Diclofenac Sodium Tablets

Description

Diclofenac Sodium Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures Diclofenac Sodium Tablets in India. Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID) used for selected painful and inflammatory conditions. The product range may include conventional, film-coated, enteric-coated or modified-release presentations depending on the registered formulation. Coating can alter where or how a tablet releases the medicine, but enteric coating should not be claimed to eliminate Diclofenac's risk of gastrointestinal ulceration or bleeding.

2. Product Specifications

3. Manufacturing Technology

• Formulation-Specific Processing: Granulation, compression and coating processes are selected according to the registered strength and dosage form.
• Enteric Coating: For enteric-coated products, acid resistance and release in the specified buffer medium are controlled according to the applicable pharmacopoeial/registered dissolution method.
• Modified Release: A 100mg product should only be described as sustained/prolonged release when that release characteristic is part of its registered formulation; strength alone does not establish SR status.
• In-Process Controls: Tablet weight, hardness, friability, coating parameters and disintegration/dissolution are monitored against approved limits.

4. Quality Assurance

• Assay & Uniformity: Diclofenac content and dosage-unit uniformity are tested against applicable specifications.
• Dissolution: Immediate, enteric or modified-release products are tested using the method and acceptance criteria appropriate to that dosage form; universal “0%/100%” release claims are avoided.
• Related Substances: Relevant impurities and degradation products are controlled using validated analytical methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Diclofenac inhibits cyclooxygenase-mediated prostaglandin synthesis, producing analgesic and anti-inflammatory effects.

• Arthritic Conditions: May be prescribed for symptomatic treatment of conditions such as osteoarthritis, rheumatoid arthritis or ankylosing spondylitis where appropriate.
• Musculoskeletal Pain: May be used for selected acute painful inflammatory conditions.
• Post-Procedural Pain: Certain formulations may be prescribed for short-term pain after procedures or injury.
• Risk-Based Use: Selection should consider gastrointestinal, cardiovascular, renal, hepatic and hypersensitivity risks, as well as interacting medicines.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Private Label: Contract manufacturing can be supported subject to formulation approval and destination-market requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Diclofenac Sodium Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Diclofenac Sodium tablet formulations in India.

Q: Are all Diclofenac Sodium Tablets enteric coated?
A: No. The supplied range includes different dosage forms. The BP/IP 50mg product may be enteric coated, while other strengths/presentations can be film-coated, uncoated or modified-release according to their registered formulation.

Q: Does enteric coating prevent stomach ulcers?
A: No. Enteric coating changes tablet release characteristics but does not remove the systemic NSAID risk of gastrointestinal ulceration, bleeding or perforation.

Q: Is every 100mg Diclofenac Sodium tablet sustained release?
A: No. A product should be called SR/prolonged release only when its approved formulation and label specify modified release.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dose: Dose and frequency depend on indication, dosage form, age, comorbidities and patient risk factors. Follow the registered prescribing information.
• Lowest Effective Exposure: Use the lowest effective NSAID dose for the shortest appropriate duration.
• Enteric / Modified-Release Tablets: Swallow whole unless the registered label specifically permits splitting or another method. Do not crush or chew formulations whose coating/release mechanism must remain intact.
• Combination Product: If Paracetamol is included, total Paracetamol/Acetaminophen exposure from all medicines must be considered to avoid overdose.

9. Side Effects and Precautions

• Gastrointestinal: Dyspepsia, nausea and abdominal discomfort may occur. Serious ulcers, bleeding or perforation can occur, sometimes without warning.
• Cardiovascular: Diclofenac and other NSAIDs can increase the risk of serious cardiovascular thrombotic events. Avoid inappropriate use in patients with significant cardiovascular disease/risk and follow label contraindications.
• Renal: Diclofenac can worsen renal function, especially in dehydration, kidney disease, heart failure or with interacting medicines.
• Hepatic: Liver enzyme abnormalities and clinically significant liver injury can occur; monitoring may be appropriate in longer treatment.
• Hypersensitivity / Asthma: Serious allergic reactions and NSAID-associated bronchospasm can occur in susceptible patients.
• Pregnancy: NSAIDs have important gestational-age-specific fetal and maternal risks; use should follow current product labeling and clinician guidance.

10. Storage Instructions

• Store below 30°C unless otherwise specified on the registered label.
• Protect from excessive light and moisture.
• Keep in original packaging and out of reach of children.