SR formulation releases Pregabalin gradually over 12–24 hours, maintaining steady plasma levels. This means fewer daily doses, reduced peak side effects like dizziness, and better overnight nerve pain control — especially beneficial for diabetic neuropathy patients.
Pregabalin SR (Sustained Release) 75 mg is a modified-release oral tablet formulation of Pregabalin, a gabapentinoid class anticonvulsant and neuropathic pain agent. It works by binding to the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system, modulating the release of excitatory neurotransmitters including glutamate, norepinephrine, and substance P — thereby reducing nerve pain signals and abnormal neuronal excitability.
Unlike immediate-release (IR) capsules that require dosing 2–3 times a day, the SR matrix tablet releases Pregabalin slowly and consistently over 12–24 hours. This controlled release profile: maintains steadier plasma drug concentrations, avoids sharp peaks (which cause dizziness and sedation), reduces pill burden, and improves overall patient adherence — especially in elderly patients and those with diabetic neuropathy requiring nighttime coverage.
Our Pregabalin SR 75 mg tablets are manufactured using polymer-based matrix technology in WHO-GMP certified facilities. Every batch undergoes in-vitro dissolution testing at multiple time points (2hr, 4hr, 8hr, 12hr) to confirm SR release profile compliance, along with HPLC assay testing and content uniformity checks for consistent therapeutic performance.
In long-term neuropathic pain management, sustained-release formulations offer significant clinical advantages — particularly in improving quality of life, reducing daytime sedation, and ensuring consistent overnight pain control.
| Parameter | Pregabalin SR 75 mg | Pregabalin IR 50/75 mg |
|---|---|---|
| Dosing Frequency | Once or Twice Daily | 2–3 times daily |
| Plasma Level Stability | ✔ Steady, consistent levels | ✘ Peak-trough fluctuations |
| Dizziness / Sedation | ✔ Lower risk (no sharp peaks) | ✘ Higher at peak concentration |
| Overnight Pain Relief | ✔ Effective (12–24 hr action) | ✘ May wear off by morning |
| Patient Compliance | ✔ Better (fewer doses) | Moderate (multiple doses) |
| Tablet Instructions | Swallow whole — do not crush | Can be opened (capsule) |
| Titration Flexibility | Moderate | ✔ Higher (more strengths) |
Initial dose: Pregabalin SR 75 mg once daily (with evening meal for better absorption). After 1 week, may be increased to 150 mg once daily. If still insufficient after 2–4 weeks, can be increased to 150 mg twice daily (300 mg/day). Maximum dose: 330 mg/day.
Start with 75 mg once daily at bedtime. Titrate to 150 mg once daily after one week based on tolerability. Dosage range for fibromyalgia: 150–300 mg/day in SR form. Evening dosing preferred to reduce daytime sedation.
SR 75 mg once or twice daily as adjunct therapy. Titration schedule similar to IR — target dose 150–300 mg/day depending on response. Always taper gradually when discontinuing to avoid withdrawal effects.
Do NOT crush, split, or chew SR tablets — this destroys the sustained-release matrix and causes rapid drug dump (risk of toxicity and severe side effects). Take with food or immediately after a meal. Evening dosing is generally preferred.
* Dosage is indicative. Dose adjustment required for patients with renal impairment (based on CrCl). Physician supervision mandatory throughout treatment.
| Composition | Pregabalin IP 75 mg (Sustained Release) |
|---|---|
| Dosage Form | Film-Coated Sustained Release Tablets |
| Strength | 75 mg per tablet |
| Release Mechanism | Polymer Matrix SR Technology (12–24 hr release) | Packaging | 10×10 Alu-Alu Blister Pack |
| Therapeutic Category | Neuropathic Pain / Anticonvulsant / Anxiolytic |
| Drug Class | Gabapentinoid (Alpha-2-Delta Ligand) |
| Drug Schedule | Schedule H (Prescription Only) |
| Pharmacopoeia Standard | IP / USP |
| Manufacturing Standard | WHO-GMP Certified |
| Dissolution Testing | Multi-point (2hr, 4hr, 8hr, 12hr) as per IP/USP |
| Available SR Strengths | 75 mg, 150 mg, 300 mg |
| Minimum Order Qty | 1,000 Units / 100 Strips |
| Country of Origin | India |
SR formulation generally causes fewer and milder side effects than IR due to the absence of sharp concentration peaks. However, the following may still be observed:
Store below 30°C in a cool, dry place. Do not refrigerate. Avoid exposure to direct sunlight or heat sources.
Protect from moisture. SR tablets are sensitive to humidity — keep in original Alu-Alu blister packaging at all times until use.
24–36 months from the date of manufacturing. Packed in 10×10 Alu-Alu blister strips, enclosed in printed cartons with full product labeling.
Shipped via standard temperature-monitored logistics. Cold chain not required. Complete export documentation — COA, MSDS, GMP Certificate, Free Sale Certificate, and Stability Data — available on request.
