Comprehensive Overview of D-Methylphenidate Hydrochloride (CAS No. 67491-41-8) Manufactured by Swapnroop Drugs & Pharmaceuticals

Q1: What is D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

🧪 D-Methylphenidate Hydrochloride is the pharmacologically active enantiomer of racemic methylphenidate, a central nervous system (CNS) stimulant commonly used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. It is a white to off-white crystalline powder that is highly soluble in water, and it is administered primarily in the form of oral solid dosage forms like tablets and extended-release capsules.

Swapnroop Drugs & Pharmaceuticals, a manufacturer known for producing high-quality active pharmaceutical ingredients (APIs), develops D-Methylphenidate Hydrochloride under stringent quality controls to meet pharmacopeial standards (such as the USP or IP). The product is designed for both generic formulations and customized pharmaceutical development, adhering to Good Manufacturing Practices (GMP).

🔬 Chemical Profile of D-Methylphenidate Hydrochloride:

IUPAC Name: (R)-methyl 2-phenyl-2-(piperidin-2-yl)acetate hydrochloride
Molecular Formula: C14H19NO2·HCl
Molecular Weight: ~269.77 g/mol
CAS Number: 23007-85-4
Stereochemistry: Only the dextro or (R)-enantiomer is present, which is considered significantly more potent and clinically relevant compared to the (S)-enantiomer.

⚙️ Pharmacological Action:

D-Methylphenidate primarily works by blocking the reuptake of dopamine and norepinephrine into the presynaptic neuron, thereby increasing their levels in the synaptic cleft. This action enhances attention, focus, and impulse control, making it highly effective in managing ADHD symptoms. Compared to racemic methylphenidate, the d-enantiomer is about 2 to 4 times more potent, which allows for lower dosing with similar or better efficacy and potentially fewer side effects.

Q2: What is D-METHYLPHENIDATE HYDROCHLORIDE by Swapnroop Drugs & Pharmaceuticals used for?

💊 D-Methylphenidate Hydrochloride, manufactured by Swapnroop Drugs & Pharmaceuticals, is primarily used as an Active Pharmaceutical Ingredient (API) in the formulation of central nervous system (CNS) stimulant medications, especially for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It is also used in managing narcolepsy, a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep.

🧠 Key Therapeutic Uses:

1. ✅ Treatment of ADHD (Attention Deficit Hyperactivity Disorder):

D-Methylphenidate Hydrochloride is the first-line pharmacological treatment for ADHD. It helps improve:

🔷 Attention span
🔷 Focus and concentration
🔷 Impulse control
🔷 Hyperactivity

By enhancing dopamine and norepinephrine activity in the brain, this API normalizes neurotransmission in brain regions involved in executive function, such as the prefrontal cortex.

2. 🛌 Treatment of Narcolepsy:

In patients suffering from narcolepsy, D-Methylphenidate Hydrochloride is used to promote wakefulness and reduce episodes of sudden sleep attacks, thereby improving overall daytime functioning.

🔬 Why D-Methylphenidate and not racemic methylphenidate?

Racemic methylphenidate contains both d- and l-isomers, but only the d-isomer (D-Methylphenidate) is pharmacologically active. Swapnroop Drugs & Pharmaceuticals manufactures the pure enantiomer to:

🎯 Increase therapeutic precision
⚖️ Allow for lower dosing with the same or enhanced efficacy
🚫 Minimize potential side effects (e.g., appetite loss, sleep disturbances)

🧰 Other Off-Label or Investigational Uses (under medical supervision only):

Cognitive enhancement in select neurocognitive disorders
Treatment-resistant depression (as an adjunct in special cases)
Fatigue related to neurological conditions like multiple sclerosis

⚠️ Note: These uses are not FDA-approved indications and require clinical justification and careful monitoring.

🏭 Role of Swapnroop Drugs & Pharmaceuticals:

Swapnroop ensures the API is optimized for formulation into extended-release or immediate-release dosage forms by providing:

✔️ High enantiomeric purity
✔️ Controlled particle size distribution
✔️ Regulatory documentation (like DMF, CoA)
✔️ Custom specifications to meet client formulation needs

📦 Typical End-Product Examples:

D-Methylphenidate Hydrochloride is commonly used in the production of branded medications such as:

🟢 Focalin® (immediate-release)
🟢 Focalin XR® (extended-release)

These are used globally under different brand names, depending on the regulatory authority and country.

🧠 Summary:

👉 D-Methylphenidate Hydrochloride by Swapnroop Drugs & Pharmaceuticals is a highly effective CNS stimulant API used primarily for ADHD and narcolepsy.
👉 It offers better efficacy and tolerability than racemic methylphenidate by targeting only the active enantiomer.
👉 Swapnroop provides a reliable, pharmaceutically compliant version of this API suitable for a wide range of dosage forms.

Q3: What are the physicochemical properties of D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

🧪 D-Methylphenidate Hydrochloride is a chiral, water-soluble hydrochloride salt of the active (R)-enantiomer of methylphenidate. The physicochemical properties of this compound are crucial for its bioavailability, stability, formulation compatibility, and therapeutic effectiveness. Swapnroop Drugs & Pharmaceuticals manufactures this API with precision, ensuring that all key physical and chemical characteristics meet pharmacopeial and industrial standards.

🔍 General Physicochemical Characteristics:

Property	Description
Chemical Name	(R)-Methyl 2-phenyl-2-(piperidin-2-yl)acetate hydrochloride
Molecular Formula	C14H19NO2·HCl
Molecular Weight	~269.77 g/mol
Appearance	White to off-white crystalline powder 🌫️
Odor	Odorless or slight characteristic odor
Taste	Slightly bitter
Solubility	Freely soluble in water 💧, soluble in methanol and ethanol, practically insoluble in ether
Melting Point	~171–176 °C (with decomposition) 🌡️
pKa	~8.8 (for the piperidine group)
Optical Rotation	Specific for (R)-enantiomer: typically [α]D ~ +56°
LogP (octanol/water)	Approximately 2.2–2.4 (indicating moderate lipophilicity)
pH of 1% solution in water	~4.0 to 6.0
Hygroscopicity	Slightly hygroscopic – should be protected from moisture 💦

🔬 Crystalline Nature and Polymorphism:

D-Methylphenidate Hydrochloride is known to exist in crystalline form, and polymorphic behavior may influence:

Dissolution rate
Solubility
Formulation stability
Bioavailability

Swapnroop Drugs & Pharmaceuticals ensures controlled crystallization conditions and thorough solid-state characterization using:

X-ray diffraction (XRD)
Differential scanning calorimetry (DSC)
Fourier-transform infrared spectroscopy (FTIR)

🧫 Chemical Stability:

Stable under normal conditions of storage if protected from light, moisture, and high temperatures.
May degrade in strong acidic or basic environments or under prolonged exposure to light.

Thus, strict adherence to storage and packaging guidelines (covered in later questions) is important.

💡 Why Are These Properties Important?

Solubility directly impacts bioavailability—especially for oral dosage forms.
Melting point and hygroscopicity are essential for defining processing conditions like granulation, compression, and encapsulation.
Optical purity ensures only the active enantiomer is present, maximizing clinical efficacy.
Crystallinity and polymorphism determine physical stability and dissolution characteristics.

🏭 Quality Assurance at Swapnroop Drugs & Pharmaceuticals:

To ensure batch-to-batch uniformity, Swapnroop employs:

High-precision analytical techniques (e.g., HPLC, polarimetry)
Rigorous in-process and post-process QC checks
Conformance to regulatory pharmacopeias (e.g., USP, Ph. Eur., IP)

🧠 Summary:

👉 D-Methylphenidate Hydrochloride, as produced by Swapnroop Drugs & Pharmaceuticals, is a high-purity, crystalline, water-soluble CNS stimulant API.
👉 Its well-characterized physicochemical profile ensures therapeutic reliability, formulation stability, and regulatory compliance.
👉 Swapnroop's strict manufacturing controls maintain consistency in key properties like solubility, particle size, polymorphism, and optical rotation.

Q4: How is D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals synthesized?

🧪 D-Methylphenidate Hydrochloride, the pharmacologically active enantiomer of methylphenidate, is synthesized using a chiral-specific synthesis pathway to ensure the selective production of the (R)-enantiomer only. Swapnroop Drugs & Pharmaceuticals employs advanced synthetic methodologies that comply with GMP standards, ensuring purity, yield, and stereoselectivity at an industrial scale.

🏗️ Overview of the Synthesis Process:

The synthesis of D-Methylphenidate Hydrochloride generally follows a multi-step chemical synthesis that includes chiral resolution or enantioselective synthesis. Here is a stepwise breakdown of a typical synthetic route:

🔬 Step 1: Formation of Key Intermediate (Phenylacetonitrile Derivative)

The synthesis begins with phenylacetic acid or phenylacetonitrile as the aromatic precursor.
This is converted into a corresponding ester or ketone derivative, which sets the foundation for the side chain.

🧬 Step 2: Chiral Center Formation (Enantioselective Alkylation or Hydrogenation)

The (R)-stereocenter at the alpha position is introduced using:
- Chiral catalysts (e.g., organometallic or enzymatic)
- Or via chiral auxiliary techniques
This step is crucial to ensure the final molecule is the D-isomer only.

🧠 Why this step matters: The therapeutic activity resides in the D-isomer. The L-isomer is inactive and may even cause side effects.

⚗️ Step 3: Formation of Piperidine Ring Substructure

The piperidine ring is introduced by reacting with 2-piperidone or by cyclization techniques.
This part of the molecule is essential for dopamine transporter binding.

🔁 Step 4: Esterification

The intermediate is then esterified to form the methyl ester group, a key functional group of methylphenidate that contributes to its pharmacokinetics.

🧂 Step 5: Formation of Hydrochloride Salt

The final compound is converted into its hydrochloride salt by reaction with hydrogen chloride gas or aqueous HCl, resulting in:
- A crystalline, water-soluble form
- Enhanced stability and formulation compatibility

🧹 Step 6: Purification and Crystallization

Purification is performed using recrystallization or chromatographic techniques to ensure:
- 💎 High enantiomeric purity (>99% D-isomer)
- ❌ Removal of any residual solvents, by-products, or L-isomer contamination

🧪 Analytical Testing Throughout Synthesis:

Swapnroop uses various quality control measures at each stage:

Chiral HPLC for enantiomeric excess
NMR and IR Spectroscopy for structural confirmation
XRD and DSC for polymorphic identity
Residual solvent analysis (e.g., by GC)

🏭 Manufacturing Considerations at Swapnroop Drugs & Pharmaceuticals:

✅ Uses highly controlled reactors and process equipment
✅ Follows cleanroom protocols for contamination control
✅ Ensures repeatable yields with minimal batch variation
✅ Adheres to environmental and safety standards during synthesis and waste disposal

Q5: What are the different dosage forms of D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

💊 D-Methylphenidate Hydrochloride, as manufactured by Swapnroop Drugs & Pharmaceuticals, is primarily produced as an Active Pharmaceutical Ingredient (API). This API is then used by formulation companies to manufacture various oral dosage forms tailored for patient needs. These dosage forms are designed to optimize onset of action, duration of effect, and patient compliance in managing disorders like ADHD and narcolepsy.

🧾 Major Dosage Forms Using D-Methylphenidate Hydrochloride:

1. 🌟 Immediate-Release (IR) Tablets

Use: Rapid onset of action, typically within 30 minutes.
Duration: Short (~3–5 hours).
Frequency: Multiple daily dosing (usually 2–3 times/day).
Advantages:
- Fast symptom relief
- Easy to titrate dosage
Example Brand Reference: Focalin® IR

2. 🕒 Extended-Release (ER) Capsules / Tablets

Use: Designed for all-day symptom control with once-daily dosing.
Duration: Long (~8–12 hours).
Mechanism: Dual-phase release (e.g., SODAS® technology — immediate + controlled release).
Advantages:
- Increased convenience
- Improved compliance, especially in school-age children
Example Brand Reference: Focalin XR®

3. ⚗️ Modified-Release (MR) Formulations

Includes biphasic, osmotic-controlled release (e.g., OROS®), or matrix-based tablets.
These are innovative formulations allowing customizable release profiles to:
- Minimize peak-related side effects
- Prolong therapeutic effect
Though not currently manufactured directly by Swapnroop, their high-quality API can be used in R&D or custom contract development for these advanced forms.

4. 🧃 Oral Solutions / Suspensions (Under development or less common)

Designed for pediatric or geriatric populations who cannot swallow tablets.
May require stabilization of the API and flavoring.
Not commonly available but possible with suitable formulation partners using Swapnroop's API.

5. 💉 Transdermal / Injectable Forms (Experimental/Research use only)

D-Methylphenidate is being researched for novel delivery routes, like patches or long-acting injectables.
These are not yet mainstream but hold potential for future pharmaceutical innovations using high-purity API.

🧪 Why Multiple Dosage Forms?

Each dosage form offers specific advantages depending on:

🧠 Patient age
🕒 Duration of required effect
⚖️ Risk of side effects
🎯 Need for tailored pharmacokinetics (PK)

Swapnroop’s API can be adapted into all these forms by pharmaceutical companies, thanks to its:

✅ Controlled particle size
✅ Excellent stability
✅ High enantiomeric and chemical purity

📦 Packaging Considerations (by formulator, not Swapnroop):

IR tablets – blister strips or bottles
ER capsules – high-barrier packaging to protect from moisture and degradation
Oral liquids – amber glass/plastic bottles with calibrated dosing devices

❓ Q6: How are D-METHYLPHENIDATE HYDROCHLORIDE dosage forms prepared by using the API manufactured by Swapnroop Drugs & Pharmaceuticals?

🏭 D-Methylphenidate Hydrochloride, as manufactured by Swapnroop Drugs & Pharmaceuticals, serves as a high-purity API for formulating multiple oral dosage forms. The preparation of these forms—such as immediate-release (IR) tablets, extended-release (ER) capsules, and others—involves carefully designed pharmaceutical manufacturing processes. These processes are optimized to maintain drug stability, ensure uniformity, and achieve targeted drug release.

Let’s explore how these dosage forms are generally prepared using Swapnroop’s API. ⬇️

💊 1. Immediate-Release (IR) Tablets

📌 Goal: Deliver the API quickly into the bloodstream with rapid onset of action.

🔧 Preparation Process:

Weighing & Blending:
- D-Methylphenidate Hydrochloride is accurately weighed and blended with diluents (e.g., lactose), disintegrants (e.g., croscarmellose), and binders.
- High-shear mixers ensure uniform API distribution.
Granulation (if wet method is used):
- A binder solution (e.g., PVP in water or alcohol) is added.
- Wet mass is dried in a fluid bed dryer or tray dryer.
Milling & Sieving:
- The dried granules are milled to desired particle size and passed through mesh.
Lubrication:
- Add magnesium stearate or similar lubricant for smooth tableting.
Compression:
- Final blend is compressed into tablets using rotary tablet presses.
Coating (optional):
- May involve film coating for taste-masking or identification purposes.

🕒 2. Extended-Release (ER) Capsules or Tablets

📌 Goal: Sustain drug release over 8–12 hours for once-daily dosing.

🔧 Preparation Process (for multiparticulate systems or matrix tablets):

A. Multiparticulate Beads in Capsules:

API layering:
- D-Methylphenidate HCl is coated onto sugar spheres or microcrystalline pellets using fluidized bed coating.
Polymer coating:
- Apply controlled-release polymer layers (e.g., ethylcellulose, HPMC) to regulate drug diffusion.
Blending & Encapsulation:
- Beads with different release profiles are blended to create biphasic release.
- Filled into hard gelatin capsules.

B. Matrix Tablets:

API mixed with hydrophilic matrix-forming agents (e.g., HPMC).
Granulation, drying, and compression into tablets.
Sustained release achieved by matrix swelling and erosion.

🧪 3. Oral Solution / Suspension (less common)

📌 Goal: Provide flexibility for pediatric patients or those with swallowing difficulty.

🔧 Preparation Process:

Dissolve the API in purified water.
Add sweeteners (e.g., sorbitol), flavoring agents, and preservatives (e.g., sodium benzoate).
Adjust pH for solubility and stability.
Homogenize and filter.
Fill into amber glass or plastic bottles with measuring caps.

💡 Key Manufacturing Considerations with Swapnroop’s API:

✅ Particle size distribution: Affects dissolution and uniformity
✅ Hygroscopic nature: Requires moisture-controlled environments
✅ Optical purity: Essential for D-isomer specificity
✅ Stability: Must be maintained during blending, granulation, and coating

Swapnroop’s high-quality D-Methylphenidate HCl ensures:

🧬 Consistent batch quality
⚖️ Accurate dosing
🧪 Smooth processing compatibility

🔬 Quality Control During Manufacturing:

Throughout the preparation process, pharmaceutical manufacturers carry out:

Blend uniformity tests
Tablet hardness, friability, and disintegration testing
Dissolution profiling
Assay and content uniformity analysis (HPLC)
Microbial testing for liquids

Q7: What is the appropriate dosage form of D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

✅ D-Methylphenidate Hydrochloride, as manufactured by Swapnroop Drugs & Pharmaceuticals, is a high-purity active pharmaceutical ingredient (API) used in several oral dosage forms. However, the most appropriate dosage form depends on various factors such as age, severity of symptoms, duration of action needed, and patient compliance.

Let’s explore the most suitable dosage forms and understand why they are considered optimal.

💊 1. Immediate-Release (IR) Tablets — 💡 Appropriate for Initial Dosing or Short-Term Control

✅ Best For:

Children and adolescents who need quick symptom control
Newly diagnosed patients starting therapy
Titration phases where dose adjustment is frequent

⏱️ Features:

Onset: Within 20–30 minutes
Duration: ~3–5 hours
Flexible dosing: Given 2–3 times a day based on symptoms

👍 Advantages:

Quick relief
Easy dose modifications
Lower cost

⚠️ Limitation:

Requires multiple doses per day → potential compliance issues

🕒 2. Extended-Release (ER) Capsules or Tablets — 🎯 Most Clinically Appropriate for Daily Therapy

✅ Best For:

School-going children, working adults, or patients with compliance issues
Those requiring all-day symptom control (up to 12 hours)

⏱️ Features:

Biphasic release: Immediate + sustained layers
Once-daily dosing
Mimics the effect of taking multiple IR doses in one convenient form

👍 Advantages:

Improved compliance
Stable plasma concentration
Reduces rebound symptoms at the end of the day

⚠️ Limitation:

Less flexibility in dose titration
More costly than IR forms

🧃 3. Oral Solutions/Suspensions — 🧒 Special-Purpose, Pediatric-Friendly Form

✅ Best For:

Children under 6 years
Elderly or patients with dysphagia (difficulty swallowing)
When precise weight-based dosing is needed

👍 Advantages:

Easy to administer and swallow
Can be flavored for palatability
Allows highly personalized dosing

⚠️ Limitation:

Requires preservatives
Shorter shelf life after opening
Needs accurate measuring tools

🧠 So, What is the Most Appropriate Form Overall?

🏆 Answer: Extended-Release (ER) Capsules/Tablets

Because they offer a once-daily regimen, stable symptom control, and better adherence, ER formulations are often the preferred choice in long-term ADHD therapy.

However, for dose initiation, fine-tuning, or in cases requiring rapid onset, IR tablets remain highly appropriate.

🔬 Why Swapnroop’s API Works for All These Forms:

Swapnroop’s pharma-grade D-Methylphenidate Hydrochloride supports all dosage forms thanks to:

✅ Controlled particle size
✅ High purity and stability
✅ Compatibility with both immediate and controlled-release excipients

Q8: When should D-METHYLPHENIDATE HYDROCHLORIDE API manufactured by Swapnroop Drugs & Pharmaceuticals be taken?

🕰️ Timing is crucial when it comes to medications like D-Methylphenidate Hydrochloride, a central nervous system stimulant primarily used in the management of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. While the API itself is manufactured by Swapnroop Drugs & Pharmaceuticals, the timing of administration is determined by the formulation (e.g., IR or ER), the condition being treated, and individual patient factors.

Let’s break down when this medication should be taken, depending on the dosage form and clinical goals. ⬇️

⏰ 1. Immediate-Release (IR) Tablets – Short Action, Fast Onset

📍 Recommended Timing:

First dose: Early in the morning, preferably after breakfast
Subsequent doses: Every 4–6 hours as prescribed, typically no later than early afternoon (e.g., before 3 PM)

⚠️ Why?

Taking IR too late in the day may cause insomnia due to its stimulant effects.
Taking it with food may help reduce stomach upset.

✅ Best For:

Managing morning symptoms of ADHD
Patients needing dose titration or flexible control

🕒 2. Extended-Release (ER) Capsules/Tablets – All-Day Symptom Management

📍 Recommended Timing:

Once daily, early in the morning (usually between 6:30–8:30 AM)
Should ideally be taken at the same time each day

🍽️ With or Without Food?

Most ER forms can be taken with or without food, but taking with food may delay absorption slightly.

⚠️ Avoid evening dosing

Can lead to difficulty falling asleep or rebound irritability later in the day.

✅ Best For:

School-aged children, students, and professionals who require sustained focus throughout the day

🧃 3. Oral Solutions / Suspensions – Customizable and Pediatric-Friendly

📍 Recommended Timing:

Same as IR tablets: Morning and early afternoon depending on dosing schedule

✅ Best For:

Children under 6
Individuals who cannot swallow tablets

🌡️ Special Considerations:

🔄 Consistency is key:

Take at the same time daily for stable blood levels and better symptom control.

🧠 Effect on Sleep:

Because D-Methylphenidate is a CNS stimulant, taking it too late in the day can cause insomnia, restlessness, or difficulty concentrating in the evening.

🩺 Doctor-Guided Titration:

Dosage timing and frequency may be customized by healthcare providers based on individual response and side effect profile.

🧬 Relation to Swapnroop’s API:

Swapnroop’s D-Methylphenidate Hydrochloride API is designed to be:

✅ High in chemical purity → ensuring predictable pharmacokinetics
✅ Stable and consistent → enabling accurate timing of drug release
✅ Compatible with IR, ER, and liquid dosage technologies → allowing tailored timing schedules

📋 Summary:

👉 The best time to take D-Methylphenidate Hydrochloride depends on the dosage form:

🕘 IR tablets: Morning and early afternoon (multiple doses/day)
⏰ ER capsules/tablets: Once daily in the early morning
🧃 Liquid forms: Dosed similarly to IR under physician guidance

Q9: What are the effects and side effects of D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

🧠 D-Methylphenidate Hydrochloride, produced by Swapnroop Drugs & Pharmaceuticals, is the pharmacologically active dextrorotatory isomer of methylphenidate. It is a potent central nervous system (CNS) stimulant used to treat ADHD (Attention Deficit Hyperactivity Disorder) and narcolepsy.

Its effects and side effects are closely linked to its mechanism of action and how it influences neurotransmitters in the brain—particularly dopamine and norepinephrine.

✅ Therapeutic (Desired) Effects

These are the beneficial outcomes patients experience when using the medication correctly:

🧠 1. Improved Focus and Attention

Helps ADHD patients concentrate better
Reduces distractibility and impulsiveness

🧘 2. Decreased Hyperactivity

Promotes calmness and behavioral control
Aids in social interactions and academic performance

⏱️ 3. Rapid Onset

Especially in immediate-release forms, effects can start within 20–30 minutes

💤 4. Reduces Daytime Sleepiness (in narcolepsy)

Increases wakefulness and energy

📈 5. Enhanced Productivity

Used off-label (controversially) by some for cognitive enhancement or improved task efficiency (not recommended without medical supervision)

⚠️ Side Effects

While D-Methylphenidate Hydrochloride is highly effective, it may also cause a range of side effects, especially during dose titration or prolonged use.

Let’s break them down by severity:

⚠️ Common Side Effects (🟡 Usually mild to moderate)

Symptom	Explanation
😴 Insomnia	Due to CNS stimulation; common if taken too late
🤢 Nausea or Stomach Pain	Often reduces with food
🧂 Loss of Appetite	May lead to weight loss in children
🌀 Headache or Dizziness	Typically during early treatment
😰 Anxiety or Nervousness	Due to dopamine overactivity
❤️ Increased Heart Rate or Blood Pressure	Mild and transient in most users

🔶 Less Common Side Effects

😡 Irritability or Mood Swings
😓 Excessive sweating
🤯 Tics or Involuntary Movements (rare, but possible in sensitive individuals)
🤐 Dry Mouth
💩 Constipation

🔴 Serious Side Effects (Rare but require medical attention)

Symptom	Concern
🫀 Chest Pain, Palpitations	Could indicate cardiac stress
😵 Hallucinations or Paranoia	Possible in very high doses or in vulnerable individuals
⚠️ Seizures	Especially in those with a history of epilepsy
🧠 Suicidal Thoughts or Severe Depression	Rare, but serious psychiatric risk (needs urgent evaluation)

⚕️ Long-Term Use Considerations

📉 Growth Suppression: May affect height/weight in children; growth should be monitored
🔄 Tolerance or Dependence: Possible with misuse, though rare when used as prescribed
🧪 Regular Monitoring: Periodic checks of BP, weight, mood, and behavior are recommended

💊 Role of Swapnroop’s API Quality

High-quality APIs like the one from Swapnroop Drugs & Pharmaceuticals:

Ensure predictable pharmacological effects
Reduce the risk of impurities that may cause unwanted reactions
Provide batch-to-batch consistency to prevent dose-related adverse events

🧾 Summary:

Aspect	Details
✅ Effects	Focus, calmness, wakefulness, behavior control
⚠️ Common Side Effects	Insomnia, appetite loss, GI upset, anxiety
🔴 Serious Risks	Rare heart, neurological, or psychiatric symptoms
💡 Monitoring Needed	Especially in long-term pediatric use
🔬 API Quality Impact	Purity and stability from Swapnroop reduces variability and enhances safety

🧠 Final Word:

👉 D-Methylphenidate Hydrochloride is a powerful and effective CNS stimulant, and when formulated using high-purity API like that from Swapnroop, it offers reliable therapeutic results with a manageable safety profile.
👉 However, close medical supervision is key to balancing its benefits and risks.

Q10: How is D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals tested?

🔬 D-Methylphenidate Hydrochloride, manufactured by Swapnroop Drugs & Pharmaceuticals, undergoes a rigorous series of quality control (QC) and quality assurance (QA) testing procedures to ensure the safety, efficacy, purity, and consistency of the active pharmaceutical ingredient (API).

The testing protocol complies with international regulatory standards, including ICH, WHO, USFDA, and Indian Pharmacopoeia (IP) or USP guidelines.

🧪 🔍 Main Categories of Testing

1️⃣ Identification Tests – 🧬 “Is it the correct substance?”

These tests confirm the identity of the compound as D-Methylphenidate HCl.

✅ Common methods:

FTIR (Fourier Transform Infrared Spectroscopy) – detects functional groups
UV-Visible Spectroscopy – confirms specific absorbance wavelengths
HPLC Retention Time Matching – compares with known standard
Mass Spectrometry (MS) – verifies molecular weight and structure
NMR (Nuclear Magnetic Resonance) – confirms atomic structure (for in-depth analysis)

2️⃣ Assay (Potency) Testing – 📏 “How much active ingredient is present?”

Measures the percentage purity of the active drug substance.

✅ Techniques used:

HPLC (High-Performance Liquid Chromatography) – standard for determining potency
Titration methods (in some pharmacopoeias)
UV Spectrophotometry – in preliminary testing

📊 Acceptance criteria: Typically 98%–102% of the labeled claim

3️⃣ Impurity Profiling & Related Substances – ⚠️ “Are there harmful by-products?”

Ensures that residual solvents, by-products, and degradation products are within acceptable limits.

✅ Methods:

GC (Gas Chromatography) – for volatile solvents
HPLC – for related substances and degradation products
LC-MS/MS – to detect and identify unknown impurities

📉 Limits: Often defined per ICH Q3A/Q3B guidelines

4️⃣ Physicochemical Testing – ⚗️ “Are the physical and chemical properties consistent?”

These tests ensure uniformity in the quality and performance of the API in dosage form manufacturing.

✅ Includes:

Melting Point Determination – confirms thermal stability
pH of aqueous solution
Water Content (Karl Fischer Titration) – crucial for hygroscopic materials
Residue on Ignition / Sulphated Ash – assesses inorganic content
Heavy Metal Testing – detects toxic impurities

5️⃣ Microbiological Testing – 🦠 “Is it microbiologically safe?”

While APIs like D-Methylphenidate HCl are chemically synthesized and usually sterile by process, microbial testing ensures there is no contamination.

✅ Tests include:

Total Viable Aerobic Count (TVAC)
Absence of pathogens (e.g., E. coli, Salmonella, P. aeruginosa, S. aureus)

🧼 Applicable mainly for APIs used in oral suspensions or pediatric preparations

6️⃣ Stability Testing – 📅 “Will it stay stable over time?”

Conducted under ICH Q1A guidelines to determine:

Shelf life
Proper storage conditions
Packaging compatibility

✅ Performed in:

Accelerated conditions (40°C/75% RH)
Long-term stability conditions (25°C/60% RH)

🕒 Test intervals: 0, 3, 6, 9, 12 months (and up to 24–36 months)

🏢 Quality Standards Followed by Swapnroop Drugs & Pharmaceuticals

Swapnroop adheres to:

Good Manufacturing Practices (GMP)
ICH Guidelines (Q6A, Q1A, Q3C, etc.)
Indian Pharmacopoeia (IP)
United States Pharmacopeia (USP) – if exporting to regulated markets
Certificate of Analysis (CoA) provided for each batch

🧾 Summary Table:

🔬 Test Type	🧪 Technique Used	🎯 Purpose
Identification	IR, UV, MS, NMR	Confirms chemical identity
Assay	HPLC	Measures drug strength/purity
Impurities	HPLC, GC, LC-MS	Detects unwanted substances
Physicochemical	KF, pH, Melting Point	Checks physical & chemical traits
Microbiological	TVAC, Pathogen tests	Ensures microbial safety
Stability	ICH Protocols	Establishes shelf life

Q11: What tests are performed on D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

🧪 Testing of D-Methylphenidate Hydrochloride API from Swapnroop Drugs & Pharmaceuticals is a critical step to ensure that the raw material meets stringent quality, safety, and efficacy standards before it is used in pharmaceutical formulations.

Below is a comprehensive list of tests commonly performed on this API:

🔬 Key Tests Performed on D-Methylphenidate Hydrochloride

1️⃣ Identification Tests

Fourier Transform Infrared Spectroscopy (FTIR): Confirms functional groups characteristic of D-Methylphenidate.
High-Performance Liquid Chromatography (HPLC) Retention Time: Matches retention time with a reference standard to verify identity.
Mass Spectrometry (MS): Confirms molecular weight and structure.
Nuclear Magnetic Resonance (NMR): Detailed structural confirmation at the atomic level.

2️⃣ Assay (Potency) Test

HPLC assay is the gold standard to quantify the exact amount of active D-Methylphenidate Hydrochloride in the batch.
Acceptable potency range is typically 98–102% of the labeled claim.

3️⃣ Impurity and Related Substances Tests

HPLC or LC-MS to detect and quantify impurities, including isomers, residual solvents, and degradation products.
Limits are established as per ICH Q3A/Q3B guidelines.

4️⃣ Residual Solvents Analysis

Gas Chromatography (GC) is used to ensure residual solvents like methanol, acetone, or others are below permissible limits (ICH Q3C).

5️⃣ Melting Point Determination

Confirms purity and consistency of the crystalline form.

6️⃣ Water Content (Karl Fischer Titration)

Measures moisture level since water content affects stability and formulation.

7️⃣ pH of Aqueous Solution

Determines acidity/basicity when dissolved, affecting formulation compatibility.

8️⃣ Heavy Metals Test

Ensures heavy metal contaminants (lead, mercury, arsenic, etc.) are below toxic levels.

9️⃣ Microbial Limit Tests

Total viable aerobic count and absence of pathogenic bacteria (e.g., E. coli, Salmonella).
Essential for APIs intended for oral solutions or suspensions.

🔟 Particle Size Analysis (Optional but useful)

Determines particle size distribution, important for uniform dissolution and bioavailability.

🧾 Summary Table

Test Name	Purpose	Method/Instrument
Identification	Verify chemical identity	FTIR, HPLC, MS, NMR
Assay	Determine potency	HPLC
Related Substances	Detect impurities	HPLC, LC-MS
Residual Solvents	Check volatile solvents	GC
Melting Point	Confirm purity	Melting point apparatus
Water Content	Measure moisture	Karl Fischer titration
pH	Check acidity/basicity	pH meter
Heavy Metals	Detect toxic metals	Atomic Absorption Spectrometry
Microbial Limits	Ensure microbiological safety	Culture media/plate count
Particle Size Analysis	Ensure uniformity	Laser diffraction/sieving

🧠 Final Note:

These tests ensure that Swapnroop’s D-Methylphenidate Hydrochloride API consistently meets regulatory requirements and pharmaceutical standards, providing a reliable foundation for producing safe and effective medications.

Q12: What are the challenges in manufacturing D-METHYLPHENIDATE HYDROCHLORIDE API by Swapnroop Drugs & Pharmaceuticals?

Manufacturing D-Methylphenidate Hydrochloride (API) at a high-quality pharmaceutical standard involves several technical, regulatory, and logistical challenges. Swapnroop Drugs & Pharmaceuticals must navigate these to ensure a safe, pure, and consistent product.

⚙️ Key Challenges in Manufacturing D-Methylphenidate Hydrochloride API

1️⃣ Stereochemical Purity & Isomer Separation 🧬

D-Methylphenidate is the dextrorotatory isomer of methylphenidate.
Ensuring high enantiomeric purity (i.e., minimizing the L-isomer or racemic mixture) is critical because the D-isomer is pharmacologically active, while the L-isomer is less effective or inactive.
This requires precise chiral synthesis or resolution techniques, which are technically demanding and can increase production costs.

2️⃣ Complex Synthesis Process 🔄

The synthetic route involves multiple chemical steps, often requiring:
- Strict control over reaction conditions (temperature, pH, solvents)
- Use of expensive catalysts or reagents
- Control of reaction intermediates to prevent side reactions
Each step needs optimization to maximize yield and minimize impurities.

3️⃣ Control of Impurities and By-products ⚠️

The process can generate related substances, such as residual solvents, stereoisomeric impurities, and degradation products.
Effective purification steps like crystallization or chromatography are needed to achieve pharmaceutical-grade purity, which can be time-consuming and resource-intensive.

4️⃣ Regulatory Compliance & Quality Standards 📋

The API must comply with stringent pharmacopeial standards (IP, USP) and international regulatory bodies like the FDA, EMA, and ICH.
This demands extensive documentation, validation, and batch consistency monitoring, adding to manufacturing complexity.

5️⃣ Scale-up Challenges 📈

Processes optimized at lab scale may not directly translate to large-scale production.
Maintaining yield, purity, and safety while scaling up can be challenging due to differences in heat transfer, mixing, and reaction kinetics.

6️⃣ Raw Material Quality and Supply Chain 🚚

Consistent quality of starting materials and reagents is essential to avoid batch variability.
Supply chain disruptions or impurities in raw materials can affect API quality.

7️⃣ Environmental, Health, and Safety (EHS) Considerations 🌱

Handling hazardous solvents and reagents requires strict EHS protocols.
Waste disposal, solvent recovery, and ensuring worker safety add complexity and cost.

8️⃣ Cost Management 💰

Balancing the cost of raw materials, advanced purification techniques, and quality testing while remaining competitive is a constant challenge.
Manufacturing processes must be efficient but not compromise quality.

9️⃣ Stability During Manufacturing and Storage 🏭

D-Methylphenidate HCl can be sensitive to moisture and temperature.
Maintaining stability throughout synthesis, drying, and storage requires optimized conditions and packaging.

🧾 Summary Table

Challenge	Description
Stereochemical Purity	Ensuring >99% D-isomer, controlling chiral purity
Complex Multi-step Synthesis	Maintaining reaction conditions and yields
Impurity Control	Removing by-products and residual solvents
Regulatory Compliance	Meeting GMP and pharmacopeial standards
Scale-up	Maintaining quality and yield at industrial scale
Raw Material Quality	Dependable, pure reagents and starting materials
Environmental Safety	Handling hazardous chemicals and waste management
Cost Management	Balancing quality with manufacturing expenses
Stability Maintenance	Controlling moisture, temperature during processing

🧠 Final Thought:

The production of D-Methylphenidate Hydrochloride API by Swapnroop Drugs & Pharmaceuticals demands advanced technical expertise, robust quality systems, and efficient supply chain management to overcome these challenges. Successfully doing so ensures a high-quality product that meets regulatory and therapeutic standards worldwide.

Q13: What are the challenges in manufacturing D-METHYLPHENIDATE HYDROCHLORIDE dosage forms by Swapnroop Drugs & Pharmaceuticals?

Manufacturing dosage forms (tablets, capsules, suspensions, etc.) containing D-Methylphenidate Hydrochloride presents unique challenges beyond API production. Swapnroop Drugs & Pharmaceuticals must address these to ensure effective, stable, and safe pharmaceutical products.

⚙️ Key Challenges in Manufacturing Dosage Forms Containing D-Methylphenidate Hydrochloride

1️⃣ Formulation Stability and Compatibility ⚗️

D-Methylphenidate Hydrochloride is sensitive to moisture, temperature, and light, which can lead to degradation.
Selecting excipients that do not react with or destabilize the API is crucial.
Ensuring the final dosage form maintains chemical and physical stability throughout shelf life is challenging.

2️⃣ Controlled Release Formulations ⏳

Many methylphenidate products are designed as immediate release (IR) or extended release (ER) to optimize therapeutic effect and reduce abuse potential.
Developing consistent and reliable controlled-release mechanisms requires precise formulation technology and robust manufacturing controls.

3️⃣ Dose Uniformity and Content Uniformity ⚖️

Ensuring each dosage unit contains an exact and uniform amount of D-Methylphenidate Hydrochloride is critical due to its narrow therapeutic index.
Variations can lead to under-dosing or overdosing, impacting efficacy and safety.

4️⃣ Particle Size and Flow Properties 🧱

The API particle size affects blending, flow, compressibility, and dissolution rates.
Controlling particle size distribution and flow properties during formulation and manufacturing impacts tablet hardness, disintegration, and bioavailability.

5️⃣ Avoiding Cross-contamination 🚫

Due to the potent nature of D-Methylphenidate, strict cleaning protocols and segregation are required to avoid cross-contamination with other products in the facility.

6️⃣ Manufacturing Process Control 🏭

Compression, granulation, coating (if applicable), and encapsulation steps must be tightly controlled to maintain dosage form integrity.
Variability in process parameters can affect dissolution profile and bioavailability.

7️⃣ Regulatory Compliance and Documentation 📑

Dosage forms must comply with regulatory requirements for stability testing, bioequivalence, labeling, and packaging.
Extensive documentation and batch records are necessary for audits and approvals.

8️⃣ Packaging Considerations 📦

Packaging must protect the dosage form from moisture, oxygen, and light to preserve drug stability.
Blister packs, HDPE bottles, or strip packs must be compatible with the product and user-friendly.

9️⃣ Scaling Up Manufacturing 📈

Transitioning from pilot to commercial scale involves challenges in reproducing formulation characteristics consistently.
Maintaining uniformity and quality at high throughput requires robust process validation.

🧾 Summary Table

Challenge	Description
Formulation Stability	API-excipient compatibility, moisture sensitivity
Controlled Release	Developing reliable extended-release profiles
Dose Uniformity	Ensuring consistent API content per unit
Particle Size Control	Impact on flow, compressibility, dissolution
Cross-contamination	Strict cleaning to avoid contamination
Process Control	Monitoring critical manufacturing steps
Regulatory Compliance	Meeting stability, bioequivalence, labeling
Packaging	Protecting from environmental factors
Scale-up	Maintaining quality from pilot to commercial

🧠 Final Thought:

Producing dosage forms with D-Methylphenidate Hydrochloride requires balancing pharmaceutical science, manufacturing technology, and regulatory compliance. Swapnroop Drugs & Pharmaceuticals must overcome these challenges to deliver safe, effective, and stable medications to patients.

❓ Q14: What are the storage conditions for D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

Proper storage of D-Methylphenidate Hydrochloride (API and dosage forms) is essential to maintain its stability, potency, and safety throughout its shelf life. Swapnroop Drugs & Pharmaceuticals follows strict storage guidelines based on pharmaceutical standards and stability studies.

🌡️ Recommended Storage Conditions

1️⃣ Temperature

Store at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F).
Avoid exposure to high temperatures or fluctuations which can accelerate degradation.

2️⃣ Humidity / Moisture Control

Maintain relative humidity (RH) below 60%, ideally around 30-50% RH.
D-Methylphenidate Hydrochloride is hygroscopic, meaning it can absorb moisture from the air, which may reduce stability and alter physicochemical properties.
Use desiccants or moisture-proof packaging to prevent moisture ingress.

3️⃣ Light Protection

Store in opaque or amber-colored containers to protect from light exposure, which can cause photodegradation.
Keep away from direct sunlight or strong artificial light sources.

4️⃣ Container & Packaging

Use airtight, moisture-resistant containers such as HDPE bottles, blister packs with foil backing, or vacuum-sealed packaging.
Packaging must comply with regulatory requirements to maintain product integrity.

5️⃣ Avoid Contamination

Store in a clean, dry area away from contaminants, dust, or other chemicals.
Facilities should maintain good warehousing practices to prevent cross-contamination.

6️⃣ Special Instructions for Dosage Forms

Tablets or capsules should be kept in original packaging until use.
Once opened, store as per manufacturer instructions, often recommending use within a defined period.

🧾 Summary Table

Storage Parameter	Recommended Condition
Temperature	20°C – 25°C (68°F – 77°F)
Humidity	≤ 60% RH, preferably 30-50% RH
Light	Protect from light, use opaque packaging
Packaging	Airtight, moisture-resistant containers
Environment	Clean, dry, contamination-free area

Q15: What is the packaging for D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

Proper packaging of D-Methylphenidate Hydrochloride (API and dosage forms) is vital to protect the drug from environmental factors, ensure stability, maintain potency, and facilitate safe handling and distribution.

📦 Packaging Details for D-Methylphenidate Hydrochloride

1️⃣ Primary Packaging

For API (Active Pharmaceutical Ingredient):
- Typically packaged in airtight, moisture-resistant containers to prevent moisture ingress and contamination.
- Common materials include high-density polyethylene (HDPE) bottles, polypropylene containers, or glass bottles with tight-fitting caps.
- Containers often include desiccants or moisture-absorbing sachets to maintain dryness.
For Dosage Forms (Tablets/Capsules):
- Blister packs made of aluminum foil and PVC or PVDC film are commonly used to protect individual doses from moisture, oxygen, and light.
- Alternatively, bottles made of amber-colored HDPE or glass with child-resistant caps are used for bulk packaging.
- Packaging is designed to provide protection from light, moisture, and mechanical damage.

2️⃣ Secondary Packaging

Boxes made from folding cartons or corrugated cardboard provide additional protection and support for transport and storage.
Printed with batch numbers, manufacturing and expiry dates, and regulatory information for traceability and compliance.

3️⃣ Labeling

Labels include drug name, strength, manufacturer details (Swapnroop Drugs & Pharmaceuticals), batch number, expiry date, storage instructions, and safety warnings.
Packaging and labeling comply with pharmaceutical regulatory standards (FDA, EMA, ICH guidelines).

4️⃣ Special Packaging Considerations

For products requiring temperature control, secondary packaging may include insulating materials or cold packs during shipping.
For controlled-release or sensitive formulations, packaging may include tamper-evident seals and child-resistant closures.

🧾 Summary Table

Packaging Type	Material/Description	Purpose
Primary (API)	HDPE/Glass bottles with airtight caps + desiccants	Moisture protection, contamination prevention
Primary (Dosage)	Blister packs (Aluminum foil + PVC/PVDC), amber HDPE bottles	Protection from moisture, light, and oxygen
Secondary	Cardboard boxes with printed batch info	Physical protection and regulatory compliance
Labeling	Clear, informative, compliant labels	Identification, traceability, safety info

🧠 Final Thought:

Packaging by Swapnroop Drugs & Pharmaceuticals for D-Methylphenidate Hydrochloride is designed to preserve drug quality, ensure patient safety, and meet regulatory standards, making it suitable for safe distribution and effective use

❓ Q16: What is the shelf life of D-METHYLPHENIDATE HYDROCHLORIDE manufactured by Swapnroop Drugs & Pharmaceuticals?

The shelf life of a pharmaceutical product indicates the period during which the drug retains its intended potency, purity, and safety when stored under recommended conditions. For D-Methylphenidate Hydrochloride manufactured by Swapnroop Drugs & Pharmaceuticals, the shelf life is determined through rigorous stability testing in compliance with international regulatory guidelines.

🕒 Shelf Life Overview

1️⃣ Typical Shelf Life Duration

The shelf life of D-Methylphenidate Hydrochloride API is generally 2 to 3 years from the date of manufacture when stored under recommended conditions.
For dosage forms (tablets, capsules), shelf life may vary but usually falls within 24 to 36 months, depending on formulation, packaging, and storage conditions.

2️⃣ Stability Testing

Stability studies are conducted according to ICH guidelines (Q1A) under accelerated (40°C ± 2°C / 75% RH ± 5% RH) and long-term (25°C ± 2°C / 60% RH ± 5% RH) conditions.
These studies monitor physical, chemical, microbiological, and performance characteristics over time.
Data from stability testing supports the assigned shelf life.

3️⃣ Factors Affecting Shelf Life

Storage conditions (temperature, humidity, light exposure) significantly impact shelf life.
Packaging that effectively protects from moisture and light can extend shelf life.
Any changes in formulation or manufacturing process require re-evaluation of shelf life.

4️⃣ Expiry Date Labeling

The expiry date printed on the packaging reflects the last date the manufacturer guarantees full potency and safety.
Using the product beyond this date is not recommended, as efficacy and safety cannot be assured.

5️⃣ Handling Post-Opening

For some dosage forms, especially liquids or suspensions, the shelf life after opening may be shorter and should be clearly indicated on the packaging.

🧾 Summary Table

Parameter	Details
Typical Shelf Life	24 to 36 months (dosage forms); 2-3 years (API)
Stability Testing	ICH Q1A accelerated and long-term conditions
Influencing Factors	Temperature, humidity, light, packaging
Expiry Date	Clearly labeled on packaging
Post-opening Stability	May vary; follow manufacturer instructions

🧠 Final Thought:

Swapnroop Drugs & Pharmaceuticals ensures the shelf life of D-Methylphenidate Hydrochloride is established through stringent testing and optimized storage and packaging, providing patients with a reliable and effective medication throughout its intended use period.