📘 Comprehensive Technical Dossier on FLUTICASONE PROPIONATE (CAS No. 80474-14-2) Manufactured by Swapnroop Drugs & Pharmaceuticals

Q1: What is FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs & Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Molecular Formula: C₂₅H₃₁F₃O₅
📌 Drug Class: Inhaled/Nasal Corticosteroid
📌 Form: White to off-white crystalline powder
📌 IUPAC Name: (6α,11β,16α)-6,9-difluoro-11-hydroxy-16-methyl-3-oxo-17-(propionyloxy)pregna-1,4-diene-21-carboxylic acid S-fluoromethyl ester

🧬 What is Fluticasone Propionate?

Fluticasone Propionate is a synthetic glucocorticoid (a type of corticosteroid) that exhibits anti-inflammatory, anti-allergic, and immunosuppressive effects. It is structurally modified to enhance topical potency, minimize systemic absorption, and improve receptor affinity.

Manufactured by Swapnroop Drugs & Pharmaceuticals, this API is produced with pharma-grade purity, and it is used globally in respiratory and allergic conditions due to its powerful local action and low systemic side effects.

💊 Key Features

Property	Details
Function	Glucocorticoid receptor agonist
Therapeutic Use	Anti-inflammatory in asthma, rhinitis, COPD
Potency	High topical activity with minimal oral bioavailability
Formulations	DPI, Nasal spray, Inhalation suspension, Creams (topical)
Administration Routes	Intranasal, Inhalation (oral), Topical

🛡️ Why It's Important

Highly potent corticosteroid—acts at the site of inflammation
Minimally absorbed systemically, reducing risk of systemic side effects
Plays a key role in maintenance therapy for chronic respiratory diseases

🧪 Swapnroop’s Manufacturing Focus:

High purity levels (>99%)
Controlled particle size for inhalation delivery
Batch-to-batch consistency
Regulatory compliance with ICH, USFDA, and EU guidelines

🧾 Summary:

FLUTICASONE PROPIONATE (CAS 80474-14-2), manufactured by Swapnroop Drugs & Pharmaceuticals, is a potent, locally acting corticosteroid used to treat asthma, allergic rhinitis, and COPD. It is developed to ensure high efficacy with minimal systemic exposure, making it a key component in modern respiratory therapy.

❓ Q2: What is FLUTICASONE PROPIONATE by Swapnroop Drugs and Pharmaceuticals used for?

📌 CAS No.: 80474-14-2
📌 Drug Class: Inhaled/Nasal Corticosteroid
📌 Mechanism of Action: Glucocorticoid receptor agonist – inhibits inflammatory cytokines & mediators

💊 Primary Therapeutic Uses of FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE (FP), manufactured by Swapnroop Drugs & Pharmaceuticals, is used to treat a range of respiratory and allergic inflammatory conditions. It is often a first-line controller medication for chronic and seasonal inflammatory diseases.

🔹 1. Asthma (Maintenance Therapy)

FP reduces airway inflammation, bronchial hyperreactivity, and mucus production
Prevents asthma attacks and helps maintain normal breathing when used regularly
Not used for acute asthma attacks

💨 Form: Inhalation via Dry Powder Inhaler (DPI) or Metered-Dose Inhaler (MDI)

🔹 2. Chronic Obstructive Pulmonary Disease (COPD)

Used in combination with long-acting bronchodilators
Reduces frequency of exacerbations and slows progression of symptoms

🫁 Form: Inhalation – usually fixed-dose combination with salmeterol

🔹 3. Allergic Rhinitis (Seasonal or Perennial)

Alleviates symptoms such as sneezing, nasal congestion, post-nasal drip, and runny nose
Acts locally in nasal passages to reduce histamine and inflammatory response

👃 Form: Intranasal spray

🔹 4. Non-Allergic Rhinitis

Beneficial in vasomotor or idiopathic rhinitis without allergic cause
Reduces mucosal inflammation and nasal hyperresponsiveness

🔹 5. Atopic Dermatitis & Psoriasis (Topical Form)

Occasionally used in topical formulations for skin inflammation
Reduces swelling, redness, and itching

🧴 Note: Swapnroop’s primary production may focus on respiratory dosage forms rather than topical

🔬 Mechanism Summary

FP binds to intracellular glucocorticoid receptors
Inhibits transcription of pro-inflammatory genes (e.g., IL-1, IL-6, TNF-α)
Reduces activation of eosinophils, mast cells, and neutrophils
Leads to suppressed inflammation and improved airflow

Q3: What are the physicochemical properties of FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Molecular Formula: C₂₅H₃₁F₃O₅
📌 Molecular Weight: 500.51 g/mol
📌 Appearance: White to off-white crystalline powder

⚗️ Key Physicochemical Properties

Property	Details
IUPAC Name	S-(fluoromethyl)6α,9-difluoro-11β,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17β-carbothioate 17-propionate
Molecular Structure	Synthetic trifluorinated corticosteroid with thioester linkage
Appearance	White or almost white crystalline powder
Odor	Odorless
Solubility (Water)	Practically insoluble
Solubility (Methanol/Ethanol)	Soluble in ethanol, methanol, acetone, and chloroform
Partition Coefficient (log P)	~2.9 – 3.0 (lipophilic)
Melting Point	273°C – 277°C
pKa	~12.5 (weakly acidic hydroxyl groups)
Hygroscopicity	Low to moderate
UV Absorption Max	~235–240 nm

🧪 Stability Characteristics

Parameter	Response
Photostability	Light-sensitive (requires opaque packaging)
Thermal Stability	Stable below 30°C in dry conditions
pH Stability	Stable in slightly acidic to neutral pH
Polymorphism	Known to exist in multiple polymorphic forms

📦 Implications for Formulation

Poor water solubility makes it suitable for suspension-based nasal sprays or dry powder inhalers
Lipophilic nature facilitates cell membrane penetration and receptor binding
Stable crystalline form aids in long-term storage under proper packaging

🧾 Summary:

FLUTICASONE PROPIONATE is a highly lipophilic, poorly water-soluble, and chemically stable corticosteroid. These properties make it well-suited for topical, nasal, and inhalation-based dosage forms that require site-specific action with minimal systemic exposure.

Q4: How is FLUTICASONE PROPIONATE synthesized by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Molecular Formula: C₂₅H₃₁F₃O₅
📌 Therapeutic Class: Corticosteroid for inhalation/nasal use

🧬 General Overview of Synthesis

The synthesis of FLUTICASONE PROPIONATE (FP) involves a semi-synthetic route that starts with prednisolone or a similar corticosteroid nucleus, which is then chemically modified through fluorination, oxidation, esterification, and sulfur functionalization.

Swapnroop Drugs & Pharmaceuticals likely follows a multi-step GMP-compliant process, ensuring high stereoselectivity, purity, and yield optimization.

🏭 Step-by-Step Synthetic Route (Simplified)

🧪 Step 1: Starting Material – Corticosteroid Nucleus Preparation

Prednisolone or a similar core (e.g., 16α-methylsteroids) is selected
Used as the backbone for FP synthesis due to appropriate functional groups

🔬 Step 2: Introduction of Fluorine Atoms

Selective fluorination at the 6α and 9α positions
Usually done using DAST (Diethylaminosulfur trifluoride) or equivalents
Improves receptor binding and anti-inflammatory potency

⚗️ Step 3: Formation of Thioester Side Chain

A fluoromethylthio group (-SCH₂F) is introduced at position C17
Achieved through reaction with fluoromethylthiolating agents
Key step that distinguishes fluticasone derivatives from other corticosteroids

🧫 Step 4: Esterification with Propionic Acid

Propionylation of the 17-hydroxyl group using propionyl chloride
Produces the propionate ester, enhancing lipophilicity and topical potency

💎 Step 5: Purification & Crystallization

Crude FP is purified using column chromatography or recrystallization
Crystalline polymorphs are often isolated to ensure solid-state stability

🧪 Step 6: Final API Testing

Characterization via:
- HPLC (Purity ≥99%)
- IR/NMR/Mass spectrometry
- Polymorph screening and DSC/TGA

🔒 Process Control Considerations

Moisture sensitivity during final steps
Control of stereochemistry (important for bioactivity)
Use of inert atmosphere (N₂) during some steps to avoid degradation

🧾 Summary:

The synthesis of FLUTICASONE PROPIONATE by Swapnroop is a high-precision, multi-step process starting from a corticosteroid nucleus. It includes fluorination, propionylation, and thioester formation, followed by stringent purification and quality testing to ensure consistent pharmaceutical-grade output.

❓ Q5: What are the different dosage forms of FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Drug Class: Inhaled/Nasal Corticosteroid
📌 Manufactured Forms: API, Nasal Spray, Inhalation DPI/MDI, Topical

💊 Dosage Forms of FLUTICASONE PROPIONATE by Swapnroop

Swapnroop Drugs and Pharmaceuticals likely manufactures and/or supplies FLUTICASONE PROPIONATE in the following pharmaceutical dosage forms, depending on market demand and regulatory approval:

1. 🌬️ Inhalation Powder for DPI (Dry Powder Inhaler)

Use: Asthma, COPD
Strengths: Commonly 50 mcg, 100 mcg, 250 mcg per actuation
Device: Diskus®, Rotacaps®, or similar dry powder inhaler system
Formulation: Micronized FP with lactose as a carrier

✅ Advantage: Delivers drug directly to lungs with minimal systemic exposure.

2. 💨 Metered-Dose Inhaler (MDI)

Use: Chronic asthma or COPD
Strengths: 50–250 mcg per spray
Formulation: Micronized FP suspended in HFA propellant
Canister Size: Typically 120 actuations

✅ Advantage: Portable, fast-acting, good for daily control.

3. 👃 Nasal Spray

Use: Allergic rhinitis (seasonal/perennial), nasal polyps
Strengths: 50 mcg per spray (commonly)
Volume: 60 to 120 sprays per bottle
Preservative: Benzalkonium chloride (often used)

✅ Advantage: Local anti-inflammatory action with low systemic absorption.

4. 🧴 Topical Cream or Ointment (Limited Use)

Use: Atopic dermatitis, eczema, psoriasis
Strengths: 0.05% w/w
Formulation: Cream or ointment base depending on skin condition

✅ Note: Less common; more typical with fluticasone propionate than fluticasone furoate.

5. 🧪 API (Active Pharmaceutical Ingredient)

Use: Supplied to formulation manufacturers
Purity: ≥99%
Form: White to off-white crystalline powder
Packaging: HDPE drums with double poly liners and desiccant

✅ Advantage: Complies with pharmacopeial standards (IP/USP/EP).

📋 Summary Table

Dosage Form	Route	Use	Strength
DPI	Inhalation	Asthma, COPD	50/100/250 mcg
MDI	Inhalation	Asthma, COPD	50–250 mcg/spray
Nasal Spray	Intranasal	Allergic rhinitis	50 mcg/spray
Cream/Ointment	Topical	Skin inflammation	0.05%
API (Bulk)	Oral/Inhaled	For formulation use	≥99% purity (powder)

🧾 Summary:

Swapnroop manufactures FLUTICASONE PROPIONATE in various dosage forms including DPI, MDI, nasal spray, and topical formulations, along with the API. Each form is tailored for precise local delivery, minimal systemic effect, and long-term inflammation control in asthma and allergic diseases.

❓ Q6: How are FLUTICASONE PROPIONATE dosage forms prepared by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Formulated Dosage Forms: DPI, MDI, Nasal Spray, Topical
📌 Manufacturing Type: cGMP-compliant, ICH-guided formulation process

🏭 Dosage Form Preparation Overview

Swapnroop Drugs & Pharmaceuticals follows strict Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., USFDA, WHO-GMP) to formulate FLUTICASONE PROPIONATE (FP) into various dosage forms, ensuring efficacy, stability, and patient compliance.

💨 1. Dry Powder Inhaler (DPI)

🌿 Application: Asthma, COPD

🔹 Key Ingredients:

Micronized Fluticasone Propionate (particle size ~1–5 µm)
Lactose Monohydrate (carrier/excipient)

⚗️ Process Steps:

Micronization of FP via jet milling (to ensure respirable particle size).
Blending of FP with lactose under controlled humidity (<35% RH).
Sieving to ensure uniformity and remove agglomerates.
Filling into Rotacaps®/Blister strips using precision powder-filling machines.
Packaging in foil pouches or DPI devices (with desiccant).

✅ Outcome: Delivers consistent dose deep into lungs with every actuation.

💥 2. Metered-Dose Inhaler (MDI)

💨 Application: Daily control of asthma/COPD

🔹 Key Ingredients:

Micronized FP
HFA Propellant (e.g., HFA-134a)
Surfactant (optional for suspension stabilization)

⚗️ Process Steps:

Suspension preparation: FP dispersed in HFA under nitrogen or vacuum.
Homogenization: Uniform mixing under pressure.
Canister filling: Dosed into aluminum canisters using crimping machines.
Valve attachment & crimping: Precision-fitted metering valves.
Leak testing, spray testing, and actuation uniformity checks.
Labeling and packaging in cartons.

✅ Outcome: Uniform spray delivering micrograms of drug per actuation.

👃 3. Nasal Spray

👃 Application: Allergic rhinitis, nasal inflammation

🔹 Key Ingredients:

FP (micronized or solubilized)
Aqueous vehicle (buffered saline)
Preservatives (e.g., benzalkonium chloride)
Stabilizers and viscosity agents (e.g., CMC)

⚗️ Process Steps:

Solution/suspension preparation in stainless steel mixing vessels.
Filtration (0.22 µm sterile filters for solution-based).
Filling into HDPE bottles or amber glass using peristaltic or piston fillers.
Crimping of metered pump spray heads.
Microbial testing, dose uniformity, and spray pattern analysis.
Packaging with leaflet & cap.

✅ Outcome: Delivers local anti-inflammatory action with minimal systemic effects.

🧴 4. Topical Cream/Ointment

🧴 Application: Atopic dermatitis, eczema (less common route)

🔹 Key Ingredients:

FP
Oil phase (e.g., mineral oil, cetostearyl alcohol)
Aqueous phase (buffered water)
Emulsifier (e.g., polysorbate 60)

⚗️ Process Steps:

Melting and blending of oil & aqueous phases.
FP dispersion into cooled base under homogenization.
Viscosity adjustment and pH control.
Filling into tubes or jars using automatic fillers.
Stability testing and microbial assay.

✅ Outcome: Non-greasy topical steroid with good skin absorption and minimal irritation.

🧪 Formulation Controls & Testing Include:

Assay & Content uniformity
Particle size distribution (for DPI/MDI)
Microbial limits
Spray pattern, plume geometry, delivered dose (for nasal/inhalers)
Stability (ICH Q1A-F)

🧾 Summary:

Swapnroop prepares FLUTICASONE PROPIONATE dosage forms using state-of-the-art, GMP-compliant techniques. DPI and nasal sprays are optimized for targeted delivery, while MDIs and creams offer alternative therapeutic routes. The process emphasizes precision, sterility, and particle control to maximize safety and effectiveness.

Q7: What is the appropriate dosage form of FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Therapeutic Class: Glucocorticoid (anti-inflammatory steroid)
📌 Primary Use: Respiratory & allergic conditions

✅ Most Appropriate Dosage Forms by Indication

Swapnroop Drugs and Pharmaceuticals likely formulates FLUTICASONE PROPIONATE (FP) in multiple dosage forms. However, selection of the most appropriate form depends on the therapeutic application, patient age, and delivery efficiency.

1. 🌬️ Dry Powder Inhaler (DPI) – Most Appropriate for Asthma & COPD

Why DPI?
✔️ Delivers drug directly to the lungs
✔️ Bypasses first-pass metabolism
✔️ Rapid onset of action
✔️ High pulmonary deposition (when properly inhaled)

Typical strength: 50 mcg, 100 mcg, 250 mcg per inhalation
Ideal for: Adults and adolescents with moderate to severe asthma/COPD
Formulated with: Micronized FP and lactose carrier

2. 👃 Nasal Spray – Most Appropriate for Allergic Rhinitis

Why Nasal Spray?
✔️ Direct local effect in nasal mucosa
✔️ Low systemic absorption (↓ side effects)
✔️ Fast relief from nasal congestion and sneezing

Typical strength: 50 mcg per spray
Dosage: 1–2 sprays per nostril once or twice daily
Form: Aqueous suspension with preservatives (e.g., benzalkonium chloride)

3. 💨 Metered-Dose Inhaler (MDI) – Alternative to DPI

✔️ Ideal for patients with low inspiratory flow (e.g., elderly or young children)
✔️ Delivers precise doses via pressurized canister
Strengths: 50–250 mcg per actuation
Often combined with: Salmeterol or formoterol (dual-action therapy)

4. 🧴 Topical Cream/Ointment – Least Common but Specific Use

✔️ Used in dermatology (eczema, dermatitis)
✔️ Applied directly to affected skin areas
Strength: 0.05% w/w
Note: Less commonly produced, not first-line for systemic inflammation

📌 Summary Table

Indication	Best Dosage Form	Delivery Route	Rationale
Asthma / COPD	DPI or MDI	Inhalation	Direct lung delivery, fast onset
Allergic Rhinitis	Nasal Spray	Intranasal	Local effect, fast relief
Atopic Dermatitis (Topical)	Cream/Ointment	Dermal	Targeted treatment, limited systemic exposure

🧾 Final Recommendation:

For asthma and COPD, the most appropriate dosage form of FLUTICASONE PROPIONATE by Swapnroop is the Dry Powder Inhaler (DPI).
For nasal allergies, the nasal spray form offers rapid, effective symptom relief.

Selection should always align with clinical indication, patient profile, and delivery convenience.

Q8: When should FLUTICASONE PROPIONATE API manufactured by Swapnroop Drugs and Pharmaceuticals be taken?

📌 CAS No.: 80474-14-2
📌 Form Used In: DPI, MDI, Nasal Spray, Topical formulations
📌 Note: The API (Active Pharmaceutical Ingredient) is not taken directly; it is used in formulated products.

⏰ When Should FLUTICASONE PROPIONATE Formulations Be Taken?

Since FLUTICASONE PROPIONATE (FP) is used in different dosage forms, timing of administration depends on the route and the indication being treated. Below is a breakdown based on common formulations:

1. 🌬️ For Asthma / COPD (Inhalers – DPI/MDI)

✅ When to Take:

Once or twice daily at the same time each day (e.g., morning and evening)
Should be used regularly, not on an as-needed basis
NOT a rescue medication – it does not relieve acute bronchospasm

📌 Tips:

Rinse mouth after each use to avoid oral thrush
Use before exercise only if prescribed as part of a long-term maintenance plan

2. 👃 For Allergic Rhinitis (Nasal Spray)

✅ When to Take:

Once daily in the morning for maintenance
Can be used twice daily (morning and evening) during severe allergy flare-ups
Should be started a few days before allergy season for seasonal rhinitis

📌 Tips:

Blow nose gently before spraying
Do not tilt head backward after use

3. 🧴 For Skin Conditions (Cream/Ointment)

✅ When to Apply:

Once or twice daily on affected skin
Apply at the same times each day
Avoid use under occlusive dressings unless prescribed

📌 Tips:

Wash hands before and after application
Do not use for more than 2 consecutive weeks unless advised by a doctor

📌 Important Notes for All Forms:

Consideration	Recommendation
Consistency	Take/apply at the same time daily
Missed Dose	Take as soon as remembered unless close to next dose
With or without food	Not applicable for nasal/inhaled/topical
Children/elderly	Use lowest effective dose

🧾 Summary:

While FLUTICASONE PROPIONATE API itself is used in the manufacture of pharmaceutical products, its timing of use is determined by the formulation. Swapnroop's FP-based inhalers, sprays, and creams should be used at consistent times daily, ideally under medical supervision, for maximum effectiveness and safety.

Q9: What are the effects and side effects of FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Drug Class: Inhaled corticosteroid (ICS) / Glucocorticoid
📌 Formulations: DPI, MDI, Nasal Spray, Topical Cream

🌟 Therapeutic Effects (Benefits)

FLUTICASONE PROPIONATE (FP), as manufactured by Swapnroop, delivers localized anti-inflammatory action with minimal systemic absorption, making it ideal for chronic respiratory, nasal, and dermatologic conditions.

✅ Inhaled/Nasal Form (DPI, MDI, Nasal Spray)

🔹 Reduces airway inflammation in asthma and COPD
🔹 Decreases frequency and severity of asthma attacks
🔹 Improves breathing capacity over time
🔹 Relieves nasal symptoms such as congestion, sneezing, and runny nose
🔹 Enhances quality of life for patients with allergic rhinitis

✅ Topical Form (Cream/Ointment)

🔹 Soothes itching and redness in eczema, psoriasis, dermatitis
🔹 Reduces inflammation and swelling of skin lesions
🔹 Promotes skin healing and restores barrier function

⚠️ Side Effects of FLUTICASONE PROPIONATE

Although generally well-tolerated, FP can cause local or systemic side effects based on dose, duration, route, and individual response.

🚨 Common Local Side Effects

Formulation	Side Effect	Notes
DPI/MDI (Inhalers)	Hoarseness, sore throat, oral thrush	Rinse mouth after use
Nasal Spray	Nosebleeds, nasal dryness, irritation	Use saline spray if needed
Cream/Ointment	Burning, stinging, skin thinning	Avoid long-term use or large areas

🚫 Less Common / Systemic Side Effects

⚠️ Headache
⚠️ Delayed growth in children (with long-term use)
⚠️ Cushingoid features (rare; from excessive systemic absorption)
⚠️ Glaucoma or cataracts (long-term nasal/inhaled use)
⚠️ Suppression of hypothalamic-pituitary-adrenal (HPA) axis (very rare)

👶 Pediatric Considerations

Use lowest effective dose
Monitor growth during prolonged use in children
Prefer nasal spray or inhalers with spacers for better control

🧾 Summary:

FLUTICASONE PROPIONATE from Swapnroop provides powerful anti-inflammatory relief for asthma, allergies, and skin disorders. While side effects are generally mild, correct usage and monitoring are essential to avoid local irritation or rare systemic effects—especially with long-term use

Q10: How is FLUTICASONE PROPIONATE tested by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Tested For: Identity, purity, potency, stability, safety
📌 Tested Forms: API (bulk drug) & formulations (DPI, MDI, Nasal Spray, Cream)

🧪 Overview of Quality Control (QC) Testing at Swapnroop

Swapnroop Drugs and Pharmaceuticals ensures that FLUTICASONE PROPIONATE (FP) meets international quality standards through comprehensive analytical, microbiological, and stability testing, complying with ICH, WHO, USFDA, and Pharmacopoeial (USP, IP, EP) guidelines.

🧬 1. Identification Tests

✅ Purpose: Confirm chemical structure and identity of FP
🔹 Methods used:

Infrared Spectroscopy (IR)
Ultraviolet Spectroscopy (UV)
HPLC Retention Time comparison
Mass Spectrometry (MS)

🔬 2. Assay (Potency Determination)

✅ Purpose: Measure % content of FP in API or dosage form
🔹 Method:

HPLC (High Performance Liquid Chromatography) – main method
Results reported as percentage of label claim (typically 98%–102%)

⚗️ 3. Impurity Profiling

✅ Purpose: Detect and quantify degradation products, related substances
🔹 Method:

HPLC with UV or PDA detectors
GC (Gas Chromatography) for residual solvents
Limits defined per ICH Q3A/B and pharmacopoeias

🔎 4. Particle Size Distribution (especially for DPI/MDI)

✅ Purpose: Ensure correct lung deposition for inhaled forms
🔹 Method:

Laser diffraction
Cascade impaction (e.g., Anderson Cascade Impactor)
Target size: 1–5 microns

🌫️ 5. Inhalation Performance Tests (for DPI/MDI)

✅ Purpose: Ensure correct dose is delivered via inhaler
🔹 Key tests:

Delivered Dose Uniformity (DDU)
Fine Particle Dose (FPD)
Plume Geometry
Spray Pattern Analysis
Actuation content uniformity

💧 6. Microbiological Testing

✅ Applicable To: Nasal spray, cream
🔹 Tests performed:

Total Viable Count (TVC)
Pathogen Screening (e.g., E. coli, S. aureus, P. aeruginosa)
Preservative efficacy test (PET)

🔁 7. Stability Testing

✅ Purpose: Determine product shelf life under various storage conditions
🔹 Method: ICH Q1A(R2) stability protocols

Accelerated: 40°C ± 2°C / 75% RH ± 5%
Long-term: 25°C ± 2°C / 60% RH ± 5%
Duration: up to 24 months or more
Parameters: appearance, assay, impurities, microbial load, delivery rate

🧴 8. Other Tests Based on Dosage Form

Dosage Form	Test Examples
Cream/Ointment	pH, Viscosity, Spreadability, Uniformity
Nasal Spray	Spray volume, Droplet size, Pump performance
API (Powder)	Bulk density, Flow properties, Loss on drying

🧾 Summary:

FLUTICASONE PROPIONATE from Swapnroop undergoes rigorous testing for identity, purity, potency, inhalation performance, microbial safety, and stability. These tests ensure regulatory compliance, patient safety, and batch-to-batch consistency—whether it's in bulk API or formulated product form.

Q11: What tests are performed on FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Tested as: API (bulk) and in finished dosage forms (DPI, MDI, nasal spray, cream)

Swapnroop Drugs and Pharmaceuticals performs a comprehensive Quality Control (QC) test panel on FLUTICASONE PROPIONATE to ensure it meets international standards (as per ICH, USP, IP, EP, and WHO-GMP).

These tests are performed at various stages:

🔹 Raw Material (API) Testing
🔹 In-Process Testing
🔹 Finished Product Testing
🔹 Stability Testing

🔬 A. Analytical Tests (API & Formulations)

Test Name	Purpose	Method
Identification	Confirms FP chemical identity	IR, UV, HPLC, MS
Assay (Potency)	Measures actual drug content	HPLC (primary), UV
Impurity Profiling	Detects related/degradant substances	HPLC, GC (for solvents)
Residual Solvents	Ensures acceptable solvent limits	Gas Chromatography (GC)
Loss on Drying / Moisture	Assesses hygroscopic nature	Karl Fischer or LOD
pH (where applicable)	Ensures pH stability in liquid/topical forms	pH Meter

🧪 B. Inhalation Product Tests (DPI / MDI)

Test Name	Purpose	Standard Used
Delivered Dose Uniformity (DDU)	Ensures consistent dosing from device	USP <601> / EP / IP
Fine Particle Dose (FPD)	Measures respirable fraction (1–5 µm)	Cascade Impactor (e.g., ACI)
Spray Pattern / Plume Geometry	Visualizes spray dispersion	Laser or High-speed Imaging
Leak Test / Valve Integrity	Ensures container closure integrity	USP <1207>
Actuation Content Uniformity	Checks dose accuracy per spray/inhalation	HPLC

🧴 C. Topical Formulation Tests

Test Name	Purpose
Viscosity & Spreadability	Ensures application comfort & consistency
pH	Compatibility with skin
Uniformity of Content	Ensures even distribution of API
Appearance / Texture	Stability and visual quality check

🦠 D. Microbiological Testing (for nasal spray/topical)

Test	Purpose
Total Viable Count (TVC)	Microbial load determination
Pathogen Screening	Detects E. coli, P. aeruginosa, etc.
Preservative Efficacy Test (PET)	Confirms preservative activity

🧪 E. Stability Testing (ICH Q1A guidelines)

Conditions	Purpose
25°C/60% RH (Long-term)	Predict real-time shelf life
40°C/75% RH (Accelerated)	Stress test for formulation resilience
30°C/65% RH (Intermediate)	Climate zone-specific testing (e.g., India)

Test parameters include:

Assay
Impurities
pH
Appearance
Performance (DPI/MDI)
Microbial Limits

📦 Summary:

Swapnroop conducts over 20+ specialized tests on FLUTICASONE PROPIONATE API and finished formulations to ensure product safety, efficacy, and global compliance.

From potency and purity to delivery accuracy and microbial safety, these tests help guarantee every dose meets stringent quality benchmarks.

❓ Q12: What are the challenges in manufacturing FLUTICASONE PROPIONATE API by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 API Type: Synthetic corticosteroid (glucocorticoid)
📌 Used In: Inhalers, nasal sprays, creams

Manufacturing FLUTICASONE PROPIONATE (FP) API involves significant complexity due to its steroidal structure, sensitivity to environmental conditions, and stringent quality requirements for inhalation-grade pharmaceuticals.

Below are the key challenges faced by manufacturers like Swapnroop Drugs and Pharmaceuticals:

⚗️ 1. Complex Multistep Synthesis

Steroid core synthesis involves multiple chemical steps with strict stereochemistry.
Requires:
- Highly pure intermediates (e.g., fluticasone base)
- Sophisticated reagents like fluorinating agents
Challenge: Avoiding racemization or unwanted isomers during synthesis.

🧪 Example step:
Synthesis of the fluorinated steroid ring demands anhydrous conditions and inert atmosphere to prevent hydrolysis and degradation.

⚠️ 2. Moisture and Light Sensitivity

FP is sensitive to hydrolysis and photo-degradation.
Handling and storage must occur under:
- Controlled humidity (≤30% RH)
- Amber lighting or light-resistant packaging

💡 Solution: Use of nitrogen-purged isolators and low-moisture reactors.

🧬 3. High Purity Requirements

Inhalation APIs require ultra-high purity (≥99.5%) with low impurities.
Impurities must be:
- Identified
- Qualified for safety
- Maintained within ICH Q3A/B limits

📊 Key issue: Controlling related substances that arise during synthesis or from starting materials.

🔬 4. Particle Size Control

For inhalation use, particle size must be <5 microns (typically 1–3 µm).
Requires:
- Micronization via jet milling
- Laser diffraction analysis for uniformity

🎯 Challenge: Ensuring uniform aerodynamic properties for optimal lung deposition.

🔁 5. Reproducibility and Scalability

Process must be scalable without compromising:
- Yield
- Purity
- Environmental safety

🧪 Common bottlenecks:

Handling of hazardous solvents
Reactions with narrow temperature or pH range

🧫 6. Regulatory & Compliance Burden

Must comply with:
- USFDA / EMA / WHO-GMP standards
- ICH Q7 for API manufacturing
- Strict documentation and validation requirements

📑 Includes:

Process validation
Analytical method validation
Change control systems

📦 7. Packaging & Stability

Must be packed in moisture-proof, light-resistant containers.
Any deviation can result in:
- Potency loss
- Formation of degradation products

🧾 Summary:

FLUTICASONE PROPIONATE API manufacturing is a highly controlled, multi-stage process that demands:

Stringent impurity control
Precise particle size handling
Moisture/light protection
Regulatory compliance

These challenges make it a technically demanding steroid API—especially for respiratory applications where even micro-level deviations can impact therapeutic efficacy and patient safety.

❓ Q13: What are the challenges in manufacturing FLUTICASONE PROPIONATE dosage forms by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Dosage Forms: DPI, MDI, Nasal spray, Topical cream/ointment
📌 Category: Inhaled/topical corticosteroid

Manufacturing FLUTICASONE PROPIONATE (FP) formulations is technically demanding due to the drug’s potency, dose precision requirements, formulation sensitivity, and strict regulatory expectations, especially for inhalation and nasal products.

Here are the major challenges Swapnroop or any pharmaceutical company may face:

💨 1. Dose Uniformity in Inhalation Products (DPI/MDI)

FP is used in microgram quantities (e.g., 50–250 mcg per dose), so uniform blending and dosing are critical.
Even slight variations in API distribution can lead to underdosing or overdosing.

🔬 Challenges include:

Ensuring uniform API distribution in carrier blends (e.g., lactose for DPI)
Minimizing segregation during filling
Accurate metering during actuation

⚗️ 2. Particle Size Control

FP must be micronized (typically 1–5 µm) to reach the lower respiratory tract.
Improper size affects lung deposition, efficacy, and safety.

🔄 Key challenge: Avoiding particle agglomeration or uneven distribution during:

Jet milling
Blending with excipients
Capsule filling or canister charging

🌫️ 3. Propellant Compatibility in MDI

FP needs to be suspended (not dissolved) in HFA propellants (like HFA-134a).
Challenges arise in:
- Suspension stability
- Valve clogging
- Ensuring dose reproducibility

🧪 Requires extensive compatibility testing with:

Propellant
Valve and actuator materials
Lubricants or dispersing agents

👃 4. Nasal Spray Manufacturing Precision

Nasal spray devices must deliver a precise volume (usually 50 mcg per spray).
Droplet size, spray pattern, and spray reproducibility are critical.

🔍 Challenges:

Avoiding nozzle clogging
Preservative compatibility
Maintaining pH and osmolarity for nasal comfort

🧴 5. Topical Formulation Challenges

FP in creams/ointments must maintain physical and chemical stability.
Challenges include:
- Achieving uniform dispersion of FP in semisolid base
- Preventing crystallization or sedimentation
- Ensuring consistent viscosity, pH, and spreadability

🧪 6. Microbial Control

Especially for nasal sprays and creams, which can support microbial growth.
Requires:
- Sterile or preservative-containing formulations
- Strict GMP-level microbiological controls

🧾 7. Regulatory & Stability Demands

Regulatory bodies (USFDA, EMA, CDSCO) require:
- Dose uniformity testing
- Impurity profiling (e.g., related substances, degradation products)
- Device performance testing
- Stability under accelerated and long-term conditions

📦 Stability Concerns:

FP is sensitive to moisture, light, and temperature
Requires:
- Light-resistant packaging
- Low humidity manufacturing zones

📋 Summary Table

Dosage Form	Main Challenge	Critical Control
DPI	Dose uniformity, particle size	Blending, jet milling, flow testing
MDI	Suspension stability in propellant	Valve design, compatibility studies
Nasal Spray	Precision dosing, microbial safety	Spray pump tech, pH/osmolarity balance
Cream/Ointment	Uniformity, crystallization, microbial safety	Base formulation, preservative efficacy

✅ Conclusion:

Manufacturing FLUTICASONE PROPIONATE dosage forms—especially for inhalation and nasal delivery—requires exceptional control over formulation variables, high-precision equipment, and robust stability data to ensure therapeutic effectiveness, patient compliance, and regulatory approval.

❓ Q14: What are the storage conditions for FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📌 Formulations: API (bulk), DPI, MDI, nasal spray, cream/ointment
📦 Storage Type: Moisture/light/temperature-sensitive corticosteroid

Proper storage of FLUTICASONE PROPIONATE (FP) is crucial to preserve its stability, potency, and safety. This applies to both the raw API and the formulated drug products.

🧊 A. Storage Conditions for FLUTICASONE PROPIONATE API

Parameter	Condition
💡 Light Protection	Store in a light-resistant container
💧 Humidity Control	Store in a dry area, preferably < 30% RH
🌡️ Temperature	15°C to 25°C (59°F to 77°F); avoid > 30°C
📦 Container	Airtight, double-lined polyethylene bags in HDPE drums, under nitrogen if possible

🧪 Rationale: FP is photosensitive and susceptible to hydrolysis, especially when exposed to heat, light, or moisture.

💊 B. Storage for Formulated Products

1. DPI (Dry Powder Inhaler)

Store at: Below 25°C
Keep in original blister pack or container
Protect from moisture and heat
Avoid freezing

2. MDI (Metered Dose Inhaler)

Store at: 15–30°C
Protect from direct sunlight and heat (>50°C)
Do not pierce or burn canisters even when empty
Do not freeze

3. Nasal Spray

Store at: 20–25°C (68–77°F)
Protect from light and freezing
Keep cap tightly closed after each use

4. Topical Cream/Ointment

Store at: Below 25°C (77°F)
Keep container tightly closed
Do not freeze
Protect from light and microbial contamination

⏱️ Stability Insights (ICH Conditions)

Swapnroop likely performs stability studies under:

Accelerated: 40°C ± 2°C / 75% RH ± 5%
Long-term: 25°C ± 2°C / 60% RH ± 5%

These data inform storage guidelines and shelf life, typically:

24 months for API and standard dosage forms
Shorter for preservative-free or specialized formulations

⚠️ What to Avoid

❌ Exposure to high humidity or wet conditions
❌ Direct exposure to UV light
❌ Temperatures > 30–40°C
❌ Freezing (especially nasal sprays and creams)
❌ Open or punctured inhaler devices (compromises dose)

🧾 Summary:

FLUTICASONE PROPIONATE must be stored in cool, dry, and protected environments to maintain its stability and therapeutic value. Swapnroop Drugs ensures appropriate storage conditions for both API and finished formulations using validated, controlled environments compliant with ICH and WHO-GMP standards.

❓ Q15: What is the packaging for FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📦 Packaging Type: Tailored to product form (API, DPI, MDI, nasal spray, cream)

Proper packaging of FLUTICASONE PROPIONATE (FP) is essential to maintain drug stability, efficacy, and safety. As a light- and moisture-sensitive corticosteroid, FP is packed using protective and regulatory-compliant materials at Swapnroop Drugs and Pharmaceuticals.

Here’s a breakdown based on product form:

🧪 A. API (Bulk Drug Substance) Packaging

Component	Description
Primary Packaging	Double-layer polythene bags (LDPE or HDPE), usually placed under nitrogen atmosphere
Secondary Packaging	HDPE drums with tamper-evident sealing and labeling
Labeling	Product name, CAS No., batch no., date of manufacture, retest date, net weight, QR/barcode

🛡️ Protection Offered:

From light, oxygen, and humidity
Complies with ICH Q7 and WHO-GMP bulk packaging standards

💨 B. DPI (Dry Powder Inhaler) Packaging

Component	Description
Blister Strips	Foil-foil (Aluminum-Aluminum) or foil-polymer laminate to protect from moisture/light
Device Container	Inhaler device (single- or multi-dose), moisture-proof and with tamper-evident seals
Secondary Carton	Printed paperboard box with patient instructions
Desiccants	Included in primary container (if multidose blister)

🌫️ C. MDI (Metered Dose Inhaler) Packaging

Component	Description
Primary	Aluminum canister with metering valve, crimped and sealed
Actuator	Plastic mouthpiece with protective cap
Secondary	Paperboard carton with patient leaflet
Optional	Protective pouch (foil or plastic)

🛡️ Canisters are resistant to light and pressure.

👃 D. Nasal Spray Packaging

Component	Description
Bottle	Amber glass or opaque plastic (HDPE)
Pump/Nozzle	Pre-calibrated for dose consistency
Cap	Snap-on or screw-type, often child-resistant
Outer Carton	Printed box with leaflet and barcode

✅ Designed for light protection and microbial safety

🧴 E. Cream/Ointment Packaging

Container Type	Description
Laminated Tubes	Aluminum or Lami-tube with internal epoxy lining
Jar (optional)	For bulk hospital packs (HDPE or PP)
Cap	Screw-on or flip-top, often tamper-evident
Outer Packaging	Individual carton with full instructions

💡 Includes proper labeling of storage conditions, expiry, batch, and directions.

🧾 Summary:

Swapnroop uses advanced, tamper-proof, and moisture-resistant packaging for FLUTICASONE PROPIONATE based on dosage form. Whether it's a bulk API drum or a finished nasal spray, the packaging is compliant with WHO-GMP, ICH, and pharmacopoeial standards to ensure product stability, protection, and patient safety.

Q16: What is the shelf life of FLUTICASONE PROPIONATE manufactured by Swapnroop Drugs and Pharmaceuticals?

📌 CAS No.: 80474-14-2
📆 Shelf Life Depends On: Dosage form, packaging, and storage conditions

⏳ 1. Shelf Life of FLUTICASONE PROPIONATE API (Bulk)

Form	Typical Shelf Life	Conditions
API (pure powder)	36 months (3 years)	Stored in a light-resistant, nitrogen-filled HDPE drum at 15–25°C, in a dry area with ≤30% RH

🧪 Shelf life confirmed through ICH Q1A(R2) stability studies (real-time and accelerated).

💨 2. Shelf Life of Finished Dosage Forms

Dosage Form	Typical Shelf Life	Storage Recommendations
Dry Powder Inhaler (DPI)	24 months	Store below 25°C, in original foil pouch/blister
Metered Dose Inhaler (MDI)	24–30 months	Store at 15–30°C, protect from heat & sunlight
Nasal Spray	24–36 months	Store at 20–25°C, do not freeze, keep upright
Cream/Ointment	24 months	Store below 25°C, protect from light & freezing

🧴 After opening (e.g., nasal sprays):
⏱️ Use within 1–3 months, depending on labeling instructions

📑 Regulatory Justification of Shelf Life

Swapnroop determines shelf life based on:

Accelerated studies (40°C/75% RH for 6 months)
Long-term stability data (25°C/60% RH or 30°C/65% RH for 12–36 months)
Microbial & preservative stability (for sprays/creams)
Performance tests (e.g., delivered dose uniformity for inhalers)

🧾 Summary:

The shelf life of FLUTICASONE PROPIONATE, whether API or finished dosage form, typically ranges from 24 to 36 months, depending on the formulation and packaging. Swapnroop ensures shelf life is supported by robust ICH-compliant stability studies and ongoing real-time monitoring.

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SWAPNROOP Drugs and Pharmaceuticals

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