Dibasic calcium phosphate, also known as dicalcium phosphate, is a widely used excipient in the pharmaceutical industry. It functions primarily as a diluent and binder in tablet formulations [1]. It is also used as a calcium and phosphate supplement [1].
What are the different forms of dibasic calcium phosphate?
Dibasic calcium phosphate exists in two forms: anhydrous and dihydrate [2]. Both are commonly used in pharmaceutical manufacturing.
How is dibasic calcium phosphate used in tablet manufacturing?
In tablet production, dibasic calcium phosphate serves as a filler to add bulk to the tablet and as a binder to help hold the ingredients together, aiding in granulation and compression [1]. Its flow properties and compressibility make it a popular choice for direct compression tablet manufacturing [3].
What are the advantages of using dibasic calcium phosphate?
Dibasic calcium phosphate offers good flowability and compressibility, which are essential for efficient tablet manufacturing [3]. It is also generally inert and compatible with a wide range of active pharmaceutical ingredients (APIs) [4].
Are there any regulatory considerations for dibasic calcium phosphate?
Dibasic calcium phosphate is recognized as safe and effective for its intended uses by regulatory bodies like the U.S. Food and Drug Administration (FDA) [1]. It is listed in the FDA's Inactive Ingredients Database [4].
What are the sources and availability of dibasic calcium phosphate?
Dibasic calcium phosphate is manufactured from calcium carbonate and phosphoric acid or by processing purified bone meal [5]. It is readily available from numerous chemical suppliers globally.
Are there alternatives to dibasic calcium phosphate for tablet formulation?
Other common diluents and binders used in tablet formulation include microcrystalline cellulose, lactose, starch, and pregelatinized starch. The choice of excipient depends on the specific API and the desired tablet characteristics [4].
What are the potential side effects of dibasic calcium phosphate?
When used as a supplement, excessive intake of dibasic calcium phosphate can lead to gastrointestinal upset, constipation, or hypercalcemia. However, as an excipient in pharmaceutical formulations, the amounts used are generally too small to cause systemic effects [1].