API's
Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients
Theophylline Sustained-Release (SR) Pellets are multiparticulate oral delivery systems designed for the prolonged and controlled release of Theophylline, a methylxanthine bronchodilator. Widely used in the management of asthma, COPD, and other chronic respiratory conditions, these pellets maintain steady plasma concentrations, reduce dosing frequency, and minimize side effects such as gastrointestinal irritation.
| Component | Function |
|---|---|
| Theophylline (USP / BP / EP) | Active Pharmaceutical Ingredient (API) – bronchodilator |
| Calcium Phosphate Dibasic Anhydrous (USP / EP) | Pellet core filler and spheronization aid |
| Microcrystalline Cellulose (MCC, USP / EP) | Pellet former and binder (extrusion/spheronization base) |
| Hydroxypropyl Cellulose (HPC, USP / EP) | Binder for drug layering or wet massing agent |
| Ethyl Cellulose Aqueous Dispersion (e.g., Surelease®) (USP) | Sustained-release polymer coating |
| Glycerol Monostearate (USP) | Lipophilic matrix former / release retarder |
| Magnesium Stearate (USP / EP) | Lubricant and anti-adherent |
| Talc (USP / EP) | Anti-adherent during coating |
| Colloidal Silicon Dioxide (USP / EP) | Glidant and moisture scavenger |
| Purified Water (USP / EP) | Processing solvent (removed during drying) |
Salius Pharma offers Theophylline SR Pellets manufactured in USFDA-approved, WHO-GMP, and ISO-certified facilities, ensuring compliance with global standards. Our pellets exhibit uniform particle size, excellent flowability, and customizable release profiles to suit various dosage forms (capsules, tablets). With proven market success in Africa, MENA, LATAM, and Southeast Asia, and full regulatory support (CTD, CoA, COPP, and GMP certificates), Salius Pharma is your ideal partner for high-quality respiratory APIs.
We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.
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Theophylline SR Pellets are used in the management of asthma, chronic bronchitis, and COPD, where sustained bronchodilation is required to improve airflow and reduce respiratory symptoms.
The pellets are engineered with sustained-release coating systems that control drug diffusion, helping maintain uniform plasma concentrations and reduce dosing fluctuations.
Yes. The pellets exhibit good stability at controlled room temperature and are supplied in export-grade, moisture-resistant packaging to preserve quality during international shipping.
Pelletization enables dose flexibility, better content uniformity, and reduced risk of dose dumping, making it suitable for respiratory formulations requiring controlled release.