Carbamide peroxide API Manufacturers

General Description:

Carbamide peroxide, identified by CAS number 124-43-6, is a notable compound with significant therapeutic applications. Carbamide peroxide, also known as urea-hydrogen peroxide, is a water-soluble, white crystalline solid compound consisting of hydrogen peroxide and urea. As it is a source of hydrogen peroxide, it can be found in disinfecting and dental bleaching products. Some adverse effects of carbamide peroxide as a dental bleaching agent include dentin sensitivity and/or gingival irritation led by unstable and reactive H+ free radicals and low pH from prolonged use. It may also alter enamel surface morphology via enamel mineral loss and surface roughening . The FDA considers carbamide peroxide to be safe in oral mucosal injury drug products as an oral wound healing agent, although there is insufficient data to establish general recognition of the effectiveness of this ingredient as an oral wound healing agent . It is available in OTC otic drugs as non-water, non-oil-based solutions used to soften, loosen and remove excessive ear wax, or cerumen.

Indications:

This drug is primarily indicated for: Indicated as a dental bleaching agent. Indicated as an oral wound healing agent in oral mucosal injuries. Indicated as an aid in the removal of hardened ear wax. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Carbamide peroxide undergoes metabolic processing primarily in: No established pharmacokinetic data. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Carbamide peroxide are crucial for its therapeutic efficacy: Upon treatment into the external auditory canal or the dental cavity, exposure to carbamide peroxide is limited to the intimate contact with the treated area without any systemic absorption. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Carbamide peroxide is an important consideration for its dosing schedule: No established pharmacokinetic data. This determines the duration of action and helps in formulating effective dosing regimens.

Protein Binding:

Carbamide peroxide exhibits a strong affinity for binding with plasma proteins: No established pharmacokinetic data. This property plays a key role in the drug's pharmacokinetics and distribution within the body.

Route of Elimination:

The elimination of Carbamide peroxide from the body primarily occurs through: No established pharmacokinetic data. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Carbamide peroxide is distributed throughout the body with a volume of distribution of: No established pharmacokinetic data. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Carbamide peroxide is a critical factor in determining its safe and effective dosage: No established pharmacokinetic data. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Carbamide peroxide exerts its therapeutic effects through: Carbamide peroxide releases hydrogen peroxide and free radicals upon contact with water or outer surfaces of ear and tooth. Hydrogen peroxide exerts cerumenolytic, enamel-bleaching and antiseptic actions. _In vitro_, the chemical stability of ceramics against bleaching agents was observed after treatment with 15% carbamide peroxide for 56 h, 16% carbamide peroxide for 126 h, 10% or 15% carbamide peroxide and 38% hydrogen peroxide for 30 minutes or 45 minutes, respectively . According to _in vitro_ studies, high (37%) or low (10 or 16%) concentrated carbamide peroxide agents were similarly effective as oral bleaching agents . Treatment with carbamide peroxide may lead to demineralization which involves decreased mineral content of enamel calcium, phosphate, and fluoride, and alteration of the chemical, structural, and mechanical properties . Carbamide peroxide may affect the organic components of the enamel and lead to increased susceptibility to erosion, fracture stability or decreased abrasion resistance of the treated area . The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Carbamide peroxide functions by: Carbamide peroxide release hydrogen peroxide upon contact with teeth, which is a strong oxidizing and bleaching agent. It also release free radicals such as H+ or H3O+ . Hydrogen peroxide also acts as an antiseptic, especially in sites with relative anaerobiosis. Following otic administration, carbamide peroxide complex releases hydrogen peroxide that breaks up the hardened wax. The hydrogen peroxide component, which further breaks down into water, is also a cerumenolytic that hydrates the desquamated sheets of corneocytes, which are the major constituent of cerumen plugs . The glycerol and urea facilitates softening of the cerumen, either with or without syringing . Both hydrogen peroxide and urea mildly induce keratolysis with disintegration of the ear wax to help reduce the keratin-load in the ear debris and allow other active components to reach the skin under the debris . This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Carbamide peroxide belongs to the class of organic compounds known as ureas. These are compounds containing two amine groups joined by a carbonyl (C=O) functional group, classified under the direct parent group Ureas. This compound is a part of the Organic compounds, falling under the Organic acids and derivatives superclass, and categorized within the Organic carbonic acids and derivatives class, specifically within the Ureas subclass.

Categories:

Carbamide peroxide is categorized under the following therapeutic classes: Amides, Anions, Anti-Infective Agents, Anti-Infective Agents, Local, Bleaching Agents, Compounds used in a research, industrial, or household setting, Electrolytes, Free Radicals, Ions, Noxae, Oxidants, Oxides, Oxygen Compounds, Peroxides, Reactive Oxygen Species, Tooth Bleaching Agents, Toxic Actions. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Carbamide peroxide include:

• Water Solubility: 500 g/L at °C
• Melting Point: 75-85