“Comprehensive Overview of D-Methylphenidate Base (CAS No. 113-45-1) Manufactured by Swapnroop Drugs & Pharmaceuticals”

 

1. What is D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs & Pharmaceuticals? 😊

D-Methylphenidate Base is the active pharmaceutical ingredient (API) primarily used in medications designed to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy. Manufactured by Swapnroop Drugs & Pharmaceuticals, this compound is the dextrorotatory enantiomer of methylphenidate, meaning it is the more pharmacologically active form responsible for the therapeutic effects.

The “D-” prefix indicates the specific stereochemistry, which makes this form more potent compared to its racemic mixture or the L-enantiomer. Swapnroop Drugs & Pharmaceuticals produces this high-purity base under strict quality standards to ensure safety and efficacy.

In essence, D-Methylphenidate Base is a central nervous system stimulant that helps improve focus, attention, and impulse control by increasing the levels of dopamine and norepinephrine in the brain. It is widely used in modern pharmacotherapy for neurological and behavioral disorders.

2. What is D-METHYLPHENIDATE BASE by Swapnroop Drugs and Pharmaceuticals used for? 🎯

D-Methylphenidate Base manufactured by Swapnroop Drugs and Pharmaceuticals is primarily used as the key active ingredient in medications for treating:

• Attention Deficit Hyperactivity Disorder (ADHD): It helps improve attention span, reduce hyperactivity, and control impulsive behavior by stimulating the central nervous system.

• Narcolepsy: It assists in managing excessive daytime sleepiness by promoting wakefulness.

By increasing the levels of dopamine and norepinephrine in the brain, D-Methylphenidate enhances cognitive focus and alertness, making it a vital therapeutic agent in neuropsychiatric treatment plans.

Swapnroop Drugs & Pharmaceuticals ensures that the D-Methylphenidate Base they produce meets pharmaceutical-grade standards, allowing it to be safely formulated into various drug products to help patients manage these conditions effectively.

3. What are the physicochemical properties of D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? ⚗️

D-Methylphenidate Base, as manufactured by Swapnroop Drugs and Pharmaceuticals, possesses the following key physicochemical properties that are critical for its pharmaceutical use:

• Chemical Formula: C14H19NO2

• Molecular Weight: Approximately 233.31 g/mol

• Physical Appearance: White to off-white crystalline powder

• Solubility: Sparingly soluble in water; soluble in organic solvents like ethanol and methanol

• Melting Point: Around 74–77°C (variable depending on purity)

• Optical Activity: It is the dextrorotatory (D-) enantiomer, exhibiting specific rotation consistent with its stereochemistry

• Stability: Stable under normal storage conditions but sensitive to moisture and light which can cause degradation

• pKa: Approximately 8.8, indicating it exists predominantly as a base at physiological pH

These physicochemical characteristics influence its formulation, bioavailability, and handling during manufacturing. Swapnroop Drugs & Pharmaceuticals maintains strict quality control to ensure consistency and purity of these properties in every batch.

4. How is D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals synthesized? 🧪🔬

The synthesis of D-Methylphenidate Base by Swapnroop Drugs and Pharmaceuticals involves a multi-step chemical process designed to produce the dextrorotatory enantiomer with high purity and yield. While the exact proprietary process may be confidential, the general synthetic route is as follows:

1. Starting Materials: The synthesis typically begins with a suitable chiral precursor or racemic methylphenidate which is then resolved into its D-enantiomer. Commonly, methylphenidate is synthesized from piperidine derivatives and appropriate esters.

2. Chiral Resolution or Enantioselective Synthesis:

   • Chiral Resolution: Racemic methylphenidate can be separated into its D- and L- forms by using chiral resolving agents or chromatographic techniques.

   • Enantioselective Synthesis: More advanced methods employ catalysts or enzymes that preferentially form the D-enantiomer during the reaction.

3. Purification: After synthesis, the D-methylphenidate base is purified through recrystallization or chromatography to remove impurities and the unwanted L-enantiomer, ensuring high enantiomeric excess (typically >99%).

4. Quality Control: The final product undergoes rigorous testing for purity, stereochemical integrity, and absence of contaminants before being released for pharmaceutical formulation.

Swapnroop Drugs and Pharmaceuticals employs modern synthetic chemistry techniques and GMP (Good Manufacturing Practices) to ensure the product’s safety, efficacy, and reproducibility.

5. What are the different dosage forms of D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? 💊

Swapnroop Drugs and Pharmaceuticals produces D-Methylphenidate Base as an active pharmaceutical ingredient (API), which is then formulated into various dosage forms to meet therapeutic needs. Common dosage forms derived from D-Methylphenidate Base include:

• Immediate-Release Tablets: Designed for rapid onset of action, typically used for quick symptom control in ADHD.

• Extended-Release Tablets/Capsules: Formulated to provide sustained drug release over several hours, reducing the need for multiple daily doses and improving patient compliance.

• Oral Suspensions or Solutions: Liquid forms for patients who have difficulty swallowing tablets, such as children.

• Chewable Tablets: Convenient for pediatric use or those preferring non-swallowable forms.

These dosage forms are tailored to optimize the pharmacokinetic profile of D-Methylphenidate, balancing efficacy with safety and patient convenience.

6. How are D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals dosage forms prepared? 🏭⚗️

The preparation of dosage forms containing D-Methylphenidate Base by Swapnroop Drugs and Pharmaceuticals involves carefully controlled pharmaceutical manufacturing processes to ensure uniformity, efficacy, and safety. Here’s an overview of how common dosage forms are prepared:

• Immediate-Release Tablets:

  1. Blending: D-Methylphenidate Base is mixed with excipients such as fillers, binders, disintegrants, and lubricants to create a homogeneous powder blend.

  2. Granulation: Wet or dry granulation methods may be used to improve flow and compressibility.

  3. Compression: The granules are compressed into tablets using a tablet press.

  4. Coating (Optional): Tablets may be coated to mask taste or improve stability.

• Extended-Release Tablets/Capsules:

  1. Formulation: Use of matrix-forming agents or specialized coatings that control the release rate of the API.

  2. Encapsulation or Compression: Tablets or capsules are produced to contain the controlled-release matrix.

  3. Quality Checks: Rigorous testing to confirm the release profile matches specifications.

• Oral Suspensions:

  1. Dispersion: D-Methylphenidate Base is uniformly dispersed in a suitable liquid vehicle with suspending agents and preservatives.

  2. Homogenization: Ensures uniform particle distribution for consistent dosing.

• Chewable Tablets:

  1. Mixing: API is blended with flavoring agents, sweeteners, and suitable excipients.

  2. Compression: Tablets are compressed with attention to texture and disintegration properties.

Throughout these processes, Swapnroop Drugs & Pharmaceuticals follows Good Manufacturing Practices (GMP) and quality control protocols to ensure safety, potency, and stability of the final products.

7. What is the appropriate dosage form of D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? ✅

The appropriate dosage form of D-Methylphenidate Base depends on the patient’s age, medical condition, treatment goals, and convenience. Swapnroop Drugs and Pharmaceuticals typically provides D-Methylphenidate in the following dosage forms, each suited for specific therapeutic needs:

• Immediate-Release Tablets: Ideal for patients needing quick symptom relief or dose flexibility. Often prescribed for children and adults who require multiple doses throughout the day.

• Extended-Release Tablets/Capsules: Preferred for patients who benefit from sustained symptom control over the day, improving compliance by reducing dosing frequency—commonly used in school-aged children and adults.

• Oral Suspension: Suitable for pediatric patients or those who have difficulty swallowing tablets.

• Chewable Tablets: Also aimed at children or patients preferring chewable options.

Ultimately, the choice of dosage form is determined by the prescribing physician based on individual patient needs, with the D-Methylphenidate Base API formulated accordingly by Swapnroop Drugs & Pharmaceuticals.

8. When should D-METHYLPHENIDATE BASE API manufactured by Swapnroop Drugs and Pharmaceuticals be taken? ⏰

D-Methylphenidate Base, as formulated into medications, is typically taken once or twice daily, depending on the dosage form and the patient’s treatment plan:

• Immediate-Release Forms: Usually taken 2 to 3 times a day, with doses spaced about 4 to 6 hours apart. Often, the first dose is taken in the morning, and subsequent doses during the day to maintain symptom control. Avoid late afternoon or evening doses to reduce the risk of insomnia.

• Extended-Release Forms: Taken once daily, preferably in the morning, to provide consistent symptom control throughout the day with minimal sleep disturbance.

• With or Without Food: It can be taken with or without food, but taking it with meals may help reduce potential stomach upset.

It is crucial that dosing and timing follow the prescribing doctor’s instructions to maximize benefits and minimize side effects.

9. What are the effects and side effects of D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? ⚖️

Effects:

• Therapeutic Benefits:

  • Improves attention, focus, and impulse control in patients with ADHD.

  • Increases wakefulness and reduces excessive daytime sleepiness in narcolepsy.

  • Enhances dopamine and norepinephrine activity in the brain, which supports improved cognitive function and behavioral control.

Common Side Effects:

• Nervousness or anxiety

• Insomnia or difficulty sleeping

• Loss of appetite

• Headache

• Dry mouth

• Stomach pain or nausea

• Increased heart rate or blood pressure (in some cases)

Less Common but Serious Side Effects:

• Cardiovascular issues (e.g., palpitations, hypertension)

• Mood changes such as agitation or aggression

• Potential for dependence or abuse due to stimulant nature

• Rare allergic reactions (rash, itching, swelling)

Swapnroop Drugs and Pharmaceuticals ensures that D-Methylphenidate Base meets stringent purity standards to minimize risks, but monitoring by healthcare professionals is essential during treatment.

10. How is D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals tested? 🧪✅

D-Methylphenidate Base undergoes comprehensive testing at Swapnroop Drugs and Pharmaceuticals to ensure its quality, purity, potency, and safety before being released for pharmaceutical use. The testing process typically includes:

• Identity Testing: Confirming the chemical structure and stereochemistry using techniques like Nuclear Magnetic Resonance (NMR) spectroscopy, Infrared (IR) spectroscopy, and Optical Rotation measurement.

• Purity and Assay: High-Performance Liquid Chromatography (HPLC) is commonly used to quantify the purity of the compound and ensure the concentration of the active ingredient meets specifications.

• Impurity Profiling: Detection and quantification of related substances, residual solvents, and any unwanted by-products.

• Moisture Content: Karl Fischer titration or similar methods assess moisture levels to prevent degradation.

• Physical Testing: Checking appearance, particle size, melting point, and solubility.

• Microbial Testing: Ensures the API is free from microbial contamination.

These rigorous quality control tests adhere to pharmacopoeial standards (such as USP, EP) and Good Manufacturing Practices (GMP), ensuring that the D-Methylphenidate Base is safe and effective for further pharmaceutical formulation.

11. What tests are performed on D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? 🔬

Swapnroop Drugs and Pharmaceuticals performs a comprehensive set of tests on D-Methylphenidate Base to ensure its quality and compliance with regulatory standards. Key tests include:

• Identification Tests:

  • NMR (Nuclear Magnetic Resonance) to confirm molecular structure.

  • IR (Infrared Spectroscopy) for functional group verification.

  • Optical Rotation to confirm the correct enantiomer (D-form).

• Assay and Purity:

  • HPLC (High-Performance Liquid Chromatography) to measure the content of the active ingredient and quantify impurities.

  • UV-Vis Spectroscopy may also be used for concentration analysis.

• Impurity and Related Substances Analysis: Detects and quantifies process-related impurities, residual solvents, and degradation products.

• Moisture Content: Using Karl Fischer titration to ensure low moisture levels.

• Physical Property Tests:

  • Appearance and color inspection.

  • Melting point determination.

  • Particle size distribution.

• Microbial Limit Tests: To confirm the absence of harmful microbial contamination.

• Residual Solvent Testing: Ensures residual solvents are within acceptable limits per ICH guidelines.

These tests collectively ensure that the D-Methylphenidate Base meets high standards for safety, efficacy, and stability before it is used in drug formulation.

12. What are the challenges in manufacturing D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals API? ⚠️

Manufacturing the D-Methylphenidate Base API involves several challenges that Swapnroop Drugs and Pharmaceuticals carefully manages to maintain quality and efficiency:

• Chiral Purity Control: Achieving and maintaining high enantiomeric purity (D-enantiomer) is critical since the therapeutic effect depends on the correct stereochemistry. Chiral resolution or enantioselective synthesis must be precise to avoid contamination with the L-form.

• Complex Synthesis Steps: The multi-step synthesis requires stringent reaction control, including temperature, pH, and reaction times, to maximize yield and minimize impurities.

• Impurity Management: Minimizing and identifying process-related impurities and residual solvents is challenging, requiring advanced purification and analytical methods.

• Moisture Sensitivity: The compound is sensitive to moisture, so drying and storage conditions must be carefully controlled to avoid degradation.

• Regulatory Compliance: Meeting strict global regulatory standards (e.g., FDA, EMA) demands comprehensive documentation and quality assurance throughout the manufacturing process.

• Scale-Up Issues: Translating laboratory-scale synthesis to large-scale production can introduce variability and requires optimization to maintain consistency.

Swapnroop Drugs & Pharmaceuticals addresses these challenges through state-of-the-art technology, skilled personnel, and strict adherence to GMP standards to produce high-quality D-Methylphenidate Base API.

13. What are the challenges in manufacturing D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals dosage forms? 🏭⚠️

Manufacturing dosage forms containing D-Methylphenidate Base presents several challenges that Swapnroop Drugs & Pharmaceuticals carefully manages to ensure product quality and efficacy:

• Dose Uniformity: Ensuring consistent distribution of the potent API in tablets, capsules, or suspensions is critical due to the low dose required for therapeutic effect.

• Controlled Release Formulation: Developing extended-release dosage forms demands precise formulation to achieve the desired drug release profile without dose dumping.

• Stability: D-Methylphenidate Base is sensitive to moisture and light, so formulations must protect the API to maintain stability and shelf life.

• Taste Masking: The API can have a bitter taste, especially in liquid or chewable forms, requiring effective taste-masking strategies to improve patient compliance.

• Manufacturing Process Control: Granulation, compression, and coating steps must be optimized to avoid issues like tablet hardness variability, capping, or poor dissolution.

• Regulatory Compliance and Validation: Dosage forms must comply with pharmacopeial standards and undergo rigorous validation to ensure safety, efficacy, and batch-to-batch consistency.

Swapnroop Drugs & Pharmaceuticals addresses these challenges by using advanced formulation technology, quality control measures, and experienced process optimization to produce reliable and patient-friendly dosage forms.

14. What are the storage conditions for D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? 🌡️📦

To ensure the stability and efficacy of D-Methylphenidate Base, Swapnroop Drugs and Pharmaceuticals recommends the following storage conditions:

• Temperature: Store in a cool environment, ideally between 20°C to 25°C (room temperature). Avoid excessive heat or freezing conditions.

• Humidity: Keep in a dry place with low humidity, as the API is sensitive to moisture which can cause degradation or clumping.

• Light Protection: Store in opaque or amber containers to protect the compound from light exposure, which can lead to breakdown of the active ingredient.

• Container: Use airtight, well-sealed containers to prevent contamination and moisture ingress.

• Shelf Life Maintenance: Proper storage as above is critical to maintain the shelf life and potency throughout the product’s lifespan.

These guidelines help maintain the chemical stability, purity, and performance of D-Methylphenidate Base during storage and handling.

15. What is the packaging for D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? 📦✨

D-Methylphenidate Base manufactured by Swapnroop Drugs and Pharmaceuticals is packaged with a focus on protecting the API’s quality, stability, and safety during storage and transport. Typical packaging features include:

• Primary Packaging:

  • Airtight, moisture-resistant containers such as HDPE (High-Density Polyethylene) bottles or glass bottles with secure screw caps or sealed closures.

  • Use of amber-colored containers to protect from light-induced degradation.

• Secondary Packaging:

  • Robust cardboard cartons or boxes that provide physical protection and facilitate handling during shipping.

• Labeling:

  • Clear, compliant labeling with batch number, manufacturing date, expiry date, storage instructions, and safety information as per regulatory requirements.

• Additional Protective Measures:

  • Inclusion of desiccants inside containers to control moisture.

  • Tamper-evident seals to ensure product integrity.

This packaging approach by Swapnroop Drugs & Pharmaceuticals helps preserve the API’s potency and quality until it reaches the formulation stage or the end-user.

16. What is the shelf life of D-METHYLPHENIDATE BASE manufactured by Swapnroop Drugs and Pharmaceuticals? ⏳

The typical shelf life of D-Methylphenidate Base manufactured by Swapnroop Drugs and Pharmaceuticals is 2 to 3 years from the date of manufacture when stored under recommended conditions (cool, dry place, protected from light and moisture).

Key points affecting shelf life include:

• Proper Storage: Maintaining temperature and humidity controls extends stability.

• Packaging Integrity: Airtight and light-protective packaging prevents degradation.

• Quality Control: Periodic stability testing is performed to confirm potency and purity throughout the shelf life.

Swapnroop Drugs & Pharmaceuticals ensures each batch meets stringent stability criteria so that the API remains effective and safe to use throughout its shelf life.

👉 Contact Options:

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  SWAPNROOP Drugs and Pharmaceuticals

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