Comprehensive Overview of PYRANTEL PAMOATE API (CAS No: 552-14-9)

 


1. What is PYRANTEL PAMOATE API manufactured by Swapnroop Drugs & Pharmaceuticals? 🧪✨

PYRANTEL PAMOATE is an active pharmaceutical ingredient (API) widely used as an anthelmintic (anti-parasitic) drug. 🌍🪱 It is primarily used to treat infections caused by intestinal worms, such as roundworms (Ascaris lumbricoides), hookworms (Ancylostoma duodenale, Necator americanus), and pinworms (Enterobius vermicularis).

Swapnroop Drugs & Pharmaceuticals manufactures high-quality PYRANTEL PAMOATE API that meets international pharmacopeial standards for purity, efficacy, and safety. ✅🏭 The API is carefully synthesized and processed under Good Manufacturing Practices (GMP) to ensure consistency, stability, and bioavailability.

💡 Key Highlights:

  • Chemical Nature: PYRANTEL PAMOATE is a tetrahydropyrimidine derivative, available as a white to off-white crystalline powder. ⚪

  • Mechanism of Action: It works by paralyzing worms’ muscles, leading to their expulsion from the intestines via natural bowel movements. 🌀💪

  • Global Use: It is commonly used in human and veterinary medicine, making it a versatile API for formulations like tablets, suspensions, and chewables. 🌐💊

  • Quality Assurance: Swapnroop Drugs & Pharmaceuticals ensures strict control over particle size, moisture content, and residual solvents, guaranteeing a stable and safe API. 🧾✔️

In short, PYRANTEL PAMOATE API by Swapnroop Drugs & Pharmaceuticals is a reliable, high-purity anti-parasitic raw material that forms the backbone of effective worm treatment medications worldwide. 🌟💊🌿



2. What is PYRANTEL PAMOATE by Swapnroop Drugs & Pharmaceuticals used for? 🌿💊

PYRANTEL PAMOATE is primarily used as an anthelmintic agent to treat intestinal worm infections. 🌍🪱

Major Uses:

  • Roundworm infections (Ascaris lumbricoides) – helps expel adult worms from the intestines. 🔄

  • Hookworm infections (Ancylostoma duodenale, Necator americanus) – interrupts the parasite’s muscle function, leading to worm paralysis and elimination. ⚡

  • Pinworm infections (Enterobius vermicularis) – effectively removes pinworms in both children and adults. 🧒👩‍🦰

  • Whipworm infections (Trichuris trichiura) – sometimes used in combination therapy for whipworm infections. 🤝

💡 Special Notes:

  • Used in both humans and animals, making it a versatile API for human tablets, suspensions, and veterinary formulations. 🐶🐱

  • Often prescribed as a single-dose treatment, but in some cases, a second dose may be required after 2–3 weeks to prevent reinfection. ⏱️

✅ Conclusion: PYRANTEL PAMOATE is a highly effective, broad-spectrum anthelmintic, essential for maintaining intestinal health and preventing parasitic complications. 🌟

3. What are the physicochemical properties of PYRANTEL PAMOATE API manufactured by Swapnroop Drugs & Pharmaceuticals? ⚗️🧪

PYRANTEL PAMOATE has distinct physicochemical properties that make it suitable for pharmaceutical formulations.

Key Properties:

  • Chemical Name: Pyrantel Pamoate

  • Molecular Formula: C₁₉H₂₄N₂•C₄H₄O₆ (Pamoate salt)

  • Molecular Weight: ~552.6 g/mol ⚖️

  • Appearance: White to off-white crystalline powder ⚪

  • Odor: Odorless or faint characteristic odor 👃

  • Solubility:

    • Poorly soluble in water 🌊

    • Soluble in ethanol, methanol, and chloroform 🧴

  • Melting Point: Approximately 165–166 °C 🌡️

  • pH: Neutral to slightly basic when in solution (pH ~6–8) 🔬

  • Stability: Stable under normal temperature and humidity; sensitive to light and moisture, requiring protective storage 🌤️💧

💡 Importance of These Properties:

  • Poor water solubility influences the choice of dosage forms, like suspensions or chewable tablets. 🥤💊

  • Crystalline form ensures uniform particle size, which is critical for consistent drug absorption and efficacy. ⚖️

  • Stability profile guides packaging and storage conditions to maintain API quality. 📦🛡️

✅ Summary: PYRANTEL PAMOATE’s physicochemical characteristics make it a safe, stable, and effective API for a variety of anti-parasitic formulations. 🌟


4. How is PYRANTEL PAMOATE API manufactured by Swapnroop Drugs & Pharmaceuticals? 🏭🧪

PYRANTEL PAMOATE is manufactured through a multi-step chemical synthesis process under strict Good Manufacturing Practices (GMP) to ensure high purity and quality. ✅

Typical Synthesis Process:

  1. Preparation of Pyrantel Base:

    • The active pyrantel moiety is synthesized via condensation reactions of appropriate pyrimidine derivatives. 🔄

    • This step creates the tetrahydropyrimidine core responsible for its anthelmintic activity. ⚡

  2. Formation of Pamoate Salt:

    • Pyrantel base is reacted with pamoic acid (dimethyl 4,4′-methylenebis(3-hydroxy-2-naphthoate)) to form pyrantel pamoate salt, which is less soluble in water and suitable for oral formulations. 💧❌

  3. Purification:

    • Crude pyrantel pamoate is filtered, washed, and recrystallized to remove impurities and by-products. 🌟

    • Ensures the API meets pharmacopeial purity standards. 🧾

  4. Drying and Milling:

    • The purified API is dried under controlled conditions to remove residual solvents. 🌡️

    • The dried material is then milled to achieve uniform particle size, critical for consistent bioavailability. ⚖️

💡 Key Notes:

  • Process is highly controlled to avoid degradation.

  • Final API is white to off-white crystalline powder, ready for formulation. ⚪

5. What are the different dosage forms of PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? 💊🥤

PYRANTEL PAMOATE API can be formulated into various oral dosage forms for humans and animals.

Common Dosage Forms:

  1. Tablets / Chewable Tablets 🟫

    • Convenient for adult and pediatric use.

    • Often flavored for children to improve compliance. 🍭

  2. Oral Suspensions / Syrups 🥤

    • Ideal for children and patients who cannot swallow tablets.

    • Requires uniform dispersion of API in the liquid vehicle.

  3. Granules / Powders ⚪

    • Can be reconstituted in water before administration.

    • Used in both human and veterinary medicine. 🐶🐱

  4. Veterinary Formulations 🐴🐓

    • Tablets, pastes, or powders for livestock and pets.

    • Allows broad-spectrum worm control in farm animals. 🌾

💡 Conclusion: The API’s poor water solubility influences the choice of formulation types, favoring suspensions, chewables, or granules over plain tablets.

6. How are PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals dosage forms prepared? 🏭💊

Preparation of dosage forms involves careful formulation to ensure stability, efficacy, and patient compliance.

Tablet / Chewable Tablet Preparation:

  1. Blending:

    • PYRANTEL PAMOATE API is mixed with excipients like binders, fillers, and flavoring agents. 🔄

  2. Granulation:

    • Wet or dry granulation is performed to achieve uniform particle size and flow properties. ⚖️

  3. Compression:

    • Granules are compressed into tablets using tablet presses. 🏭

  4. Coating / Flavoring (Optional):

    • Chewable tablets may be flavored or lightly coated for better taste. 🍓

Oral Suspension Preparation:

  1. Dispersing API:

    • API is suspended in suitable liquid vehicles with stabilizers to prevent settling. 🥤

  2. Addition of Sweeteners / Flavors:

    • Improves palatability for pediatric use. 🍯

  3. Homogenization:

    • Ensures uniform distribution of API throughout the suspension. 🔄

Quality Control:

  • Each batch undergoes testing for content uniformity, stability, and microbial limits. 🧾✅

💡 Key Point: Proper formulation ensures optimal bioavailability, ease of administration, and patient compliance, especially in pediatric and veterinary applications. 🌟



7. What is the appropriate dosage form of PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? 💊🧪

The appropriate dosage form depends on patient age, weight, and preference, as well as clinical requirements.

Commonly Recommended Forms:

  1. Chewable Tablets 🍓

    • Ideal for children who cannot swallow tablets.

    • Typically single-dose treatment, sometimes flavored to enhance compliance.

  2. Oral Suspensions / Syrups 🥤

    • Suitable for infants, toddlers, and patients with swallowing difficulties.

    • Dosage is adjusted according to body weight (mg/kg).

  3. Tablets / Granules 🟫⚪

    • Preferred for adults and older children.

    • Easy to store and transport, widely used in mass deworming programs.

💡 Important Notes:

  • Pediatric patients often receive suspensions or flavored chewables.

  • Adult patients typically take tablets.

  • Veterinary use may include pastes, powders, or medicated feed for livestock. 🐄🐓

✅ Conclusion: Dosage form is chosen based on age, ease of administration, and bioavailability, ensuring maximum therapeutic effect. 🌟

8. When should PYRANTEL PAMOATE API manufactured by Swapnroop Drugs & Pharmaceuticals be taken? ⏰🌿

Timing and administration of PYRANTEL PAMOATE are critical for optimal worm eradication.

Recommended Guidelines:

  • Usually taken once as a single dose. 💊

  • Best taken after food to reduce stomach upset. 🍽️

  • Pediatric doses are calculated based on body weight (mg/kg). ⚖️

  • In cases of heavy worm infestation, a second dose may be administered 2–3 weeks later to prevent reinfection. 🔄

  • For mass deworming programs, often administered under supervision to ensure correct dosage. 🏫🏥

💡 Tips:

  • Ensure adequate hydration after administration. 💧

  • Avoid combining with other anti-parasitic drugs unless prescribed. 🚫

✅ Conclusion: PYRANTEL PAMOATE should be taken orally, usually as a single dose after meals, with careful weight-based dosing for children. 🌟

9. What are the effects and side effects of PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? ⚡🩺

Effects / Mechanism of Action:

  • Paralyzes intestinal worms by interfering with their neuromuscular activity. 💪🪱

  • Paralyzed worms are expelled naturally via feces within 24–48 hours. ⏱️

  • Effective against roundworms, hookworms, pinworms, and some whipworms. 🌍

Common Side Effects:

  • Mild gastrointestinal discomfort: nausea, vomiting, diarrhea, or abdominal cramps 🤢💫

  • Headache or dizziness 🧠💫

  • Rare: allergic reactions, skin rashes, or itching 🩹

Special Notes:

  • Side effects are usually mild and transient, resolving within 1–2 days. ⏳

  • Rarely, severe allergic reactions require medical attention. 🚨

  • Safe for most children and adults when used at recommended doses. ✅

💡 Conclusion: PYRANTEL PAMOATE is highly effective and generally safe, with side effects being rare and mild, making it a first-line anti-parasitic treatment globally. 🌟



10. How is PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals tested? 🧪🔬

Testing of PYRANTEL PAMOATE API is essential to ensure purity, potency, and safety before formulation.

Key Testing Processes:

  1. Identification Tests ✅

    • Confirms the chemical identity of PYRANTEL PAMOATE using IR spectroscopy, UV spectroscopy, or HPLC. 🔍

  2. Assay / Potency 💊

    • Measures the active ingredient content to ensure dose accuracy.

  3. Impurity & Residual Solvent Analysis ⚗️

    • Detects organic solvents, heavy metals, or unwanted by-products using GC, HPLC, or ICP-MS.

  4. Moisture Content & Loss on Drying 💧

    • Ensures API stability and shelf life.

  5. Microbial Limit Tests 🦠

    • Confirms the API is free from harmful microorganisms, meeting pharmacopeial standards.

💡 Summary: Testing ensures that PYRANTEL PAMOATE API is safe, potent, and pharmaceutically suitable for dosage form manufacturing. ✅

11. What tests are performed on PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? 🧾🧪

Standard Quality Control Tests Include:

  1. Physical Tests:

    • Appearance, color, odor, particle size, and flow properties ⚪🔍

  2. Chemical Tests:

    • Assay for active content 💊

    • Melting point determination 🌡️

    • pH of solutions 🔬

  3. Purity & Impurity Analysis:

    • HPLC/GC for organic impurities

    • Heavy metals testing using ICP-MS 🧪

  4. Microbiological Tests:

    • Total bacterial/fungal count

    • Pathogen screening 🦠

  5. Stability Testing:

    • Checks API performance under temperature, humidity, and light stress 🌤️💧

✅ Conclusion: These tests ensure that every batch of PYRANTEL PAMOATE meets global pharmacopeial standards and is safe for human and veterinary use. 🌟

12. What are the challenges in manufacturing PYRANTEL PAMOATE API manufactured by Swapnroop Drugs & Pharmaceuticals? ⚠️🏭

Manufacturing PYRANTEL PAMOATE API involves technical and regulatory challenges:

Common Challenges:

  1. Purity & Yield Control ⚗️

    • Ensuring high purity while maintaining good synthetic yield can be difficult due to complex multi-step reactions.

  2. Moisture Sensitivity 💧

    • API is prone to hydrolysis or degradation if exposed to humidity, requiring controlled drying and storage.

  3. Residual Solvent Removal 🌡️

    • Organic solvents must be completely removed, as per pharmacopeial limits, which can complicate purification.

  4. Batch Consistency 🔄

    • Achieving uniform particle size, crystal form, and bioavailability across batches is critical.

  5. Regulatory Compliance 📜

    • Meeting GMP and pharmacopeial guidelines for global markets adds complexity.

💡 Summary: The main challenges are maintaining purity, stability, and batch-to-batch consistency while meeting strict regulatory requirements. ✅

13. What are the challenges in manufacturing PYRANTEL PAMOATE dosage forms manufactured by Swapnroop Drugs & Pharmaceuticals? ⚠️💊

Formulating PYRANTEL PAMOATE into tablets, chewables, or suspensions also comes with challenges:

Key Dosage Form Challenges:

  1. Poor Water Solubility 💧❌

    • Limits bioavailability; requires formulation strategies like suspensions or flavored chewables.

  2. Taste Masking 🍓

    • PYRANTEL PAMOATE is bitter, so pediatric formulations require effective flavoring.

  3. Uniform Distribution in Formulations 🔄

    • Ensuring consistent API content in each tablet or suspension is crucial for efficacy.

  4. Stability Concerns 🌡️

    • Exposure to moisture or heat can degrade API, requiring protective packaging.

  5. Regulatory & Quality Control 📜✅

    • Each dosage form must comply with pharmacopeial specifications, including dissolution, microbial limits, and assay tests.

💡 Conclusion: Manufacturing dosage forms of PYRANTEL PAMOATE requires innovative formulation techniques to ensure stability, palatability, and therapeutic efficacy. 🌟



14. What are the storage conditions for PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? 🌡️📦

Proper storage of PYRANTEL PAMOATE API is essential to maintain its stability, potency, and shelf life.

Recommended Storage Conditions:

  • Temperature: Store in a cool, dry place, ideally 20–25°C. ❄️

  • Humidity: Protect from moisture to prevent hydrolysis or degradation. 💧

  • Light Exposure: Keep away from direct sunlight; store in opaque or amber containers if necessary. 🌤️

  • Containers: Use airtight, moisture-proof containers made of glass or high-quality plastic. 🏺🛡️

  • Segregation: Store separately from oxidizing agents and incompatible chemicals. ⚗️

💡 Tip: Following these conditions ensures that the API remains stable and retains its pharmacological activity for the intended shelf life. ✅

15. What is the packaging for PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? 📦💊

PYRANTEL PAMOATE API is packaged to protect it from moisture, light, and contamination while facilitating safe handling and transport.

Common Packaging Formats:

  1. Drums / Barrels:

    • Fiber or HDPE drums lined with moisture-resistant bags.

    • Typically 25–50 kg per drum for bulk API supply. 🥁

  2. Plastic or Glass Containers:

    • Smaller quantities (1–5 kg) may use airtight jars or bottles. 🏺

  3. Protective Inner Lining:

    • Polyethylene or polypropylene bags to prevent moisture uptake. 💧

  4. Labeling:

    • Clearly marked with API name, batch number, manufacturing date, expiry date, storage conditions, and hazard symbols. 🏷️

💡 Summary: Packaging ensures API stability, safety during transport, and compliance with regulatory standards. ✅

16. What is the shelf life of PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals? ⏳🌟

Shelf life refers to the period during which the API remains stable and effective under recommended storage conditions.

Key Points:

  • Typical shelf life: 3–5 years from the date of manufacture. 📆

  • Stability may vary depending on storage conditions, packaging, and formulation.

  • Regular stability testing ensures that API retains potency, purity, and safety throughout its shelf life. 🔬

💡 Tip: Proper storage (cool, dry, protected from light) is crucial to maximize shelf life and maintain therapeutic efficacy. ✅

✅ Conclusion: PYRANTEL PAMOATE manufactured by Swapnroop Drugs & Pharmaceuticals is a high-quality, stable, and effective anti-parasitic API, with carefully controlled manufacturing, testing, packaging, and storage practices to ensure global compliance and therapeutic reliability. 🌍💊




        

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