Calcium β-glycerophosphate (Calcium glycerophosphate) API Manufacturers & Suppliers
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Calcium glycerophosphate | CAS No: 27214-00-2 | GMP-certified suppliers
A medication that supports dental health by preventing caries through enamel mineralization and serves as a calcium and phosphate supplement in patients with mineral deficiencies.
Therapeutic categories
Primary indications
- Calcium glycerophosphate is found in OTC dental products such as toothpastes for the prevention of dental caries
- As OTC products these do not have an official indication
- In prescription products it is indicated as a [DB01373] or phosphate donor for replacement or supplementation in patients with insufficient [DB01373] or phosphate
Product Snapshot
- Calcium glycerophosphate is available in multiple formulations including capsules, liquids, tablets, pastes, and dentifrices suitable for oral, dental, topical, and injectable routes
- It is primarily used as a phosphate donor for supplementation or replacement in patients with phosphate insufficiency and is included in over-the-counter dental products aimed at caries prevention
- This API is approved for use in key markets including the US and Canada
Clinical Overview
Clinically, calcium glycerophosphate is used primarily in over-the-counter dental care products such as toothpastes aimed at the prevention of dental caries. Although these OTC formulations do not carry formal regulatory indications, the compound is recognized for its role in promoting the mineralization and integrity of tooth enamel. In prescription applications, calcium glycerophosphate serves as a calcium and phosphate donor to supplement or replace electrolytes in patients with deficiencies of these essential minerals.
Pharmacodynamically, calcium glycerophosphate exerts anti-caries effects through multiple postulated mechanisms. These include enhancing enamel acid resistance and mineralization, buffering dental plaque pH, modifying plaque composition, and elevating calcium and phosphate ion concentrations within the plaque and enamel microenvironment. Notably, calcium glycerophosphate facilitates higher retention of phosphate ions when compared to alternative salts such as calcium phosphate or combinations like calcium gluconate with potassium phosphate, which may support improved incorporation of these ions into bone and dental tissue.
Mechanistically, when combined with sodium monofluorophosphate, calcium glycerophosphate has been demonstrated to reduce enamel acid solubility, likely by promoting increased uptake of fluoride in a form less soluble in alkali, thereby enhancing remineralization. The buffering action occurs via phosphate ions reacting with hydrogen ions to form bisphosphate and dihydrogen phosphate species, compounds with amphoteric properties that stabilize plaque pH under acidic challenge. While some studies suggest plaque-modifying effects such as reductions in plaque mass or area, these findings lack consistent confirmation and do not provide a definitive causal linkage to the compound’s anti-caries efficacy.
Absorption, distribution, metabolism, and excretion (ADME) profiles of calcium glycerophosphate relate primarily to its components—calcium and phosphate ions—which play critical roles in systemic mineral homeostasis. As an electrolyte supplement, calcium glycerophosphate’s improved solubility profile confers advantages over less soluble calcium phosphate salts.
Safety evaluations by the FDA designate calcium glycerophosphate as Generally Recognized as Safe (GRAS) for use as a nutrient supplement and an additive in food products, including gelatins and puddings. Toxicity concerns are minimal at typical usage levels, with no significant adverse effects documented in the context of dental or nutritional applications.
Commercially, calcium glycerophosphate is incorporated into various dental hygiene products due to its cariostatic properties and in pharmaceutical electrolyte replacement formulations. Typical usage contexts include anti-caries toothpastes and calcium/phosphate supplementation in clinical scenarios of mineral depletion.
From an API sourcing perspective, quality considerations include ensuring the correct stereoisomeric composition and verifying the purity of the salt mixtures. Due to its hygroscopic nature, proper storage and packaging are warranted to maintain stability. Compliance with pharmacopeial standards and regulatory approvals in target markets should be confirmed, alongside traceability of raw material sources, to ensure consistent quality and efficacy in downstream formulation development.
Identification & chemistry
| Generic name | Calcium glycerophosphate |
|---|---|
| Molecule type | Small molecule |
| CAS | 27214-00-2 |
| UNII | Y56W30YB7O |
| DrugBank ID | DB11264 |
Pharmacology
| Summary | Calcium glycerophosphate acts primarily as a donor of calcium and inorganic phosphate ions, supporting enamel remineralization and increasing acid resistance to reduce dental caries risk. It also contributes to plaque pH buffering through phosphate ion donation. Additionally, calcium glycerophosphate enhances phosphate retention compared to other calcium-phosphate salts, facilitating incorporation of these minerals into tooth and bone structures. |
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| Mechanism of action | Calcium glycerophosphate in combination with sodium monofluorophosphate was found to reduce the acid solubility of enamel. This is thought to be due to increased uptake of fluoride in a non-alkali soluble form at the expense of a fraction remaining in the alkali-soluble form of calcium fluoride . It is also thought that calcium glycerophosphate enhances the remineralization effect of sodium monofluorophosphate leading to greater remineralization of enamel but the mechanism behind this is unknown. Calcium glycerophosphate reduces the decrease in plaque pH produced by sucrose solutions . This may be due to the buffering action of donated phosphate which acts as an acceptor to three hydrogen ions to form biphosphate, dihydrogen phosphate, and finally phosphoric acid. As bisphosphate and dihydrogen phosphate are amphoteric, these molecules can act as buffers against both acids and bases. Studies on plaque-modification by calcium glycerophosphate have been inconsistent . Redections in plaque weight and plaque area have been noted in separate studies but neither has been confirmed and no causative link has been established in regards to calcium glycerophosphate's anti-caries effect. Calcium glycerophosphate donates [DB01373] and inorganic phosphate resulting in elevated levels of the ions in plaque . These ions are important components of the mineral structure of teeth. As such, their presence supports maintenance of healthy tooth structure and mineralization. In electrolyte replacement calcium glycerophosphate again acts as a donor of [DB01373] and phosphate. See [DB11348] for pharmacological descriptions of calcium and phosphate. |
| Pharmacodynamics | It is thought that calcium glycerophosphate may act through a variety of mechanisms to produce an anti-caries effect . These include increasing acid-resistance of the enamel, increasing enamel mineralization, modifying plaque, acting as a pH-buffer in plaque, and elevating [DB01373] and phosphate levels. When used as an electrolyte replacement, calcium glycerophosphate donates [DB01373] and inorganic phosphate. Calcium glycerophosphate is preferable to calcium phosphate due to its increased solubility. Compared to combination calcium gluconate and potassium phosphate, calcium glycerophosphate produces greater phosphate retention which allows for increased [DB01373] retention and ultimately greater incorporation of the ions into bone structure . |
Formulation & handling
- Calcium glycerophosphate is a small molecule suitable for multiple administration routes including oral, parenteral (IM, IV, SC), topical, and dental applications.
- The compound exhibits high water solubility and low lipophilicity (LogP -2), indicating good aqueous compatibility for formulation development.
- Handling does not require special stability measures beyond standard precautions for water-soluble organic salts.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently marketed in Canada and the US, with patent protection having expired recently, allowing for generic competition and increasing market availability. Market maturity is characterized by established product formulations and multiple authorized manufacturers. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | The manufacturing and supply landscape for calcium glycerophosphate involves multiple originator companies producing branded formulations across markets in Canada and the US. Branded products are present primarily in North America, with limited information on European or other regional distribution. Patent expirations in this category suggest the presence of existing generic competition alongside established branded offerings. |
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Calcium glycerophosphate is a type of Alkalinizing agents
Alkalinizing agents, a pharmaceutical API category, refers to a group of substances used to increase the pH (alkalinity) of a solution or body fluid. These agents play a crucial role in various medical applications, such as the treatment of acidosis, kidney disorders, and certain drug overdoses.
One commonly used alkalinizing agent is sodium bicarbonate, which is highly effective in raising the pH of blood and urine. It works by neutralizing excess acid and restoring the acid-base balance in the body. Sodium bicarbonate is often administered intravenously in emergency situations to rapidly correct severe acidosis.
Another alkalinizing agent, acetazolamide, is frequently employed in the treatment of glaucoma and certain types of epilepsy. By inhibiting carbonic anhydrase, acetazolamide reduces the production of bicarbonate ions, leading to a systemic decrease in pH. This mechanism is particularly useful in lowering the intraocular pressure associated with glaucoma.
Alkalinizing agents are also utilized in the management of certain drug toxicities. For instance, methotrexate, a chemotherapy medication, can cause severe toxicity if its elimination is hindered. Alkalinizing the urine with agents like sodium bicarbonate enhances methotrexate solubility, preventing the formation of toxic crystals in the kidneys.
In conclusion, alkalinizing agents are indispensable pharmaceutical APIs that help correct acid-base imbalances, treat specific medical conditions, and mitigate drug toxicities. Their diverse applications make them valuable tools in modern medicine.
Calcium glycerophosphate API manufacturers & distributors
Compare qualified Calcium glycerophosphate API suppliers worldwide. We currently have 2 companies offering Calcium glycerophosphate API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
When sending a request, specify which Calcium glycerophosphate API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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