Description

Montelukast Tablets (4mg / 5mg / 10mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Montelukast Sodium Tablets in India. Montelukast is a potent Leukotriene Receptor Antagonist (LTRA) used for the maintenance treatment of Asthma and the relief of symptoms of Seasonal and Perennial Allergic Rhinitis (Hay Fever). It is a non-steroidal alternative that is particularly effective for patients whose asthma is triggered by allergies or exercise.

We offer Contract Manufacturing (Third Party) services for this high-demand respiratory drug. We manufacture two distinct dosage forms:

1. Film Coated Tablets (10mg): For adults and adolescents (15+ years).

2. Chewable Tablets (4mg & 5mg): Specially formulated for pediatric patients (2-14 years) with pleasant flavors (Cherry/Strawberry) and a smooth mouthfeel to ensure compliance in children.

   Healthy Inc manages the export logistics, supplying pediatric clinics and respiratory centers across the USA, Europe, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stability and taste are the manufacturing pillars.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Photosensitivity & Hygroscopicity: Montelukast Sodium is unstable in light and absorbs moisture rapidly. We manufacture in Dehumidified Suites under controlled lighting. We use Alu-Alu Cold Form Blisters to provide a complete barrier against light and moisture, ensuring the product stays potent.

  • Chewable Technology: For the 4mg and 5mg tablets, we use Direct Compression with specialized excipients (like Mannitol) to create a tablet that is hard enough to package but dissolves continuously with a pleasant, cooling mouthfeel when chewed, without any gritty aftertaste.

  • Flavoring: We use high-quality, stable flavors (Cherry/Tutti-Frutti) to mask the slight metallic taste of the API, ensuring children will take their medicine willingly.

• The Exporter: Healthy Inc

  • Light-Proof Packaging: Standard PVC blisters are not sufficient. We strictly use opaque Alu-Alu packs to prevent the degradation of the active ingredient into its sulfoxide impurity.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution:

  • FCT: >80% release in 20 minutes.

  • Chewable: Rapid disintegration to ensure safety for children.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Impurity Profiling: We strictly monitor for the S-oxide impurity (formed by light exposure) and Michael Adducts to ensure safety.

5. Why Use Montelukast?

It targets the inflammation pathway that inhalers sometimes miss.

• Mechanism: It blocks the CysLT1 receptor. Leukotrienes are inflammatory chemicals released by the body during an allergic reaction. They cause the airways to tighten (bronchoconstriction) and fill with mucus. By blocking them, Montelukast keeps the airways open.

• Key Indications:

  • Asthma: Prophylaxis (prevention) and chronic treatment.

  • Allergic Rhinitis: Relief of stuffy/runny nose and sneezing (Seasonal & Perennial).

  • Exercise-Induced Bronchoconstriction (EIB): Prevention of wheezing triggered by exercise.

     

• Advantage: It is an oral tablet (once daily), which is often easier for patients than using inhalers.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Montelukast Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it a steroid?

  A: NO. It is a non-steroidal anti-inflammatory drug. It does not carry the long-term risks associated with corticosteroids.

• Q: Can I use it for a sudden asthma attack?

  A: NO. It is a “controller” medicine, not a “rescue” medicine. It takes hours/days to work. Use a Salbutamol inhaler for sudden attacks.

• Q: When should I take it?

  A: For asthma, it is best taken in the evening. For allergies, it can be taken at any time.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults (15+ years): One 10mg tablet daily.

• Children (6-14 years): One 5mg chewable tablet daily.

• Children (2-5 years): One 4mg chewable tablet daily.

• Administration: Usually taken in the evening. Chewable tablets must be chewed thoroughly, not swallowed whole.

9. Side Effects and Precautions

• Neuropsychiatric Events: Boxed Warning: Serious behavior and mood-related changes have been reported (agitation, depression, sleeping problems, suicidal thoughts). Patients should be monitored.

• Upper Respiratory Infection: Mild cold-like symptoms.

• Headache: Common side effect.

• Churg-Strauss Syndrome: Rare systemic vasculitis (usually in patients reducing steroid doses).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture. (Do not open blister until use).