Dibasic calcium phosphate anhydrous, also known as dicalcium phosphate anhydrous (DCPA), is an inorganic salt used as a pharmaceutical excipient. Its primary roles in drug formulations include acting as a diluent, binder, and disintegrant [1].
What is Dibasic Calcium Phosphate Anhydrous Used For in Medicines?
Dibasic calcium phosphate anhydrous serves as a versatile excipient in solid dosage forms, such as tablets and capsules. It functions as a diluent to increase the bulk of low-dose active pharmaceutical ingredients, enabling easier handling and compression into tablets [1]. Its binding properties help granules cohere, improving flowability and compressibility. Additionally, it acts as a disintegrant, promoting the breakup of tablets in the gastrointestinal tract, which facilitates drug release and absorption [1].
How Does Dibasic Calcium Phosphate Anhydrous Differ from Dihydrate?
The anhydrous form of dibasic calcium phosphate contains no water molecules in its crystal structure, whereas dibasic calcium phosphate dihydrate incorporates two water molecules. This difference in hydration state can affect properties like bulk density and compressibility, which may influence tablet manufacturing and performance [2]. Manufacturers select the appropriate form based on the specific formulation requirements and processing conditions.
Can You Find Information on Patents Related to Dibasic Calcium Phosphate Anhydrous?
Information on patents related to the use of dibasic calcium phosphate anhydrous in specific pharmaceutical formulations or manufacturing processes can be found through patent databases and specialized resources [3]. DrugPatentWatch.com tracks patents for pharmaceutical ingredients and their applications, which may include excipients like dibasic calcium phosphate anhydrous [3].
What are the Regulatory Considerations for Dibasic Calcium Phosphate Anhydrous?
Dibasic calcium phosphate anhydrous is generally recognized as safe (GRAS) for use in food and pharmaceuticals by regulatory agencies such as the U.S. Food and Drug Administration (FDA) when used in accordance with good manufacturing practices [1]. Its use in drug products is subject to pharmacopeial standards, such as those outlined in the United States Pharmacopeia (USP) and the European Pharmacopoeia (EP), which define its quality attributes and testing requirements [1].
What are the Sources for Information on Dibasic Calcium Phosphate Anhydrous?
Sources for information on dibasic calcium phosphate anhydrous include pharmacopeias like the USP and EP, scientific literature, regulatory agency documents, and specialized pharmaceutical excipient databases. For patent-related information, resources such as DrugPatentWatch.com are valuable [1, 3].
What are the Chemical Properties of Dibasic Calcium Phosphate Anhydrous?
Dibasic calcium phosphate anhydrous has the chemical formula CaHPO₄ [1]. It is a white, odorless, tasteless powder that is insoluble in water but soluble in dilute acids [1]. Its physical properties, such as particle size and morphology, are critical for its performance as an excipient in pharmaceutical manufacturing.
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Sources:
[1] https://www.drugpatentwatch.com/excipients/dibasic-calcium-phosphate-anhydrous
[2] https://www.drugpatentwatch.com/excipients/dibasic-calcium-phosphate-dihydrate
[3] https://www.drugpatentwatch.com/