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

Parameter	Specification
Product Name	Bisacodyl Tablets
Generic Name	Bisacodyl Tablets USP / BP / IP
CAS Number	603-50-9
Strength	5mg (Standard) / 10mg (Forte)
Dosage Form	Enteric Coated Tablet (Yellow / Round / Sugar-Coated appearance)
Standard	USP / BP / IP Compliant
Therapeutic Class	Stimulant Laxative / Cathartic
Shelf Life	36 Months
Packaging	10×10 Blister / 1000s Bulk Jar

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).

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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.