Comprehensive Overview of Divalproex Sodium (CAS No. 26523-78-4) Manufactured by Swapnroop Drugs & Pharmaceuticals
Q1: What is DIVALPROEX SODIUM manufactured by Swapnroop Drugs & Pharmaceuticals? π§ͺπ
Answer:
DIVALPROEX SODIUM is a pharmaceutical drug substance manufactured by Swapnroop Drugs & Pharmaceuticals, primarily used for its anticonvulsant, mood-stabilizing, and antimigraine properties. It is the sodium salt of valproic acid, presented in the form of a coordination compound of sodium valproate and valproic acid in a 1:1 molar ratio.
π Swapnroop Drugs & Pharmaceuticals produces this Active Pharmaceutical Ingredient (API) adhering to stringent quality standards (often as per IP/USP/EP guidelines), ensuring high purity, consistent particle size, and stability—essential for formulation into tablets or other dosage forms.
π Key Highlights:
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Classification: Antiepileptic / Mood stabilizer
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API Type: Divalproex Sodium
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Chemical Nature: Coordination complex of sodium valproate and valproic acid
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Manufacturing Standard: Typically GMP-compliant facilities with validated processes
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Appearance: White to off-white crystalline powder
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Use in Formulations: Mainly used in delayed-release and extended-release tablet forms
π§ It is widely used in treating:
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Epilepsy (various seizure types)
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Bipolar disorder (especially manic episodes)
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Migraine prophylaxis
Q2: What is DIVALPROEX SODIUM by Swapnroop Drugs and Pharmaceuticals used for? ππ§
Answer:
DIVALPROEX SODIUM, manufactured by Swapnroop Drugs & Pharmaceuticals, is a broad-spectrum medication primarily used to manage neurological and psychiatric conditions. It is widely prescribed for its anticonvulsant, mood-stabilizing, and migraine-preventive properties.
π Primary Uses:
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Epilepsy/Seizure Disorders ⚡
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Treats various types of seizures, including absence seizures, complex partial seizures, and generalized tonic-clonic seizures.
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Helps in long-term seizure control when used as monotherapy or in combination with other antiepileptics.
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Bipolar Disorder (Manic Episodes) π΅π«➡️π
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Acts as a mood stabilizer, especially effective in controlling acute manic or mixed episodes associated with bipolar I disorder.
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Prevents mood swings when taken consistently over time.
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Migraine Prophylaxis π©️π
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Reduces the frequency and severity of migraine headaches (though not used to treat an acute migraine attack).
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Off-label Uses (under physician guidance):
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Schizoaffective disorder
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Borderline personality disorder (BPD)
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Aggression or irritability in some neurological conditions
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𧬠Mechanism of Action:
Divalproex Sodium increases gamma-aminobutyric acid (GABA) levels in the brain — a neurotransmitter that helps calm nerve activity — thereby stabilizing electrical activity in the brain and improving mood regulation.
✅ Why it's preferred:
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Delayed and extended-release formulations improve compliance.
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Offers broad therapeutic coverage in a single medication.
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Well-tolerated when dosed properly and monitored.
Q3: What are the physicochemical properties of DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? ⚗️π
Answer:
Divalproex Sodium, as manufactured by Swapnroop Drugs & Pharmaceuticals, possesses distinct physicochemical characteristics critical for its quality, stability, and formulation performance.
Key Physicochemical Properties:
| Property | Description |
|---|---|
| Chemical Name | Divalproex Sodium |
| Molecular Formula | C16H30Na2O4 |
| Molecular Weight | ~288.33 g/mol |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water; soluble in methanol and ethanol |
| Melting Point | Approximately 150–154 °C (decomposes) |
| pH (in solution) | Slightly alkaline, typically around 8–9 in aqueous solution |
| Hygroscopicity | Slightly hygroscopic |
| Stability | Stable under normal conditions but sensitive to moisture and light over extended periods |
| Bulk Density | Varies depending on particle size, typically around 0.3-0.5 g/cm³ |
| Particle Size | Usually micronized for enhanced bioavailability (ranges from 20–100 microns) |
| LogP (Partition Coefficient) | Approximately 2.7 (indicates moderate lipophilicity) |
Additional Notes:
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Physical Form: Typically supplied as a fine powder to facilitate blending in tablet formulation.
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Purity: High purity (>99%) is ensured to meet pharmacopeial standards (USP/IP/EP).
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Chemical Stability: The sodium salt form enhances stability compared to valproic acid alone.
Why These Matter:
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Solubility and stability directly impact drug absorption and shelf life.
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Particle size influences uniformity and dissolution rate in tablets or capsules.
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Hygroscopic nature requires proper storage conditions to prevent moisture uptake.
Q4: How is DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals synthesized? π§ͺ⚙️
Answer:
The synthesis of Divalproex Sodium by Swapnroop Drugs & Pharmaceuticals involves a carefully controlled chemical process to produce a stable coordination compound consisting of valproic acid and sodium valproate in a 1:1 molar ratio. Here’s an overview of the typical synthesis route used in pharmaceutical manufacturing:
Overview of Synthesis Process:
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Starting Materials:
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Valproic Acid (2-propylpentanoic acid) — the active acid form
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Sodium Hydroxide (NaOH) or another suitable sodium base
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Formation of Sodium Valproate:
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Valproic acid is neutralized by sodium hydroxide to form sodium valproate, a salt.
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This reaction occurs in an aqueous or alcoholic medium under controlled temperature.
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Preparation of the Coordination Complex:
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A precise molar ratio (1:1) of valproic acid and sodium valproate solutions are mixed under controlled temperature and pH conditions.
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The mixture is stirred to allow complexation, forming the divalproex sodium compound.
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Isolation and Purification:
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The compound is isolated by precipitation or crystallization methods.
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Washing and drying steps follow to obtain the pure, white to off-white crystalline powder.
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Micronization:
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The dried API is micronized to reduce particle size, improving solubility and uniformity for formulation.
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Quality Control:
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Throughout the process, critical parameters like temperature, pH, and purity are monitored.
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The final product is tested for residual solvents, moisture content, and chemical purity to meet pharmacopeial standards.
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Why This Method?
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This method ensures high purity and consistent molecular composition.
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The 1:1 ratio provides improved pharmacokinetic properties (e.g., better gastrointestinal tolerability than valproic acid alone).
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Produces an API form suitable for extended-release formulations.
Q5: What are the different dosage forms of DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? ππ¦
Answer:
Swapnroop Drugs & Pharmaceuticals produces Divalproex Sodium primarily as an Active Pharmaceutical Ingredient (API), which is then formulated by pharmaceutical companies into several dosage forms for patient use. The common dosage forms available for divalproex sodium include:
Common Dosage Forms of Divalproex Sodium:
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Delayed-Release Tablets
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Designed to release the drug slowly after passing through the stomach, reducing gastrointestinal irritation.
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Common strengths: 125 mg, 250 mg, 500 mg.
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Extended-Release Tablets
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Provide a controlled release of the drug over an extended period, allowing once-daily dosing.
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Helps maintain steady blood levels, improving compliance.
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Strengths vary, commonly 250 mg and 500 mg.
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Oral Capsules (Less common)
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Some formulations use coated capsules for controlled release.
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Oral Syrups or Suspensions (Typically for pediatric use)
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Liquid forms for patients who have difficulty swallowing tablets.
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Dosage concentration varies, e.g., 250 mg/5 mL.
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Notes:
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Swapnroop Drugs & Pharmaceuticals mainly supplies the API that goes into these formulations.
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The delayed-release and extended-release forms help minimize side effects like stomach upset and improve dosing convenience.
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Other combination or specialty formulations may exist but are less common.
Q6: How are DIVALPROEX SODIUM dosage forms manufactured by Swapnroop Drugs and Pharmaceuticals prepared? ππ
Answer:
The preparation of DIVALPROEX SODIUM dosage forms—especially tablets and capsules—by pharmaceutical companies (using API supplied by Swapnroop Drugs & Pharmaceuticals) involves several key steps focused on ensuring uniformity, stability, and controlled drug release.
Common Manufacturing Process for Tablets (Delayed-Release or Extended-Release):
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Weighing and Dispersion:
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The divalproex sodium API is carefully weighed according to the batch size.
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It is blended with excipients like fillers (e.g., microcrystalline cellulose), binders (e.g., PVP), disintegrants, and coating agents.
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Granulation:
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Either wet granulation or dry granulation techniques are used to improve powder flow and compressibility.
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Wet granulation involves using a binder solution to form granules, which are then dried.
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Dry granulation uses compression rollers to form granules without liquids.
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Milling and Sieving:
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The granules are milled and sieved to achieve uniform particle size.
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Blending:
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Final blending with lubricants (e.g., magnesium stearate) ensures smooth tablet compression and prevents sticking.
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Compression:
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The powder blend is compressed into tablets using rotary tablet presses.
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Compression force and speed are controlled to produce tablets of consistent hardness and thickness.
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Coating (for delayed/extended release):
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Tablets may undergo film coating or enteric coating to control drug release and protect from stomach acid.
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Coating also improves tablet appearance and stability.
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Quality Control:
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Tablets are tested for weight variation, hardness, friability, dissolution, assay, and stability before release.
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For Oral Suspensions:
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API is dispersed in a suitable vehicle with suspending agents, sweeteners, and preservatives, ensuring even drug distribution and palatability.
Summary:
The manufacturing process prioritizes:
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Uniform drug distribution
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Controlled release profile
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Product stability and patient compliance
Q7: What is the appropriate dosage form of DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? π✅
Answer:
The appropriate dosage form of Divalproex Sodium depends on the therapeutic use, patient age, and clinical condition, but generally, the most common and clinically preferred forms are:
Appropriate Dosage Forms:
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Delayed-Release Tablets
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Suitable for most adult patients with epilepsy or bipolar disorder.
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These tablets release the drug slowly after passing through the stomach, minimizing gastric irritation.
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Often prescribed for twice-daily dosing.
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Extended-Release Tablets
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Preferred when once-daily dosing is desirable for better patient compliance.
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Maintains more stable blood drug levels over 24 hours.
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Commonly used in epilepsy and bipolar disorder maintenance therapy.
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Oral Suspension (Liquid Form)
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Appropriate for children or patients who have difficulty swallowing tablets.
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Allows flexible dosing adjustments.
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Capsules (Less common)
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May be used if a controlled release form is needed and tablets are not suitable.
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Choosing the Right Form:
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Adults: Usually prescribed delayed-release or extended-release tablets for convenience and to reduce side effects.
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Pediatrics: Oral suspensions are often used to ease administration and dose accuracy.
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Gastrointestinal sensitivity: Delayed-release or coated forms reduce stomach upset.
Summary:
Swapnroop Drugs & Pharmaceuticals supplies the API used in these dosage forms, and pharmaceutical companies tailor formulations to meet patient needs based on the above factors.
Q8: When should DIVALPROEX SODIUM API manufactured by Swapnroop Drugs and Pharmaceuticals be taken? ⏰π
Answer:
The timing for taking Divalproex Sodium depends on the dosage form prescribed and the medical condition being treated. Here are general guidelines:
Recommended Timing:
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Delayed-Release Tablets
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Typically taken twice daily, usually morning and evening.
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Taken with or after food to minimize stomach upset.
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Extended-Release Tablets
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Usually taken once daily, preferably at the same time each day to maintain steady blood levels.
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Also recommended with food to improve tolerance.
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Oral Suspension
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Administered according to prescribed dosing schedules, often divided doses throughout the day.
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Important Considerations:
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Consistency: Take doses at the same times daily to keep stable drug levels.
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With Food: Taking the medication with meals helps reduce gastrointestinal side effects like nausea or indigestion.
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Avoid Abrupt Changes: Do not suddenly stop the medication without medical advice, as this can cause seizures or mood destabilization.
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Adjustments: Dosage timing may be adjusted based on blood level monitoring and patient response.
Q9: What are the effects and side effects of DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? ⚖️π
Answer:
Therapeutic Effects of Divalproex Sodium:
Divalproex Sodium is primarily used for its ability to:
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Control seizures in epilepsy by stabilizing electrical activity in the brain.
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Stabilize mood in bipolar disorder, particularly effective for manic episodes.
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Prevent migraines by reducing the frequency and severity of attacks.
It works by increasing levels of GABA (gamma-aminobutyric acid), an inhibitory neurotransmitter that calms brain activity.
Common Side Effects:
While generally well tolerated, divalproex sodium may cause:
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Gastrointestinal issues: nausea, vomiting, indigestion, diarrhea
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Drowsiness or dizziness
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Tremor (shaking)
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Weight gain
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Hair thinning or hair loss
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Fatigue
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Blurred or double vision
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Mood changes (rare)
Serious but Less Common Side Effects:
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Hepatotoxicity: Liver damage (especially in young children or those with pre-existing liver disease)
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Pancreatitis: Inflammation of the pancreas, which can be life-threatening
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Thrombocytopenia: Low platelet count causing bleeding issues
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Hyperammonemia: Elevated ammonia levels leading to confusion or coma
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Teratogenicity: Risk of birth defects if taken during pregnancy (especially first trimester)
Monitoring and Precautions:
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Regular liver function tests and blood counts are recommended during therapy.
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Patients should avoid abrupt discontinuation to prevent seizure recurrence or mood destabilization.
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Pregnancy should be avoided or carefully managed during treatment.
Summary:
Swapnroop Drugs & Pharmaceuticals manufactures divalproex sodium API, which is effective in treating epilepsy, bipolar disorder, and migraines but requires careful monitoring to manage potential side effects and ensure patient safety.
Q10: How is DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals tested? π§ͺ✔️
Answer:
Divalproex Sodium produced by Swapnroop Drugs & Pharmaceuticals undergoes rigorous quality control testing to ensure it meets pharmacopeial standards (such as USP, IP, or EP) and is safe and effective for pharmaceutical formulation. Testing covers identity, purity, potency, and safety aspects.
Common Testing Procedures:
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Identification Tests
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Confirm the chemical identity of divalproex sodium using techniques such as Infrared (IR) Spectroscopy, UV Spectroscopy, and NMR (Nuclear Magnetic Resonance).
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Comparison with reference standards ensures the API is genuine.
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Assay (Potency) Tests
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Quantitative measurement of the active drug content, typically by High-Performance Liquid Chromatography (HPLC).
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Ensures the API contains the labeled amount (usually 98-102%).
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Purity and Impurity Profiling
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Testing for related substances, residual solvents, and degradation products using HPLC or Gas Chromatography (GC).
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Ensures impurities are within acceptable limits.
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Physical Tests
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Melting Point Determination to confirm purity.
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Particle Size Analysis to ensure consistency for formulation.
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Bulk Density and Flow Properties for processing suitability.
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Moisture Content
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Measured by Karl Fischer titration or loss on drying methods to confirm low moisture levels and prevent degradation.
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Microbial Testing
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Ensures the API is free from harmful microbial contamination.
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Q11: What tests are performed on DIVALPROEX SODIUM Manufactured by Swapnroop Drugs and Pharmaceuticals? π§ͺπ¬
Answer:
To ensure the quality and compliance of DIVALPROEX SODIUM API, Swapnroop Drugs & Pharmaceuticals performs a series of standardized tests aligned with pharmacopeial requirements (USP/IP/EP). These tests cover identity, purity, potency, and safety.
Common Tests Performed:
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Identification Tests:
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Infrared (IR) Spectroscopy — confirms chemical structure.
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UV-Visible Spectroscopy — identifies characteristic absorption peaks.
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Nuclear Magnetic Resonance (NMR) — structural confirmation.
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Assay (Potency) Test:
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High-Performance Liquid Chromatography (HPLC) — quantifies active content; ensures API strength.
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Related Substances / Impurities:
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HPLC or Gas Chromatography (GC) — detects and quantifies impurities and degradation products within set limits.
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Physical Property Tests:
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Melting Point Determination — verifies purity and identity.
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Particle Size Analysis — critical for formulation consistency.
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Bulk Density and Tapped Density — important for flow and compression properties.
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Moisture Content:
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Karl Fischer Titration or Loss on Drying — measures moisture to prevent stability issues.
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Residual Solvents:
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Gas Chromatography — ensures solvents used during synthesis are below toxic levels.
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Microbial Limit Tests:
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Ensures the API is free from harmful microbial contamination.
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Heavy Metals Test:
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Ensures trace metals are within safe limits.
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Q12: What are the challenges in manufacturing DIVALPROEX SODIUM API manufactured by Swapnroop Drugs and Pharmaceuticals? ⚙️⚠️
Answer:
Manufacturing high-quality DIVALPROEX SODIUM API involves overcoming several technical and process challenges to ensure purity, stability, and consistent performance. Here are some key challenges faced by Swapnroop Drugs & Pharmaceuticals during API production:
Key Manufacturing Challenges:
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Maintaining High Purity and Consistency
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The API must meet strict impurity and related substances limits.
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Controlling side reactions during synthesis to avoid undesired by-products is critical.
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Controlling Moisture Content
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Divalproex sodium is slightly hygroscopic, so controlling moisture during drying and storage is essential to prevent degradation and clumping.
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Complex Coordination Chemistry
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Achieving the precise 1:1 molar complex of valproic acid and sodium valproate requires tight control of reaction conditions (pH, temperature, stoichiometry).
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Particle Size Control
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Proper micronization is required to achieve uniform particle size, which affects bioavailability and formulation properties.
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Avoiding excessive fines that can cause poor flow or dust hazards.
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Residual Solvent Removal
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Ensuring removal of solvents used in synthesis to below toxic limits, without compromising yield.
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Scaling Up Production
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Consistent quality across large batches while maintaining cost-effectiveness can be challenging.
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Maintaining batch-to-batch reproducibility.
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Environmental and Safety Concerns
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Handling corrosive chemicals like sodium hydroxide safely.
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Managing waste and emissions responsibly.
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Q13: What are the challenges in manufacturing DIVALPROEX SODIUM dosage forms manufactured by Swapnroop Drugs and Pharmaceuticals? π⚠️
Answer:
Manufacturing dosage forms of Divalproex Sodium (such as delayed-release or extended-release tablets and oral suspensions) presents unique formulation and production challenges, including:
Key Challenges in Dosage Form Manufacturing:
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Controlled Release Formulation:
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Designing coatings and matrix systems that provide consistent delayed or extended release is complex.
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Ensuring the drug releases at the right rate to maintain therapeutic blood levels without causing irritation.
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Stability of the Dosage Form:
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Divalproex sodium is sensitive to moisture; dosage forms must be protected from humidity to prevent degradation and maintain efficacy.
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Formulation must remain stable throughout shelf life.
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Uniform Drug Distribution:
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Ensuring content uniformity is crucial, especially in low-dose formulations or suspensions.
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Proper mixing and granulation processes are required.
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Taste Masking:
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Divalproex sodium has a bitter taste; oral suspensions and chewable forms need effective taste masking to improve patient compliance.
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Powder Flow and Compressibility:
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Achieving good powder flow and compressibility for tablet compression can be difficult due to the API’s physical properties.
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Requires optimization of excipients and granulation techniques.
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Micronization and Particle Size Control:
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Maintaining consistent particle size in the finished product affects dissolution and bioavailability.
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Packaging to Prevent Moisture Ingress:
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Moisture-barrier packaging is essential to preserve dosage form stability.
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Q14: What are the storage conditions for DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? π‘️π¦
Answer:
Proper storage of Divalproex Sodium API and its dosage forms is essential to maintain drug stability, potency, and safety. Swapnroop Drugs & Pharmaceuticals recommends the following storage conditions:
Recommended Storage Conditions:
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Temperature:
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Store at controlled room temperature, typically between 20°C to 25°C (68°F to 77°F).
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Avoid exposure to excessive heat or freezing conditions.
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Humidity:
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Protect from moisture and humidity, as divalproex sodium is somewhat hygroscopic and can degrade or clump when exposed to high humidity.
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Use airtight, moisture-proof containers.
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Light Exposure:
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Store in a cool, dry place away from direct sunlight to prevent photodegradation.
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Packaging:
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Keep in original tightly sealed containers to avoid contamination and moisture ingress.
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Shelf Life Preservation:
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Avoid frequent opening of containers to maintain the integrity of the API or dosage forms.
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Q15: What is the packaging for DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? π¦π‘️
Answer:
Swapnroop Drugs & Pharmaceuticals packages Divalproex Sodium API in materials designed to protect the product from moisture, contamination, and physical damage during storage and transport.
Typical Packaging for Divalproex Sodium API:
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Primary Packaging:
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High-density polyethylene (HDPE) drums or bottles with airtight, moisture-proof seals.
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Sometimes lined with polyethylene bags or moisture barrier liners inside the container for extra protection.
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Secondary Packaging:
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Corrugated fiberboard cartons or boxes for safe handling and stacking.
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Proper labeling with batch number, manufacturing date, storage instructions, and safety info.
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For Dosage Forms (by formulation manufacturers):
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Blister packs or bottles for tablets or capsules, often with desiccant packs to control moisture.
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Plastic or glass bottles for oral suspensions with child-resistant caps.
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Packaging Considerations:
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Ensures moisture barrier to prevent hygroscopic degradation.
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Protects from light and physical damage during shipping.
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Complies with regulatory requirements for pharmaceutical APIs.
Q16: What is the shelf life of DIVALPROEX SODIUM manufactured by Swapnroop Drugs and Pharmaceuticals? ⏳π
Answer:
The typical shelf life of Divalproex Sodium API manufactured by Swapnroop Drugs & Pharmaceuticals is:
Shelf Life Duration:
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3 to 5 years from the date of manufacture when stored under recommended conditions (cool, dry place, away from moisture and light).
Factors Influencing Shelf Life:
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Storage conditions: Proper temperature and humidity control are crucial to maintain potency and prevent degradation.
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Packaging integrity: Moisture-proof, airtight packaging helps preserve stability.
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Stability testing: Shelf life is supported by stability data conducted according to ICH guidelines, ensuring the API remains within specification over this period.
Shelf Life for Dosage Forms:
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Dosage forms (tablets, capsules, suspensions) typically have shelf lives ranging from 2 to 3 years, depending on formulation and packaging.
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