Phenylephrine + Lignocaine

The combination of Phenylephrine and Lignocaine (Lidocaine) is a well-established and effective topical therapy commonly used in the management of hemorrhoids, anal fissures, and proctitis, as well as for local pain relief in minor procedures or surgeries. This dual-acting preparation provides both vasoconstrictive and anesthetic effects, delivering fast, targeted, and symptomatic relief from pain, swelling, and discomfort.

At BluepillExpress, we provide end-to-end third-party and contract manufacturing services for Phenylephrine + Lignocaine formulations, tailored to the needs of domestic brands, international distributors, and hospital procurement systems. Our WHO-GMP-certified facilities, comprehensive regulatory support, and focus on quality excellence make us a trusted partner for clients seeking customized and export-ready solutions.

Therapeutic Applications

The Phenylephrine + Lignocaine combination is widely used for:

• Symptomatic relief in hemorrhoids (piles)
• Management of anal fissures and anorectal discomfort
• Adjunct therapy post-hemorrhoidectomy or anal surgeries
• Local anesthesia for minor dermatologic or gynecologic procedures
• Pain relief in rectal inflammation and pruritus ani

The formulation is suitable for both prescription-based and OTC markets, depending on the strength, region, and regulatory approval.

Mechanism of Action

1. Phenylephrine:
A selective α1-adrenergic receptor agonist, Phenylephrine causes vasoconstriction of blood vessels, reducing blood flow to the hemorrhoidal tissues. This results in:

• Decreased swelling
• Reduction in itching and redness
• Temporary relief from bleeding

2. Lignocaine (Lidocaine):
An amide-type local anesthetic, Lignocaine blocks sodium ion channels, preventing the initiation and transmission of nerve impulses. This produces:

• Rapid onset of pain relief
• Temporary numbness at the site of application
• Enhanced patient comfort during defecation or recovery

The combination synergistically reduces both pain and vascular congestion, offering targeted and sustained relief.

Available Dosage Forms by BluepillExpress

At BluepillExpress, we manufacture various strengths and formats of Phenylephrine + Lignocaine to meet diverse clinical needs and market specifications:

1. Rectal Creams/Ointments

• Phenylephrine HCl 0.25% w/w + Lignocaine HCl 2.5% w/w
• Phenylephrine HCl 0.12% w/w + Lignocaine HCl 2% w/w
• Customized concentrations available on request

2. Rectal Gel / Suppositories (custom formulation)

• For institutional or pediatric use
• Easy-to-administer formats for sensitive patients

3. Topical Solutions or Sprays (on demand)

• For dermatologic or gynecological application
• Fast-acting anesthetic for minor outpatient procedures

Packaging Formats:

• 15g / 30g aluminum tubes
• 20g HDPE tubes with applicators
• Suppository strips in PVC/Alu packs
• Multilingual outer cartons with inserts

All dosage forms are developed under controlled temperature and humidity, ensuring consistent performance and long-term stability.

Manufacturing Infrastructure at BluepillExpress

We offer state-of-the-art manufacturing infrastructure and validated processes to produce consistent, high-quality topical preparations.

Key Capabilities Include:

• Dedicated topical and semi-solid manufacturing lines
• WHO-GMP and ISO 9001:2015 certified facilities
• Cleanrooms with HEPA filtration and controlled zones
• Homogenizers and planetary mixers for uniformity
• Automated tube filling, sealing, and labeling systems
• Real-time batch monitoring with ERP integration

Our experienced team of pharmacists, chemists, and engineers ensures every product complies with global quality and safety benchmarks.

Quality Control and Assurance

At BluepillExpress, Quality Control (QC) and Quality Assurance (QA) are embedded into every stage of manufacturing. Each batch of Phenylephrine + Lignocaine is subject to:

• Identity and assay confirmation for both APIs
• pH and viscosity testing for topical preparations
• Microbial limit tests and sterility (if required)
• Stability studies under ICH conditions (Zone III/IV)
• Homogeneity and spreadability evaluations
• Heavy metal and preservative content analysis

All test results are documented, validated, and maintained with full traceability for regulatory audits and client assurance.

Packaging and Customization Services

To support private labeling and market differentiation, BluepillExpress offers custom formulation and branding services for all topical products.

Customization Includes:

• Brand name selection and logo incorporation
• Custom artwork design (tube, carton, leaflet)
• Viscosity or fragrance modifications (where permitted)
• Language-specific labeling and inserts
• E-commerce and retail-ready packaging

We ensure that all packaging materials are moisture-resistant, tamper-evident, and aligned with the market-specific regulatory guidelines.

Regulatory Documentation and Support

Our team provides comprehensive regulatory documentation and submission assistance for international markets. Documentation packages include:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Batch Manufacturing Record (BMR)
• Master Formula Record (MFR)
• Material Safety Data Sheet (MSDS)
• Product Development Reports
• Dossiers in CTD/eCTD/ACTD formats
• Stability Data Reports
• Method of Analysis (MOA) and validation protocols

We assist clients with product registration, health authority queries, and label compliance, ensuring seamless global market access.

Export Support and Global Presence

BluepillExpress is a global exporter of pharmaceutical products, trusted by healthcare organizations, procurement agencies, and private label brands. We supply Phenylephrine + Lignocaine formulations to:

• Africa – Nigeria, Ghana, Ethiopia, Kenya, South Africa
• Middle East – UAE, Iraq, Oman, Yemen, Saudi Arabia
• Asia – Vietnam, Philippines, Myanmar, Sri Lanka, Nepal
• CIS Countries – Uzbekistan, Armenia, Kyrgyzstan, Kazakhstan
• Latin America – Bolivia, Guatemala, Honduras, Paraguay

We provide fast production turnarounds, flexible MOQs, and support with customs clearance, COAs, and shipping documentation.

Research and Development Services

Our R&D division offers formulation development and product optimization services to meet specific therapeutic and commercial goals.

Capabilities Include:

• Development of pediatric or elderly-friendly dosage forms
• Fragrance-free and hypoallergenic options
• Formulations with added moisturizers or herbal extracts
• Fixed-dose combination development (e.g., with hydrocortisone)
• Non-prescription (OTC) variants for select markets
• Stability enhancement in high-humidity zones

We also support clinical trial material (CTM) supply, pilot batches, and bioequivalence support through partner CROs.

Shelf Life and Storage Guidelines

• Standard Shelf Life: 24 to 36 months
• Storage Conditions: Below 30°C; store in a cool, dry place away from direct sunlight
• Stability Testing: Conducted under ICH guidelines for Zone III & IV countries
• Packaging: Designed for light protection, tamper resistance, and product preservation

We ensure that our topical formulations remain physically and chemically stable throughout their commercial life.

Ethical, Environmental, and Safety Commitment

BluepillExpress integrates ethical sourcing, eco-conscious production, and employee safety protocols in all operations:

• Non-animal tested ingredients and cruelty-free development
• GMP-compliant waste and solvent management
• Occupational health monitoring and PPE compliance
• Energy-efficient manufacturing practices
• Support for community health initiatives

We are committed to sustainable, responsible, and patient-focused manufacturing.

Why Choose BluepillExpress for Phenylephrine + Lignocaine Manufacturing?

• WHO-GMP & ISO-certified semi-solid production lines
• Full-spectrum support for private label manufacturing
• Customization flexibility and low minimum order quantities
• Global compliance and regulatory documentation
• Quick lead times and scalable production capacity
• Proven expertise in topical formulations and rectal therapeutics

Whether you are launching a new OTC product, expanding your prescription line, or entering new markets, BluepillExpress is your trusted partner for contract manufacturing.

Conclusion

The Phenylephrine + Lignocaine combination is an effective, dual-action therapy that addresses both vascular and sensory symptoms of hemorrhoids and related conditions. With increasing demand for safe, accessible, and fast-acting topical medications, this formulation plays a key role in both clinical and OTC markets.

BluepillExpress offers high-quality, compliant, and customizable third-party manufacturing services for Phenylephrine + Lignocaine, enabling brands to confidently supply this essential therapeutic product to their target regions. Our end-to-end manufacturing support, regulatory expertise, and global shipping capabilities ensure a smooth path from production to market.