Active Pharmaceutical Ingredients
Doxofylline is a phosphodiesterase-inhibiting bronchodilator utilized in the management of chronic respiratory conditions, including asthma and COPD. It is a derivative of xanthine, just like theophylline. Its Modified Release (MR) granule form ensures sustained plasma levels, better compliance, and reduced dosing frequency compared to conventional formulations.
| Component | Function |
|---|---|
| Doxofylline | Active Ingredient (Bronchodilator) |
| Hydroxypropyl Methylcellulose (HPMC) / Ethylcellulose | Sustained Release Matrix Former |
| Lactose Monohydrate / Mannitol | Diluent / Filler |
| Croscarmellose Sodium / Crospovidone | Disintegrant |
| Magnesium Stearate | Lubricant |
| Colloidal Silicon Dioxide | Glidant |
Outsourcing DC Granules through a trusted partner like Salius Pharma can be a strategic decision to save both time and resources, without compromising on quality or compliance. Instead, partnering with Salius Pharma—a leading developer aligned with USFDA-approved and WHO-GMP-certified manufacturers in India—allows you to leverage high-quality products, seamless logistics, and professional support under one roof.
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Doxofylline MR granules are used to formulate modified release tablets or capsules for the management of asthma and chronic obstructive pulmonary disease (COPD). The MR form ensures sustained bronchodilation and helps maintain stable therapeutic levels over time.
MR granules provide a controlled and prolonged drug release, which reduces the frequency of dosing, ensures consistent therapeutic effects, and improves patient compliance compared to immediate-release formulations.
The granules can be formulated into tablets of 400 mg and 800 mg equivalent, and strengths can be customized based on market or regulatory requirements.
MR granules offer ease of processing, consistent quality, and compliance with USP/EP standards, enabling the production of high-quality, patient-friendly modified-release tablets or capsules.