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Methylphenidate | CAS No: 113-45-1 | GMP-certified suppliers
A medication that supports management of ADHD and helps control narcolepsy symptoms, enabling reliable incorporation into a broad range of central nervous system therapy products.
Therapeutic categories
Acids, CarbocyclicAgents that produce hypertensionAgents that reduce seizure thresholdCentral Nervous System AgentsCentral Nervous System StimulantsCentral Nervous System Stimulation
Generic name
Methylphenidate
Molecule type
small molecule
CAS number
113-45-1
DrugBank ID
DB00422
Approval status
Approved drug, Investigational drug
ATC code
N06BA04
Primary indications
- Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy
Product Snapshot
- Methylphenidate is an oral small‑molecule API available in multiple immediate‑ and modified‑release forms, along with transdermal and solution presentations
- It is used in products for ADHD and narcolepsy
- It is approved in the US and Canada with some formulations classified as investigational
Clinical Overview
Methylphenidate (CAS 113-45-1) is a centrally acting sympathomimetic stimulant indicated for Attention Deficit Hyperactivity Disorder in patients six years of age and older and for narcolepsy. It is marketed globally in multiple immediate‑release and extended‑release products, including Ritalin, Concerta, and Biphentin, which differ in delivery systems and duration of effect.
The compound is a racemic mixture of d- and l-isomers, with the d-isomer contributing most of the pharmacological activity. Its clinical effects arise primarily from inhibition of dopamine and norepinephrine reuptake, increasing extracellular concentrations in the prefrontal cortex and other dopamine-rich regions. At therapeutic doses, this action supports improvements in sustained attention, working memory, and behavioral regulation. At higher exposures, broader catecholaminergic stimulation may increase locomotor activity and impair cognition, consistent with a dose-dependent pharmacodynamic profile. Additional activity at alpha-1 adrenergic receptors appears to contribute to attentional benefits.
Absorption and elimination parameters vary by formulation, with extended-release systems such as OROS (Concerta) and multilayer-release platforms (Biphentin) designed to maintain plasma concentrations for 10 to 12 hours. Methylphenidate undergoes rapid de-esterification to ritalinic acid, its major inactive metabolite, followed by renal excretion.
Safety considerations reflect its stimulant pharmacology. Common adverse effects include appetite reduction, insomnia, and cardiovascular effects such as modest blood pressure or heart rate increases. Methylphenidate carries a boxed warning for abuse and dependence due to the reinforcing potential associated with increased dopaminergic signaling at higher doses. It can lower the seizure threshold and requires careful use in patients with underlying cardiac, psychiatric, or seizure conditions.
For formulation and sourcing teams, API procurement should focus on enantiomeric consistency, control of impurity profiles, and verification of particle-size distributions appropriate for the intended dosage form. Suppliers should provide comprehensive regulatory documentation, including evidence of compliance with Good Manufacturing Practice and validated analytical methods aligned with pharmacopeial standards.
The compound is a racemic mixture of d- and l-isomers, with the d-isomer contributing most of the pharmacological activity. Its clinical effects arise primarily from inhibition of dopamine and norepinephrine reuptake, increasing extracellular concentrations in the prefrontal cortex and other dopamine-rich regions. At therapeutic doses, this action supports improvements in sustained attention, working memory, and behavioral regulation. At higher exposures, broader catecholaminergic stimulation may increase locomotor activity and impair cognition, consistent with a dose-dependent pharmacodynamic profile. Additional activity at alpha-1 adrenergic receptors appears to contribute to attentional benefits.
Absorption and elimination parameters vary by formulation, with extended-release systems such as OROS (Concerta) and multilayer-release platforms (Biphentin) designed to maintain plasma concentrations for 10 to 12 hours. Methylphenidate undergoes rapid de-esterification to ritalinic acid, its major inactive metabolite, followed by renal excretion.
Safety considerations reflect its stimulant pharmacology. Common adverse effects include appetite reduction, insomnia, and cardiovascular effects such as modest blood pressure or heart rate increases. Methylphenidate carries a boxed warning for abuse and dependence due to the reinforcing potential associated with increased dopaminergic signaling at higher doses. It can lower the seizure threshold and requires careful use in patients with underlying cardiac, psychiatric, or seizure conditions.
For formulation and sourcing teams, API procurement should focus on enantiomeric consistency, control of impurity profiles, and verification of particle-size distributions appropriate for the intended dosage form. Suppliers should provide comprehensive regulatory documentation, including evidence of compliance with Good Manufacturing Practice and validated analytical methods aligned with pharmacopeial standards.
Identification & chemistry
| Generic name | Methylphenidate |
|---|---|
| Molecule type | Small molecule |
| CAS | 113-45-1 |
| UNII | 207ZZ9QZ49 |
| DrugBank ID | DB00422 |
Pharmacology
| Summary | Methylphenidate blocks norepinephrine and dopamine reuptake transporters, increasing extracellular levels of these neurotransmitters, with prominent activity in dopamine‑rich regions such as the prefrontal cortex. At therapeutically used low doses, it selectively enhances catecholaminergic signaling in circuits relevant to attention and executive control, partly involving alpha‑1 adrenergic receptor activity. Its pharmacologic effects align with modulation of pathways implicated in ADHD and narcolepsy. |
|---|---|
| Mechanism of action | While its exact mechanism is unclear, methylphenidate (MPH) has been shown to act as a norepinephrine and dopamine reuptake inhibitor (NDRI), thereby increasing the presence of these neurotransmitters in the extraneuronal space and prolonging their action.There is a dose-related effect of psychostimulants on receptor stimulation, where higher doses are shown to increase norepinephrine (NE) and dopamine (DA) efflux throughout the brain which can result in impaired cognition and locomotor-activating effects. In contrast, low doses are found to selectively activate NE and DE neurotransmission within the prefrontal cortex which is an area of the brain thought to play a prominent role in ADHD pathophysiology, thereby improving clinical efficacy and preventing side effects.The lower doses used to treat ADHD are not associated with the locomotor-activating effects associated with higher doses and instead reduce movement, impulsivity, and increase cognitive function including sustained attention and working memory.Methylphenidate's beneficial effects in sustaining attention have also been shown to be mediated by alpha-1 adrenergic receptor activity. Clinical findings have shown that children with ADHD have an abnormality in the dopamine transporter gene (DAT1), the D4 receptor gene (DRD-4), and/or the D2 receptor gene that may be at least partly overcome by the dopaminergic effects of methylphenidate, suggesting a possible mode of action. |
| Pharmacodynamics | Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Radioligand binding studies demonstrate that binding of methylphenidate in the brain is localized to dopamine-rich areas, in particular in the prefrontal cortex which has been demonstrated to play a prominent role in ADHD pathophysiology.In a number of animal models, methylphenidate enhances locomotor activity and induces stereotypic behaviours. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium-dependent dopamine transporter | Humans | inhibitor |
| 5-hydroxytryptamine receptor 1A | Humans | |
| Sodium-dependent noradrenaline transporter | Humans | inhibitor |
ADME / PK
| Absorption | Concerta®: Methylphenidate is readily absorbed. Following oral administration of Concerta, plasma methylhphenidate concentrations reach an initial maximum at about 1 hour followed by gradual ascending concentrations over the next 5-9 hours. Mean times to reach peak plasma concentrations across all doses of Concerta occurred between 6-10 hours. Once daily dosing minimizes the fluctuations between peak and trough concentrations associated with multiple doses of immediate-release methylphenidate treatments.Depending on the doses provided, Cmax was found to range from 6.0-15.0ng/mL, Tmax ranged from 8.1-9.4h, and AUC ranged from 50.4-121.5 ng·h/mL in children. When provided as Concerta®, methylphenidate is released through the patented Osmotic Controlled-Release Oral Delivery (OROS) system where 22% of the dose is provided as an immediate release and 78% is provided through a gradual release.OROS is comprised of an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. Within an aqueous environment, such as the stomach, the drug overcoat, which consists of 22% of the dose, dissolves within one hour, providing an initial immediate-release formulation of methylphenidate. Water then permeates through the membrane into the tablet core where the osmotically active polymer excipients expand, allowing methylphenidate to release slowly through the orifice over a period of 6-7 hours. Concerta also provides a sustained 10-12 hour effect, allowing for once-daily dosing. Biphentin®: Methylphenidate is rapidly and extensively absorbed following oral administration, with peak blood levels obtained in 1-3 hours. When provided as Biphentin®, methylphenidate is released through a multi-layer release delivery system (MLRTM) where 40% of the dose is provided as an immediate release and 60% is provided through a gradual release. Biphentin was designed to be an alternative to separate doses of immediate-release (IR) methylphenidate by providing a biphasic concentration-time profile when given as a single dose. The MLRTM release system allows for a sustained effect for 10-12 hours, allowing for once-daily dosing that covers the major times that ADHD impairment might occur (such as school, homework periods, during the workday, etc). Methylphenidate (immediate release): Methylphenidate hydrochloride is rapidly and extensively absorbed from the tablets following oral administration; however, owing to extensive first-pass metabolism, bioavailability is low (approx. 30%) and large individual differences exist (11-52%). In one study, the administration of methylphenidate hydrochloride with food accelerated absorption but had no effect on the amount absorbed. Peak plasma concentrations of 10.8 and 7.8 ng/mL were observed, on average, 2 hours after administration of 0.30 mg/kg in children and adults, respectively. Peak plasma concentrations showed marked variability between subjects. Both the area under the concentration-time curve (AUC), and the peak plasma concentrations (Cmax) showed dose-proportionality. |
|---|---|
| Half-life | Concerta: The half-life of methylphenidate in adults following oral administration of Concerta® was approximately 3.5 h. Biphentin: Methylphenidate is eliminated from plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults. Methylphenidate (immediate release): Methylphenidate is eliminated from the plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults. |
| Protein binding | Concerta: In humans, 15 ± 5% of methylphenidate in the blood is bound to plasma proteins. Biphentin: In blood, methylphenidate and its metabolites are distributed between plasma (57%) and erythrocytes (43%). Methylphenidate and its metabolites exhibit low plasma protein binding (approximately 15%). Methylphenidate (immediate release): In blood, methylphenidate and its metabolites are distributed between plasma (57%) and erythrocytes (43%). Methylphenidate and its metabolites exhibit low plasma protein binding (approx. 15%). |
| Metabolism | Methylphenidate is hepatically metabolized. More specifically, it is rapidly and extensively metabolized by carboxylesterase CES1A1. Via this enzyme, methylphenidate undergoes de-esterification to ritalinic acid (a-phenyl-2-piperidine acetic acid, PPAA), which has little to no pharmacologic activity. |
| Route of elimination | After oral administration of an immediate release formulation of methylphenidate, 78%-97% of the dose is excreted in the urine and 1%-3% in the feces in the form of metabolites within 48-96 hours. Only small quantities (<1%) of unchanged methylphenidate appear in the urine. Most of the dose is excreted in the urine as ritalinic acid (60%-86%), the remainder being accounted for by minor metabolites. |
| Volume of distribution | Concerta: Plasma methylphenidate concentrations in adults decline bi-exponentially following oral administration. Biphentin: The apparent distribution volume of methylphenidate in children is approximately 20 L/kg, with substantial variability (11 to 33 L/kg). Methylphenidate (immediate release): The apparent distribution volume of methylphenidate in children was approximately 20 L/kg, with substantial variability (11-33 L/kg). The volume of distribution after an intravenous dose (Vss) is 2.23 L/kg for the racemate in healthy adult volunteers. |
| Clearance | The apparent mean systemic clearance after an oral dose is 10.2 and 10.5 L/h/kg in children and adults, respectively for a 0.3 mg/kg dose, and 0.565 L/h/kg after an intravenous dose of the racemate in healthy adult volunteers. |
Formulation & handling
- Extended‑release oral formulations require matrices or coated multiparticulates that resist alcohol‑induced dose dumping and maintain controlled release despite moderate aqueous solubility.
- Low water solubility and moderate lipophilicity support use of solubilizers or pH‑modifying excipients for liquid and ODT formats to ensure consistent dissolution.
- Transdermal systems rely on permeation enhancers and controlled adhesive matrices to manage steady flux of this small, lipophilic molecule.
Regulatory status
| Lifecycle | Most key patents for the API in the US and Canada have expired, though one U.S. patent remains in force until 2033, indicating a mix of mature and protected elements. Overall, the product shows characteristics of a largely mature market with some ongoing exclusivity in the United States. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Multiple originator and major pharmaceutical companies have developed and supplied methylphenidate, with a large number of manufacturers and packagers supporting broad commercial distribution. Branded and generic products are well established in North American markets, particularly the US and Canada. Several key patents have already expired, while some extended‑release formulation patents remain active into the 2030s, indicating mature generic competition for older formulations and continued protection for select newer technologies. |
|---|
Safety
| Toxicity | Symptoms of overdose include vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes. LD<sub>50</sub>=190mg/kg (orally in mice) |
|---|
High Level Warnings:
- Overdose exposure is associated with CNS excitation and neuromuscular effects including agitation, tremors, hyperreflexia, muscle twitching, and convulsions
- Severe cases may progress to coma
- Cardiovascular stress responses such as tachycardia, arrhythmias, hypertension, and palpitations are noted at toxic levels, alongside hyperpyrexia and autonomic signs
Methylphenidate is a type of Psychostimulants
Psychostimulants are a specific subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that have gained significant attention in the medical field. These compounds are known for their stimulating effects on the central nervous system, making them valuable for treating various conditions such as attention deficit hyperactivity disorder (ADHD), narcolepsy, and certain cases of depression.
The primary mechanism of action of psychostimulants involves increasing the levels of certain neurotransmitters in the brain, particularly dopamine and norepinephrine. This heightened neurotransmitter activity results in enhanced cognitive functions, improved focus, and increased alertness. The most commonly prescribed psychostimulants include methylphenidate and amphetamines.
Methylphenidate is a well-known psychostimulant that works by blocking the reuptake of dopamine and norepinephrine, thereby increasing their concentrations in the synaptic cleft. This leads to improved concentration and reduced impulsivity in individuals with ADHD. Similarly, amphetamines stimulate the release of these neurotransmitters while also inhibiting their reuptake.
Psychostimulants are typically administered orally in the form of tablets or capsules, allowing for controlled and sustained release of the medication. These APIs undergo rigorous quality control measures to ensure their purity, potency, and safety.
In conclusion, psychostimulants are a specialized class of pharmaceutical APIs that effectively stimulate the central nervous system, leading to improved cognitive functions and reduced symptoms associated with ADHD, narcolepsy, and certain cases of depression. Their mechanisms of action involve enhancing neurotransmitter activity in the brain, particularly dopamine and norepinephrine. By adhering to strict quality control standards, these psychostimulant APIs provide safe and effective treatment options for patients in need.
Methylphenidate (Psychostimulants), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Frequently asked questions about Methylphenidate API
Sourcing
What matters most when sourcing GMP-grade Methylphenidate?
Key considerations include verifying GMP compliance and ensuring the supplier meets US and Canadian regulatory requirements for controlled substances. It is important to confirm the API’s suitability for the intended formulation, especially given ongoing patent protection for certain extended‑release technologies. A broad and mature supply base exists, so assessing traceability, quality documentation, and consistency across manufacturers is essential.
Which documents are typically required when sourcing Methylphenidate API?
Request the core API documentation set: CoA (16 companies), CEP (10 companies), GMP (9 companies), USDMF (8 companies), FDA (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Methylphenidate API?
Known or reported manufacturers for Methylphenidate: . Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Methylphenidate 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 Methylphenidate manufacturers?
Audit reports may be requested for Methylphenidate: 7 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Methylphenidate API on Pharmaoffer?
Reported supplier count for Methylphenidate: 16 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Methylphenidate API?
Production countries reported for Methylphenidate: United States (6 producers), India (5 producers), Spain (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Methylphenidate usually hold?
Common certifications for Methylphenidate suppliers: CoA (16 companies), CEP (10 companies), GMP (9 companies), USDMF (8 companies), FDA (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Methylphenidate (CAS 113-45-1) used for?
Methylphenidate (CAS 113-45-1) is used for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age and older and for narcolepsy. It improves attention, working memory, and behavioral control through inhibition of dopamine and norepinephrine reuptake.
Which therapeutic class does Methylphenidate fall into?
Methylphenidate belongs to the following therapeutic categories: Acids, Carbocyclic, Agents that produce hypertension, Agents that reduce seizure threshold, Central Nervous System Agents, Central Nervous System Stimulants. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Methylphenidate mainly prescribed for?
The primary indications for Methylphenidate: Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Methylphenidate work?
While its exact mechanism is unclear, Methylphenidate (MPH) has been shown to act as a norepinephrine and dopamine reuptake inhibitor (NDRI), thereby increasing the presence of these neurotransmitters in the extraneuronal space and prolonging their action.There is a dose-related effect of psychostimulants on receptor stimulation, where higher doses are shown to increase norepinephrine (NE) and dopamine (DA) efflux throughout the brain which can result in impaired cognition and locomotor-activating effects. In contrast, low doses are found to selectively activate NE and DE neurotransmission within the prefrontal cortex which is an area of the brain thought to play a prominent role in ADHD pathophysiology, thereby improving clinical efficacy and preventing side effects.The lower doses used to treat ADHD are not associated with the locomotor-activating effects associated with higher doses and instead reduce movement, impulsivity, and increase cognitive function including sustained attention and working memory.Methylphenidate's beneficial effects in sustaining attention have also been shown to be mediated by alpha-1 adrenergic receptor activity.
Clinical findings have shown that children with ADHD have an abnormality in the dopamine transporter gene (DAT1), the D4 receptor gene (DRD-4), and/or the D2 receptor gene that may be at least partly overcome by the dopaminergic effects of Methylphenidate, suggesting a possible mode of action.
What should someone know about the safety or toxicity profile of Methylphenidate?
Methylphenidate’s safety profile reflects its stimulant pharmacology, with common effects such as appetite suppression, insomnia, and modest increases in heart rate or blood pressure. It carries a boxed warning for abuse and dependence and can lower the seizure threshold, requiring caution in individuals with cardiac, psychiatric, or seizure disorders. Toxic exposures may cause CNS excitation with agitation, tremors, hyperreflexia, muscle twitching, convulsions, and, in severe cases, coma. Cardiovascular stress responses, hyperpyrexia, and autonomic signs can also occur at overdose levels.
What are important formulation and handling considerations for Methylphenidate as an API?
Important considerations include controlling dissolution of this moderately water‑soluble API to achieve consistent release, especially in extended‑release systems that must resist alcohol‑induced dose dumping. Multiparticulate or matrix technologies should maintain predictable release despite variable gastrointestinal conditions. For liquid or orally disintegrating formats, solubilizers or pH‑modifying excipients can support reliable dissolution. Transdermal delivery requires permeation enhancers and adhesive matrices that provide stable flux of the lipophilic molecule.
Is Methylphenidate a small molecule?
Methylphenidate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Methylphenidate?
Extended‑release oral Methylphenidate relies on matrix or coated multiparticulate systems that must remain intact to prevent alcohol‑induced dose dumping. Its low water solubility means formulations may need solubilizers or pH‑modifying excipients to maintain consistent dissolution. Ensuring the stability of these release‑controlling and solubility‑enhancing components is the primary concern.
Regulatory
Where is Methylphenidate approved or in use globally?
Methylphenidate is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Methylphenidate right now?
Regulatory oversight for Methylphenidate is established in Canada and the United States, where it is controlled under each country’s applicable drug and controlled‑substance frameworks. Patent considerations for this ingredient follow standard pharmaceutical and chemical patent rules in these jurisdictions, including protections related to manufacturing processes and specific formulations.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Methylphenidate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Methylphenidate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Methylphenidate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Methylphenidate: 1621 verified transactions across 429 suppliers and 67 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Methylphenidate?
Market report availability for Methylphenidate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
