Description

Bisacodyl Tablets (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 Bisacodyl Gastro-Resistant Tablets in India. Bisacodyl is a potent Stimulant Laxative (diphenylmethane derivative) acting directly on the colonic mucosa to induce peristalsis. It is the global standard for the short-term treatment of Constipation and is extensively used for Bowel Preparation prior to surgery, colonoscopy, or radiological examinations.

We offer Contract Manufacturing (Third Party) services for this technically demanding Enteric-Coated product. Bisacodyl is a gastric irritant; if released in the stomach, it causes severe cramping and vomiting. Our WHO-GMP certified facility in Mumbai utilizes advanced Methacrylic Acid Copolymer Coating technology to create a robust acid-resistant barrier. This ensures the tablet passes through the stomach intact and releases the active drug only in the alkaline environment of the colon (pH > 7.0). Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across the USA, Europe, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Precision coating for targeted release.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Enteric Coating Integrity: The success of Bisacodyl depends entirely on the coating. We use Eudragit-type polymers that remain insoluble in gastric acid (pH 1.2) for 2 hours but dissolve rapidly in intestinal fluid (pH 6.8+). This prevents gastric irritation and ensures the drug works exactly where needed.

  • Sugar Coating Finish: Traditionally, Bisacodyl tablets are sugar-coated over the enteric layer to provide a smooth, glossy, easy-to-swallow finish that masks any chemical taste.

  • Stability: Bisacodyl is sensitive to moisture (hydrolysis). We use low-moisture manufacturing suites and high-barrier blister films (PVC/PVDC) to prevent the drug from degrading into desacetyl-bisacodyl (which is less effective) during storage.

• The Exporter: Healthy Inc

  • Hospital Packs: We supply 1000-count jars for hospital wards where bowel prep is a daily routine, offering significant cost savings over retail blisters.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (Two-Stage):

  • Stage 1 (Acid): 0.1N HCl for 2 hours. (Tablet must not release drug).

  • Stage 2 (Buffer): pH 6.8 Phosphate Buffer. (Tablet must release >75% drug within 45 mins).

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

• Related Substances: We strictly monitor for hydrolysis by-products.

5. Why Use Bisacodyl?

Predictable relief, usually overnight.

• Mechanism: Bisacodyl is a prodrug. Bacterial enzymes in the colon convert it into its active metabolite. This metabolite:

  1. Stimulates Nerve Endings: It irritates the mucosal nerve plexus in the colon wall, triggering strong muscle contractions (peristalsis).

  2. Fluid Secretion: It promotes the accumulation of water and electrolytes in the colon, softening the stool and increasing the pressure to evacuate.

• Key Indications:

  • Acute Constipation: Relief from irregularity.

  • Bowel Prep: Cleansing the colon before X-rays, endoscopy, or surgery (often combined with a polyethylene glycol solution).

  • Post-Operative Care: Establishing bowel function after surgery (once safe to do so).

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 Bisacodyl Tablets?

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

• Q: Is it Dulcolax?

  A: Dulcolax is the brand name (Sanofi/Boehringer). We manufacture the Generic Equivalent (Bisacodyl), which is bioequivalent.

• Q: Can I take it with milk?

  A: NO. Milk is alkaline. It can dissolve the special enteric coating while the tablet is still in your stomach. This will cause severe stomach pain and indigestion. Wait 1 hour after drinking milk.

• Q: Is it safe for weight loss?

  A: ABSOLUTELY NOT. Abusing laxatives causes dehydration, not fat loss. Long-term abuse can permanently damage the bowel (Cathartic Colon).

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 5mg to 15mg (1-3 tablets) once daily.

• Children (6-12 years): 5mg (1 tablet) once daily.

• Timing: Take at night for a bowel movement the next morning (onset takes 6-12 hours).

• Administration: Swallow whole with water. Do not chew or crush. Do not take within 1 hour of antacids or dairy products.

9. Side Effects and Precautions

• Gastrointestinal: Abdominal cramps (common), diarrhea, nausea.

• Electrolytes: Chronic use leads to Hypokalemia (low potassium), which causes muscle weakness.

• Contraindications: Appendicitis, Intestinal Obstruction, Acute Surgical Abdomen, Severe Dehydration.

• Dependency: Habit-forming if used daily for long periods. Limit use to < 1 week.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from humidity.