Propantheline

Propantheline bromide is a well-established anticholinergic and antispasmodic agent, widely used to treat a variety of gastrointestinal and urological conditions. It works by inhibiting the actions of acetylcholine on muscarinic receptors in smooth muscles, thereby reducing involuntary contractions in the gut and bladder. Propantheline is especially effective in managing symptoms of irritable bowel syndrome (IBS), peptic ulcers, and urinary incontinence, making it a crucial therapeutic agent in gastroenterology and urology practices worldwide.

At BluepillExpress, we specialize in the third-party manufacturing of Propantheline with WHO-GMP and ISO-certified infrastructure, extensive formulation capabilities, and a commitment to regulatory compliance. Our high-precision production systems ensure consistent quality, efficacy, and safety—making us a trusted partner for pharmaceutical companies, hospitals, and global exporters.

What is Propantheline?

Propantheline is a quaternary ammonium compound with antimuscarinic properties, commonly used to treat gastrointestinal hypermotility, bladder spasms, and excessive sweating (hyperhidrosis). It is classified as an anticholinergic that blocks the parasympathetic nervous system’s effects, leading to muscle relaxation and reduced secretions.

Therapeutic Class: Anticholinergic / Antispasmodic
Mechanism of Action: Competitively blocks acetylcholine at muscarinic receptors in smooth muscle tissues
Route of Administration: Oral

Therapeutic Indications

Propantheline bromide is used alone or in combination therapy to manage multiple conditions where involuntary muscle activity contributes to symptoms.

Primary Indications:

• Irritable Bowel Syndrome (IBS)
• Peptic Ulcer Disease (as adjunct therapy)
• Functional gastrointestinal disorders
• Hyperhidrosis (off-label use)
• Bladder spasms and urinary urgency
• Pancreatic secretion control
• Preoperative preparation to reduce secretions

This medication is favored for its targeted smooth muscle relaxation with limited central nervous system penetration, reducing systemic side effects.

Why Choose BluepillExpress?

BluepillExpress is an industry leader in high-quality, cost-effective, third-party pharmaceutical manufacturing, supporting pharmaceutical brands across the globe with scalable, compliant production solutions.

Key Strengths:

• WHO-GMP and ISO 9001:2015 certified units
• IP/BP/USP/EP compliant formulations
• Experienced formulation and analytical R&D team
• State-of-the-art tablet and capsule manufacturing lines
• Complete regulatory documentation support
• Custom dosage strength and packaging design
• On-time delivery and global logistics management
• Private label and OEM services for domestic and export markets

Our fully integrated pharmaceutical services empower businesses to expand their therapeutic portfolio and market presence with confidence.

Available Dosage Forms and Strengths

We offer Propantheline in various standard and customizable oral dosage forms:

Tablet Formulations:

• Propantheline Bromide 15 mg Tablets
• Propantheline Bromide 30 mg Tablets
• Propantheline Bromide 15 mg + Antacid combination (on request)

We also support development of sustained-release, sugar-coated, or film-coated tablets for enhanced patient compliance and formulation stability.

Product Composition

Every formulation is designed for accurate dosage delivery, optimized absorption, and minimal side effects.

Example Composition: Propantheline Bromide 15 mg Tablet

• Active Ingredient: Propantheline Bromide IP/BP/USP 15 mg
• Excipients: Lactose monohydrate, microcrystalline cellulose, magnesium stearate, starch, talc, and PVP
• Tablet Core: Compressed and optionally coated for ease of ingestion
• Coating (Optional): Film or sugar coating depending on client preference

Custom formulations (e.g., gluten-free, lactose-free) are available on request for niche markets.

Manufacturing Process

Our GMP-compliant manufacturing process for Propantheline tablets ensures safety, potency, and consistency across batches.

Key Manufacturing Steps:

1. API Quality Check and Weighing
2. Granulation (wet or dry) to ensure uniformity and compressibility
3. Blending with lubricants and binders
4. Tablet Compression using high-speed rotary machines
5. Coating (if required) for taste masking and shelf-life enhancement
6. Packaging in moisture-resistant material
7. In-process QC monitoring and final release testing

All equipment is validated, and processes follow SOPs to ensure adherence to national and international regulatory norms.

Quality Assurance and Testing

At BluepillExpress, every batch undergoes comprehensive quality control to ensure product safety, consistency, and therapeutic efficacy.

Key QC Parameters:

• Assay of active ingredient
• Uniformity of dosage units
• Dissolution and disintegration time
• Impurity profiling and related substances
• Moisture content analysis
• Hardness and friability
• Microbial contamination testing
• Packaging integrity and stability studies

We issue Certificates of Analysis (COA) for each batch and provide full documentation in accordance with IP, BP, USP, or EP monographs.

Packaging and Labeling Options

We offer customized packaging tailored to your branding, market, and compliance needs.

Common Packaging Formats:

• Blister packs (PVC-Alu or Alu-Alu)
• HDPE bottles with desiccant lining
• 10×10, 3×10, or bulk 1000’s tablet configurations
• Mono-cartons with printed inserts
• Multilingual labels and barcoded cartons
• Tamper-evident and child-resistant packaging (if required)

We provide private label services, including brand design, foil printing, box artwork, and logo incorporation.

Regulatory and Documentation Support

We offer full-spectrum technical and regulatory documentation for Propantheline to support registrations in both regulated and semi-regulated markets.

Documentation Includes:

• WHO-GMP certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Analysis (COA)
• Stability Data (real-time and accelerated)
• Product Dossier in CTD/ACTD format
• Master Formula Record (MFR)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Safety Data Sheet (SDS)
• Label content and prescribing information

We support regulatory submissions and tenders in markets across Africa, Southeast Asia, the CIS, Latin America, and the Middle East.

Export Capabilities

BluepillExpress is a proven global exporter with robust supply chain infrastructure and export logistics expertise.

Primary Export Markets:

• Africa: Nigeria, Kenya, Ghana, Ethiopia, South Africa
• Asia-Pacific: Sri Lanka, Philippines, Vietnam, Myanmar
• Middle East: UAE, Iraq, Jordan, Saudi Arabia
• CIS Region: Uzbekistan, Armenia, Kyrgyzstan
• Latin America: Bolivia, Peru, Dominican Republic, Ecuador
• Island Nations: Maldives, Papua New Guinea, Mauritius

We manage air and sea freight logistics, customs clearance, and compliance documentation, ensuring efficient global delivery.

Ideal Clients for Propantheline Manufacturing

Our Propantheline third-party manufacturing services are ideal for:

• Generic pharmaceutical companies
• Contract manufacturers
• Hospital supply chains and procurement agencies
• Government health departments and NGOs
• OTC and gastro-intestinal healthcare brands
• E-pharmacy platforms
• Private label product marketers
• International traders and exporters

Why Partner with BluepillExpress?

• WHO-GMP certified manufacturing with global export compliance
• Formulation expertise in gastroenterology and urology segments
• Scalable batch sizes with MOQ flexibility
• Competitive pricing with quality assurance
• Dedicated R&D and documentation team
• Custom branding, packaging, and design solutions
• Transparent production timelines and after-sales support