A thermoplastic, fast-hydrating polymer that forms a hydrogel barrier in situ. Ten grades from 100,000 to 7,000,000 molecular weight cover hydrophilic matrix ER tablets, push-pull osmotic pumps and mucoadhesive systems.
热塑性、快速水合的高分子材料,遇水原位形成水凝胶屏障。分子量从 10 万到 700 万共 10 个规格,覆盖亲水骨架缓释片、推拉式渗透泵与黏膜黏附体系。
| Chemical name化学名称 | Polyethylene Oxide (PEO)聚环氧乙烷(PEO,又称聚氧化乙烯) |
| Alias别名 | Macrogols, high molecular mass高分子量聚乙二醇(Macrogols, high molecular mass) |
| CAS No. | 25322-68-3 |
| Function功能 | Thermoplastic with a fast hydration rate; forms a hydrogel rapidly. Its combination of properties supports modified-release formulations, tablet binding and mucoadhesion. 热塑性、水合速率快,可迅速形成水凝胶。综合性能使其适用于缓控释制剂、片剂黏合与黏膜黏附给药系统。 |
| Appearance性状 | White to off-white, free-flowing powder白色至类白色自由流动粉末 |
| Solubility溶解性 | Freely soluble in water易溶于水 |
| Molecular weight分子量 | 100,000 – 7,000,000 (10 grades)(10 个规格) |
| Standards质量标准 | Compliant with current USP-NF / EP / ChP符合现行 USP-NF / EP / ChP |
Forms a gel barrier on the tablet surface that controls the rate of drug release over the dosing interval.
在片剂表面形成凝胶屏障,控制药物在给药周期内的释放速率。
High-molecular-weight grades act as the bulking agent in the push layer, delivering zero-order release independent of pH and food effect.
高分子量规格用作推动层的膨胀剂,实现不依赖 pH 与食物的零级释放。
Maintains uniform dispersion of the drug in PPOP drug layers and in suspension-based systems.
在渗透泵药层与混悬体系中维持药物的均匀分散。
Equivalent grades to the Dow POLYOX™ WSR and Sumitomo PEO series. Direct substitution — no reformulation required.
与 Dow POLYOX™ WSR 及住友 PEO 系列对应的型号,可直接替换,无需重新配方。
| Our grade本司型号 | Molecular weight分子量 | Dynamic viscosity (mPa·s)动力黏度(mPa·s) | Test solution测定浓度 / 溶剂 | Dow POLYOX™ | Sumitomo |
|---|---|---|---|---|---|
| PEO-10 | 100,000 | 12 – 50 | 30 g / (570 + 125) mL H₂O + IPA | WSR N-10 | PEO-1 |
| PEO-20 | 200,000 | 65 – 115 | 30 g / (570 + 125) mL H₂O + IPA | WSR N-80 | PEO-1 |
| PEO-40 | 400,000 | 2,250 – 4,500 | 30 g / (570 + 125) mL H₂O + IPA | WSR N-3000 | — |
| PEO-60 | 600,000 | 4,500 – 8,800 | 30 g / (570 + 125) mL H₂O + IPA | WSR-205 | — |
| PEO-90 | 900,000 | 8,800 – 17,600 | 30 g / (570 + 125) mL H₂O + IPA | WSR-1105 | — |
| PEO-100 | 1,000,000 | 400 – 800 | 12 g / (588 + 125) mL H₂O + IPA | WSR N-12K | PEO-3 |
| PEO-200 | 2,000,000 | 2,000 – 4,000 | 12 g / (588 + 125) mL H₂O + IPA | WSR N-60K | PEO-8NF |
| PEO-400 | 4,000,000 | 1,650 – 5,500 | 6 g / (594 + 125) mL H₂O + IPA | WSR-301 | PEO-15 |
| PEO-500 | 5,000,000 | 5,500 – 7,500 | 6 g / (594 + 125) mL H₂O + IPA | WSR Coagulant | PEO-18 |
| PEO-700 | 7,000,000 | 7,500 – 10,000 | 6 g / (594 + 125) mL H₂O + IPA | WSR-303 | PEO-20NF |
Grade correspondence is indicative and based on molecular-weight and viscosity equivalence. Confirm the substitution against your own dissolution profile before filing. A signed equivalence table is available from the manufacturer on request.
型号对应关系为基于分子量与黏度等效性的指示性对照。正式变更前请以自有溶出曲线进行确认;工厂可提供签章版对标表。
Drop-in substitution. Users of Dow WSR-301 / WSR-303 typically switch directly to PEO-400 / PEO-700. CoA and batch-to-batch consistency data are provided with every shipment. 可直接替换。原使用 Dow WSR-301 / WSR-303 的客户通常直接切换至 PEO-400 / PEO-700。每批随货提供 CoA 与批间一致性数据。
Proven in real formulations, not theoretical substitution.
是在真实处方中验证过的替代,不是理论推演。
| Component组分 | Amount用量 |
|---|---|
| Metformin HCl | 50% |
| PEO (WSR-301 / 303 grade) | 30% |
| MCC | 19% |
| Lubricant润滑剂 | 1% |
| Process工艺 | Direct compression直接压片 |
Illustrative formulation published in the product literature. Higher molecular weight → stronger gel viscosity → slower release.
处方摘自产品资料,仅作示例。分子量越高 → 凝胶黏度越强 → 释放越慢。
Increasing molecular weight raises chain entanglement and gel strength, which lowers the drug diffusion rate. Beyond a certain molecular weight, further increase has little effect on dissolution.
分子量升高使高分子链缠结加剧、凝胶强度提高,从而降低药物扩散速率。超过某一分子量后,继续提高对溶出的影响很小。
Below 20% the gel barrier is incomplete — a significant amount of drug releases rapidly, and the tablet may disintegrate. From 20% to 40% the dissolution rate falls as the surface reaches the required concentration of de-entangled chains. Above the threshold, further increase has little effect.
低于 20% 时无法形成完整凝胶屏障,药物大量快速释放,甚至导致片剂崩解;20%–40% 区间内,随着表面解缠结高分子链浓度达到要求,溶出速率下降;超过该阈值后,继续增加用量对溶出影响不明显。
| Drug layer药层 | ||
|---|---|---|
| Component组分 | Function作用 | Range用量 |
| Drug药物 | Active ingredient活性成分 | 1 – 30% |
| PEO (N-80 grade) | Polymer / suspending agent高分子 / 助悬剂 | 70 – 95% |
| HPMC or或 PVP | Granulation binder制粒黏合剂 | 2 – 5% |
| Magnesium stearate硬脂酸镁 | Lubricant润滑剂 | 0.5 – 1% |
| Push layer推动层 | ||
|---|---|---|
| Component组分 | Function作用 | Range用量 |
| PEO Coagulant | Bulking agent膨胀剂 | 50 – 70% |
| Sodium chloride氯化钠 | Osmotic enhancer渗透促进剂 | 30 – 40% |
| Colour lake色淀 | Colorant着色剂 | 0.20% |
| Magnesium stearate硬脂酸镁 | Lubricant润滑剂 | 0.5 – 1% |
Semipermeable membrane: cellulose acetate, with a laser-drilled drug-release orifice. Result: zero-order release kinetics, independent of pH and food effect. Our technical team supports grade selection and dissolution profiling.
半透膜为醋酸纤维素,激光打孔形成释放孔。结果为不依赖 pH 与食物的零级释放动力学。我们的技术团队可协助型号选择与溶出曲线研究。
Excipient GMP certification issued by SGS.
由 SGS 签发的药用辅料 GMP 认证。
Manufacturer registered with NMPA; China DMF filed to support your formulation registration.
生产企业在 NMPA 完成注册,并已递交中国 DMF,可支持贵司制剂注册。
Site audit welcomed. Written supplier questionnaire accepted in most cases.
欢迎现场审计;多数情况下可先以书面供应商问卷完成评估。
Complete document pack: quality system, safety statements, impurity control, product and regulatory files.
完整资料包:质量体系、安全性声明、杂质控制、产品与法规文件。
Send us the dosage form, the current polymer and your target release profile. We will reply with the matching grade and a sample plan.
把剂型、现用高分子与目标释放曲线发给我们,我们会回复匹配型号与样品方案。