Dried Aluminium Hydroxide Gel + Magnesium Hydroxide + Dimethylpolysiloxane Tablets

Description

Dried Aluminium Hydroxide, Magnesium Hydroxide & Dimethylpolysiloxane Tablets

(Antacid & Antiflatulent)

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 antacid and antiflatulent tablets in India. This formulation combines aluminium hydroxide and magnesium hydroxide for acid neutralization with dimethylpolysiloxane (simethicone) for relief of gas-related symptoms. It may provide temporary symptomatic relief from heartburn, acid indigestion, dyspepsia-associated discomfort, bloating and flatulence according to approved labeling.

Contract manufacturing options can include chewable presentations and market-specific flavors, sweeteners and packaging where these are separately developed, validated and registered.

2. Product Specifications

3. Manufacturing Technology

• Dimethylpolysiloxane Incorporation: Suitable carrier/adsorption and blending approaches may be used to incorporate the silicone-based active into a compressible solid formulation, subject to the validated manufacturing process.
• Mineral Blend Control: Aluminium and magnesium components are dispensed and blended according to the registered formula. Their combination may balance some gastrointestinal effects but cannot guarantee neutral bowel motility in every patient.
• Palatability: Particle-size selection and permitted flavor/sweetener systems can improve mouthfeel in chewable formulations.
• Packaging: Moisture-protective packaging is selected using product-specific stability data.

4. Quality Assurance

• Acid-Neutralizing Capacity: Tested where required using the applicable registered method and acceptance criteria.
• Antiflatulent Component: Dimethylpolysiloxane/simethicone quality and performance are assessed according to the applicable product specification; a universal “under 15 seconds” claim should not be assumed.
• Assay / Identity: Active ingredients are tested against approved specifications using validated methods.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

1. Acid Neutralization: Aluminium hydroxide and magnesium hydroxide react with gastric acid, increasing gastric pH and providing temporary relief of acid-related symptoms.
2. Gas Relief: Dimethylpolysiloxane/simethicone acts physically as an antifoaming agent, reducing surface tension so smaller gas bubbles can combine and be passed more readily.

Potential symptom uses: heartburn/acid indigestion, gas and bloating, and dyspepsia-associated discomfort according to the approved label. Persistent reflux or recurrent symptoms require medical assessment rather than prolonged self-treatment.

6. Export and Regulatory Support

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

7. Frequently Asked Questions

Q: Who manufactures these tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures antacid and antiflatulent tablet formulations in India.

Q: Is this the same as Digene or Gelusil?
A: Brand compositions and strengths can vary by market and presentation. This product should not be described as a generic equivalent of a specific brand unless the exact formulation and required regulatory equivalence have been established.

Q: Why is Dimethylpolysiloxane included?
A: Dimethylpolysiloxane/simethicone is an antifoaming agent that acts locally in the gastrointestinal tract to help reduce gas-related discomfort.

Q: Is it sugar-free?
A: Sugar-free formulations may be developed using suitable permitted excipients, but a product should be labeled sugar-free or suitable for a specific patient group only when the exact registered formulation supports that claim.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Product-Specific Dosing: Number of tablets, timing and frequency should follow the exact registered label because active strengths and acid-neutralizing capacity vary between products.
• Chewable Form: If registered as a chewable tablet, chew thoroughly before swallowing according to label directions.
• Persistent Symptoms: Frequent or persistent heartburn, swallowing difficulty, gastrointestinal bleeding, unexplained weight loss or recurrent severe pain warrants medical assessment.

9. Side Effects and Precautions

• Gastrointestinal: Aluminium salts can contribute to constipation and magnesium salts can contribute to diarrhea; individual response varies.
• Interactions: Aluminium/magnesium antacids can reduce absorption of tetracyclines, fluoroquinolones, iron, levothyroxine and other medicines. Separation intervals are medicine-specific; do not apply a universal two-hour rule.
• Kidney Disease: Significant renal impairment increases the risk of aluminium or magnesium accumulation; use requires professional assessment and may be inappropriate depending on the product label.
• Phosphate: Prolonged or excessive aluminium-containing antacid use may contribute to hypophosphatemia.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive heat and moisture.
• Keep container/package securely closed and out of reach of children.