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Calcium Carbonate Excipient | Uses, Suppliers, and ...

May. 06, 2024

Calcium Carbonate Excipient | Uses, Suppliers, and ...

Calcium carbonate is a highly versatile material excipient. It is used in oral solid and liquid dosage forms both as an excipient and active pharmaceutical ingredient.

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Calcium Carbonate Uses an Excipient

In oral solid dosage forms, Calcium carbonate functions as a filler – diluent and as a dry binder. It is widely used to formulate tablets and capsules, as well as granules and powders where the use of an inorganic, less abrasive filler-diluent is preferred over traditional fillers.

Calcium carbonate is often the preferred excipient in formulations where the active pharmaceutical ingredient is poorly soluble and/or present in low doses.

Furthermore, the chalky-soft texture in the mouth makes Calcium carbonate suitable for formulating chewable and buccal tablets and well as conventional swallow tablets produced both by wet granulation, roller compaction, and direct compression. The addition of small amounts of Calcium carbonate to tablet formulations enhances compressibility in direct compression formulations.

Three grades of Calcium carbonate are available:

  • Natural/Ground Calcium carbonate, which is ideal for formulating chewable tablets, orally disintegrating tablets, granules, capsules, and swallow tablets

  • Precipitated/Synthetic Calcium carbonate, which is mainly used to formulate orally disintegrating tablets, and standard swallow tablets obtained by wet granulation or roller compaction.

  • Co-processed Calcium carbonate, which is promoted for formulating swallow tablets and buccal chewable tablets by direct compression.

A representation of how Calcium carbonate compares with other commonly used excipients is shown below:

When formulating Calcium carbonate tablets, care must be taken not to exceed the daily suggested Calcium (<2.5 g per day for those under 50). It is recommended that no more than 500mg be included in a single dose. If the tablet fill weight necessitates a higher amount of Calcium carbonate to be used, this should be split, and taken 4 hours apart.

Not that higher Calcium doses (i.e >500mg) are also less bioavailable. A combination with Vitamin D can also aid the uptake of Calcium, which helps the the body utilise it more effectively.

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An example of a simple tablet formulation utilising Calcium carbonate as a filler that can be processed via direct compression or wet granulation is shown below:

Use of Calcium Carbonate as an Absorbent for Oily liquids

Fine or micronized Calcium carbonate grades can be used to absorb oils or oily active pharmaceutical ingredients or other formulation additives allowing them to be transformed into dry, highly compressible powders. The higher the specific surface area, the greater the extent of oil absorption.

Nutraceutical Applications of Calcium Carbonate

Many dietary supplements take the form of tablets, capsules, or stick packs. It is suitable for formulating chewable, swallow, or effervescent tablets. For tablet production, direct compaction is often the preferred approach as it is faster and more efficient.

Calcium carbonate is commonly used as a filler-diluent and dry binder in nutraceutical tablets. It offers the added advantage of providing highly bioavailable Calcium in a cost-effective and accessible format for many consumers.

Generally, highly pure, co-processed natural or ground Calcium carbonate grades are the preferred raw materials for the formulation of nutraceutical tablets. These grades are highly compressible and free-flowing, rendering them the ideal ingredient for tablet formulation.

With the exception of Calcium citrate, Calcium carbonate is preferred as a filler in nutraceutical tablets over other Calcium salts, such as Calcium phosphate, Calcium citrate, and Calcium gluconate, as its more cost-effective and more bioavailable, particularly when ingested with/after a meal due to the helpful action of gastric hydrochloric acid.

Application of Calcium Carbonate as a Pigment

Calcium carbonate has been used as a white pigment since antiquity. It is still used as an extender in construction paints as well as a pigment in many other fields. While lacking the whiteness of titanium dioxide, it is a safer, more widely accepted material and known for its high binding and coverage properties, especially when used to formulate high solids coatings.

Use of Calcium Carbonate as an Active Pharmaceutical Ingredient

Speciality grades of Calcium carbonate certified to the purity requirements of the pharmacopoeia are used as sources of calcium for the treatment of osteoporosis.

Calcium carbonate is also an important active in the formulation of over-the-counter digestive aids and antacids. Being alkaline, it reacts with gastric hydrochloric acid, according to the following scheme:

CaCO3 + 2HCl -> CaCl2 + Co2 + H2O

Calcium carbonate is suitable for formulating tablets and liquids. An example of an antacid Calcium carbonate formulation is shown below:

 

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