Description

Spironolactone Tablets (25mg – 100mg)

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 Spironolactone Tablets in India. Spironolactone is a potassium-sparing diuretic and Aldosterone Antagonist widely used to treat fluid retention (edema) in patients with heart failure, liver cirrhosis, and nephrotic syndrome. It is also a critical add-on therapy for resistant hypertension.

We offer Contract Manufacturing (Third Party) services for this versatile formulation. Unlike loop diuretics (like Furosemide) that deplete potassium, Spironolactone helps the body retain potassium while excreting excess sodium and water. Our WHO-GMP certified facility in Mumbai utilizes advanced odor-masking coating technologies to handle this API, which naturally has a distinct scent. Healthy Inc manages the export logistics, supplying pharmacy chains and hospitals across the USA, Europe, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Bioavailability and consumer acceptance are the key challenges.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronization: Spironolactone is poorly water-soluble (BCS Class II). We use Micronized API (reduced particle size) to significantly increase surface area, ensuring the drug dissolves and absorbs consistently in the digestive tract.

  • Odor Masking: The raw material has a characteristic, mild mercaptan (sulfur-like) odor. We apply a flavored Film Coating (often Peppermint or Vanilla) to mask this scent and improve patient compliance.

  • Uniformity: We use high-shear granulation to ensure the active ingredient is evenly distributed, which is critical for the lower 25mg dosage strength.

• The Exporter: Healthy Inc

  • Stability: We use high-barrier PVC/PVDC Blisters or HDPE bottles to protect the product from light and moisture, ensuring it remains stable and effective for 3 years.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% of the drug releases within 60 minutes.

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

• Impurity Profiling: We strictly monitor for degradation products like Canrenone and other sulfur-containing impurities to ensure safety.

5. Why Use Spironolactone?

It targets the hormonal cause of fluid retention.

• Mechanism: It blocks the hormone Aldosterone in the kidneys. Aldosterone normally signals the body to hold onto salt and water and release potassium. By blocking it, Spironolactone causes salt/water excretion while conserving potassium.

• Key Indications:

  • Heart Failure: Increases survival and reduces hospitalizations in severe heart failure (NYHA Class III-IV).

  • Liver Cirrhosis: The drug of choice for treating ascites (fluid in the abdomen).

  • Hormonal Acne/PCOS: (Off-label) Used in women to block androgen receptors, reducing acne and unwanted hair growth.

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 Spironolactone Tablets?

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

• Q: Can I use salt substitutes while taking this?

  A: NO. Salt substitutes often contain Potassium Chloride. Since Spironolactone already retains potassium, adding more can lead to fatal Hyperkalemia (high potassium).

• Q: Why does the tablet smell like mint?

  A: We add a peppermint flavor to the coating to mask the natural, slightly unpleasant smell of the Spironolactone medicine itself.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Edema (Heart Failure): 25mg once daily, titrated up to 50mg if needed.

• Hypertension: 25mg to 100mg daily.

• Administration: Swallow whole with food (food increases absorption).

9. Side Effects and Precautions

• Hyperkalemia: High potassium levels can cause heart rhythm problems. Regular blood tests are mandatory.

• Gynecomastia: Breast enlargement/pain in men (due to anti-androgen effects). This is usually reversible.

• Renal Function: Use with caution in patients with kidney impairment.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.