Q1 — What is Zonisamide API (manufactured by Swapnroop Drugs & Pharmaceuticals)? —

🧪💊🌟

Short definition (one line):
Zonisamide API is the active pharmaceutical ingredient of zonisamide — a sulfonamide-based anticonvulsant agent used mainly for treating epilepsy (adjunctive therapy for partial seizures) and occasionally for other neurologic/behavioral uses. 🔬🧠

Chemical & physical identity 🧩

Class: Sulfonamide anticonvulsant (benzisoxazole-sulfonamide derivative).
Form (as supplied as API): Typically a white to off-white crystalline powder with good chemical stability when dry. ❄️
Key quality attributes: high chemical purity (pharmacopoeial grade), low residual solvents, controlled particle size distribution for downstream formulation, low levels of related impurities and heavy metals. ✅

I’ve avoided listing a numeric molecular formula or melting point here to keep the answer robust; if you want exact physico-chemical constants (molecular formula, molar mass, pKa, melting point), I can add those precisely.

Pharmacology — mechanism of action (concise) ⚙️

Primary actions: Zonisamide stabilizes neuronal membranes and reduces abnormal electrical activity by blocking voltage-gated sodium channels and inhibiting T-type calcium channels.
Secondary effects: It also shows weak carbonic anhydrase inhibition and may modulate GABAergic/glutamatergic neurotransmission — together these effects contribute to anticonvulsant activity. 🧠⚡

Therapeutic use (clinical role) 🩺

Main indication: Adjunctive therapy for partial (focal) seizures in adults and pediatric patients (in many markets).
Other uses / off-label: Sometimes used off-label for other seizure types, certain movement disorders, or weight-management adjuncts in research/clinical practice (varies by region). Regulatory-approved indications depend on the country/label. 🌍

Key safety considerations & contraindications ⚠️

Sulfonamide hypersensitivity: Because zonisamide is a sulfonamide derivative, caution or avoidance in patients with known sulfonamide allergy is recommended. ❗
Common adverse effects: Dizziness, somnolence, headache, anorexia/weight loss, paresthesia — severity varies with dose and patient.
Serious but rare risks: Kidney stones (nephrolithiasis; related to carbonic anhydrase activity), metabolic acidosis, severe skin reactions (rare), and psychiatric/behavioral changes in vulnerable patients.
Drug interactions: Interacts with other antiepileptics and drugs that alter renal excretion or cytochrome P450 enzymes; dosing adjustments may be needed. 🔁

Pharmaceutical perspective — why the API matters ✅

API quality drives safety & efficacy: The purity, crystalline form, particle size, and impurity profile of the zonisamide API directly affect formulation performance (dissolution), dose uniformity, stability, and patient safety.
Manufacturing controls: Good Manufacturing Practice (GMP) for the API, validated synthetic route, impurity control, residual solvent limits, and documented stability data are all essential to supply reliable drug product. 🏭📋

Typical supply & packaging (API commercial view) 📦

Supplied as: Bulk crystalline powder in sealed containers.
Packaging examples: Multi-layer bags, lined drums, or IBCs depending on scale — with desiccant and nitrogen blanketing for moisture-sensitive batches if required.
Storage: Store in a cool, dry place away from strong light and moisture; follow manufacturer’s certificate of analysis (CoA) and stability instructions. 🌡️

How Swapnroop’s API would be positioned (what buyers expect) 🤝

Buyers expect a pharmacopeial-grade zonisamide API with:

Complete documentation (CoA, GMP statement, MSDS/IFS, batch release test results).
Low impurity profile and validated analytical methods.
Regulatory support information for dossier filing (if you intend to register finished dosage forms in regulated markets). 🗂️

Q2. What is Zonisamide API by Swapnroop Drugs & Pharmaceuticals used for? 💊🧠🌟

Zonisamide API serves as the core active ingredient in the formulation of anticonvulsant (anti-seizure) medications. Once formulated into capsules or tablets, it helps manage and prevent abnormal brain activity responsible for seizures. ⚡

🌍 Primary Medical Uses

Epilepsy (Partial Seizures):
Zonisamide is mainly prescribed as an adjunctive therapy in the treatment of partial (focal) seizures in adults and children. It helps control episodes that are not fully managed by first-line antiepileptic drugs. 🧩
Generalized Seizures:
In some cases, it may be effective in controlling tonic-clonic or myoclonic seizures, though this is typically off-label. ⚙️
Other Investigational/Off-label Uses:
- Management of migraine and neuropathic pain
- Weight management (due to mild appetite-suppressing effect)
- Adjunct therapy in Parkinson’s disease and bipolar disorder (under research) 🧬

💊 Clinical Benefits

Broad-spectrum anticonvulsant activity
Long half-life (enables once-daily dosing)
Synergistic effects when combined with other antiepileptics like valproate or lamotrigine

⚠️ Precautions

Not suitable for patients with sulfa allergies
Regular monitoring of kidney function, metabolic acidosis, and mood changes is important

👉 In summary:
Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals is a high-quality, GMP-compliant pharmaceutical ingredient used worldwide to manufacture antiepileptic drugs, ensuring effective seizure control and improved quality of life for patients. 🌿💚

Q3. What are the Physicochemical Properties of Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals? ⚗️🧪

Understanding the physicochemical profile of Zonisamide API is essential for its formulation, stability, and bioavailability.

🔹 Chemical Identity

IUPAC Name: 1,2-benzisoxazole-3-methanesulfonamide
Molecular Formula: C₈H₈N₂O₃S
Molecular Weight: ≈ 212.23 g/mol
CAS Number: 68291-97-4

⚪ Appearance

White to off-white crystalline powder 🧂
Practically odorless

💧 Solubility

Slightly soluble in water
Soluble in acetone, methanol, and ethanol
Low aqueous solubility → affects bioavailability, making particle size reduction important during formulation

🌡️ Melting Point

Approximately 162–164°C

⚙️ pKa Value

Around 10.2, indicating a weakly acidic nature (due to sulfonamide group)

💨 Partition Coefficient (log P)

About 0.9–1.0, showing moderate lipophilicity → suitable for crossing the blood–brain barrier 🧠

🧱 Stability

Chemically stable under dry, cool conditions
Sensitive to strong light and high humidity
Should be stored in tightly closed containers away from moisture 🌤️

👉 Summary:
The physicochemical profile of Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals ensures excellent purity, stability, and reproducibility—key factors in producing consistent dosage forms.

Q4. How is Zonisamide API manufactured (synthesized) by Swapnroop Drugs & Pharmaceuticals? 🏭⚗️🔬

Zonisamide synthesis involves several controlled organic reactions designed for safety, efficiency, and impurity control. Below is an overview of the typical industrial synthetic pathway used for producing pharmaceutical-grade Zonisamide API.

⚙️ Stepwise Synthesis Process (Simplified)

Formation of Benzisoxazole Core:
- Starting from 2-hydroxybenzaldehyde and hydroxylamine, a benzisoxazole ring is formed through cyclization and oxidation reactions.
- This forms the basic structural backbone of zonisamide. 🧩
Introduction of Methanesulfonamide Group:
- The benzisoxazole intermediate is reacted with chloromethyl sulfonamide or equivalent reagents to introduce the –CH₂SO₂NH₂ group.
- This step defines zonisamide’s sulfonamide functionality, critical for its anticonvulsant activity. ⚗️
Purification and Crystallization:
- The crude product undergoes multiple recrystallization and filtration steps to remove by-products and color impurities.
- Controlled crystallization yields the desired polymorphic form (stable and pharmacopeial). 💎
Drying & Milling:
- The purified API is dried under vacuum at controlled temperatures, then milled and sieved to achieve a uniform particle size distribution ideal for formulation. 🌬️
Final Quality Testing:
- Each batch undergoes HPLC purity, residual solvent analysis, heavy metals test, and polymorphic characterization (XRPD/DSC) to ensure compliance with pharmacopeial standards (USP/EP/JP). 📊✅

🧴 Manufacturing Highlights at Swapnroop Drugs & Pharmaceuticals

Operates under GMP and ICH Q7 guidelines
Utilizes validated synthesis and purification steps
Ensures batch consistency, regulatory documentation, and environmental safety
Continuous in-process monitoring for yield optimization and impurity control

✨ Summary

Zonisamide API manufacturing at Swapnroop Drugs & Pharmaceuticals combines precise organic synthesis, stringent purification, and robust quality control to produce a high-purity, pharmacopeial-grade API ready for formulation into safe and effective antiepileptic medicines. 💊🌿

Q5. What are the different dosage forms of Zonisamide manufactured from Zonisamide API by Swapnroop Drugs & Pharmaceuticals? 💊🧠

Zonisamide API serves as the foundation for several pharmaceutical dosage forms designed for oral administration. Since it is a potent and stable molecule, formulations are developed to ensure consistent bioavailability, ease of dosing, and patient compliance.

🔹 Common Dosage Forms

Capsules (Hard Gelatin or HPMC):
- The most widely used form worldwide 🌍
- Contain micronized Zonisamide mixed with excipients for uniform distribution
- Available in strengths like 25 mg, 50 mg, and 100 mg
Tablets:
- Alternative solid dosage form for easy swallowing
- May include binders, lubricants, and disintegrants
- Can be film-coated to enhance stability and mask taste
Suspension (Research/Paediatric use):
- For patients who cannot swallow capsules
- Prepared using suspending agents and sweeteners
Extended-release formulations (under development):
- Designed for once-daily dosing
- Provide a steady release of Zonisamide over 24 hours

💡 Why Capsules Are Preferred

Zonisamide’s low water solubility makes capsules ideal for content uniformity and consistent dissolution rate.
Easy to dose and stable during long-term storage.

👉 Summary:
Swapnroop Drugs & Pharmaceuticals supplies Zonisamide API suitable for manufacturing capsules, tablets, and research-based suspension forms, ensuring flexibility across formulations. 🏭💊

6. How are Zonisamide dosage forms prepared from Zonisamide API? ⚗️🏭💎

The preparation process focuses on achieving uniform dispersion, stability, and controlled particle size for predictable pharmacokinetics.

🔬 1. Capsule Manufacturing Process

Weighing and Sieving:
- Accurately weigh Zonisamide API and excipients.
- Sieve to ensure consistent particle size. ⚖️
Blending:
- Mix API with diluents (e.g., lactose, microcrystalline cellulose), lubricants (e.g., magnesium stearate), and glidants (e.g., colloidal silica). 🔄
Filling:
- Blend filled into hard gelatin capsules using capsule-filling machines.
Inspection and Testing:
- Capsules tested for content uniformity, weight variation, and disintegration. 🧪

🧱 2. Tablet Manufacturing Process

Granulation:
- Wet or dry granulation used depending on flow properties.
Compression:
- Granules compressed into tablets using rotary presses.
Coating:
- Film coating for stability and identification.

🧴 3. Suspension Preparation (For R&D or Paediatrics)

API dispersed in a vehicle containing suspending agents (e.g., xanthan gum) and flavoring agents.
Preservatives added for microbial control.

👉 Summary:
Each dosage form derived from Zonisamide API by Swapnroop Drugs & Pharmaceuticals undergoes precise formulation control, ensuring consistent drug release and therapeutic efficiency. 🌿💪

Q7. What is the appropriate dosage form of Zonisamide manufactured by Swapnroop Drugs & Pharmaceuticals? 💊📏

The appropriate dosage form depends on patient needs, disease type, and treatment duration.

💠 Preferred Dosage Form

Capsules are the most appropriate form for general use due to:
- High content uniformity
- Long shelf life
- Simple once-daily dosing
- Minimal degradation during storage

🧩 Other Suitable Forms

Tablets: For adult patients preferring a solid dosage form
Suspensions: For pediatric or geriatric patients who have swallowing difficulties

🕐 Pharmacokinetic Advantage

Zonisamide has a long elimination half-life (~60 hours), enabling once-daily administration, improving adherence and therapeutic stability.

👉 Conclusion:
For most clinical applications, capsule dosage form of Zonisamide (using Swapnroop API) offers optimal stability, bioavailability, and patient compliance. 🌿💊

Q8. When should Zonisamide API (as a medicine) be taken? ⏰💧

Although the API itself is not consumed directly, understanding the ideal administration schedule of Zonisamide formulations ensures proper therapeutic outcomes.

🕒 Administration Timing

Once daily, preferably at the same time each day
Can be taken with or without food, as food has minimal impact on absorption 🍽️

⚖️ Dosing Guidelines

Adults: Initial dose typically 100 mg/day, titrated gradually up to 200–400 mg/day (depending on clinical response and tolerance)
Children (above 6 years): Dose based on body weight, usually 2–8 mg/kg/day

⚠️ Important Instructions

Maintain consistent daily intake to prevent seizure recurrence
Avoid sudden discontinuation → may lead to seizure rebound
Drink adequate water to minimize risk of kidney stones 💧🪨

👉 Summary:
Zonisamide-based medication prepared from Swapnroop Drugs & Pharmaceuticals’ API should be taken once daily, at the same time each day, with or without food — as prescribed by a healthcare professional. ⏱️💊

Q9. What are the effects and side effects of Zonisamide manufactured by Swapnroop Drugs & Pharmaceuticals? ⚡💀🌿

🌟 Therapeutic Effects (Positive)

Seizure Control: Reduces abnormal neuronal firing, stabilizing brain activity 🧠
Mood Stabilization: May improve emotional balance in epilepsy patients
Neuroprotection: Some studies suggest Zonisamide may protect against neuronal damage
Weight Management: Mild appetite suppression (secondary benefit in some patients) ⚖️

⚠️ Common Side Effects

Drowsiness or fatigue 😴
Dizziness or lightheadedness
Loss of appetite
Nausea, mild headache
Difficulty concentrating

🚨 Serious (but rare) Side Effects

Kidney stones (nephrolithiasis) due to carbonic anhydrase inhibition 🪨
Metabolic acidosis (especially in pediatric or renal-impaired patients)
Severe rash or Stevens–Johnson syndrome (rare hypersensitivity)
Mood changes or depression in sensitive individuals

💡 How to Manage Side Effects

Adequate hydration is key
Regular renal function monitoring
Report any rash, confusion, or mood alteration immediately

👉 Summary:
Zonisamide API from Swapnroop Drugs & Pharmaceuticals enables formulation of an effective anticonvulsant that offers significant benefits in seizure control. However, appropriate dosing, hydration, and monitoring ensure patient safety and optimal outcomes. 💚💊

Q10. How is Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals tested? 🧪⚗️✅

Every batch of Zonisamide API undergoes stringent quality control (QC) and analytical testing to ensure that it meets pharmacopeial standards such as USP, EP, JP, or IP. These tests verify identity, purity, potency, and safety before the API is released for formulation or export. 🌍

🧫 1. Identity Testing

Infrared (IR) Spectroscopy: Confirms structural fingerprint against reference standard.
UV-Visible Spectrophotometry: Verifies absorbance maxima consistent with zonisamide’s chromophore.
HPLC Retention Time Comparison: Confirms compound identity by matching retention time to the reference standard.

⚗️ 2. Assay (Potency Determination)

High-Performance Liquid Chromatography (HPLC):
- Quantifies Zonisamide content in the sample (typically 98.0%–102.0% of label claim).
- Ensures consistent potency across batches.

🔬 3. Impurity & Related Substances

HPLC with UV or PDA detection:
- Detects organic impurities, degradation products, and unreacted intermediates.
- Impurities are kept within ICH limits (<0.10% each, <0.5% total).

🌡️ 4. Physical & Chemical Tests

Melting point: To confirm compound integrity.
pH of 1% suspension: Within pharmacopeial range.
Loss on drying (LOD): Measures residual moisture content (typically ≤0.5%).
Sulphated Ash / Residue on Ignition: Determines inorganic residue (<0.1%).

🧴 5. Microbiological & Safety Testing

Total viable count and absence of pathogens (E. coli, Salmonella, etc.) for sterile compliance.
Residual solvents (GC analysis): Ensures levels below ICH Q3C thresholds.

📋 Summary

Every batch of Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals is tested with HPLC, IR, GC, and microbial assays to guarantee high purity, potency, and safety, ensuring it meets all regulatory and customer expectations. 💚✅

Q11. What tests are performed on Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals? 🔍📊🧫

🧪 Analytical & Quality Control Tests

Category	Test Name	Purpose / Acceptance Criteria
Identification	IR Spectroscopy, UV Spectrum, HPLC Retention	Confirms chemical structure
Assay	HPLC Assay	98–102% of labeled amount
Purity Tests	HPLC for related compounds	Individual impurity ≤0.10%, total ≤0.5%
Residual Solvents	Gas Chromatography	Below ICH limits
Heavy Metals	ICP-OES or Colorimetric	≤10 ppm
Loss on Drying	Gravimetric	≤0.5%
Melting Range	Capillary method	162–164°C
pH of Suspension	pH meter	Within 6.0–7.5
Microbial Limits	Plate count test	Within pharmacopeial limits
Polymorphism Check	X-ray Diffraction (XRPD), DSC	Confirms stable crystalline form
Particle Size Distribution	Laser Diffraction	D90 within specification for uniformity

🧾 Certificate of Analysis (CoA) Includes

Appearance
Assay results
Impurity profile
Water content
Residual solvent data
Microbial results
Compliance with pharmacopeial monograph

👉 Summary:
Swapnroop Drugs & Pharmaceuticals performs a comprehensive suite of chemical, physical, and microbiological tests to ensure the Zonisamide API is pure, stable, and pharmacopeial grade, meeting both customer and regulatory standards. 🧪📋🌿

Q12. What are the challenges in manufacturing Zonisamide API at scale? ⚙️🏭💥

Manufacturing Zonisamide API at commercial scale involves complex organic synthesis and tight impurity control. Below are key industrial challenges faced by producers like Swapnroop Drugs & Pharmaceuticals.

🧪 1. Impurity Control

The synthesis involves multiple steps that can generate organic impurities and sulfonamide intermediates.
Maintaining purity within ICH limits (<0.10%) requires optimized reaction and purification steps. ⚗️

🌡️ 2. Crystallization & Polymorphism

Zonisamide can exist in different polymorphic forms (crystalline structures).
Only one form is stable and pharmaceutically acceptable.
Controlling crystallization temperature and solvent composition is critical. 💎

💧 3. Moisture Sensitivity

Though relatively stable, Zonisamide can absorb moisture leading to reduced flowability and altered assay.
Requires low-humidity production environments and vacuum drying. 🌤️

♻️ 4. Waste Management

Organic solvents (methanol, acetone) must be recovered or treated to minimize environmental impact.
Swapnroop implements green chemistry and solvent recovery systems. 🌱

🧱 5. Scalability

Maintaining consistent yield, particle size, and impurity profile during scale-up from lab to industrial batches is a major challenge.

👉 Summary:
Producing high-purity Zonisamide API demands rigorous process optimization, impurity profiling, and strict environmental controls — all integral to Swapnroop’s GMP-certified manufacturing process. 💪🏭💚

Q13. What are the challenges in manufacturing Zonisamide dosage forms? 💊🧩⚙️

After API production, converting Zonisamide API into effective dosage forms (like capsules or tablets) also involves several formulation and stability challenges.

⚗️ 1. Poor Water Solubility

Zonisamide has low aqueous solubility, which can limit bioavailability.
Requires techniques such as micronization, solid dispersion, or use of surfactants to improve dissolution. 💧

🧱 2. Content Uniformity

Due to fine particle size, achieving uniform blending in capsules or tablets can be difficult.
Controlled particle size distribution and advanced mixers are used. ⚙️

🌡️ 3. Stability During Storage

Sensitive to moisture and light → needs protective film coating and moisture-resistant packaging. 🌤️

🧬 4. Compatibility with Excipients

Zonisamide may interact with certain fillers or binders, affecting dissolution rate.
Pre-formulation studies ensure excipient compatibility. 🧫

📦 5. Controlled Release Formulations

Developing extended-release dosage forms requires precise control of polymer matrix or coating thickness.
Achieving steady plasma concentration without dose dumping is complex.

👉 Summary:
Formulating Zonisamide into stable, bioavailable, and patient-friendly dosage forms requires tackling solubility, stability, and uniformity challenges. Swapnroop’s R&D and formulation teams optimize excipients and process parameters to overcome these hurdles. 💊🌿

14️⃣ What are the storage conditions for Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals?

🧊 Storage Conditions:
Zonisamide API should be stored in a cool, dry, and well-ventilated area away from light and moisture. The recommended temperature range is below 25°C, and the material should be kept in tightly sealed containers to prevent contamination and degradation.

📦 Key points:

Protect from direct sunlight and humidity ☀️💧
Store in airtight, light-resistant HDPE or aluminum containers 🧴
Avoid exposure to strong oxidizing agents ⚗️
Follow Good Storage Practices (GSP) to maintain stability

Proper storage ensures chemical integrity, consistent potency, and extended shelf life of Zonisamide API.

15️⃣ What is the packaging for Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals?

📦 Packaging Details:
Zonisamide API is typically packed in HDPE or fiber drums lined with double polyethylene bags to ensure product safety and stability during storage and transportation.

🔹 Packaging Specifications:

Inner liner: Two layers of polyethylene bags 🛍️
Outer container: HDPE drum or fiberboard drum 🛢️
Net weight: Usually 25 kg per drum (customizable) ⚖️
Labeling: Includes batch number, manufacturing date, expiry date, and handling instructions 🏷️

🌿 Swapnroop Drugs & Pharmaceuticals ensures that all packaging complies with international pharmacopeial and export standards, maintaining product quality and traceability.

16️⃣ What is the shelf life of Zonisamide API manufactured by Swapnroop Drugs & Pharmaceuticals?

⏳ Shelf Life:
The typical shelf life of Zonisamide API is 3 to 5 years when stored under recommended conditions. Stability studies conducted under ICH guidelines (Q1A) confirm that the API remains stable and within specification limits during this period.

📈 Shelf Life Factors:

Controlled temperature and humidity 🌡️
Quality of packaging material 🧴
Absence of light exposure ☀️
Compliance with storage guidelines 📚

🧪 Proper adherence to these conditions ensures that Zonisamide API retains its purity, potency, and therapeutic efficacy throughout its declared shelf life.

📘 **Comprehensive Study on Zonisamide API Manufactured by Swapnroop Drugs & Pharmaceuticals** 💊✨