Beclomethasone + Phenylephrine + Lignocaine Cream

Beclomethasone + Phenylephrine + Lignocaine Cream belongs to the Creams and External Preparations category, positioned within the Gastroenterology and Dermatology therapeutic segments. It is a prescription-only anorectal topical cream designed for the multi-symptom management of haemorrhoidal disease — a condition estimated to affect 50–75% of individuals at some point in their lifetime.

The formulation rationale rests on the multifactorial symptomology of anorectal conditions: oedema (addressed by beclomethasone’s anti-inflammatory action), vascular engorgement (managed by phenylephrine’s alpha-adrenergic vasoconstriction), pain and pruritus (relieved by lignocaine’s local anaesthetic block), and product microbiological stability (maintained by chlorocresol preservative action). Saar Biotech manufactures this DCGI-positioned formulation at our Baddi manufacturing facility for third-party and contract manufacturing partners across India.

At Saar Biotech, we manufacture Beclomethasone + Phenylephrine + Lignocaine Cream using a proprietary four-API semi-solid homogenization process that maintains content uniformity and chemical stability across the full batch.

• Multi-Active Distribution Control: Four pharmacologically diverse APIs — a corticosteroid ester, an alpha-adrenergic amine, an amide local anaesthetic, and an antimicrobial phenolic — must be homogenously distributed in the cream base without chemical interaction. Our validated mixing protocol and in-process sampling confirm uniform dispersion at every production stage.
• Preservative System Integrity: Chlorocresol at 0.1% functions as the primary preservative but requires pH and base compatibility for effective antimicrobial activity. Our formulation chemistry maintains the correct physicochemical environment to keep the preservative system effective across the 24-month shelf life.
• Patient-Optimized Texture: Anorectal creams must spread comfortably on sensitive perianal tissue. Saar Biotech’s base selection delivers a smooth, non-gritty, non-sting-on-application texture that supports patient compliance for prescription-led brands.
• Applicator-Ready Packaging: Our 20gm laminated tube format is compatible with rectal applicator inserts for brands targeting internal anorectal application positioning.

Beclomethasone + Phenylephrine + Lignocaine Cream is manufactured by Saar Biotech for the following prescription-approved applications:

• Haemorrhoids (Internal & External): Symptomatic relief of pain, oedema, pruritus, and vascular congestion in grade I–II haemorrhoidal disease
• Anal Fissures: Local anti-inflammatory and anaesthetic management of acute anal fissure discomfort
• Pruritus Ani: Perianal itching of non-infective aetiology requiring corticosteroid and anaesthetic topical management
• Post-Procedural Anorectal Care: Topical symptom management following minor anorectal procedures where inflammation and pain relief are required

Schedule H — Requires a valid medical prescription. Steroid-containing anorectal preparations must be used strictly as directed and not for more than the prescribed duration.

Clinical Mechanism of Action

Beclomethasone Dipropionate (0.025%) undergoes enzymatic conversion to its active metabolite beclomethasone-17-monopropionate in the skin, which binds glucocorticoid receptors to inhibit phospholipase A2 via lipocortin synthesis. This suppresses the arachidonic acid cascade, reducing prostaglandin E2 and leukotriene B4 synthesis — the primary mediators of oedema, erythema, and pruritus in inflamed anorectal tissue.

Phenylephrine Hydrochloride (0.10%) is a selective alpha-1 adrenergic agonist that causes arteriolar constriction in the haemorrhoidal plexus. By reducing blood flow to engorged vessels, it decreases tissue swelling and provides visible reduction in prolapse and venous congestion.

Lignocaine Hydrochloride (2.50%) reversibly blocks fast voltage-gated Na⁺ channels in sensory nerve C-fibres and Aδ-fibres, preventing action potential propagation from the anorectal pain receptors. Onset of local anaesthesia occurs within 5–10 minutes of application, providing rapid itch and pain relief.

Manufacturing Integrity

• pH-Buffered Base: The cream pH is controlled to maintain lignocaine hydrochloride in its ionized (water-soluble) form while also preserving beclomethasone ester stability — a critical dual-constraint formulation challenge managed through validated excipient selection.
• API Stability Testing: All four active components are individually monitored for chemical degradation through accelerated and real-time stability studies as part of batch release protocol.

Saar Biotech provides Third-Party Manufacturing and Contract Manufacturing (CMO) for Beclomethasone + Phenylephrine + Lignocaine Cream from our semi-solid manufacturing facility in Baddi.

• Facility: Semi-solid topical cream manufacturing block with planetary homogenizer, temperature-controlled blending, and automated tube-filling and sealing lines.
• Packaging: 20gm laminated tube — sticker label, printed tube, drip-off embossed carton, applicator insert options.
• MOQ: 5,000 to 2,00,000+ tubes per batch.
• Turnaround: New orders — 30 to 45 working days from artwork sign-off; Repeat orders — 20 to 25 working days.

Every commercial batch undergoes the following release tests before dispatch:

• HPLC Assay: Individual quantification of Beclomethasone Dipropionate, Phenylephrine HCl, and Lignocaine HCl against IP reference standards
• pH Testing: pH verification within approved stability specification
• Viscosity Testing: Batch-to-batch consistency in the target viscosity band for anorectal cream texture
• Microbial Limit Testing (MLT): Total aerobic count and absence of specified pathogens per IP topical preparation standards
• Net Content & Tube Seal Integrity: Fill weight and crimp/seal inspection
• Certificate of Analysis (COA): Provided with every B2B consignment for partner quality records

For B2B manufacturing enquiries, third-party contract pricing, or complete product dossier for Beclomethasone Dipropionate + Phenylephrine HCl + Lignocaine HCl Cream, please use the enquiry form below.