Today’s pharmaceutical industry has developed fast acting, safe, and low-cost antacids, many of which  contain calcium carbonate as the active ingredient.

Why calcium carbonate in antacids?
Calcium carbonate is an efficient acid neutralizer that goes to work rapidly. Neutralizing the excess acid in the stomach raises the pH so these liquids are less irritating if they rise back up into the esophagus.

A second benefit is the elemental calcium brought into the body, which contributes to healthy bones and helps prevent osteoporosis. Calcium carbonate has the highest level of elemental calcium at 40 percent, so each antacid dose helps to meet the daily calcium requirement.

Finally, calcium carbonate is one of the least expensive antacid actives.

Antacid Limits and Guidelines
In the United States, antacids are normally OTC (Over The Counter) pharmaceuticals. Calcium carbonate is approved as an active ingredient in antacids, in section 21 CFR 331.10 of the Code of Federal Regulations. Each suggested single dosage unit must contain at least 5 mEq (milliequivalents) of acid neutralizing capacity. The maximum daily dosage under this regulation is 160 mEq of calcium ion, which in the case of pure calcium carbonate, corresponds to 8 grams per day. Calcium carbonate antacid tablets must disintegrate within 10 minutes and show complete dissolution within 30.

Calcium carbonate can also be used with other antacid actives in combination as long as it contributes at least 25 percent of the total acid neutralizing capacity of the product. Other countries will have similar approvals and limitations, which should be checked before formulating your antacid product.

Also in the United States, calcium-based antacids are subject to the requirements of California Proposition 65, which limits the amount of lead that can be ingested daily. One of the Learn More links below will take you to an information sheet that outlines this regulation, and how it can be met using Specialty Minerals precipitated calcium carbonates.

Antacid Dosage Forms
Consumers have a variety of forms to choose from when picking a calcium antacid. These include chewable, swallowable and effervescent tablets, liquids, soft chews, soft gels  and antacid chewing gums.

Each dosage form has different formulating parameters, which can often be difficult to meet just one simple ground calcium carbonate raw material. Specialty Minerals Inc. (SMI) has 20 pharmaceutical grade precipitated calcium carbonates, of different sizes, shapes, surface areas, and oil absorptions. With this variety, the formulator can choose the particle that gives the drug performance needed, while providing the excellent product taste consumers demand. Click on one of these links for information on the use of SMI PCCs in antacids:

• Antacid Tablets: Chewable, Swallowable, Effervescent
• Antacid Liquids
• Antacid Soft Chews and Soft Gels
• SMI Precipitated Calcium Carbonates for Antacids

Learn more:

• SMI calcium carbonates for pharmaceuticals
• SMI minerals used in consumer products See the many products you use every day that contain SMI minerals
• SMI Quality: Good Manufacturing Practices and Kosher Certification
  
  
• What is Precipitated Calcium Carbonate (PCC)?
• What is PCC for Healthcare? A downloadable information sheet
  
  
• Resources and Useful Information for Formulators Downloadable information sheets on bioavailability, economics of formulating with calcium carbonate, and effect of particle size and shape on pharmaceutical properties
• California Proposition 65 and Lead Levels
• Osteoporosis: Anyone Can Be At Risk—Even You! A downloadable information sheet