Description

Misoprostol Tablets (25mcg / 200mcg)

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 Misoprostol Tablets in India. Misoprostol is a synthetic Prostaglandin E1 (PGE1) Analog. It is a critical medication used in gastroenterology for the prevention of NSAID-induced Gastric Ulcers and widely in obstetrics/gynecology for the Induction of Labor, management of Postpartum Hemorrhage (PPH), and other gynecological indications.

We offer Contract Manufacturing (Third Party) services for this highly unstable molecule. Pure Misoprostol is a viscous oil that is extremely sensitive to moisture and temperature. Our WHO-GMP certified facility in Mumbai utilizes specialized HPMC Dispersion Technology and ultra-low humidity processing suites to stabilize the drug into a solid dosage form. Healthy Inc manages the export logistics, supplying hospitals, NGOs, and Ministries of Health across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stabilizing a liquid oil into a tablet is the challenge.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • HPMC Dispersion: Since Misoprostol is an oily liquid at room temperature, we stabilize it by adsorbing it onto Hydroxypropyl Methylcellulose (HPMC) to create a 1:100 solid dispersion. This ensures the drug remains stable in powder form for compression.

  • Moisture Control: The API degrades rapidly in the presence of water. We manufacture in Dehumidified Suites (< 20% RH) to prevent hydrolysis.

  • Content Uniformity: Since the dose is extremely low (micrograms), we use high-precision geometric blending to ensure that every tablet contains exactly 200mcg, preventing dangerous dosing variability.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: We exclusively use Cold Form Alu-Alu Blisters. This provides a complete barrier against moisture and atmospheric oxygen, which is essential for preserving the potency of Misoprostol in tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure rapid availability.

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

• Related Substances: We strictly monitor for Misoprostol Acid and Isomers (Type A, B degradation products) to ensure the product remains safe and effective.

5. Why Use Misoprostol?

It protects the stomach lining and manages uterine tone.

• Mechanism:

  • Gastric: It mimics natural prostaglandins, which inhibit acid secretion and stimulate the secretion of mucus and bicarbonate, protecting the stomach lining from NSAIDs (like Aspirin/Ibuprofen).

  • Uterine: It binds to myometrial cells to cause strong uterine contractions and softens the cervix (cervical ripening).

• Key Indications:

  • Gastric Ulcers: Prevention of ulcers in patients taking chronic NSAIDs.

  • Postpartum Hemorrhage (PPH): Prevention and treatment of severe bleeding after childbirth (vital in low-resource settings).

  • Labor Induction: Used for cervical ripening and induction of labor.

  • Gynecological Procedures: Cervical softening before hysteroscopy or IUD insertion.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Stability Data) 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 Misoprostol Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using stabilized dispersion technology.

• Q: Is it heat sensitive?

  A: Yes. It is very sensitive. While our Alu-Alu pack protects it, it should ideally be stored in a cool place to prevent degradation.

• Q: Can it be handled with bare hands?

  A: No. It can be absorbed through the skin. Pregnant women should strictly avoid handling crushed tablets or direct contact with the medication.

• Q: How is it taken?

  A: Depending on the indication, it can be taken orally, sublingually (under the tongue), or vaginally. Follow the specific medical protocol.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• NSAID Ulcer Prevention: 200mcg four times daily with food.

• Postpartum Hemorrhage: 600mcg to 800mcg (oral or sublingual) immediately after delivery.

• Induction of Labor: 25mcg to 50mcg (vaginal/oral) every 4-6 hours.

• Administration: Swallow whole or dissolve under tongue as prescribed.

9. Side Effects and Precautions

• Diarrhea: Very common (dose-dependent). Usually resolves after a few days.

• Cramping: Abdominal pain and uterine cramping.

• Chills/Shivering: Common side effect of prostaglandins (thermoregulatory effect).

• Pregnancy: Contraindicated for ulcer treatment in pregnant women (causes abortion/birth defects). Only used in pregnancy for labor induction or PPH under strict medical supervision.

10. Storage Instructions

• Store below 25°C in a dry place.

• Do not remove from blister until use. (Highly hygroscopic).