🔹 “Zuclopenthixol Decanoate API – Properties, Uses, and Manufacturing Insights by Swapnroop Drugs & Pharmaceuticals”

💊 Q1 — What is Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals?

Zuclopenthixol decanoate is a long-acting injectable antipsychotic (depot) API from the thioxanthene class of typical antipsychotics. Swapnroop Drugs & Pharmaceuticals produces it as a pharmaceutical-grade API, intended primarily for formulation into intramuscular depot injections used for maintenance therapy in chronic psychotic disorders, such as schizophrenia. 🧪🏥

🧠 Pharmacology & Mechanism

Class: Typical antipsychotic (thioxanthene derivative)
Mechanism: Acts as a dopamine D₂ receptor antagonist, reducing dopaminergic overactivity that contributes to psychotic symptoms like hallucinations and delusions.
Additional Effects: Partial antagonism at α-adrenergic and histamine H₁ receptors contributes to sedation and mild hypotension. ⚖️🧬

🩺 Clinical Role & Typical Use Cases

Primary Use: Long-term maintenance therapy in schizophrenia or other chronic psychotic disorders. 🏥
Administration: Given as intramuscular depot injections every 2–4 weeks to ensure sustained plasma levels. ⏱️💉
Benefits: Improves treatment adherence, reduces relapse rates, and minimizes frequent oral dosing. 🔁

🧾 Quality & Regulatory Profile (Swapnroop)

Swapnroop ensures the API is GMP-compliant and suitable for pharmaceutical manufacturing. Key features:

High Purity: ≥99% assay, with low impurities. 📊
Pharmacopeial Compliance: Meets IP/BP/EP/USP standards. ✔️
QC Documentation: Each batch includes Certificate of Analysis (CoA), impurity profile, and stability guidance. 📜
Intended Supply: For licensed pharmaceutical manufacturers who formulate sterile depot injections. 🏭

🔬 Typical Physicochemical Properties

Appearance: White to off-white crystalline powder ❄️
Solubility: Insoluble in water; soluble in organic solvents (e.g., ethanol, chloroform). 💧
Molecular Weight: 502.1 g/mol (C₂₉H₃₇ClN₂OS·C₇H₁₄O₂) ⚛️
Stability: Sensitive to light and moisture — requires controlled storage. 🌡️
Depot Suitability: The decanoate ester allows slow hydrolysis, providing sustained release over weeks. ⏳

🏭 Manufacturing & Supply Intent

Swapnroop supplies API, not finished product.
Formulation partners convert it into sterile IM depot injections, which release the drug gradually over weeks. 💉
Technical support: Swapnroop provides pre-formulation data, solubility info, and regulatory documentation to ensure compliance. 🧾

⚠️ Handling, Safety & Packaging

Handling: PPE required; controlled environment during weighing and dispensing. 🧤😷
Packaging: Typically supplied in HDPE drums with inner liners or other pharma-grade containers. 📦
Storage: Protected from light, moisture, and extreme temperatures. 🌡️🛡️

🧩 Q2. What is Zuclopenthixol Decanoate by Swapnroop Drugs & Pharmaceuticals used for?

Zuclopenthixol Decanoate is a long-acting injectable antipsychotic used primarily for maintenance therapy in chronic psychotic disorders like schizophrenia. 🧠💉

🔹 Therapeutic Applications

Maintenance therapy: Prevents relapse in chronic psychosis. 🏥
Ensures compliance: Reduces missed doses compared to oral antipsychotics. 🔁
Stabilization: Provides steady plasma drug levels over 2–4 weeks per injection. ⏱️
Adjunct in acute management: Can be started after initial short-acting therapy (like Zuclopenthixol acetate) to maintain calm behavior. ⚡

🌍 Clinical Benefits

Reduces relapse rates
Improves patient adherence and overall treatment outcomes
Minimizes oral dosing errors and frequent clinic visits

⚗️ Q3. What are the physicochemical properties of Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals?

🔬 Physicochemical Characteristics

Property	Description
Chemical Name	Cis-(Z)-4-[3-(2-chloro-9H-thioxanthen-9-ylidene)propyl]-N,N-dimethylpiperazine-1-ethanamine decanoate
Molecular Formula	C₂₉H₃₇ClN₂OS·C₁₀H₂₀O₂
Molecular Weight	≈ 502.1 g/mol ⚛️
Appearance	White to off-white crystalline powder ❄️
Solubility	Practically insoluble in water 💧; soluble in organic solvents like ethanol or chloroform
Melting Point	75–80 °C 🌡️
Log P	~6.0 → highly lipophilic 🧪
Stability	Sensitive to light and moisture; requires airtight, dry storage 🌡️☀️

💡 Key Note: The decanoate ester ensures slow hydrolysis, giving the drug its long-acting depot property.

⚙️ Q4. How is Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals?

🧬 Simplified Synthesis Pathway

Starting Material: Zuclopenthixol base (from thioxanthene derivative).
Esterification: Reaction with decanoic acid or its activated derivative → forms Zuclopenthixol decanoate. 🧪
Purification: Multiple recrystallizations to remove unreacted decanoate and impurities.
Drying & Milling: Dried under controlled conditions; milled for uniform particle size for depot suspension formulation. ⚖️

🧾 Quality & Control Checks

Assay and purity (HPLC ≥99%)
Residual solvents analysis (GC)
Moisture content and heavy metal testing
Particle size analysis for depot stability ⚙️

✅ Outcome: High-quality GMP-compliant API ready for sterile depot formulation.

💊 Q5. What are the different dosage forms of Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals?

🧴 Common Market Dosage Forms

Long-acting IM Depot Injection:
- Oil-based suspension (e.g., sesame oil)
- Concentration: 50 mg/mL or 200 mg/mL 💉
Combination Kits:
- Sometimes combined with short-acting Zuclopenthixol acetate for initial stabilization. 🔄

📦 Formulation Intent

Depot form provides sustained release over 2–4 weeks, reducing frequency of administration.
Ensures steady plasma levels → better symptom control and reduced relapse.

⚗️ Q6. How are Zuclopenthixol Decanoate dosage forms prepared?

💉 Typical IM Depot Suspension Manufacturing Steps

API Dispersion: Zuclopenthixol decanoate is dispersed in sterile oil vehicle (sesame oil or fractionated coconut oil). 🌿
Wetting & Stabilization: Surfactants added for uniform particle distribution.
Homogenization: Ensures smooth, uniform suspension ⚙️
Sterile Filtration or Aseptic Filling: Ensures sterility and absence of particulate contamination 🔬
Filling & Sealing: Into amber vials or ampoules, maintaining sterility. 💡
Quality Testing: Assay, particle size, sterility, endotoxin, and uniformity checks. 🧫

💡 Note: Swapnroop supplies the API and technical guidance, while sterile depot formulation is done by licensed GMP facilities.

💊 Q7. What is the appropriate dosage form of Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals?

The appropriate dosage form is the long-acting intramuscular (IM) depot injection. 💉

⚙️ Why IM Depot Form?

Sustained release: Slowly hydrolyzed in muscle tissue, providing steady plasma levels for 2–4 weeks ⏳
Patient compliance: Eliminates need for daily oral dosing 🔁
Safety: Reduces risk of missed doses and relapse in chronic psychosis 🧠
Strengths: Typically 50 mg/mL, 100 mg/mL, or 200 mg/mL depending on clinical need

✅ Summary: IM depot injection is the clinically and pharmaceutically appropriate form for long-term management.

🕒 Q8. When should Zuclopenthixol Decanoate API be taken?

Zuclopenthixol Decanoate is not orally administered; it is formulated into IM depot injections given under medical supervision. 🏥💉

⏱️ Timing & Administration

Given every 2–4 weeks, depending on patient condition and prior oral stabilization.
Initiation may follow short-acting Zuclopenthixol acetate for rapid control. ⚡
Ensures continuous therapeutic levels for maintenance therapy, preventing relapse.

⚠️ Note: Administration and dosing must be guided by a qualified psychiatrist or healthcare professional.

💥 Q9. What are the effects and side effects of Zuclopenthixol Decanoate?

🌿 Therapeutic Effects

Long-term control of psychotic symptoms (delusions, hallucinations) 🧠
Reduces agitation and aggression in chronic patients ⚖️
Provides steady plasma drug levels → stable symptom management ⏳
Improves treatment adherence and quality of life 🔁

⚠️ Side Effects

Category	Common Effects
🧠 Neurological	Extrapyramidal symptoms (rigidity, tremor), akathisia, sedation
💓 Cardiovascular	Hypotension, rare tachycardia or arrhythmia
😴 Sedation	Mild to moderate, usually at initiation
🧍‍♂️ General	Weight gain, dry mouth, constipation, blurred vision
💉 Injection site	Pain, swelling, or irritation (temporary)

💡 Precautions:

Monitor elderly patients and those with cardiovascular disease.
Avoid alcohol or CNS depressants during therapy.

🧪 Q10. How is Zuclopenthixol Decanoate manufactured by Swapnroop Drugs & Pharmaceuticals tested?

Swapnroop ensures each API batch undergoes comprehensive quality control according to GMP and pharmacopeial standards. 🧬✔️

🧫 Testing Includes

Identification Tests: IR spectroscopy, UV fingerprint, chemical confirmation 🧪
Assay: HPLC analysis for content and purity (≥99%) 📊
Impurity Analysis: HPLC or GC to detect degradation products
Residual Solvent Testing: GC to ensure safe solvent levels
Moisture Content: Karl Fischer or oven method 💧
Particle Size Analysis: Ensures suitability for depot formulation ⚙️
Heavy Metals & Elemental Impurities: ICP-OES or AAS to meet ICH Q3D
Stability Studies: Monitored under accelerated and long-term conditions 🌡️

📜 Documentation

Certificate of Analysis (CoA) for each batch
Batch Manufacturing Record (BMR)
Regulatory-compliant data for global markets 🌍

🧬 Q11. What tests are performed on Zuclopenthixol Decanoate?

Here’s a detailed list of routine QC tests:

🧪 Test	🧾 Purpose
Description / Appearance	Visual check for consistency
Identification (IR, UV, TLC)	Confirms chemical identity
Assay (HPLC)	Determines API purity (≥99%)
Related Substances	Detects impurities or degradation products
Water Content	Moisture level for stability
Residual Solvents (GC)	Confirms safe solvent levels per ICH Q3C
Heavy Metals	Ensures low elemental contamination
Particle Size Analysis	Ensures uniformity for depot formulation
Melting Point / DSC	Confirms crystallinity and polymorphic stability
Microbial Limits (if sterile grade)	Ensures absence of microorganisms 🧫

✅ Outcome: A pharmacopeia-compliant API suitable for long-acting depot formulations with predictable pharmacokinetics.

⚗️ Q12. What are the challenges in manufacturing Zuclopenthixol Decanoate API?

Producing Zuclopenthixol Decanoate is complex due to its chemical structure and long-acting nature. ⚙️

⚠️ Key Challenges

Purity & Impurity Control:
- Multiple synthetic steps increase risk of process-related impurities. 🔬
Esterification Reaction Control:
- Precise conditions are needed for decanoate ester formation; deviations can reduce yield. ⚗️
Moisture Sensitivity:
- Highly hygroscopic; moisture can cause hydrolysis or degradation. 💧
Crystallization & Polymorphism:
- Controlling particle size and crystal form is crucial for depot suspension performance. 💎
Residual Solvents:
- Proper removal of organic solvents is essential to meet ICH Q3C guidelines. 🧯
Regulatory Compliance:
- Documentation for DMF, CoA, stability data is required for global approvals. 🌍📑

💉 Q13. What are the challenges in manufacturing Zuclopenthixol Decanoate dosage forms?

Formulating long-acting IM depot injections involves multiple technical challenges. 🧴⚙️

🧪 Major Formulation Challenges

Sterile Processing:
- Must be done under aseptic conditions in cleanrooms (Class 100/Grade A). 🧼
Particle Size Control:
- Too large → injection pain; too small → rapid release. 💉
Suspension Stability:
- Uniform dispersion in oil vehicle (sesame oil, coconut oil) is critical 🌿
Viscosity Optimization:
- Too viscous → injection difficulty; too thin → poor depot effect ⚖️
Sterility Assurance:
- Final product must pass sterility, endotoxin, and particulate tests 🔬
Packaging Compatibility:
- Vial and stopper must be compatible with oil-based suspension 📦
Regulatory Validation:
- Requires process validation per GMP, ICH Q8–Q10 standards 📋

✅ Result: Safe, uniform, long-acting depot injections with predictable pharmacokinetics.

❄️ Q14. What are the storage conditions for Zuclopenthixol Decanoate API?

Proper storage ensures stability and potency. 🌡️

🌡️ Recommended Storage Conditions

Parameter	Requirement
Temperature	20–25°C (room temperature)
Humidity	<40% RH 🌫️
Light Protection	Store in dark or amber containers ☀️❌
Container Type	Airtight HDPE drums with inner liners 📦
Handling	Avoid prolonged air/moisture exposure 🧤
Transport	Maintain temperature-controlled, moisture-free conditions 🚚

⚠️ Note: Improper storage may lead to hydrolysis, color change, or potency loss.

📦 Q15. What is the packaging for Zuclopenthixol Decanoate API?

🏭 API Packaging

Primary: HDPE drums with double polyethylene liners
Closure: Airtight and tamper-evident 🔒
Labeling: Includes product name, batch number, manufacture/expiry date, storage instructions 🏷️
Capacity: 1 kg, 5 kg, 10 kg, or 25 kg drums

🌍 Export / Transport Packaging

Cartons with shock-resistant padding
Desiccant sachets to maintain low humidity 🌿
Compliant with UN packaging regulations

💊 Formulated Depot Packaging

Amber glass vials or ampoules
Cartons with batch number, strength, storage instructions
Protects from light, moisture, and contamination 💉

⏳ Q16. What is the shelf life of Zuclopenthixol Decanoate API?

🧬 Shelf Life of API

Standard: 36 months (3 years) from manufacture date 📆
Storage: 20–25°C, protected from light and moisture 🌡️
Packaging Integrity: Must remain sealed in original HDPE drums

🔬 Stability Studies

Accelerated: 40°C ±2°C / 75% RH ±5% for 6 months
Long-term: 25°C ±2°C / 60% RH ±5% for 36 months
Monitored Parameters: Assay, impurities, moisture content, physical appearance

✅ Result: API maintains ≥99% purity, stable crystallinity, suitable for depot formulations.

⚠️ Note: Once opened or improperly stored, shelf life may decrease — follow Swapnroop’s handling guidelines.