications of preventing nausea and vomiting is unclear but is linked to its anticholinergic effect and ability to alter signalling through the CNS associated with vomiting. |
| Pharmacodynamics | Scopolamine is an anticholinergic belladonna alkaloid that, through competitive inhibition of muscarinic receptors, affects parasympathetic nervous system function and acts on smooth muscles that respond to acetylcholine but lack cholinergic innervation. Formulated as a patch, scopolamine is released continuously over three days and remains detectable in urine over a period of 108 hours. Scopolamine is contraindicated in angle-closure glaucoma and should be used with caution in patients with open-angle glaucoma due to scopolamine's ability to increase intraocular pressure. Also, scopolamine exhibits several neuropsychiatric effects: exacerbated psychosis, seizures, seizure-like, and other psychiatric reactions, and cognitive impairment; scopolamine may impair the ability of patients to operate machinery or motor vehicles, play underwater sports, or perform any other potentially hazardous activity. Women with severe preeclampsia should avoid scopolamine. Patients with gastrointestinal or urinary disorders should be monitored frequently for impairments, and scopolamine should be discontinued if these develop. Scopolamine can cause blurred vision if applied directly to the eye, and the transdermal patch should be removed before an MRI procedure to avoid skin burns. Due to its gastrointestinal effects, scopolamine can interfere with gastric secretion testing and should be discontinued at least 10 days before performing the test. Finally, scopolamine may induce dependence and resulting withdrawal symptoms, such as nausea, dizziness, vomiting, gastrointestinal disturbances, sweating, headaches, bradycardia, hypotension, and various neuropsychiatric manifestations following treatment discontinuation; severe symptoms may require medical attention. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Muscarinic acetylcholine receptor M1 | Humans | antagonist |
| Muscarinic acetylcholine receptor M2 | Humans | antagonist |
| Muscarinic acetylcholine receptor M3 | Humans | antagonist |
ADME / PK
| Absorption | The pharmacokinetics of scopolamine differ substantially between different dosage routes. Oral administration of 0.5 mg scopolamine in healthy volunteers produced a C<sub>max</sub> of 0.54 ± 0.1 ng/mL, a t<sub>max</sub> of 23.5 ± 8.2 min, and an AUC of 50.8 ± 1.76 ng\*min/mL; the absolute bioavailability is low at 13 ± 1%, presumably because of first-pass metabolism.By comparison, IV infusion of 0.5 mg scopolamine over 15 minutes resulted in a C<sub>max</sub> of 5.00 ± 0.43 ng/mL, a t<sub>max</sub> of 5.0 min, and an AUC of 369.4 ± 2.2 ng\*min/mL. Other dose forms have also been tested. Subcutaneous administration of 0.4 mg scopolamine resulted in a C<sub>max</sub> of 3.27 ng/mL, a t<sub>max</sub> of 14.6 min, and an AUC of 158.2 ng\*min/mL. Intramuscular administration of 0.5 scopolamine resulted in a C<sub>max</sub> of 0.96 ± 0.17 ng/mL, a t<sub>max</sub> of 18.5 ± 4.7 min, and an AUC of 81.3 ± 11.2 ng\*min/mL. Absorption following intranasal administration was found to be rapid, whereby 0.4 mg of scopolamine resulted in a C<sub>max</sub> of 1.68 ± 0.23 ng/mL, a t<sub>max</sub> of 2.2 ± 3 min, and an AUC of 167 ± 20 ng\*min/mL; intranasal scopolamine also had a higher bioavailability than that of oral scopolamine at 83 ± 10%. Due to dose-dependent adverse effects, the transdermal patch was developed to obtain therapeutic plasma concentrations over a longer period of time. Following patch application, scopolamine becomes detectable within four hours and reaches a peak concentration (t<sub>max</sub>) within 24 hours. The average plasma concentration is 87 pg/mL, and the total levels of free and conjugated scopolamine reach 354 pg/mL. |
|---|---|
| Half-life | The half-life of scopolamine differs depending on the route. Intravenous, oral, and intramuscular administration have similar half-lives of 68.7 ± 1.0, 63.7 ± 1.3, and 69.1 ±8/0 min, respectively. The half-life is greater with subcutaneous administration at 213 min.Following removal of the transdermal patch system, scopolamine plasma concentrations decrease in a log-linear fashion with a half-life of 9.5 hours. |
| Protein binding | Scopolamine may reversibly bind plasma proteins in humans.In rats, scopolamine exhibits relatively low plasma protein binding of 30 ± 10%. |
| Metabolism | Little is known about the metabolism of scopolamine in humans, although many metabolites have been detected in animal studies.In general, scopolamine is primarily metabolized in the liver, and the primary metabolites are various glucuronide and sulphide conjugates.Although the enzymes responsible for scopolamine metabolism are unknown, _in vitro_ studies have demonstrated oxidative demethylation linked to CYP3A subfamily activity, and scopolamine pharmacokinetics were significantly altered by coadministration with grapefruit juice, suggesting that CYP3A4 is responsible for at least some of the oxidative demethylation. |
| Route of elimination | Following oral administration, approximately 2.6% of unchanged scopolamine is recovered in urine.Compared to this, using the transdermal patch system, less than 10% of the total dose, both as unchanged scopolamine and metabolites, is recovered in urine over 108 hours. Less than 5% of the total dose is recovered unchanged. |
| Volume of distribution | The volume of distribution of scopolamine is not well characterized.IV infusion of 0.5 mg scopolamine over 15 minutes resulted in a volume of distribution of 141.3 ± 1.6 L. |
| Clearance | IV infusion of 0.5 mg scopolamine resulted in a clearance of 81.2 ± 1.55 L/h, while subcutaneous administration resulted in a lower clearance of 0.14-0.17 L/h. |
Formulation & handling
- Scopolamine is a small, water‑soluble molecule suitable for oral, transmucosal, parenteral, ophthalmic, and transdermal formulations, with solid-state API handling typical for moderately polar tertiary amines.
- Oral formulations may require consideration of altered absorption with grapefruit products, though no food‑dependent stability issues are noted.
- Transdermal and ophthalmic products benefit from attention to chemical stability and controlled permeation, as the molecule is sensitive to hydrolysis in aqueous solution over extended contact times.
Regulatory status
| Lifecycle | Patent protection in the US and Canada has elapsed or is nearing completion, indicating a mature stage of market exclusivity. With products already established in both markets, the API is transitioning toward a competitive generic landscape. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Scopolamine is an established active ingredient with no single dominant originator, and its supply landscape is characterized by a small number of manufacturers supported by a wide network of U.S.‑focused packagers and distributors. Branded and combination products are available primarily in the United States and Canada, reflecting mature market penetration rather than active global brand expansion. Patent protections for scopolamine have long expired, indicating that generic competition is already well‑established. |
|---|
Safety
| Toxicity | Scopolamine overdose may manifest as lethargy, somnolence, coma, confusion, agitation, hallucinations, convulsion, visual disturbance, dry flushed skin, dry mouth, decreased bowel sounds, urinary retention, tachycardia, hypertension, and supraventricular arrhythmias. In some cases, overdose symptoms may appear similar to those associated with withdrawal following discontinuation. However, withdrawal symptoms such as bradycardia, headache, nausea, abdominal cramps, and sweating can help to distinguish between these possibilities. Overdose management primarily involves the removal of all transdermal patch systems combined with symptomatic and supportive care. Ensuring an adequate airway, supplemental oxygen, establishing intravenous access, and continuous monitoring are recommended. In cases where patients have swallowed one or more patch systems, it may be necessary to remove them or administer activated charcoal. Animal studies revealed an oral LD<sub>50</sub> of 1880 mg/kg in mice and 1270 mg/kg in rats, and a subcutaneous LD<sub>50</sub> of 1650 mg/kg in mice and 296 mg/kg in rats. |
|---|
High Level Warnings:
- Central anticholinergic toxicity is prominent, with risks of CNS depression or excitation and cardiac effects such as tachycardia and supraventricular arrhythmias
- Marked antimuscarinic activity may lead to severe peripheral effects including xerostomia, urinary retention, decreased GI motility, and hyperthermia‑prone dry flushed skin
- High acute toxicity in animals (oral LD50 ~1880 mg/kg in mice, ~1270 mg/kg in rats
Scopolamine 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.
Scopolamine (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.
Scopolamine API manufacturers & distributors
Compare qualified Scopolamine API suppliers worldwide. We currently have 7 companies offering Scopolamine 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 |
|---|---|---|---|---|---|
| Alkaloids Corporation | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 11 products |
| Alps Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 8 products |
| Boehringer Ingelheim | Producer | Germany | Unknown | CoA, JDMF | 35 products |
| Fine Chemicals | Producer | South Africa | South Africa | CoA, USDMF | 14 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Phytex Australia | Producer | Australia | Australia | CoA, USDMF | 3 products |
| Vital Laboratories Pvt. L... | Producer | India | India | CoA, GMP, USDMF, WC | 22 products |
When sending a request, specify which Scopolamine 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 Scopolamine 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.
Frequently asked questions about Scopolamine API
Sourcing
What matters most when sourcing GMP-grade Scopolamine?
Key factors include verifying GMP compliance and meeting U.S. and Canadian regulatory requirements for an established active ingredient. Reliability of supply is important given the small number of manufacturers and reliance on packagers and distributors. It is also essential to confirm that the chosen source aligns with applicable quality standards for generic APIs.
Which documents are typically required when sourcing Scopolamine API?
Request the core API documentation set: CoA (7 companies), USDMF (5 companies), JDMF (3 companies), GMP (3 companies), WC (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Scopolamine API?
Known or reported manufacturers for Scopolamine: Pharm Rx Chemical Corp. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Scopolamine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Scopolamine manufacturers?
Audit reports may be requested for Scopolamine: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Scopolamine API on Pharmaoffer?
Reported supplier count for Scopolamine: 7 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Scopolamine API?
Production countries reported for Scopolamine: India (2 producers), South Africa (1 producer), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Scopolamine usually hold?
Common certifications for Scopolamine suppliers: CoA (7 companies), USDMF (5 companies), JDMF (3 companies), GMP (3 companies), WC (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Scopolamine (CAS 51-34-3) used for?
Scopolamine is used to prevent nausea and vomiting associated with motion sickness and to reduce postoperative nausea and vomiting related to anesthesia or opioid analgesia. Its effect comes from non‑selective antagonism of muscarinic receptors, which suppresses cholinergic signaling in vestibular and central vomiting pathways.
Which therapeutic class does Scopolamine fall into?
Scopolamine belongs to the following therapeutic categories: Adjuvants, Adjuvants, Anesthesia, Agents producing tachycardia, Alimentary Tract and Metabolism, Alkaloids. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Scopolamine mainly prescribed for?
The primary indications for Scopolamine: Scopolamine is indicated in adult patients for the prevention of nausea and vomiting associated with motion sickness and for the prevention of postoperative nausea and vomiting (PONV) associated with anesthesia or opiate analgesia. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Scopolamine work?
[Acetylcholine] (ACh) is a neurotransmitter that can signal through ligand-gated cation channels (nicotinic receptors) and G-protein-coupled muscarinic receptors (mAChRs). ACh signalling via mAChRs located in the central nervous system (CNS) and periphery can regulate smooth muscle contraction, glandular secretions, heart rate, and various neurological phenomena such as learning and memory.mAChRs can be divided into five subtypes, M1-M5, expressed at various levels throughout the brain.Also, M2 receptors are found in the heart and M3 receptors in smooth muscles, mediating effects apart from the direct modulation of the parasympathetic nervous system.While M1, M3, and M5 mAChRs primarily couple to Gq proteins to activate phospholipase C, M2 and M4 mainly couple to Gi/o proteins to inhibit adenylyl cyclase and modulate cellular ion flow.This system, in part, helps to control physiological responses such as nausea and vomiting.
Scopolamine acts as a non-selective competitive inhibitor of M1-M5 mAChRs, albeit with weaker M5 inhibition; as such, Scopolamine is an anticholinergic with various dose-dependent therapeutic and adverse effects.The exact mechanism(s) of action of Scopolamine remains poorly understood. Recent evidence suggests that M1 (and possibly M2) mAChR antagonism at interneurons acts through inhibition of downstream neurotransmitter release and subsequent pyramidal neuron activation to mediate neurological responses associated with stress and depression.Similar antagonism of M4 and M5 receptors is associated with potential therapeutic benefits in neurological conditions such as schizophrenia and substance abuse disorders.The significance of these observations to Scopolamine's current therapeutic indications of preventing nausea and vomiting is unclear but is linked to its anticholinergic effect and ability to alter signalling through the CNS associated with vomiting.
What should someone know about the safety or toxicity profile of Scopolamine?
Scopolamine has a prominent anticholinergic toxicity profile characterized by central effects such as sedation, cognitive impairment, agitation, or psychosis, and peripheral effects including mydriasis, xerostomia, urinary retention, reduced gastrointestinal motility, and hyperthermia‑prone dry flushed skin. Cardiac effects such as tachycardia and supraventricular arrhythmias may occur due to muscarinic receptor blockade. Central anticholinergic toxicity can manifest as either CNS depression or excitation. High acute toxicity has been demonstrated in animals, and use requires particular caution in conditions like glaucoma, urinary retention, and gastrointestinal obstruction.
What are important formulation and handling considerations for Scopolamine as an API?
Important considerations include managing Scopolamine’s sensitivity to hydrolysis in aqueous environments, which requires controlled pH and limited aqueous exposure in solution formulations. Its water solubility supports oral, transmucosal, parenteral, ophthalmic, and transdermal forms, but transdermal and ophthalmic systems need attention to chemical stability and controlled permeation. Oral products may need to account for altered absorption when coadministered with grapefruit products. Solid‑state handling is typical for moderately polar tertiary amines.
Is Scopolamine a small molecule?
Scopolamine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Scopolamine?
Oral Scopolamine does not have special food‑ or pH‑dependent stability concerns, and solid‑state handling is typical for a moderately polar tertiary amine. The main chemical liability is hydrolysis in aqueous solution during prolonged contact, which is more relevant to liquid formulations than to solid oral dosage forms. Grapefruit products can alter absorption and metabolism but do not affect API stability.
Regulatory
Where is Scopolamine approved or in use globally?
Scopolamine is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Scopolamine right now?
In the US and Canada, Scopolamine is regulated as an approved prescription drug. Patent considerations are generally tied to individual products or formulations rather than the active ingredient itself, and can vary by manufacturer.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Scopolamine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Scopolamine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Scopolamine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Scopolamine: 543 verified transactions across 202 suppliers and 123 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Scopolamine?
Market report availability for Scopolamine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
