Comprehensive Overview of PRUCALOPRIDE API (CAS No: 100356-82-2) Manufactured by Swapnroop Drugs & Pharmaceuticals: Properties, Uses, Dosage Forms, Manufacturing, Testing, Storage, and Shelf Life 🌿💊
What is PRUCALOPRIDE API manufactured by Swapnroop Drugs & Pharmaceuticals?
PRUCALOPRIDE is a highly selective serotonin (5-HT4) receptor agonist used primarily for the treatment of chronic idiopathic constipation (CIC) in adults. It works by stimulating colonic motility, thereby enhancing bowel movements and improving overall gastrointestinal function.
🌟 Key Highlights:
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API Name: Prucalopride
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Chemical Name: [(S)-4-amino-5-chloro-2,3-dihydro-N-[1-(3-methoxypropyl)piperidin-4-yl]-7-oxo-1H-benzo[d]imidazole-1-carboxamide]
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CAS Number: 100356-82-2 ✅
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Molecular Formula: C₂₂H₂₈ClN₃O₄
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Molecular Weight: 413.92 g/mol
Mechanism of Action:
Prucalopride selectively activates 5-HT4 receptors in the gastrointestinal tract, which triggers peristalsis (wave-like muscle contractions) and accelerates colonic transit. This makes it highly effective in treating constipation that has not responded to other conventional therapies.
Therapeutic Use:
💊 Primarily prescribed for:
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Chronic idiopathic constipation in adults
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Patients who have inadequate response to dietary fiber or laxatives
Advantages of Prucalopride API:
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High receptor selectivity reduces off-target effects 💡
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Well-tolerated with minimal cardiovascular side effects ❤️
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Fast onset of action, usually within 24 hours after administration ⏱️
Pharmaceutical Relevance:
Swapnroop Drugs & Pharmaceuticals manufactures high-quality Prucalopride API meeting stringent pharmacopoeial standards (USP/BP/EP), ensuring purity, potency, and stability suitable for formulation into tablets, capsules, or other dosage forms. 🏭
2️⃣ What is PRUCALOPRIDE API by Swapnroop Drugs & Pharmaceuticals used for?
Prucalopride API is primarily used in the treatment of chronic idiopathic constipation (CIC) in adults, especially in patients who have inadequate response to conventional laxatives.
🌟 Therapeutic Uses:
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Chronic Idiopathic Constipation (CIC):
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Stimulates bowel movements in patients with persistent constipation.
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Improves stool frequency, consistency, and ease of passage. 💨
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Functional Gastrointestinal Disorders (Off-label/Research Use):
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Sometimes studied for irritable bowel syndrome with constipation (IBS-C).
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Enhances gastrointestinal motility without significant cardiovascular effects. 🫀
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Improvement in Quality of Life:
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Reduces abdominal discomfort, bloating, and straining associated with chronic constipation. 🌿
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Mechanism of Action Related to Use:
Prucalopride activates 5-HT4 receptors in the colon → triggers peristaltic reflexes → accelerates colonic transit → facilitates regular bowel movements. ⚡
Why Swapnroop Drugs & Pharmaceuticals API is Preferred:
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Ensures high purity and stability suitable for formulation into oral dosage forms like tablets or capsules. 🏭
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Consistent pharmacological activity ensures reliable efficacy in therapeutic use. ✅
Summary Table:
| Feature | Details |
|---|---|
| Primary Use | Chronic idiopathic constipation |
| Target Receptor | 5-HT4 receptor |
| Patient Group | Adults with inadequate response to laxatives |
| Key Benefits | Increased bowel movements, improved stool consistency, reduced discomfort |
3️⃣ What are the physicochemical properties of PRUCALOPRIDE API Manufactured by Swapnroop Drugs & Pharmaceuticals?
PRUCALOPRIDE API exhibits physicochemical characteristics that are crucial for its formulation, stability, and bioavailability.
🌟 Physicochemical Properties:
| Property | Details |
|---|---|
| CAS Number | 100356-82-2 ✅ |
| Molecular Formula | C₂₂H₂₈ClN₃O₄ |
| Molecular Weight | 413.92 g/mol |
| Appearance | White to off-white crystalline powder ⚪ |
| Solubility | Soluble in water and polar solvents; slightly soluble in ethanol and methanol 💧 |
| Melting Point | ~220–225°C 🌡️ |
| pKa | ~9.8 (basic) |
| LogP | 2.9 (moderate lipophilicity) |
| Stability | Stable under normal temperature and humidity; sensitive to strong oxidizing agents 🛡️ |
Key Insights:
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The water solubility allows it to be formulated effectively in oral tablets and capsules.
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Crystalline nature ensures consistent dissolution and bioavailability.
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Moderate lipophilicity favors absorption in the gastrointestinal tract.
4️⃣ How is PRUCALOPRIDE API Manufactured by Swapnroop Drugs & Pharmaceuticals?
Prucalopride synthesis involves multi-step organic reactions with high precision to ensure purity, yield, and pharmacological activity.
🌟 General Synthetic Route:
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Formation of Piperidine Derivative:
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Start with a substituted piperidine intermediate.
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Introduce the 3-methoxypropyl group via alkylation.
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Benzimidazole Core Construction:
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Condensation of o-phenylenediamine with appropriate carboxylic acid derivatives forms the benzimidazole nucleus.
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Chlorination at specific positions is performed for receptor selectivity.
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Amide Formation:
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Coupling of the piperidine derivative with the benzimidazole carboxylic acid forms the final amide linkage.
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Purification:
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Crystallization and washing to achieve high-purity API (>99%).
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Quality control ensures absence of residual solvents and by-products. 🧪
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Highlights of Swapnroop Drugs & Pharmaceuticals Manufacturing:
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Follows cGMP guidelines for pharmaceutical APIs. 🏭
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Ensures consistent particle size and polymorphic form for optimal formulation performance.
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Stability and shelf-life optimization through careful selection of solvents and reaction conditions. ⏳
5️⃣ What are the different dosage forms of PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals?
PRUCALOPRIDE API is primarily formulated into oral dosage forms due to its systemic activity in the gastrointestinal tract.
🌟 Common Dosage Forms:
| Dosage Form | Description | Advantages |
|---|---|---|
| Oral Tablets 💊 | Most common; immediate or controlled-release forms | Easy to administer, accurate dosing, stable |
| Oral Capsules 🧴 | Hard gelatin or HPMC capsules containing API | Good for taste masking and rapid absorption |
| Oral Solution / Suspension 🌊 | Less common; used in specific patient populations (elderly or pediatric) | Easier swallowing, flexible dosing |
| Modified/Controlled Release Tablets ⏱️ | Sustained release formulations for prolonged effect | Reduces dosing frequency, maintains steady plasma levels |
Notes:
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Oral solid forms (tablets/capsules) are preferred for adults.
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Liquid formulations are used for patients with swallowing difficulties.
6️⃣ How are PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals dosage forms prepared?
Preparation of oral dosage forms involves careful formulation steps to ensure stability, bioavailability, and patient compliance.
🌟 Typical Steps for Tablets and Capsules:
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Weighing and Blending ⚖️
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API is weighed according to batch size.
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Mixed with excipients like fillers (lactose, microcrystalline cellulose), binders, disintegrants, and lubricants.
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Granulation (for tablets) 🏭
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Wet granulation: API + excipients mixed with a binder solution → dried → sieved.
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Dry granulation: API + excipients compressed into slugs → milled into granules.
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Compression / Encapsulation 💊
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Tablets are compressed using rotary or single-punch tablet presses.
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Capsules are filled with API-excipient mixture using capsule filling machines.
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Coating (Optional) 🎨
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Film coating for taste masking, stability, or controlled release.
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Ensures uniform appearance and patient acceptability.
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Quality Control Testing 🧪
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Weight variation, hardness, friability, disintegration, dissolution, and assay tests are performed to meet pharmacopeial standards (USP/BP/EP).
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Highlights of Swapnroop Drugs & Pharmaceuticals Approach:
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Ensures high content uniformity ✅
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Maintains stability under storage conditions 🏷️
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Uses cGMP-compliant equipment and processes 🏭
7️⃣ What is the appropriate dosage form of PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals?
The appropriate dosage form of Prucalopride API is determined based on patient convenience, efficacy, and pharmacokinetics.
🌟 Recommended Dosage Forms:
| Dosage Form | Typical Use | Highlights |
|---|---|---|
| Oral Tablets (Immediate Release) 💊 | Most widely prescribed | Provides accurate dosing and predictable absorption |
| Oral Tablets (Modified/Controlled Release) ⏱️ | For sustained action | Reduces frequency of administration, maintains steady plasma levels |
| Capsules 🧴 | Alternative to tablets | Useful for taste masking or patients who prefer capsules |
| Oral Solution/Suspension 🌊 | For elderly or patients with swallowing difficulties | Flexible dosing and easier ingestion |
Key Point:
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Immediate-release tablets are the standard for adult patients with chronic idiopathic constipation. ✅
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The choice may vary depending on age, swallowing ability, and clinical requirements.
8️⃣ When should PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals be taken?
Prucalopride is usually administered once daily and timing can impact efficacy and tolerability.
🌟 Administration Guidelines:
| Parameter | Recommendation |
|---|---|
| Frequency ⏱️ | Once daily |
| Time of Day 🌞 | Morning, preferably with or without food |
| With Food? 🍽️ | Can be taken with or without food; food does not significantly affect absorption |
| Dosage 💊 | Typical adult dose: 2 mg once daily (may vary with renal impairment or physician guidance) |
| Special Populations 👵👴 | Dose adjustment required in elderly or patients with severe renal impairment |
Clinical Notes:
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Taking in the morning may help align bowel movements with the day and reduce sleep disturbances. 🌅
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Consistency in timing improves therapeutic outcomes and reduces gastrointestinal side effects. 💨
9️⃣ What are the effects and side effects of PRUCALOPRIDE API manufactured by Swapnroop Drugs and Pharmaceuticals?
Effects: 🌟
Prucalopride is a selective 5-HT4 receptor agonist that primarily acts on the gastrointestinal tract:
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Stimulates colonic motility ⚡ → enhances bowel movements
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Increases stool frequency 💨 → improves constipation
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Improves stool consistency 🌿 → reduces straining and discomfort
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Reduces bloating and abdominal discomfort 😌 → improves overall quality of life
Side Effects: ⚠️
Most side effects are mild to moderate and often transient:
| System | Common Side Effects | Notes |
|---|---|---|
| Gastrointestinal | Diarrhea, nausea, abdominal pain, bloating | Usually occurs during first few days |
| Nervous System | Headache, dizziness | Mild and self-limiting |
| Cardiovascular | Rare palpitations, tachycardia ❤️ | Minimal risk due to high receptor selectivity |
| Others | Fatigue, insomnia | Usually mild |
Safety Tips:
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Side effects often subside within the first week of therapy ⏱️
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Monitoring is recommended in patients with renal impairment or cardiac conditions 🫀
🔟 How is PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals tested?
Quality testing ensures that the API meets pharmacopeial standards (USP/BP/EP) for purity, potency, and safety.
🌟 Key Testing Parameters:
| Test | Purpose |
|---|---|
| Identification Tests 🔬 | Confirm chemical identity using IR, NMR, UV, and mass spectrometry |
| Assay / Potency 💊 | Determine API content (usually by HPLC) to ensure correct dosage |
| Impurity Profiling ⚗️ | Detect residual solvents, related substances, and degradation products |
| Moisture Content 💧 | Karl Fischer titration or loss on drying to ensure stability |
| Particle Size & Morphology 🔎 | Ensures consistent dissolution and bioavailability |
| Melting Point / Thermal Analysis 🌡️ | Confirms polymorphic form and thermal stability |
| Residual Solvent Analysis 🧪 | Ensures solvents from synthesis are within safe limits |
| Microbial Testing 🦠 | Confirms absence of bacterial or fungal contamination |
Highlights of Swapnroop Drugs & Pharmaceuticals Testing:
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Uses state-of-the-art analytical instruments 🏭
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Follows cGMP guidelines and validated standard operating procedures (SOPs) ✅
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Ensures high-purity API suitable for formulation into dosage forms 💊
1️⃣1️⃣ What tests are performed on PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals?
To ensure quality, safety, and efficacy, PRUCALOPRIDE API undergoes rigorous pharmacopeial and in-house testing.
🌟 Common Tests Performed:
| Test | Purpose | Method / Technique |
|---|---|---|
| Identification Tests 🔬 | Confirm chemical identity | IR spectroscopy, NMR, UV-Vis, Mass Spectrometry |
| Assay / Potency 💊 | Determine API content | High-Performance Liquid Chromatography (HPLC) |
| Impurity Profiling ⚗️ | Detect related substances or degradation products | HPLC or LC-MS |
| Melting Point & Thermal Analysis 🌡️ | Verify polymorphic form and stability | DSC, TGA |
| Moisture Content 💧 | Ensure proper drying and stability | Karl Fischer titration |
| Residual Solvent Analysis 🧪 | Confirm solvent levels are within safe limits | GC or GC-MS |
| Particle Size & Morphology 🔎 | Ensure uniform dissolution | Laser diffraction, microscopy |
| Microbial Testing 🦠 | Confirm absence of contamination | Total aerobic microbial count, fungal count |
Key Notes:
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Testing ensures purity >99% ✅
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Confirms compliance with USP/BP/EP standards
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Essential for safe formulation into tablets, capsules, or other dosage forms 💊
1️⃣2️⃣ What are the challenges in manufacturing PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals?
Manufacturing PRUCALOPRIDE API involves several technical and regulatory challenges due to its complex synthesis and pharmacological requirements.
🌟 Key Challenges:
| Challenge | Description |
|---|---|
| Complex Multi-Step Synthesis 🧪 | Requires precise control of reaction conditions for high yield and purity |
| Chirality & Stereochemistry 🔄 | Maintaining the correct enantiomer (S-enantiomer) is critical for efficacy and safety |
| Control of Impurities ⚗️ | Formation of related substances, by-products, or residual solvents must be minimized |
| Polymorphic Form Control 🌡️ | Ensuring consistent crystalline form is essential for dissolution and bioavailability |
| Regulatory Compliance 📜 | Manufacturing must adhere to cGMP guidelines and pharmacopeial standards |
| Scale-Up Challenges 🏭 | Reproducibility during large-scale production without loss of purity or yield |
| Stability During Storage 🛡️ | Protecting API from moisture, heat, and light to prevent degradation |
Swapnroop Drugs & Pharmaceuticals Approach:
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Uses state-of-the-art reactors and purification techniques
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Implements stringent quality control at every step ✅
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Optimizes reaction conditions and crystallization processes to maintain purity and stability 💊
1️⃣3️⃣ What are the challenges in manufacturing PRUCALOPRIDE API dosage forms Manufactured by Swapnroop Drugs and Pharmaceuticals?
Formulating Prucalopride API into dosage forms such as tablets or capsules involves multiple challenges to ensure efficacy, stability, and patient compliance.
🌟 Key Challenges:
| Challenge | Description |
|---|---|
| Content Uniformity ⚖️ | Ensuring each tablet or capsule contains the exact API dose |
| Flow Properties of API 💨 | Fine crystalline powders may have poor flow, complicating tablet compression or capsule filling |
| Stability During Formulation 🌡️ | API may degrade under heat, moisture, or light during granulation and compression |
| Excipients Compatibility 🧪 | Selecting excipients that do not interact with API chemically or physically |
| Controlled Release Formulations ⏱️ | Designing sustained-release tablets requires precise matrix or coating technologies |
| Taste Masking 😋 | Prucalopride API has a bitter taste; coatings or encapsulation may be needed |
| Regulatory Compliance 📜 | Formulation must meet pharmacopeial specifications and cGMP guidelines |
Swapnroop Drugs & Pharmaceuticals Solutions:
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Optimizes granulation, coating, and encapsulation processes
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Performs compatibility and stability studies before final formulation
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Uses advanced tablet presses and capsule filling machines for uniformity ✅
1️⃣4️⃣ What are the storage conditions for PRUCALOPRIDE API Manufactured by Swapnroop Drugs and Pharmaceuticals?
Proper storage is essential to maintain the stability, potency, and shelf-life of Prucalopride API.
🌟 Recommended Storage Conditions:
| Parameter | Condition | Notes |
|---|---|---|
| Temperature 🌡️ | 20–25°C (room temperature) | Avoid excessive heat |
| Humidity 💧 | <60% RH (relative humidity) | Prevents moisture-induced degradation |
| Light Exposure ☀️ | Store in dark or opaque containers | Protects from photodegradation |
| Container Type 🏺 | Airtight, moisture-resistant containers | Glass or high-quality plastic drums with tight seals |
| Handling 🧤 | Use dry, clean equipment during transfer | Prevent contamination |
Additional Notes:
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Do not store near oxidizing agents ⚗️
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Follow WHO/cGMP storage guidelines for APIs 🏭
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Regular stability testing ensures the API maintains >99% purity during storage
1️⃣6️⃣ What is the shelf life of PRUCALOPRIDE API manufactured by Swapnroop Drugs and Pharmaceuticals?
Shelf life refers to the period during which Prucalopride API retains its potency, purity, and safety when stored under recommended conditions.
🌟 Shelf Life Details:
| Parameter | Specification | Notes |
|---|---|---|
| Typical Shelf Life ⏳ | 36 months (3 years) from the date of manufacture | When stored under recommended conditions |
| Storage Conditions 🌡️ | 20–25°C, <60% RH, protected from light ☀️ | Prevents degradation and moisture absorption |
| Packaging 🏺 | Airtight, moisture-resistant containers | Glass or high-quality plastic drums with sealed lids |
| Stability Monitoring 🔬 | Periodic testing during shelf life | Ensures API maintains >99% purity and pharmacological activity |
| Degradation Signs ⚠️ | Changes in color, solubility, or odor | API should not be used if any changes are observed |
Key Highlights:
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Proper storage and handling are critical for maintaining efficacy ✅
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Swapnroop Drugs & Pharmaceuticals performs stability studies in accordance with ICH guidelines to guarantee shelf life
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The API remains pharmaceutically active and safe for use throughout its shelf life when stored correctly 💊
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