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Chlorhexidine | CAS No: 55-56-1 | GMP-certified suppliers
A medication that serves as a topical antiseptic for surgical preparation and a prescription dental agent for treating gingivitis and reducing periodontal pocket depth in periodontitis patients.
Therapeutic categories
Primary indications
- Chlorhexidine is available over-the-counter in various formulations (e
- G
- Solution, sponge, cloth, swab) as a topical antiseptic to sanitize prior to surgeries and/or medical procedures
- Dental formulations, available by prescription only, include an oral rinse indicated for the treatment of gingivitis and a slow-release "chip" which is inserted into periodontal pockets and is indicated for the reduction of pocket depth in adult patients with periodontitis as an adjunct therapy to dental scaling and root planing procedures
Product Snapshot
- Chlorhexidine is available in multiple formulation types including topical solutions, gels, sponges, mouthwashes, and dental inserts for antimicrobial use
- Its primary therapeutic applications include topical antisepsis prior to medical procedures and dental treatment adjunctive to scaling and root planing for gingivitis and periodontitis
- Chlorhexidine products are approved for use in the US and Canada markets
Clinical Overview
Clinically, chlorhexidine is indicated primarily for antisepsis of skin and mucous surfaces prior to surgical or medical procedures. In dental practice, it is employed to treat inflammatory dental conditions, specifically gingivitis and periodontitis. Prescription formulations include oral rinses for gingivitis treatment and slow-release chips inserted into periodontal pockets as adjuncts to scaling and root planing to reduce pocket depth.
The antimicrobial activity of chlorhexidine is concentration-dependent. At lower concentrations (0.02%-0.06%), it exerts bacteriostatic effects by causing leakage of intracellular ions. Higher concentrations (›0.12%) are bactericidal, inducing cytoplasmic precipitation within microbial cells. Mechanistically, the positively charged chlorhexidine binds to negatively charged phosphate groups on microbial cell membranes, disrupting membrane integrity and allowing intracellular entry that leads to cell death.
Pharmacokinetic data on oral rinses indicate approximately 30% of chlorhexidine is retained in the oral cavity post-rinse, with slow release into saliva, a property known as substantivity. This persistence enhances antimicrobial efficacy by preventing microbial colonization on surfaces such as dentine.
Safety considerations include the potential for oral surface staining with extended use, notably beyond six months, warranting cautious use to minimize aesthetic concerns. Allergic reactions range from mild dermatitis to rare but severe anaphylaxis. The FDA withdrew approval for chlorhexidine gluconate 0.5% topical tincture due to reports of chemical and thermal burns; however, other chlorhexidine formulations remain available globally.
For API procurement, sourcing high-purity chlorhexidine with consistent physicochemical properties and free from chlorhexidine degradation products is essential. Compliance with pharmacopeial standards and certificates of analysis supporting identity, purity, and microbial limits should be verified to ensure quality and safety in pharmaceutical manufacturing.
Identification & chemistry
| Generic name | Chlorhexidine |
|---|---|
| Molecule type | Small molecule |
| CAS | 55-56-1 |
| UNII | R4KO0DY52L |
| DrugBank ID | DB00878 |
Pharmacology
| Summary | Chlorhexidine is a topical antiseptic agent targeting bacterial cell membranes through electrostatic interactions that disrupt membrane integrity and induce cytoplasmic precipitation, leading to microbial cell death. It exhibits broad-spectrum antimicrobial activity against gram-positive and gram-negative bacteria, yeasts, and viruses, with dose-dependent bacteriostatic and bactericidal effects. Its substantial retention on oral surfaces, known as substantivity, contributes to sustained antimicrobial action in dental applications. |
|---|---|
| Mechanism of action | Chlorhexidine’s broad-spectrum antimicrobial effects are due to its ability to disrupt microbial cell membranes. The positively charged chlorhexidine molecule reacts with negatively charged phosphate groups on microbial cell surfaces - this reaction both destroys the integrity of the cell, allowing leakage of intracellular material, and allows chlorhexidine to enter the cell, causing precipitation of cytoplasmic components and ultimately cell death. The specific means of cell death is dependent on the concentration of chlorhexidine - lower concentrations are bacteriostatic and result in leakage of intracellular substances such as potassium and phosphorous, whereas higher concentrations are bactericidal and cause cytoplasmic precipitation. |
| Pharmacodynamics | Chlorhexidine is a broad-spectrum antimicrobial with demonstrated activity against both gram-positive and gram-negative bacteria, yeasts, and viruses. Antimicrobial activity is dose-dependent - chlorhexidine is bacteriostatic at lower concentrations (0.02%-0.06%) and bactericidal at higher concentrations (>0.12%). Pharmacokinetic studies of oral chlorhexidine rinses indicate that approximately 30% of the active ingredient is retained in the mouth following rinsing, which is subsequently slowly released into oral fluids. This ability to adsorb to dentine, shared with tetracycline antibiotics such as [doxycycline], is known as "substantivity" and is the result of chlorhexidine's positive charge - it is likely that this substantivity plays at least some role in chlorhexidine's antimicrobial activity, as its persistence on surfaces such as dentine prevent microbial colonization. Dental chlorhexidine rinses may result in staining of oral surfaces, such as teeth. This effect is not ubiquitous and appears to be more significant with extended therapy (i.e. up to 6 months) - nevertheless, patients for whom oral staining is unacceptable should use chlorhexidine rinse with caution and for the shortest effective interval. Allergic reactions to chlorhexidine have been associated with the development of anaphylaxis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Bacterial outer membrane | Bacteria | incorporation into and destabilization |
ADME / PK
| Absorption | Topically, chlorhexidine is unlikely to undergo any degree of systemic absorption. Orally administered chlorhexidine, such as that found in oral rinses for dental purposes, is very poorly absorbed from the gastrointestinal tract - the C<sub>max</sub> in human subjects following an oral dose of 300mg was 0.206 µg/g and occurred approximately 30 minutes after ingestion (T<sub>max</sub>). Following the insertion of 4 PerioChips in 18 adult patients, no detectable plasma or urine chlorhexidine levels were observed. |
|---|---|
| Protein binding | Chlorhexidine is known to bind albumin in both serum and saliva, though the extent of this binding is unclear. |
| Metabolism | As chlorhexidine is very poorly absorbed in the gastrointestinal tract, it is unlikely to undergo metabolic conversion to any significant extent. |
| Route of elimination | Excretion of chlorhexidine gluconate occurs almost exclusively via the feces, with less than 1% of an ingested dose excreted in the urine. |
Formulation & handling
- Chlorhexidine is a small molecule primarily formulated for topical and oral use, including gels, solutions, and mouthwashes.
- It has low water solubility and a relatively high LogP, indicating the need for appropriate solubilizing agents in formulations.
- Oral formulations should consider administration timing separate from meals due to potential taste alteration and reduced efficacy.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is approaching patent expiry in the United States between 2023 and 2027, indicating increasing market maturity and potential for generic competition. It is currently marketed in the US and Canada. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Chlorhexidine manufacturing involves a diverse group of originator companies and contract manufacturers, with both pharmaceutical and medical device firms contributing to its supply. Branded products are primarily present in the US and Canadian markets, reflecting a concentrated geographic presence. Existing patents have recently expired or will expire soon, indicating established and potential generic competition in these markets. |
|---|
Safety
| Toxicity | The LD<sub>50</sub> of subcutaneously administered chlorhexidine in mice is >5 g/kg. Small children are likely to be more susceptible to chlorhexidine overdose - ingestion of 1-2 ounces by a small child may result in gastric distress, nausea, and intoxication. Treatment should consist of symptomatic and supportive measures. Seek medical attention if a child ingests >4 ounces of chlorhexidine solution or if symptoms of intoxication develop post-exposure. |
|---|
- Handle chlorhexidine with appropriate protective equipment to avoid inadvertent ingestion or dermal exposure
- In case of accidental ingestion, particularly in pediatric settings, monitor for gastrointestinal symptoms and systemic toxicity
- Maintain secure storage to prevent access by children, as small volumes may elicit adverse effects
Chlorhexidine is a type of Disinfectants
Disinfectants are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a vital role in maintaining cleanliness and preventing the spread of harmful microorganisms. These chemical agents are designed to eliminate or inhibit the growth of bacteria, viruses, fungi, and other pathogens on various surfaces and objects.
Pharmaceutical-grade disinfectants are formulated to meet stringent quality standards and are commonly used in hospitals, laboratories, pharmaceutical manufacturing facilities, and other healthcare settings. They are also utilized in the food and beverage industry, as well as in households, to ensure proper sanitation and hygiene.
Disinfectants typically contain active ingredients such as quaternary ammonium compounds, chlorine compounds, hydrogen peroxide, or alcohol, which have been proven effective against a broad spectrum of microorganisms. These active ingredients work by disrupting the cell membranes or enzymatic processes of the pathogens, rendering them incapable of replication and causing their eventual destruction.
When selecting a disinfectant, factors such as the intended application, target microorganisms, and compatibility with the surfaces or objects being treated need to be considered. It is crucial to follow proper usage instructions and adhere to recommended contact times for effective disinfection.
In conclusion, disinfectants are essential pharmaceutical APIs used to control and prevent the spread of harmful microorganisms. Their efficacy in eliminating pathogens makes them indispensable in maintaining cleanliness and ensuring public health and safety.
Chlorhexidine (Disinfectants), classified under Antidotes, Deterrents, and Toxicologic Agents
Antidotes, Deterrents, and Toxicologic Agents are an important category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a critical role in healthcare and toxicology. These substances are designed to counteract the effects of poisons, toxins, and overdoses, thereby saving lives and preventing severe health consequences.
Antidotes are substances that neutralize the toxic effects of certain drugs, chemicals, or poisons. They work by either directly binding to the toxic substance or by blocking its harmful actions on the body. Antidotes are administered in emergency situations to quickly reverse the effects of poisoning and restore normal physiological functions.
Deterrents, on the other hand, are pharmaceutical agents used to discourage or prevent harmful behaviors, such as substance abuse. They are designed to make the ingestion or misuse of certain substances unpleasant or less desirable. Deterrents can be formulated to cause unpleasant side effects, such as nausea or vomiting, when a particular substance is consumed in excessive amounts.
Toxicologic agents encompass a broad range of pharmaceutical APIs used in toxicology studies and research. These substances are employed to investigate the toxicity, metabolism, and mechanisms of action of various chemicals and compounds. Toxicologic agents are vital for understanding the potential hazards and risks associated with certain substances, ensuring the safety of drugs, and developing effective treatments for poisoning cases.
In conclusion, Antidotes, Deterrents, and Toxicologic Agents are essential categories of pharmaceutical APIs that address poisoning emergencies, deter harmful behaviors, and enable toxicological research. Their development and availability are crucial for safeguarding public health, enhancing patient care, and advancing our understanding of toxicology.
Chlorhexidine API manufacturers & distributors
Compare qualified Chlorhexidine API suppliers worldwide. We currently have 15 companies offering Chlorhexidine API, with manufacturing taking place in 7 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| BAJAJ HEALTHCARE LTD | Producer | India | India | CEP, CoA, GMP | 8 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | India | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chr. Olesen Group | Distributor | Denmark | India | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| Evonik TC | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 7 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| Maruishi Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP, USDMF | 39 products |
| R.N. Laboratories | Producer | India | India | CEP, CoA, USDMF | 2 products |
| Schütz & Co | Producer | Germany | Germany | CEP, CoA | 2 products |
| Shaanxi Dasheng Pharma | Producer | China | China | CoA, WC | 3 products |
| Sogo Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 5 products |
| Xttrium Labs. | Producer | United States | United States | CoA, USDMF | 1 products |
When sending a request, specify which Chlorhexidine 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.).
Use the list above to find high-quality Chlorhexidine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
