Dried Aluminium Hydroxide Gel + Magnesium Trisilicate + Peppermint Oil Tablets

Description

Dried Aluminium Hydroxide, Magnesium Trisilicate & Peppermint Oil Tablets

(Antacid & Carminative)

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 chewable antacid tablets in India. This formulation combines dried aluminium hydroxide gel and magnesium trisilicate for gastric acid neutralization with peppermint oil as a flavoring/carminative component. According to the registered formulation, it may provide temporary symptomatic relief from heartburn, acid indigestion, dyspepsia-associated discomfort and gas/bloating.

Contract manufacturing can include market-specific chewable formulations, flavors, sweeteners and packaging. Persistent or recurrent reflux, dyspepsia or abdominal symptoms require appropriate medical evaluation rather than prolonged self-treatment.

2. Product Specifications

3. Manufacturing Technology

• Mineral Blend Control: Aluminium and magnesium ingredients are dispensed and blended according to the approved formula. Their combination may balance some gastrointestinal effects but does not guarantee neutral bowel motility in every patient.
• Volatile Oil Handling: Peppermint oil may be incorporated using a suitable carrier/adsorption process designed to support uniformity and minimize volatile loss, subject to validation.
• Chewable Matrix: Particle-size control and permitted excipients can be used to improve texture and palatability. Mannitol, sorbitol or other excipients should only be claimed when present in the actual registered formula.
• Packaging: Packaging is selected to protect the product from moisture and volatile loss throughout the validated shelf life.

4. Quality Assurance

• Acid-Neutralizing Capacity: Tested where required using the applicable registered method and acceptance criteria.
• Identity / Assay: Mineral components are controlled according to approved pharmacopoeial or in-house specifications.
• Peppermint Component: Raw-material identity and finished-product controls are applied according to the validated formulation and specification.
• Stability: Shelf life, packaging and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

1. Acid Neutralization: Aluminium hydroxide and magnesium trisilicate react with gastric acid, increasing gastric pH and providing temporary relief of acid-related symptoms.
2. Carminative / Sensory Role: Peppermint oil can provide a cooling flavor and may help some gastrointestinal symptoms. However, peppermint can reduce lower-esophageal-sphincter tone in some people and may worsen heartburn/reflux; it should therefore not be described as universally beneficial for GERD.

Potential symptom uses: acid indigestion, dyspepsia-associated discomfort and gas/bloating according to approved labeling.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where applicable.
• Certificates: FSC, COPP and COA where applicable.
• Packaging: Retail, institutional or roll-pack presentations according to approved 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 tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures antacid tablet formulations in India.

Q: Should a chewable tablet be swallowed whole?
A: If the registered dosage form is chewable, it should be chewed thoroughly according to label directions. Chewing increases dispersion/contact area before swallowing.

Q: Why is Peppermint Oil included?
A: It can provide flavor and carminative effects. In some people peppermint may aggravate reflux/heartburn, so individual response and the product label matter.

Q: What about kidney problems?
A: Significant renal impairment can increase the risk of aluminium or magnesium accumulation. Patients with kidney disease should seek professional advice before using aluminium/magnesium antacids.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Product-Specific Dosing: Number of tablets, frequency, timing and maximum daily amount should follow the exact registered label; do not apply a universal 1–2 tablet or eight-tablet maximum to every formulation.
• Chewable Form: Chew thoroughly before swallowing when the product is registered as a chewable tablet.
• Persistent Symptoms: Frequent or severe heartburn, difficulty swallowing, gastrointestinal bleeding, unexplained weight loss or recurrent pain requires medical evaluation.

9. Side Effects and Precautions

• Gastrointestinal: Aluminium salts may cause constipation and magnesium salts may cause diarrhea. Peppermint can cause heartburn/reflux symptoms in susceptible individuals.
• Interactions: Aluminium/magnesium antacids can reduce absorption of tetracyclines, fluoroquinolones, iron, levothyroxine, Digoxin and other medicines. Required separation intervals are medicine-specific; a universal two-hour rule is not appropriate.
• Kidney Disease: Significant renal impairment requires medical assessment because aluminium and magnesium can accumulate.
• 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 packaging securely closed to minimize moisture uptake and volatile-oil loss, and keep out of reach of children.