🌿 Comprehensive Guide to Tolnaftate API & Dosage Forms Manufactured by Swapnroop Drugs & Pharmaceuticals – πŸ“¦πŸ’Š

 


🌿 What is Tolnaftate manufactured by Swapnroop Drugs & Pharmaceuticals?

Tolnaftate is a synthetic antifungal active pharmaceutical ingredient (API) belonging to the thiocarbamate class of compounds πŸ§ͺ. It is chemically known as O-2-naphthyl methyl(3-methylphenyl)thiocarbamate and has the molecular formula C₁₉H₁₇NOS ⚗️.

πŸ”¬ Nature & Appearance:

  • Tolnaftate appears as a pale yellow crystalline powder ✨.

  • It has a melting point of ~110–111 °C 🌑️.

  • It is insoluble in water πŸ’§ but soluble in organic solvents such as ethanol, chloroform, and DMSO.

πŸ’Š Pharmacological Role:
Tolnaftate acts as a fungistatic agent — meaning it inhibits fungal growth rather than directly killing fungi. It primarily targets dermatophytes (fungi that cause skin infections) by interfering with ergosterol biosynthesis πŸ›‘️, an essential component of fungal cell membranes.

🌍 Applications in Healthcare:

  • Widely used in topical formulations (creams, powders, sprays, aerosols).

  • Indicated for athlete’s foot (tinea pedis) 🦢, jock itch (tinea cruris) 🩳, and ringworm (tinea corporis) πŸ”„.

  • Available as an over-the-counter (OTC) antifungal medication in many countries, making it highly accessible.

🏭 Swapnroop Drugs & Pharmaceuticals manufactures Tolnaftate API under stringent Good Manufacturing Practices (GMP) ✅, ensuring:

  • High purity

  • Controlled particle size distribution (important for creams/powders)

  • Compliance with pharmacopeial standards

✨ Summary in one line:
Tolnaftate API by Swapnroop Drugs & Pharmaceuticals is a trusted antifungal ingredient 🌿🧴 used globally in topical products to treat and prevent common fungal skin infections.



πŸ’Š What is Tolnaftate by Swapnroop Drugs & Pharmaceuticals used for?

Tolnaftate is a topical antifungal medication 🌿 designed to combat superficial fungal infections of the skin. It is an over-the-counter (OTC) API incorporated into various dosage forms such as creams, powders, sprays, and solutions 🧴.

πŸ”Ή Primary Medical Uses

  1. Athlete’s Foot (Tinea Pedis) 🦢

    • Treats itching, burning, and scaling between toes or on soles.

    • Prevents recurrence when used regularly.

  2. Jock Itch (Tinea Cruris) 🩳

    • Relieves redness, irritation, and discomfort in the groin area.

  3. Ringworm (Tinea Corporis) πŸ”„

    • Clears circular, itchy, red patches on the skin caused by dermatophytes.

  4. Other Dermatophyte Infections 🧬

    • Sometimes applied for tinea barbae (beard area) or tinea capitis (scalp), though creams and sprays are mainly indicated for body infections.

πŸ”Ή Preventive Uses

  • Powders and sprays containing Tolnaftate are used to prevent fungal growth in moist areas πŸ‘£.

  • Commonly recommended for people who wear tight shoes, athletes, or individuals prone to sweaty skin conditions.

πŸ”Ή Why It’s Preferred

✨ Safe & Well-Tolerated – Minimal systemic absorption → fewer side effects.
✨ Convenient – Available without prescription in many countries 🌍.
✨ Effective – Inhibits fungal growth by blocking ergosterol synthesis, which is vital for fungal cell membranes πŸ›‘️.


⚗️ What are the Physicochemical Properties of Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals?

Tolnaftate is a synthetic thiocarbamate antifungal compound πŸ§ͺ with unique physicochemical characteristics that make it suitable for topical dosage forms like creams, powders, and sprays.

πŸ”Ή Basic Chemical Identity

  • IUPAC Name: O-2-naphthyl methyl(3-methylphenyl)thiocarbamate

  • Molecular Formula: C₁₉H₁₇NOS

  • Molecular Weight: ≈ 303.41 g/mol ⚖️

  • Chemical Class: Thiocarbamate derivative

πŸ”Ή Appearance & Physical Properties

  • Form: Pale yellow crystalline powder ✨

  • Odor: Almost odorless πŸ‘ƒ

  • Melting Point: ~110–111.5 °C 🌑️

  • Boiling Point: Not typically reported (decomposes before boiling)

  • Density: ~1.28 g/cm³

πŸ”Ή Solubility Profile πŸ’§

  • Water: Practically insoluble πŸš«πŸ’¦

  • Ethanol / Chloroform / Acetone / DMSO: Freely soluble ✅

  • Reason: Nonpolar aromatic structure → hydrophobic nature

πŸ”Ή Stability

  • Stable under normal conditions of temperature and pressure 🌍.

  • Sensitive to strong oxidizing agents ⚡ and extreme pH conditions.

  • Requires dry, cool, and sealed packaging to maintain stability πŸ›‘️.

πŸ”Ή Other Properties

  • LogP (lipophilicity): ~5.5 → highly lipophilic 🌿

  • pKa: Non-ionizable under physiological pH (neutral compound)

  • Pharmacological Relevance: Lipophilic nature ensures good penetration into skin layers πŸ‘©‍⚕️.

πŸ‘‰ Summary in one line:
Tolnaftate is a lipophilic, pale yellow crystalline powder ✨ with poor water solubility but excellent stability, making it ideal for topical antifungal formulations πŸŒΏπŸ’Š.



πŸ§ͺ Q4) How is Tolnaftate manufactured (synthesized) by Swapnroop Drugs & Pharmaceuticals?

Tolnaftate is produced through organic synthesis involving thiocarbamate chemistry.

πŸ”Ή General Synthetic Route:

  1. Starting Materials:

    • 2-naphthol (aromatic alcohol) 🌿

    • N-methyl-3-toluidine (aromatic amine) πŸ’§

    • Chlorothionoformate (reactive thio-ester) πŸ§ͺ

  2. Reaction Step:

    • The aryl chloroformate (derived from 2-naphthol) reacts with N-methyl-3-toluidine under controlled conditions.

    • A thiocarbamate bond is formed → producing Tolnaftate.

  3. Purification:

    • Product is crystallized from organic solvents ✨

    • Dried under vacuum to yield pure API.

πŸ”Ή Industrial Considerations:

  • Careful temperature control 🌑️ (exothermic reaction).

  • Containment systems to handle sulfur byproducts πŸ›‘️.

  • Crystallization optimization ensures correct particle size & purity.

✨ Summary:
Tolnaftate is synthesized by condensation of a naphthol derivative with a substituted toluidine to form a thiocarbamate antifungal API ⚗️🌿.

πŸ’Š Q5) What are the different dosage forms of Tolnaftate manufactured by Swapnroop Drugs & Pharmaceuticals?

Tolnaftate is formulated into a variety of topical dosage forms for ease of use and patient compliance ✅:

πŸ”Ή Creams & Ointments 🧴

  • 1% Tolnaftate cream is the most common formulation.

  • Used for direct skin application in athlete’s foot, jock itch, and ringworm.

πŸ”Ή Powders πŸ‘£

  • Blended with carriers like talc or starch.

  • Keeps skin dry, prevents fungal recurrence in shoes/feet.

πŸ”Ή Sprays & Aerosols 🌬️

  • Alcohol or propylene glycol-based solutions.

  • Convenient for large or hairy areas.

πŸ”Ή Solutions / Liquids πŸ’§

  • Applied with droppers or applicators.

  • Useful for nails, scalp, or hard-to-reach areas.

πŸ”Ή Gel Formulations ❄️

  • Transparent, non-greasy, fast-drying alternative to creams.

✨ Summary:
Tolnaftate by Swapnroop Drugs & Pharmaceuticals is available as creams, powders, sprays, solutions, and gels πŸŒΏπŸ’Š — offering flexibility for treating and preventing superficial fungal infections.



🏭 Q6) How are Tolnaftate dosage forms prepared by Swapnroop Drugs & Pharmaceuticals?

Tolnaftate is poorly soluble in water πŸ’§, so its dosage forms are prepared using techniques that ensure uniform distribution, stability, and patient convenience.

πŸ”Ή Creams / Ointments 🧴

  • Process:

    1. Heat the oil and aqueous phases separately 🌑️.

    2. Dissolve or suspend Tolnaftate in the oil phase (since it is lipophilic).

    3. Combine both phases with high-shear mixing → form an emulsion.

    4. Cool gradually while stirring to achieve a smooth, uniform cream ✨.

  • Excipients: emulsifying agents, humectants (glycerin), preservatives.

πŸ”Ή Powders πŸ‘£

  • Process:

    1. API is finely micronized for uniformity.

    2. Blended with carriers like talc or starch using tumbling or ribbon blenders.

    3. Filled into bottles or aerosol containers.

  • Advantage: keeps skin dry, ideal for preventive use.

πŸ”Ή Sprays / Aerosols 🌬️

  • Process:

    1. Tolnaftate suspended or dissolved in solvents (alcohol, propylene glycol).

    2. Stabilizers added to prevent settling.

    3. Filled into spray pumps or pressurized aerosol cans.

  • Benefit: convenient for hairy areas, no touch application.

πŸ”Ή Solutions / Liquids πŸ’§

  • Process:

    1. Dissolve Tolnaftate in a suitable organic solvent system.

    2. Add co-solvents (PEG, propylene glycol) for stability.

    3. Pack in bottles with applicators.

πŸ”Ή Gels ❄️

  • Process:

    1. Tolnaftate dispersed into a gel base (carbomer or hydroxypropyl cellulose).

    2. Neutralize and adjust viscosity.

    3. Air bubbles removed under vacuum.

  • Benefit: lightweight, non-greasy, fast-drying.

✨ Summary:
Tolnaftate dosage forms are prepared through dispersion, emulsification, or suspension techniques, ensuring stability, efficacy, and patient compliance 🌿🧴.

πŸ’‘ Q7) What is the appropriate dosage form of Tolnaftate manufactured by Swapnroop Drugs & Pharmaceuticals?

The appropriate dosage form depends on the type of fungal infection, location on the body, and patient preference ✅.

πŸ”Ή Creams / Gels 🧴❄️

  • Best for athlete’s foot, jock itch, and ringworm.

  • Creams hydrate dry skin; gels are non-greasy for hairy/moist areas.

πŸ”Ή Powders πŸ‘£

  • Ideal for prevention of recurrent fungal infections.

  • Commonly used inside shoes or on feet to control moisture.

πŸ”Ή Sprays 🌬️

  • Suitable for large surface areas or areas with hair growth.

  • Hands-free, hygienic application.

πŸ”Ή Solutions πŸ’§

  • Useful for hard-to-reach areas like between toes, under nails, or scalp.

✨ Summary:

  • Treatment of active infection → Creams/Gels.

  • Prevention & maintenance → Powders/Sprays.

  • Special cases (scalp, nails) → Solutions.

🌿 Swapnroop’s Tolnaftate API can be formulated into all these dosage forms, offering flexibility for different clinical needs.


Q8. When should Tolnaftate API Manufactured by Swapnroop Drugs & Pharmaceuticals be taken? ⏰

Tolnaftate is not taken orally; it is mainly used in topical formulations (creams, powders, sprays, gels). ✅

  • It should be applied directly to the affected skin area that is infected with fungi.

  • Usually applied twice daily (morning & evening), unless otherwise directed by a physician.

  • Skin should be clean and dry before applying. 🚿

  • Avoid using it on open wounds, broken skin, or near eyes, nose, mouth, or genitals.

πŸ‘‰ In summary: Tolnaftate is used topically and not ingested. Best applied after washing and drying the skin, at regular intervals for maximum antifungal effectiveness.

Q9. What are the effects and side effects of Tolnaftate manufactured by Swapnroop Drugs & Pharmaceuticals? ⚖️

✅ Effects (Therapeutic Benefits):

  • Antifungal action: Inhibits growth of dermatophytes (fungi causing infections like ringworm πŸ‘£).

  • Effective in athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).

  • Helps reduce itching, burning, scaling, and redness.

  • Prevents recurrence of fungal infections if used consistently.

⚠️ Possible Side Effects:

  • Mild skin irritation (redness, stinging, itching) at the site of application.

  • Dryness or peeling of skin.

  • Rare allergic reaction (rash, swelling, dizziness).

  • Very rare systemic effects since absorption into bloodstream is minimal.

πŸ‘‰ In summary: Tolnaftate is well tolerated and highly effective against superficial fungal infections, with only minor local side effects in rare cases.

Q10. How is Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals tested? πŸ”

Tolnaftate API undergoes strict quality testing to ensure purity, potency, and safety before being released for pharmaceutical use. Common testing methods include:

  • Identification Tests 🧬

    • Infrared Spectroscopy (IR) to confirm molecular structure.

    • UV Spectrophotometry for Ξ»max verification.

  • Purity & Assay ⚖️

    • High-Performance Liquid Chromatography (HPLC) is used to determine assay (typically should be 98–102% of labeled amount).

    • Thin Layer Chromatography (TLC) for impurity profiling.

  • Melting Point & Appearance 🌑️

    • Confirms physicochemical consistency (Tolnaftate is a white crystalline powder).

  • Loss on Drying (LOD) πŸ’§

    • Ensures minimal moisture content.

  • Residual Solvents Test πŸ”¬

    • Per ICH guidelines, ensures solvents used in synthesis are within safe limits.

Q11. What tests are performed on Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals? πŸ§ͺ✅

For API quality control, the following pharmacopoeial and in-house tests are carried out:

  1. Physicochemical Tests

    • Appearance, Solubility, Melting Range, pH (where applicable).

  2. Assay (Potency Check)

    • HPLC or UV methods to ensure correct active content.

  3. Impurity Testing

    • Related substances by HPLC

    • Ensures impurities are below pharmacopeial limits.

  4. Microbial Tests 🦠

    • Ensures API is free from harmful microbial contamination.

  5. Heavy Metals Test ⚠️

    • To check for toxic metals (like Pb, As, Cd, Hg) contamination.

  6. Stability Studies πŸ“¦

    • Accelerated & long-term stability under ICH conditions to determine shelf life.

πŸ‘‰ In summary: Tolnaftate API undergoes identity, purity, potency, impurity, microbial, and stability tests before approval.

Q12. What are the challenges in manufacturing Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals API? 🏭

Manufacturing Tolnaftate API requires precision, consistency, and compliance with regulatory standards. Some major challenges include:

  1. Raw Material Quality & Availability 🌿

    • Consistent supply of high-purity intermediates is essential.

    • Any variability can affect yield and final product purity.

  2. Synthesis Complexity ⚗️

    • Multi-step synthesis with strict reaction control.

    • Impurity generation during synthesis needs effective purification.

  3. Regulatory Compliance πŸ“‘

    • Must meet pharmacopeial standards (USP, EP, IP).

    • Requires detailed documentation and GMP adherence.

  4. Impurity Control πŸ§ͺ

    • By-products, unreacted materials, and residual solvents must be within ICH limits.

  5. Batch Consistency πŸ”„

    • Ensuring reproducibility in large-scale production is critical.

  6. Cost Efficiency πŸ’°

    • Balancing high quality with cost-effective synthesis is a constant challenge.

Q13. What are the challenges in manufacturing Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals dosage forms? πŸ’Š

Formulating Tolnaftate into creams, powders, gels, sprays presents unique hurdles:

  1. Solubility Issues 🌊

    • Tolnaftate is practically insoluble in water → requires solvents or formulation enhancers.

  2. Uniform Dispersion ⚖️

    • Needs proper mixing techniques to ensure even distribution in creams/powders.

  3. Stability ⏳

    • Sensitive to light, heat, and moisture → must ensure stability throughout shelf life.

  4. Skin Compatibility 🧴

    • Formulation should avoid irritation, especially in sensitive areas (e.g., jock itch).

  5. Patient Acceptability 😊

    • Creams should be non-greasy, powders should be smooth, sprays should be easy to apply.

  6. Packaging Challenges πŸ“¦

    • Must be packed in moisture-proof, airtight containers to maintain potency.

πŸ‘‰ In summary: The challenges lie in synthesis control for API and solubility + stability for dosage forms, requiring innovative formulation and strict quality checks.



Q14. What are the storage conditions for Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals? ❄️

Proper storage is crucial to maintain stability, potency, and safety of Tolnaftate API and formulations.

  • Temperature: Store at room temperature (15–30°C). 🌑️

  • Light Protection: Tolnaftate is sensitive to light; should be stored in opaque or amber containers. ☀️🚫

  • Moisture Control: Keep in a dry place, as excess humidity can degrade the API and affect topical formulations. πŸ’§

  • Air Tight Containers: Prevents oxidation and contamination.

  • Formulated Products (cream, spray, powder) should also be stored away from heat sources and direct sunlight.

πŸ‘‰ In summary: Store in a cool, dry, light-protected environment, tightly sealed to maintain quality.

Q15. What is the packaging for Tolnaftate Manufactured by Swapnroop Drugs & Pharmaceuticals? πŸ“¦

Packaging is designed to protect the drug and ensure patient convenience:

πŸ“Œ For API (Bulk Form):

  • Packed in HDPE (High-Density Polyethylene) drums with double LDPE liners.

  • Sometimes in fiber drums with inner polyethylene bags.

  • Tamper-evident seals to ensure integrity.

πŸ“Œ For Dosage Forms (Finished Products):

  • Creams/Ointments: Aluminum or laminated tubes with screw caps.

  • Powders: Plastic bottles or shakers with moisture-proof caps.

  • Sprays: Aerosol cans or pump-spray bottles.

  • Gels: Tubes or pump containers for easy application.

πŸ‘‰ In summary: Packaging ensures stability, safety, and patient usability, protecting Tolnaftate from light, moisture, and contamination.


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

The shelf life of Tolnaftate depends on form, storage conditions, and packaging.

πŸ”Ή Tolnaftate API (Bulk Powder)

  • Typical Shelf Life: 2–3 years from the date of manufacture πŸ“†

  • Conditions: Must be stored in cool, dry, and light-protected containers ❄️πŸ›‘️

  • Packaging: HDPE drums or fiber drums with inner polyethylene liners to prevent moisture and contamination πŸ“¦

πŸ”Ή Tolnaftate Dosage Forms

  • Creams, Gels, Ointments: Usually 2–3 years under recommended storage conditions 🧴

  • Powders: 2–3 years if kept dry and sealed πŸ’¨

  • Sprays / Aerosols: 2–3 years, provided the container is not punctured and stored away from heat 🌬️

πŸ”Ή Factors Affecting Shelf Life

  • Moisture πŸ’§ → can cause degradation or clumping of API

  • Light ☀️ → can degrade Tolnaftate chemically

  • Temperature 🌑️ → excessive heat can reduce stability

  • Packaging Integrity πŸ“¦ → compromised packaging can shorten shelf life

✨ Summary:
Tolnaftate API and dosage forms manufactured by Swapnroop Drugs & Pharmaceuticals have a shelf life of 2–3 years, provided they are stored in sealed, moisture-proof, and light-protected containers in a cool, dry place. 🌿🧴


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