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Surelease BP EP USP Pharma Grade functions as a specialised aqueous ethylcellulose dispersion, developed specifically for pharmaceutical applications that require reliable film-coating material for tablets and multi-particulate systems. This raw material stands out in oral dosage form technology. As someone who has seen the shift toward more controlled drug release, the demand for Surelease highlights how the industry leans on consistent and reproducible processes, especially for products demanding precise drug release profiles and robust protection against light, moisture, and oxidation.
The unique structure of Surelease sets it apart. It holds a mixture of ethylcellulose as the principal film-forming polymer, integrated with a plasticizer—commonly dibutyl sebacate or similar agents—as well as stabilizers and other excipients. Ethylcellulose appears as a white to light tan solid at room temperature, yet Surelease, as a ready-to-use dispersion, is supplied as a uniform, milky, odorless liquid with a viscosity optimized for spray application. The solid content usually sits between 25% and 30% by weight, which helps ensure a strong, cohesive film on tablets. Surelease in bulk shows a density in the range of 0.95–1.05 g/cm³ at 25°C. Its pH typically falls between 6.0 and 8.0, safe for sensitive actives that can degrade under acidic or strongly basic conditions. Temperature storage limits rest between 5°C and 30°C, avoiding both freezing and excessive heat.
At the core of Surelease, ethylcellulose embodies a cellulose derivative where hydroxyl groups get replaced with ethyl ether units, giving the polymer its characteristic resistance to water and many solvents. The general molecular formula is C12H23O6 for the repeating ethylcellulose unit, though the overall structure of Surelease will include additional stabilizing and plasticizing molecules. Molecular weight can range anywhere from 80,000 to 120,000 Daltons, dependent on the grade and manufacturing process. The substance is classified under HS Code 391290 for customs purposes—pertaining to cellulose ether derivatives in primary form.
As for form, Surelease is primarily available as a viscous milky liquid, chosen for immediate usability in industrial coating pan or fluid bed systems. Ethylcellulose, by itself, might come in powders, flakes, and even pearls, but processing for pharmaceutical coatings converts that polymer into a stable aqueous dispersion. When dried on pharmaceutical products, it leaves a thin, flexible, nearly invisible film. The handling of Surelease liquid calls for mixing before use, as some settling may occur over time if storage conditions fluctuate. This ensures consistency and prevents dosing errors on production lines.
Surelease aligns with major pharmacopeial standards—BP, EP, and USP—ensuring traceable quality at every point. Typical certificates of analysis list solid content, viscosity (usually measured in centipoise at 25°C), pH, and microbial limits, since product safety rides on the absence of contamination that could ruin entire batches of medications. The manufacturers often share additional test results, checking for the presence of heavy metals, residual solvents, and particulate matter that grows relevant when patients require sensitive or sterile products. From firsthand experience, procuring genuine, pharma-grade Surelease makes a difference in yield, coating integrity, and batch repeatability.
Surelease itself, as a dispersion, mixes readily with water, but the ethylcellulose component inside is practically insoluble in water and most aqueous solutions. It needs organic solvents like ethanol for solution, if used outside the dispersion. Yet, in the final tablet coating, ethylcellulose ensures robustness because it forms a barrier that resists both stomach and intestinal liquors, helping with both delayed and sustained drug release. Manufacturers take pains to clarify that Surelease does not introduce hazardous volatile solvents, making it a safer, environmentally responsible choice for large pharmaceutical installations. This advantage has real meaning to anyone who has worked around solvent-based systems that require specialized ventilation, fire precautions, and regulatory oversight.
Safety matters with every raw material entering a pharmaceutical plant. Surelease BP EP USP Pharma Grade receives a non-hazardous status in most safety data sheets, compliant with global chemical regulations such as REACH. There’s no risk of acute toxicity from handling, though adherence to workplace safety—gloves, goggles, and normal mixing precautions—prevents minor irritations or contamination. For transport, Surelease is not classified as flammable or corrosive. Large-scale operations rarely see issues, but leaks or spills still require cleanup to stop floors from getting slippery or drying into films that are tough to remove. Surelease contains no known allergens or sensitizers unless mishandled or adulterated, which strict audits and vendor checks keep in line.
Surelease has become a go-to excipient because of its role in sustained-release and enteric-coated tablets, granules, and pellets. It shields sensitive actives from stomach acid, mitigates taste masking, and enables dual-release profiles. Surelease simplifies the process, demanding less intensive cleaning after production. For pharmaceutical companies chasing high-throughput and steady margins, the cost of switching to a cheaper or lower-grade coating rarely compensates for yield losses or regulatory risk associated with out-of-spec finished goods. From a procurement angle, sticking with the correct BP EP USP Pharma Grade avoids sourcing delays and documentation headaches during audits—or, worse, during recalls.
Not everything is perfect. Surelease still calls for keen management to maintain batch-to-batch consistency. Viscosity shifts and sediment formation can cause uneven coatings or even damage nozzles in automated coating pans. Maintaining storage below 30°C and regular rotation of stock helps curb these headaches. Manufacturers highlight the value of supplier audits and real-time QC checks, not just for compliance but because customers—especially in regulated markets—expect thorough records and timely responses to trace issues.
Industry leaders who depend on Surelease recommend investing in automated dispersion mixers and recirculation pumps, which help stabilize the suspension prior to application. While older equipment was prone to clogging and layering, newer lines incorporate inline homogenizers, more consistent temperature control, and intelligent software to monitor every batch. Staff training pays dividends too: familiar teams spot anomalies in Surelease batches, and quick intervention prevents rework or scrap. Sourcing pharma-grade and keeping direct vendor relationships gives greater transparency, allowing rapid action if defects or supply disruptions arise. These hands-on adjustments mean companies can deliver safe, effective products and avoid regulatory and business setbacks.
Chengguan District, Lanzhou, Gansu, China
