Description

Hyoscine Butylbromide Tablets (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 Hyoscine Butylbromide Tablets in India. This medication is a potent Antispasmodic agent used globally to relieve abdominal pain, cramping, and discomfort associated with Irritable Bowel Syndrome (IBS) and renal colic. It works by relaxing the smooth muscles of the gastrointestinal and urinary tracts.

We offer Contract Manufacturing (Third Party) services for this product, often known by its trade name “Buscopan”. Our WHO-GMP certified facility in Mumbai utilizes specialized coating technologies (Sugar Coating or Film Coating) to ensure product stability and mask the bitter taste of the active ingredient. Healthy Inc manages the export logistics, supplying pharmacies, hospitals, and distributors across Africa, the Middle East, and Southeast Asia.

2. Product Specifications

3. Manufacturing Hyoscine Butylbromide Tablets

Producing antispasmodics requires precise control over coating and content.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Hyoscine Butylbromide is sensitive to moisture and has a bitter taste. We predominantly use Sugar Coating (a traditional multi-step process) or aqueous Film Coating to create a barrier that protects the core tablet and makes it easy to swallow. We use automated compression machines to ensure that every 10mg tablet has uniform weight and hardness, ensuring consistent disintegration in the stomach.

• The Exporter: Healthy Inc

  Healthy Inc ensures safe global distribution. We utilize high-quality PVC/PVDC Blister Packs or Alu-Alu packs to protect the tablets from humidity during sea freight. We are experienced in handling the regulatory documentation required for anticholinergic drugs in various international markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test to ensure the tablet releases the drug effectively to provide rapid relief from spasms (typically within 15-30 minutes).

• Assay: We use HPLC to confirm the potency is within 90-110% limits.

• Related Substances: We strictly monitor for degradation products (like Hyoscine) to ensure safety over the 3-year shelf life.

5. Why Use Hyoscine Butylbromide?

It is the first-line treatment for stomach cramps.

• Mechanism: It is an anticholinergic drug that blocks acetylcholine receptors on smooth muscle cells. This prevents the muscles from contracting (spasming), effectively relaxing the gut.

   

• Key Indications:

  • IBS: Relief of pain and cramping associated with Irritable Bowel Syndrome.

     

  • Menstrual Cramps: Relief of spasmodic dysmenorrhea.

     

  • Renal/Biliary Colic: Relief of spasms in the urinary or bile ducts.

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 Hyoscine Butylbromide Tablets?

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

• Q: Is this the generic for Buscopan?

  A: Yes, Hyoscine Butylbromide is the active ingredient in Buscopan.

   

• Q: Does it cross the blood-brain barrier?

  A: No, unlike Atropine, it does not cross the blood-brain barrier significantly, so it causes fewer central nervous system side effects (like drowsiness).

   

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Adult Dose: 10mg to 20mg (1-2 tablets) taken 3 to 4 times daily.

   

• Maximum Dose: Do not exceed 60mg-100mg per day.

• Administration: Swallow whole with water; do not crush or chew.

   

9. Side Effects and Precautions

• Common Side Effects: Dry mouth, blurred vision, constipation, and tachycardia (fast heart rate).

   

• Contraindications: Do not use in patients with Myasthenia Gravis, Megacolon, or untreated Narrow-Angle Glaucoma.

• Precautions: Caution in elderly patients prone to urinary retention.

10. Storage Instructions

• Store below 30°C in a dry place.

• Protect from light.