Dried Ferrous Sulphate + Elemental Iron + Folic Acid SR Tablets

Description

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

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 manufacturer of Ferrous Sulphate sustained-release formulations in India. These products combine dried ferrous sulphate, supplying elemental iron, with folic acid in a modified-release tablet formulation. Sustained-release technology can alter the location and rate of iron release and may improve gastrointestinal tolerability for some patients, but it should not be described as eliminating nausea or gastric adverse effects.

Iron absorption is greatest in the proximal small intestine, and prolonged-release designs can sometimes release iron beyond the most efficient absorption sites. For that reason, clinical suitability, elemental-iron dose and release profile should be supported by the specific registered formulation rather than assuming SR is universally more effective or better tolerated.

2. Product Specifications

3. Manufacturing Technology

• Matrix Tablets: Hydrophilic matrix systems such as HPMC may be used in a registered formulation to control fluid penetration and drug release. This technology should only be claimed when actually used.
• Elemental Iron Control: Elemental-iron content is calculated from the actual dried ferrous-sulphate grade and verified against the registered specification rather than inferred from a universal percentage.
• Folic Acid Stability: Formulation, separation/barrier strategies and protective packaging may be used to maintain folic-acid stability where supported by validation.

4. Quality Assurance

• Multi-Point Dissolution: Modified-release products are tested at multiple time points using the product-specific registered method and acceptance criteria. Universal targets such as <30% at 1 hour, >50% at 4 hours and >80% at 8 hours should not be applied unless they are the approved specification for that exact product.
• Assay & Uniformity: Iron and folic-acid content are tested using validated methods.
• Modified-Release Performance: Manufacturing controls are designed to reduce the risk of unintended rapid release and to maintain the validated release profile.
• Stability: Shelf life and packaging are supported by product-specific stability studies.

5. Why Use Sustained Release?

A sustained-release formulation spreads drug release over time rather than delivering the entire labeled amount immediately. This may improve tolerability or dosing convenience for some patients, but gastrointestinal effects such as nausea, abdominal discomfort, constipation and dark stools can still occur. Choice between immediate- and modified-release iron should consider elemental-iron requirements, absorption, tolerability, adherence and clinical guidance.

• Iron Deficiency: May be used where oral iron replacement is clinically indicated and the product's elemental-iron dose is appropriate.
• Pregnancy: Iron/folate supplementation is commonly recommended, but SR products are not automatically preferred for morning sickness or gastritis. Strength and formulation should match local maternal-health guidance and clinician assessment.
• Tolerability: Patients unable to tolerate one oral iron product may benefit from adjustments in formulation, dose, schedule or alternative therapy under professional guidance.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Packaging: Blister and bottle presentations according to registration and stability requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures these SR formulations?
A: Healthy Life Pharma Pvt. Ltd. manufactures iron and folic-acid formulations in India.

Q: Is this equivalent to a specific branded prolonged-release iron product?
A: Brand formulations can differ in iron salt, elemental-iron content, folic-acid strength and release technology. Generic/bioequivalent claims should only be made when supported by the required product-specific regulatory evidence.

Q: Why do 150mg, 200mg and 270mg ferrous-sulphate products provide different elemental-iron amounts?
A: Elemental-iron content depends on the salt's hydration/grade and formulation specification. The exact labeled elemental iron must come from the registered product specification.

Q: Can an SR tablet be crushed?
A: Modified-release tablets generally should not be crushed or chewed because doing so may alter the release characteristics. However, follow the exact label because some dosage forms may have different administration instructions.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Dose and frequency should be based on elemental-iron and folic-acid content, diagnosis, age, pregnancy status, laboratory findings, tolerability and the registered product label; once-daily dosing is not universal.
• Food: Food can improve gastrointestinal tolerance but may reduce iron absorption. Follow the specific product instructions and clinician advice.
• Administration: Preserve the modified-release mechanism; do not crush or chew unless the exact registered label explicitly allows it.
• Monitoring: Hemoglobin and iron-status assessment may be appropriate to confirm response and guide duration of treatment.

9. Side Effects and Precautions

• Gastrointestinal: Nausea, abdominal discomfort, constipation or diarrhea and dark stools can still occur with SR iron.
• Overdose: Accidental iron overdose, especially in children, can be life-threatening and requires urgent medical attention.
• Interactions: Iron can interact with antacids, calcium, tetracyclines, quinolones, levothyroxine and other medicines. Required separation intervals are medicine-specific.
• GI Narrowing / Obstruction: Certain modified-release dosage forms may require caution in patients with significant gastrointestinal narrowing or obstructive disorders; contraindications depend on the exact product design and registered label rather than applying universally to all SR iron products.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive heat and moisture.
• Keep in original packaging and securely out of reach of children.