Lignocaine Hydrochloride + Metronidazole + Chlorhexidine Gel

Lignocaine + Metronidazole + Chlorhexidine Gel belongs to the Gels and External Preparations category within the Dental and Anti-Infectives therapeutic segments. This formulation is specifically designed for the oral and periodontal healthcare segment — addressing the most common acute dental prescribing scenario where pain, anaerobic bacterial infection, and antiseptic plaque control must be managed simultaneously.

Lignocaine Hydrochloride IP 2% w/w delivers fast-onset topical anaesthesia on oral mucosa and gingival surfaces. Metronidazole Benzoate IP 1% w/w (the dental gel-preferred form, chosen for its lower water solubility and controlled release in the gel matrix) provides selective bactericidal action against anaerobes. Chlorhexidine Gluconate IP 1% w/w adds broad-spectrum antiseptic coverage with substantive 8–12-hour binding to oral surfaces.

Saar Biotech manufactures this DCGI-positioned formulation at our manufacturing facility in Baddi for third-party and contract manufacturing partners supplying the dental, hospital pharmacy, and clinical channels.

At Saar Biotech, we manufacture this triple-active gel using a proprietary controlled gel-base hydration and sequential API incorporation process that ensures uniform dispersion of all three active components without chemical interaction.

• Metronidazole Benzoate Incorporation: Unlike metronidazole base, metronidazole benzoate has low water solubility and requires specific blending conditions for uniform suspension in a hydrophilic gel matrix. Our validated blending sequence ensures fine, consistent particle distribution throughout the gel.
• Chlorhexidine Compatibility: Chlorhexidine gluconate can form incompatible complexes with certain anionics. Our excipient system is pre-validated for compatibility with chlorhexidine, preventing precipitation or activity loss.
• Gel Texture and Mouth Feel: Dental gels must be comfortable in application, neither too thin (poor retention) nor too thick (difficult to apply sub-gingivally). Saar Biotech optimizes the carbomer/polymer base for ideal dental gel viscosity and smooth mucosal contact.
• Tube Precision for Dental Channels: 15gm and 30gm are standard dental channel tube sizes. Packaging can include blunt dental applicator tips for periodontal pocket delivery.

This gel is manufactured by Saar Biotech for the following clinically recognized dental and oral applications:

• Acute Necrotizing Ulcerative Gingivitis (ANUG): First-choice combination therapy — metronidazole targets anaerobic periodontopathic bacteria, chlorhexidine provides antiseptic plaque suppression, lignocaine relieves severe gingival pain
• Pericoronitis: Pericoronal flap inflammation and infection associated with partially erupted third molars — local pain relief and anaerobic antimicrobial coverage
• Oral Ulcers with Secondary Infection: Aphthous or traumatic ulcers with secondary bacterial involvement requiring anaesthetic and antimicrobial topical management
• Periodontal Pocket Adjunct: Sub-gingival gel application as adjunct to scaling and root planing in chronic periodontitis with anaerobic flora
• Post-Extraction Site Care: Local antimicrobial and pain management support for extraction sockets

Schedule H — Requires a valid medical or dental prescription.

Clinical Mechanism of Action

Lignocaine (2%) reversibly blocks mucosal and gingival sensory Na⁺ channels, delivering local anaesthesia within 3–5 minutes of application and lasting 20–30 minutes — sufficient for procedure support and pain management during active treatment.

Metronidazole Benzoate (1%) slowly hydrolyses in the oral environment to active metronidazole. Inside anaerobic bacteria, ferredoxin-type reductases generate reactive nitro-radical intermediates that break microbial DNA strands selectively in the anaerobic environment — fungicidal and bactericidal against the specific oral anaerobes implicated in periodontal disease.

Chlorhexidine (1%) disrupts both gram-positive and gram-negative bacterial cell membranes through cationic binding. Its substantivity — binding to the oral pellicle and gradually releasing over 8–12 hours — provides extended post-treatment antimicrobial action beyond the time of gel application.

Manufacturing Integrity

• Sequential Incorporation: APIs are incorporated in a validated sequence to prevent chemical interaction during blending.
• Triple HPLC Release: All three APIs are independently verified by HPLC against IP reference standards before any batch is authorized for dispatch.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing for this dental gel from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.

• Facility: Semi-solid/gel manufacturing with controlled gel hydration vessels, high-shear blending, tube filling, and carton packing lines.
• Packaging: 15gm and 30gm laminated tubes — sticker label, printed tube, mono-carton, drip-off embossed carton, dental applicator tip inclusion.
• MOQ: 5,000 to 2,00,000+ tubes per SKU.
• Turnaround: New orders — 30–45 working days; Repeat orders — 20–25 working days.
• Documentation: Full COA, batch manufacturing record, and stability data on request.

Every commercial batch undergoes the following analytical release protocol:

• Lignocaine HCl Assay (HPLC): 95–105% of label claim vs IP reference
• Metronidazole Benzoate Assay (HPLC): 95–105% of label claim vs IP reference
• Chlorhexidine Gluconate Assay (HPLC): 95–105% of label claim vs IP reference
• pH Testing: Within approved gel base stability specification
• Viscosity Testing: Batch-to-batch dental gel consistency confirmed
• Microbial Limit Testing (MLT): Per IP topical/semi-solid specification
• Net Content Verification: Within ±3% of declared fill weight per tube
• Certificate of Analysis (COA): Issued with every B2B batch

For B2B manufacturing enquiries, contract pricing, or complete product dossier for Lignocaine HCl + Metronidazole Benzoate + Chlorhexidine Gluconate Gel, please use the enquiry form below.