Extended-release excipient

Polyethylene Oxide (PEO) 聚环氧乙烷 (PEO)

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。

USP-NF · EP · ChPUSP-NF · EP · ChP CAS 25322-68-3 Excipact GMP (SGS)Excipact GMP(SGS) China DMF filed中国 DMF 备案

Product profile产品概况

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

Key applications主要应用

01

Hydrophilic matrix ER tablets亲水骨架缓释片

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。

02

Push-pull osmotic pump (PPOP)推拉式渗透泵(PPOP)

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。

03

Suspending agent in the drug layer药层中的助悬剂

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。

Grade matching型号对标

Which series are you using? Find the match.你现在用的是哪个系列?在这里找到对应型号。

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-10100,00012 – 5030 g / (570 + 125) mL H₂O + IPAWSR N-10PEO-1
PEO-20200,00065 – 11530 g / (570 + 125) mL H₂O + IPAWSR N-80PEO-1
PEO-40400,0002,250 – 4,50030 g / (570 + 125) mL H₂O + IPAWSR N-3000
PEO-60600,0004,500 – 8,80030 g / (570 + 125) mL H₂O + IPAWSR-205
PEO-90900,0008,800 – 17,60030 g / (570 + 125) mL H₂O + IPAWSR-1105
PEO-1001,000,000400 – 80012 g / (588 + 125) mL H₂O + IPAWSR N-12KPEO-3
PEO-2002,000,0002,000 – 4,00012 g / (588 + 125) mL H₂O + IPAWSR N-60KPEO-8NF
PEO-4004,000,0001,650 – 5,5006 g / (594 + 125) mL H₂O + IPAWSR-301PEO-15
PEO-5005,000,0005,500 – 7,5006 g / (594 + 125) mL H₂O + IPAWSR CoagulantPEO-18
PEO-7007,000,0007,500 – 10,0006 g / (594 + 125) mL H₂O + IPAWSR-303PEO-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。

Formulation notes处方要点

Validated in mainstream extended-release formulations在主流缓释处方中已验证

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。

Matrix ER tablet — Metformin HCl ER骨架缓释片 —— 盐酸二甲双胍缓释片

Component组分 Amount用量
Metformin HCl50%
PEO (WSR-301 / 303 grade)30%
MCC19%
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。

Molecular weight & concentration effects分子量与用量的影响

Molecular weight

分子量

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。

Polymer concentration

高分子用量

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。


Push-pull osmotic pump — reference composition推拉式渗透泵 —— 参考处方

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 PVPGranulation 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 CoagulantBulking 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。

Zero regulatory risk, full audit access零法规风险,审计全程开放

Excipact GMP

Excipient GMP certification issued by SGS.

由 SGS 签发的药用辅料 GMP 认证。

NMPA registered

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。

Audit support

审计支持

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。

Regulatory documents

法规文件

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。

Download the PEO document set下载 PEO 文件清单

Need a grade recommendation?需要选型建议?

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。