Trifluoperazine & Trihexyphenidyl

The management of schizophrenia and psychotic disorders remains one of the most complex challenges in mental healthcare. Effective treatment often requires a combination of antipsychotic medications along with anticholinergic agents to address both primary symptoms and associated side effects. The fixed-dose combination of Trifluoperazine, a typical antipsychotic, and Trihexyphenidyl, an anticholinergic, is a well-established and cost-effective solution used extensively in clinical psychiatry to treat schizophrenia and related conditions.

BluepillExpress, a WHO-GMP certified third-party pharmaceutical manufacturer, offers high-quality, scalable manufacturing of Trifluoperazine & Trihexyphenidyl combination tablets. Our formulations are crafted with precision to meet pharmacopoeial standards, ensuring therapeutic efficacy, tolerability, and global regulatory compliance. We support private label brands, export companies, government tenders, hospital procurement, and pharmaceutical marketing firms across domestic and international markets.

What is Trifluoperazine & Trihexyphenidyl?

Trifluoperazine is a first-generation (typical) antipsychotic belonging to the phenothiazine class, known for its dopamine D2 receptor antagonism in the mesolimbic pathway. It is effective in reducing positive symptoms of schizophrenia such as hallucinations, delusions, and agitation.

Trihexyphenidyl, on the other hand, is an anticholinergic (antimuscarinic) agent that is added to counteract extrapyramidal side effects (EPS) such as rigidity, tremor, and akathisia that often occur due to dopamine blockade in the nigrostriatal pathway.

When combined, these two drugs provide a balanced therapeutic approach to manage both psychotic symptoms and movement-related side effects, improving overall treatment adherence and patient quality of life.

Therapeutic Class

• Trifluoperazine: Typical Antipsychotic (Phenothiazine Class)
• Trihexyphenidyl: Anticholinergic (Centrally Acting Antimuscarinic Agent)

Key Benefits of Trifluoperazine & Trihexyphenidyl Combination

1. Effective Management of Psychotic Symptoms

Trifluoperazine is highly effective in treating hallucinations, delusions, disorganized speech, aggression, and paranoia in schizophrenia and acute psychotic episodes.

2. Reduces Extrapyramidal Symptoms

Trihexyphenidyl helps prevent and manage movement disorders such as dystonia, parkinsonism, and akathisia that commonly arise during antipsychotic treatment.

3. Improves Compliance and Treatment Continuity

The fixed-dose combination reduces the number of tablets taken per day, thereby enhancing adherence in patients requiring long-term antipsychotic therapy.

4. Cost-Effective for Resource-Limited Settings

Affordable and widely used in public mental health programs and government-funded healthcare schemes.

5. Clinically Proven and Widely Accepted

The combination is part of several national essential medicine lists and widely prescribed by psychiatrists for stable and maintenance-phase schizophrenia.

Indications

This combination is indicated for the management of:

• Schizophrenia (all stages – acute, sub-chronic, and chronic)
• Schizoaffective disorders
• Delusional disorders
• Psychosis associated with mood disorders (as adjunct therapy)
• Paranoid states
• Manic episodes (in combination with mood stabilizers)
• Extrapyramidal disorders induced by other medications

This formulation is especially helpful in patients requiring long-term psychotropic therapy and those experiencing movement-related side effects.

Available Strengths and Formulations

BluepillExpress manufactures Trifluoperazine + Trihexyphenidyl tablets in the following standard strengths:

• Trifluoperazine 1 mg + Trihexyphenidyl 2 mg
• Trifluoperazine 5 mg + Trihexyphenidyl 2 mg

We also offer custom strength formulations as per market demand or regulatory requirements.

Each tablet is:

• Film-coated to protect the active ingredients from degradation
• Manufactured with uniform dispersion and stability
• Compliant with USP, BP, or IP standards, depending on market requirements
• Packaged in tamper-evident blister or bottle packaging with clear labeling

Dosage and Administration

Standard Dosage:

• Adults: One tablet two or three times a day depending on clinical response
• Maximum dose: As prescribed by the treating psychiatrist
• Pediatric and Geriatric Use: Not recommended unless specifically indicated

The dosage must be individualized according to the severity of symptoms, patient tolerance, and previous treatment history. Tablets should be taken with or without food and swallowed whole with water.

Pharmacodynamics and Mechanism of Action

Trifluoperazine:

• Blocks dopamine D2 receptors in the mesolimbic system, reducing psychotic symptoms
• Also affects other receptors (e.g., alpha-adrenergic, serotonergic) which may contribute to both efficacy and side effects

Trihexyphenidyl:

• Acts as a centrally acting antimuscarinic agent that balances the cholinergic-dopaminergic imbalance in the extrapyramidal system
• Reduces muscle stiffness, rigidity, and tremor associated with dopamine blockade

The combination provides a holistic approach to schizophrenia management by addressing both therapeutic needs and treatment-related side effects.

Manufacturing Capabilities

BluepillExpress has extensive infrastructure to produce large volumes of combination tablets, offering clients fast turnaround and consistent quality.

Our Capabilities Include:

• High-speed tablet compression lines
• Automated film-coating and polishing systems
• Blister packing, strip packing, and bottle filling lines
• Dedicated zones for psychotropic and CNS-active substances
• In-house stability chambers for ICH testing (Zone II and Zone IVB)

All processes are backed by standard operating procedures (SOPs), good manufacturing practices (GMP), and full traceability across production and quality checkpoints.

Packaging Options

We offer flexible packaging configurations to suit market-specific and regulatory requirements:

Primary Packaging:

• Alu-Alu or PVC blister strips (10×10, 10x1x10 formats)
• HDPE bottles with desiccants and tamper-proof caps for institutional supply

Secondary Packaging:

• Customizable mono cartons with batch number, expiry, and product details
• Multilingual labeling for export-ready packaging
• QR codes and serialization available for regulatory markets
• Information leaflets (PIL) provided as per guidelines

We support private labeling, OEM branding, and bulk supply for institutional use.

Quality Control and Certifications

Our manufacturing process complies with WHO-GMP and ISO 22000:2018 standards, ensuring reliable performance, safety, and quality in every batch.

Quality Tests Performed:

• API assay and content uniformity
• Dissolution and disintegration
• Impurity profiling (related substances, degradation products)
• Tablet friability and hardness testing
• Microbiological safety testing
• Accelerated and real-time stability testing under ICH guidelines

Each batch is released only after QC clearance and is accompanied by a Certificate of Analysis (CoA) and batch manufacturing record.

Regulatory and Export Support

BluepillExpress provides full regulatory assistance and export documentation for partners targeting domestic or international markets.

Documentation Includes:

• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin (COO)
• Free Sale Certificate (FSC)
• Stability Data (Zone II/IVB)
• Product Dossier (CTD/ACTD format)
• Manufacturing license and GMP certificate
• MSDS (Material Safety Data Sheet)
• Label design and artwork files

We also assist with product registration and local health authority submissions in countries across Asia, Africa, Latin America, and CIS.

Logistics and Supply Chain Services

We provide seamless logistics support for all product shipments under:

• EXW, FOB, CIF, and DDP Incoterms
• Export-grade packing with shrink wrap and cartons
• Temperature-controlled shipping (if required)
• Support for tenders and institutional supply chains
• Air and sea freight coordination for large orders

Our team ensures timely dispatch, customs clearance, and real-time order tracking.

Minimum Order Quantities and Lead Times

Product Type	MOQ	Lead Time
Trifluoperazine + Trihexyphenidyl Tabs	100,000 tablets	20–25 working days
Customized Strengths or Branding	50,000 tablets	25–30 working days
Sample Batch (Pilot)	20–50 strips	7–10 working days

Lead times may vary depending on packaging complexity, regulatory approvals, and order volume.

Global Demand and Market Potential

The combination of Trifluoperazine + Trihexyphenidyl remains one of the most widely used treatments for schizophrenia in:

• Government-funded mental health programs
• Community psychiatry settings
• Long-term institutional care
• Low-resource countries prioritizing cost-effective care

Its inclusion in essential medicines lists and consistent clinical efficacy ensures steady demand across Asia, Africa, and Latin America.

Ideal Business Partners

Our third-party manufacturing services are ideal for:

• Generic pharmaceutical companies targeting CNS/psychotropic portfolios
• Hospitals and psychiatric institutions
• Government tender suppliers
• Exporters to regulated and semi-regulated markets
• NGOs and mental health non-profits
• E-pharmacies and telehealth brands
• Private-label marketers

Whether you need white-label products or custom formulations, BluepillExpress provides the support to bring your product to market smoothly and efficiently.

Why Choose BluepillExpress?

• WHO-GMP certified and ISO-compliant infrastructure
• Dedicated CNS formulation zone for quality psychotropic manufacturing
• Competitive pricing for domestic and global partners
• Full regulatory and dossier support for exports
• Proven capacity for high-volume, high-consistency production
• End-to-end service including packaging, documentation, and logistics

Our team works with you from product development to global market launch—ensuring your brand meets the demands of both clinicians and patients.

Conclusion

The fixed-dose combination of Trifluoperazine and Trihexyphenidyl offers a clinically validated, cost-effective, and comprehensive approach to managing schizophrenia and related psychotic disorders. With its dual benefit of antipsychotic efficacy and EPS control, it remains an indispensable tool in mental health treatment.

BluepillExpress is proud to be your third-party manufacturing partner, offering regulatory-compliant, scalable, and high-quality solutions that empower your brand to succeed in this essential therapeutic area.