"Tolfenamic Acid API (CAS No. 13710-19-5) – Properties, Uses, Synthesis, and Dosage Forms"

 

Q1. What is Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 💊✨

Short Answer:
Tolfenamic Acid is a non-steroidal anti-inflammatory drug (NSAID) used as an active pharmaceutical ingredient (API) for managing pain, inflammation, and fever. It works by inhibiting cyclooxygenase (COX) enzymes, which reduces the production of prostaglandins, key mediators of inflammation and pain.

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Detailed Description (In-Depth) 🌟

1. Pharmacological Class & Mechanism 🔬

• Tolfenamic Acid belongs to the NSAID class.

• It selectively inhibits COX-1 and COX-2 enzymes, blocking prostaglandin synthesis.

• This action leads to reduction of inflammation, pain, and fever in various clinical conditions. 🌡️💪

2. Clinical Uses & Therapeutic Significance 🏥💚

• Migraine Management 🧠 – Effective in reducing migraine pain and frequency.

• Musculoskeletal Pain Relief 💪 – Relieves arthritis pain, back pain, and post-operative discomfort.

• Fever Reduction 🌡️ – Helps manage pyrexia in inflammatory conditions.

• Other Inflammatory Disorders 🔬 – Used in conditions requiring NSAID therapy under physician supervision.

3. Chemical Identity & Formulation 🧪

• IUPAC Name: 2-[(3-chloro-2-methylphenyl)amino]benzoic acid

• CAS Number: 13710-19-5

• Molecular Formula: C₁₄H₁₂ClNO₂

• Molecular Weight: 261.7 g/mol

• Appearance: White to off-white crystalline powder, suitable for oral and injectable formulations.

4. Physicochemical Characteristics ⚗️

• Appearance: White to off-white crystalline powder

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

• Stability: Stable under dry, cool conditions; sensitive to light and heat

• Melting Point: ~140–144°C

• pH: Slightly acidic in aqueous solution

• Hygroscopicity: Low, but requires controlled storage conditions

5. Manufacturing Importance 🏭

• Tolfenamic Acid API is used to formulate tablets, capsules, and injectable solutions for systemic therapy.

• High-quality API ensures consistent potency, efficacy, and patient safety. 🌍💊

🌿 Q2. What is Tolfenamic Acid API by Swapnroop Drugs & Pharmaceuticals used for? 🌿

Therapeutic Uses:

• Migraine Relief 🧠 – Reduces severity and duration of migraine attacks.

• Musculoskeletal Pain 💪 – Effective in arthritis, back pain, and post-operative discomfort.

• Anti-inflammatory 🔥 – Reduces inflammation in soft tissues and joints.

• Fever Reduction 🌡️ – Lowers elevated body temperature in inflammatory conditions.

• Other Uses ⚕️ – Can be used in certain conditions requiring NSAID therapy, under medical supervision.

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🧪 Q3. What are the physicochemical properties of Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 🧪

• Chemical Name: 2-[(3-chloro-2-methylphenyl)amino]benzoic acid

• CAS Number: 13710-19-5

• Molecular Formula: C₁₄H₁₂ClNO₂

• Molecular Weight: 261.7 g/mol

• Appearance: White to off-white crystalline powder

• Solubility: Poorly soluble in water; soluble in ethanol, methanol, and other organic solvents

• Stability: Stable under dry, cool conditions; sensitive to heat and light

• Melting Point: ~140–144°C

• pH: Slightly acidic in aqueous solution

• Hygroscopicity: Low, but requires moisture-controlled storage

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⚙️ Q4. How is Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals synthesized? ⚙️

Tolfenamic Acid is synthesized via organic chemical reactions following a multi-step process:

1. Acylation & Substitution Reactions 🧪 – Introduction of the amino and chloro groups onto the benzoic acid core.

2. Cyclization & Aromatic Ring Formation ⚗️ – Ensures correct molecular structure and stability.

3. Purification ✨ – Recrystallization or solvent-based purification to obtain high-purity API.

4. Drying & Milling 🌬️ – Produces crystalline powder with uniform particle size.

5. Quality Control 🔬 – Confirms identity, purity, and compliance with pharmacopeial standards.

This ensures that Swapnroop Drugs & Pharmaceuticals delivers API with consistent quality and therapeutic reliability.

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💊 Q5. What are the different dosage forms of Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 💊

• Oral Tablets 💊 – Most common form for systemic pain and inflammation relief.

• Oral Capsules 🏺 – Occasionally used for controlled-release or specific dosing.

• Injectable Solutions 💉 – For rapid pain relief or in hospital settings.

• Topical Gels / Creams 🌿 – For localized musculoskeletal pain relief.

All dosage forms are designed to deliver the API effectively for its anti-inflammatory and analgesic action.

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⚗️ Q6. How are Tolfenamic Acid API dosage forms prepared? ⚗️

• Tablets:

  • API is blended with excipients like fillers, binders, and disintegrants ⚖️.

  • Compression using tablet presses 🏭.

  • Optional film coating for taste masking or stability 🌈.

• Capsules:

  • API-excipient blend is filled into gelatin or HPMC capsules 🏺.

• Injectable Solutions:

  • API is dissolved in suitable solvents, with stabilizers and preservatives 💧.

• Topical Gels / Creams:

  • API is dispersed in a suitable gel base, sometimes with penetration enhancers 🌿.

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✅ Q7. What is the appropriate dosage form of Tolfenamic Acid manufactured by Swapnroop Drugs & Pharmaceuticals? ✅

• Primary Form: Oral tablets 💊 – standard for outpatient use.

• Injectables: 💉 – For rapid or hospital-administered therapy.

• Topical Form: 🌿 – For localized musculoskeletal pain.

• Dosage Strength: Selected based on clinical condition and patient profile, often guided by physician prescription.

• Administration Guidance: Taken with or without food, following medical advice 🍽️.

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🕒 Q8. When should Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals be taken? 🕒

• Dosing Schedule: Usually once or twice daily, depending on condition and physician prescription.

• Timing: Can be taken with food or milk 🍽️ to reduce gastric irritation.

• Treatment Duration: As advised by a physician; typically short-term for acute pain or migraines.

• Monitoring: Patients with renal, hepatic, or gastrointestinal issues should be monitored during therapy 🩺.

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🌬️ Q9. What are the effects and side effects of Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 🌬️

Therapeutic Effects:

• Anti-inflammatory 🔥 – Reduces swelling and inflammation.

• Analgesic 💊 – Relieves mild to moderate pain.

• Antipyretic 🌡️ – Reduces fever.

Common Side Effects:

• Gastrointestinal: Nausea 🤢, dyspepsia, abdominal pain 💧

• CNS: Headache 🤕, dizziness 🌀

• Allergic Reactions: Rash, itching, or mild hypersensitivity 🌿

• Rare but Serious: GI bleeding ⚠️, kidney or liver function alterations

Important: Side effects are generally dose-dependent; adherence to prescribed dosage minimizes risks.

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🔬 Q10. How is Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals tested? 🔬

• Identity Tests 🧪 – Confirm chemical structure using HPLC, NMR, and IR spectroscopy.

• Purity Assays ✨ – HPLC ensures API purity ≥98%.

• Impurity Profiling ⚗️ – Detects residual solvents, by-products, and degradation compounds.

• Melting Point Determination 🌡️ – Confirms crystalline purity.

• Moisture Content 💧 – Measured via Karl Fischer titration.

• Microbial Testing 🦠 – Ensures absence of microbial contamination.

• Dissolution / Solubility Tests 💧 – Ensures proper bioavailability in oral dosage forms.

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🧪 Q11. What tests are performed on Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 🧪

• Melting Point Determination 🌡️ – Confirms crystalline purity and stability.

• Spectroscopic Analysis 🔬 – UV, IR, and NMR for structural verification.

• Chromatographic Assays 🏭 – HPLC or GC to quantify impurities and ensure batch consistency.

• Assay of Active Ingredient 💊 – Confirms correct API content per pharmacopeial standards.

• Impurity Profiling ⚗️ – Detects residual solvents, by-products, and degradation compounds.

• Moisture Content 💧 – Ensures stability of crystalline API.

• Microbial Testing 🦠 – Verifies the absence of contamination.

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⚙️ Q12. What are the challenges in manufacturing Tolfenamic Acid API by Swapnroop Drugs & Pharmaceuticals? ⚙️

• Complex Organic Synthesis 🧪 – Requires precise chemical reactions to maintain high yield and purity.

• Purity Control ✨ – Removal of unreacted intermediates and by-products is critical.

• Light & Heat Sensitivity 🌡️ – API may degrade if exposed to high temperatures or direct sunlight.

• Regulatory Compliance 📜 – Strict adherence to cGMP and pharmacopeial standards.

• Analytical Verification 🔬 – Advanced instruments needed for accurate identification, assay, and impurity profiling.

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💊 Q13. What are the challenges in manufacturing Tolfenamic Acid dosage forms by Swapnroop Drugs & Pharmaceuticals? 💊

• Dose Uniformity ⚖️ – Ensuring consistent distribution of API in tablets or capsules.

• Stability Issues ❄️ – Preventing degradation during formulation and storage.

• Excipients Compatibility ⚗️ – Selecting fillers, binders, and coatings that do not affect API efficacy.

• Patient Compliance 👵👨‍🦳 – Tablets or capsules must be easy to swallow and administer.

• Quality Control 🧪 – Continuous testing for dissolution, uniformity, and microbial safety.

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🌡️ Q14. What are the storage conditions for Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 🌡️

• Temperature: Store at 20–25°C, away from excessive heat or freezing 🌡️.

• Moisture Protection: Keep in airtight, moisture-resistant containers 💧.

• Light Sensitivity: Protect from direct sunlight ☀️.

• Handling: Follow standard laboratory precautions to avoid contamination.

• Stability Monitoring: Regular checks to ensure potency, purity, and physical integrity.

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📦 Q15. What is the packaging for Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? 📦

• Primary Packaging:

  • HDPE bottles 🧴 – protects against moisture and contamination.

  • Desiccants 💧 – included to maintain low humidity.

  • Sealed foil or laminated bags 🛡️ – optional for bulk API transport.

• Secondary Packaging:

  • Cartons with protective inserts 📦 – safeguards primary containers during storage and shipping.

  • Labeling: Batch number, manufacturing date, expiration date, storage instructions, and safety information.

• Special Considerations:

  • Packaging prevents light and moisture exposure, ensuring API stability.

  • Suitable for controlled-condition transport to maintain quality.

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⏳ Q16. What is the shelf life of Tolfenamic Acid API manufactured by Swapnroop Drugs & Pharmaceuticals? ⏳

• Typical Shelf Life: 24–36 months when stored under recommended conditions (20–25°C, protected from light and moisture).

• Post-Opening / Handling: Containers must remain tightly sealed; avoid prolonged exposure to humidity or heat.

• Stability Monitoring: Conducted as per ICH guidelines, including tests for temperature, humidity, and light stress.

• Expiry Labeling: Clearly indicated on packaging to ensure safe and effective use of the API.

✅ Proper storage and handling help maintain potency, purity, and therapeutic efficacy throughout the shelf life.