賦形劑的多樣性：merck藥品及其原料藥廠的原料藥解析
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Clariant 製藥原料

VitiPure 系列：PEG以及PEG衍生物，主要作為增溶劑，提高難溶性 API 的溶解性、穩定性和生物利用度。

Product Name

Chemical Name

Grade

Applications

Product details

VitiPure LEX 300

Polyethylene Glycol 300
聚乙二醇 300

EP,USP,JP

Solublizers
(For high-risk applications)

Widely used solvent
Low Endotoxin : Max. 1 IU/ml
Average molar mass 300 g/mol

VitiPure LEX 400

Polyethylene Glycol 400
聚乙二醇 400

EP,USP,JP

Solublizers
(For high-risk applications)

Widely used solvent
Low Endotoxin : Max. 1 IU/ml
Average molar mass 400g/mol

VitiPure HCO 40

Polyoxyl 40 castor oil
PEG-40 氫化蓖麻油

EP,USP

Solublizers

Non-ionic surfactant, HLB : 14~16

VitiPure HCO 40 LEX

Polyoxyl 40 castor oil
PEG-40 氫化蓖麻油

EP,USP

Solublizers
(For high-risk applications)

Non-ionic surfactant, HLB : 14~16
Low Endotoxin : Max. 1 IU/ml

VitiPure CO 35

Polyoxyl 35 castor oil
PEG-35 蓖麻油

EP,USP

Solublizers

Non-ionic surfactant, HLB : 12~14

VitiPure CO 35 LEX

Polyoxyl 35 castor oil
PEG-35 蓖麻油

EP,USP

Solublizers
(For high-risk applications)

Non-ionic surfactant, HLB : 12~14
Low Endotoxin : Max. 1 IU/ml

VitiPure L 20

Polyoxyethylene 20 sorbitan monolaurate(Polysorbate 20)
聚山梨酯 20

EP,USP

Solublizers

Non-ionic surfactant, HLB : 16.7

VitiPure L 20 LEX

Polyoxyethylene 20 sorbitan monolaurate(Polysorbate 20)
聚山梨酯 20

EP,USP

Solublizers
(For high-risk applications)

Non-ionic surfactant, HLB : 16.7
Low Endotoxin : Max. 1 IU/ml

VitiPure O 80

Polyoxyethylen 80 sorbitan monooleate(Polysorbate 80)
聚山梨酯 80

EP,USP

Solublizers

Non-ionic surfactant, HLB : 15

VitiPure O 80 LEX

Polyoxyethylen 80 sorbitan monooleate(Polysorbate 80)
聚山梨酯 80

EP,USP

Solublizers
(For high-risk applications)

Non-ionic surfactant, HLB : 15
Low Endotoxin : Max. 1 IU/ml

VitiPure P 188

Methyl Oxirane polymer with Oxirane
(Poloxamer 188)
泊洛沙姆 188

EP,USP

Solublizers

Non-ionic surfactant, HLB : 29

VitiPure P 188 LEX

Methyl Oxirane polymer with Oxirane
(Poloxamer 188)
泊洛沙姆 188

EP,USP

Solublizers
(For high-risk applications)

Non-ionic surfactant, HLB : 29
Low Endotoxin : Max. 1 IU/ml
 

The LEX grade represents Low Endotoxins & Low bioburden grade product especially suitable for customers using it in high-risk applications.

Motusflex系列 : 合成交聯聚合物，主要功能為流變改質劑(乳化增稠劑)，操作簡易、無需中和，耐離子，膚感佳。

Product Name

Chemical Name

Grade

Applications

Product details

Motusflex MF

Sodium Polyacryloyldimethyl Taurate
聚丙烯醯基二甲基牛磺酸鈉

On going DMF filing

Rheology modifier

Synthetic Cross-linked Polymers
Great sensorial effect
Multi-functional
Excellent salt stability

Motusflex HV

Ammonium Acryloyldimethyltaurate/VP Copolymer
丙烯醯二甲基牛磺酸銨/VP 共聚物

DMF Type IV

Rheology modifier

Synthetic Cross-linked Polymers
Great sensorial effect
High viscosity applications
Compatible with organic solvents

Motusflex LV

Ammonium Acryloyldimethyltaurate/ Beheneth-25 Methacrylate Crosspolymer
丙烯醯二甲基牛磺酸銨/山崳醇聚醚-25甲基丙烯酸酯交聯聚合物

DMF Type IV

Rheology modifier

Synthetic Cross-linked Polymers
Great sensorial effect
Low viscosity applications
Effective at low usage levels
 

VitiPure M系列 : 甲基聚乙二醇，製備脂質體和蛋白質PEG化的原材料。

Product Name

Chemical Name

Grade

Applications

Product details

VitiPure M 350 USP

Methyl polyglycol (MPEGs)
甲基聚乙二醇 350

USP

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 350 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 500

Methyl polyglycol (MPEGs)
甲基聚乙二醇 500

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 500 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 550

Methyl polyglycol (MPEGs)
甲基聚乙二醇 550

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 550 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 750

Methyl polyglycol (MPEGs)
甲基聚乙二醇 750

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 750 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 1000

Methyl polyglycol (MPEGs)
甲基聚乙二醇 1000

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 1000 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 1250

Methyl polyglycol (MPEGs)
甲基聚乙二醇 1250

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 1250 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 2000 PE

Methyl polyglycol (MPEGs)
甲基聚乙二醇 2000

USP

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 2000 g/mol
Used as starting material in the production of PEG lipid component for COVID-19 mRNA vaccine.

VitiPure M 3000

Methyl polyglycol (MPEGs)
甲基聚乙二醇 3000

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 3000 g/mol
Targeted delivery for mRNA
Increase circulating half life time

VitiPure M 5000

Methyl polyglycol (MPEGs)
甲基聚乙二醇 5000

-

Raw Materials for Liposomes & Protein PEGylation

Average molar mass 5000 g/mol
Targeted delivery for mRNA
Increase circulating half life time
 

Meglumine : 可用作抗衡離子與 API 形成鹽類，或是調節 pH 值以增強 API 溶解度和穩定性。

Product Name

Chemical Name

Grade

Applications

Product details

VitiPure Meglumine LEX

Meglumine
葡甲胺

EP,USP

Solublizers, Neutralizer

Counter-ion
 

Polyglykol系列 : 各式不同的分子量的PEG (不同等級)

Product Name

Chemical Name

Grade

Applications

Product details

Polyglykol 200 USP

Polyethylene glycol
聚乙二醇 200

USP

Excipent

Liquid

Polyglykol 300

Polyethylene glycol
聚乙二醇 300

-

Excipent

Liquid

Polyglykol 400

Polyethylene glycol
聚乙二醇 400

-

Excipent

Liquid

Polyglykol 400 J

Polyethylene glycol
聚乙二醇 400J

-

API

Liquid

Polyglykol 600

Polyethylene glycol
聚乙二醇 600

-

Excipent

Liquid

Polyglykol 1000

Polyethylene glycol
聚乙二醇 1000

-

Excipent

Liquid

Polyglykol 1500 S

Polyethylene glycol
聚乙二醇 1500

-

Excipent

S : Flakes

Polyglykol 1500 FL

Polyethylene glycol
聚乙二醇 1500

-

Excipent

Paste

Polyglykol 2000 S

Polyethylene glycol
聚乙二醇 2000

-

Excipent

S : Flakes

Polyglykol 3000 S

Polyethylene glycol
聚乙二醇 3000

-

Excipent

S : Flakes

Polyglykol 3000 P

Polyethylene glycol
聚乙二醇 3000

-

Excipent

P : Powder, milled

Polyglykol 3350 S

Polyethylene glycol
聚乙二醇 3350

-

Excipent / API

S : Flakes

Polyglykol 3350 P

Polyethylene glycol
聚乙二醇 3350

-

Excipent / API

P : Powder, milled

Polyglykol 3350 PS

Polyethylene glycol
聚乙二醇 3350

-

API

PS : Powder, sprayed

Polyglykol 3350 PSB

Polyethylene glycol
聚乙二醇 3350

-

API

Coarse Powder, sprayed

Polyglykol 3350 PSH/PSC

Polyethylene glycol
聚乙二醇 3350

-

API

PS : Powder, sprayed
Manufactured in China

Polyglykol 4000 S

Polyethylene glycol
聚乙二醇 4000

-

Excipent / API

S : Flakes

Polyglykol 4000 P

Polyethylene glycol
聚乙二醇 4000

-

Excipent / API

P : Powder, milled

Polyglykol 4000 PF

Polyethylene glycol
聚乙二醇 4000

-

Excipent

PF : Fine Powder, milled

Polyglykol 4000 PS

Polyethylene glycol
聚乙二醇 4000

-

API

PS : Powder, sprayed

Polyglykol 4000 PSH/PSC

Polyethylene glycol
聚乙二醇 4000

-

API

PS : Powder, sprayed
Manufactured in China

Polyglykol 6000 S

Polyethylene glycol
聚乙二醇 6000

-

Excipent

S : Flakes

Polyglykol 6000 P

Polyethylene glycol
聚乙二醇 6000

-

Excipent

P : Powder, milled

Polyglykol 6000 PF

Polyethylene glycol
聚乙二醇 6000

-

Excipent

PF : Fine Powder, milled

Polyglykol 8000 S

Polyethylene glycol
聚乙二醇 8000

-

Excipent

S : Flakes

Polyglykol 8000 P

Polyethylene glycol
聚乙二醇 8000

-

Excipent

P : Powder, milled

Polyglykol 8000 PF

Polyethylene glycol
聚乙二醇 8000

-

Excipent

PF : Fine Powder, milled

Polyglykol 10000 S

Polyethylene glycol
聚乙二醇 10000

-

Excipent

S : Flakes

Polyglykol 12000 S

Polyethylene glycol
聚乙二醇 12000

-

Excipent

S : Flakes

Polyglykol 20000 S

Polyethylene glycol
聚乙二醇 20000

-

Excipent

S : Flakes

Polyglykol 20000 P

Polyethylene glycol
聚乙二醇 20000

-

Excipent

P : Powder, milled

Polyglykol 35000 S

Polyethylene glycol
聚乙二醇 35000

-

Excipent

S : Flakes

Lanogen 1500

Polyethylene glycol
聚乙二醇 300+聚乙二醇 1500

-

Excipent

Ointment base
PEG 300 and PEG 1500 in a 50 :50 ratio
 

S (German Schuppen = flakes)

P (powder, milled)

PF (powder fine, milled)

PS (powder, sprayed)

Bulk quantities of melt can be delivered in heated road tankers under the code fl.

 

散劑（緩瀉/清腸）：

緩瀉/清腸劑中常用平均分子量為3350、4000的聚乙二醇作為原料藥，具有高度的水溶性且不被人體吸收，其引起的噁心或氣體形成等副作用較少。

 

液體製劑：

低分子量的聚乙二醇Polyglykol™ 200～400具有極好的溶解能力，因此廣泛用於液體製劑，如滴劑、腸外製劑，或軟膠囊劑。

 

軟膏劑：

聚乙二醇在水中的溶解度良好，固態聚乙二醇複配液態聚乙二醇適合作為水性基質，搭載多種原料藥用於配方中。聚乙二醇基質也可與其他基質結合，例如鯨蠟醇、硬脂酸、1,2-丙二醇、甘油、甘油單硬脂酸酯等。

 

栓劑：

固態聚乙二醇是栓劑產品的首選基質。多種原料藥可溶於聚乙二醇中，在體內不僅可以通過變成液態消除，還可以通過溶解於體液中消除。

 

片劑：

聚乙二醇可作為原料藥的載體、增溶劑和吸收促進劑；在片劑生產過程中，還可作為潤滑劑、粘合劑。固態聚乙二醇也經常用於片劑包衣、增塑劑。

 

滴眼液：

聚乙二醇300、400、600可用作滴眼液中的潤濕劑。

 

器官保存劑：

使用線性高分子量聚乙二醇（20000道爾頓）作為組合組分時，其顯示出抗凋亡活性，因此聚乙二醇可用於保護、保存或恢復細胞、組織或器官功能。

 

口腔護理：

主要功能是提高黏度和儲存穩定性，可以使用聚乙二醇Polyglykol™ 200至Polyglykol™ 2000。