Description

Dried Ferrous Sulphate & Folic Acid Sustained Release (SR) Tablets / Capsules

(The “Gentle Iron” Formulation)

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 Ferrous Sulphate Sustained Release (SR) Formulations in India. While standard iron tablets release all their iron in the stomach at once (causing nausea and gastric pain), our Sustained Release (SR) technology releases the iron gradually over 6 to 8 hours.

This formulation contains Dried Ferrous Sulphate equivalent to a precise dose of Elemental Iron, combined with Folic Acid. By targeting the release in the duodenum and upper jejunum (where absorption is highest) and minimizing exposure to the sensitive stomach lining, this product offers the high efficacy of Ferrous Sulphate with significantly Reduced Gastrointestinal Side Effects. It is the preferred choice for pregnant women who cannot tolerate standard iron tablets due to morning sickness or gastritis.

2. Product Specifications

3. Manufacturing Technology

Iron that respects the stomach.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Pelletization Technology (Spansules): For capsules, we manufacture Neutral Pellets layered with Dried Ferrous Sulphate and Folic Acid, then coated with varying thicknesses of ethylcellulose. Some pellets release immediately, while others release later. This “Time-Release” mechanism ensures steady iron absorption without the “dose dumping” that hurts the stomach.

  • Matrix Tablet Technology: For tablets, we use a hydrophilic matrix (HPMC) that swells upon contact with fluid, forming a gel layer. The iron diffuses slowly through this gel, preventing high concentrations of iron from irritating the gastric mucosa.

  • Elemental Iron Precision: We strictly control the stoichiometry to ensuring the “Dried” salt delivers the exact labeled amount of Elemental Iron, which is the only part of the salt the body actually uses.

• The Exporter: Healthy Inc

  • Premium Segment: We position this product for private clinics and gynecologists who prioritize patient comfort over the lowest cost.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (Multi-Point): Unlike standard tablets (tested at 1 point), we test SR formulations at 1 hour, 4 hours, and 8 hours.

  • 1 Hr: < 30% release (Protects stomach).

  • 4 Hrs: > 50% release (Ensures absorption).

  • 8 Hrs: > 80% release (Complete dose delivery).

• Assay: We confirm the potency of Iron and Folic Acid.

• Degradation Control: Folic acid is unstable in the presence of iron. We use Barrier Coating on the iron pellets to physically separate it from the Folic Acid, ensuring 100% potency of both.

5. Why Use Sustained Release (SR)?

The “No-Nausea” Iron.

• Mechanism:

  • Standard Iron: Dissolves instantly in the stomach. High concentration = High irritation = Vomiting/Pain.

  • SR Iron: Bypasses the stomach largely intact. It releases iron ions slowly in the small intestine. This matches the body’s natural absorption rate limit, reducing “free iron” that causes side effects.

• Key Indications:

  • Pregnancy: For women experiencing nausea/vomiting (morning sickness) who cannot take regular iron.

  • Gastritis Patients: Patients with sensitive stomachs or history of ulcers.

  • Non-Compliant Patients: Patients who stopped taking iron because “it hurts their stomach.”

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD available.

• 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 these SR formulations?

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

• Q: Is it “FeFol”?

  A: FeFol is a brand of Spansule (SmithKline). We manufacture the Generic Equivalent (SR Capsule/Tablet).

• Q: Why is the dose different (150mg vs 200mg)?

  A: Dried Ferrous Sulphate is ~30% elemental iron. 150mg gives ~47mg iron. 200mg gives ~65mg iron. The SR formulation often uses slightly different strengths to optimize the release profile.

• Q: Can I crush the tablet?

  A: NEVER. Crushing destroys the “Slow Release” mechanism. You will get the full dose instantly, which can cause severe stomach pain. Swallow whole.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: 1 Capsule/Tablet once daily.

• Timing: Can be taken with or after food. (Unlike standard iron, SR formulations are often taken with food to further improve tolerance, though absorption is slightly better on an empty stomach).

9. Side Effects and Precautions

• Gastrointestinal: significantly reduced compared to standard iron, but may still cause mild constipation or dark stools.

• Contraindications: Diverticular Disease, Intestinal Obstruction (due to the non-deformable nature of some matrix tablets).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture.