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Kollicoat® MAE 100-55

1 of 8 products in this brand
Kollicoat® MAE 100-55 is a white redispersible powder with a faint characteristic odor. The product contains 0.7% sodium lauryl sulfate (USP) and 2.3% Polysorbate 80 (Ph. Eur.) as emulsifying agents. The fatty acids used in the manufacture of Polysorbate 80 are of vegetable origin. Kollicoat® MAE 100-55 is a weakly acidic copolymer that dissolves at a pH above 5.5. Kollicoat® MAE 100-55 dissolves in methanol and ethanol to yield clear to slightly cloudy solutions. It is also soluble in dilute alkaline solutions.

Chemical Name: Acrylates Copolymer, Methacrylic Acid Ethyl Acrylate Copolymer (1:1)

Functions: Filler, Film Former, Matrix Forming Agent, Solubilizer

Dosage Form: Dispersions, Soft Gels

Labeling Claims: Additive-free, Aflatoxin-free, Allergen-free, BSE-free, Contamination-free, Dioxin-free, Dust-free, Halal, Kosher, Latex-free, Melamine-free, Microplastics-free, Non-GMO, Not Engineered With Nanomaterials, Phthalates-free, Plasticizer-free, Solvent-free, Sustainable, TSE-free

Certifications & Compliance: ECOVADIS, EXCiPACT, European Pharmacopeia (Ph. Eur.), ISO 14001, ISO 9001, International Standards For Phytosanitary Measures No. 15 (ISPM 15) Compliant, Japanese Pharmaceutical Excipients (JPE), National Formulary (NF), OHSAS, REACH Exempt (Europe), RSPO MassBalance Certified, United States Pharmacopeia (USP), cGMP

Technical Data Sheet

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Identification & Functionality

Chemical Name

Acrylates Copolymer,

Methacrylic Acid Ethyl Acrylate Copolymer (1:1)

Country of Origin

Germany

Ingredient Origin

Non-Animal Origin

Pharma & Nutraceuticals Functions

Filler,

Film Former,

Matrix Forming Agent,

Solubilizer

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Fillers & Diluents,

Other Excipients,

Pharmaceutical Coatings,

Solvents & Solubilizers

Features & Benefits

Labeling Claims

Additive-free,

Aflatoxin-free,

Allergen-free,

BSE-free,

Contamination-free,

Dioxin-free,

Dust-free,

Halal,

Kosher,

Latex-free,

Melamine-free,

Microplastics-free,

Non-GMO,

Not Engineered With Nanomaterials,

Phthalates-free,

Plasticizer-free,

Solvent-free,

Sustainable,

TSE-free

Key Benefits
  • Direct substitution in commercial enteric release formulations based on methacrylic acid-ethylacrylate copolymer with an opening pH >5.5
  • Easier handling due to dust-free material

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Dosage Form

Dispersions,

Soft Gels

Manufacturing Technology

Hot Melt Extrusion,

Melt Granulation,

Spray Drying,

Tablet Coating

Properties

Physical Form

Capsules,

Pellets,

Powder,

Solid,

Tablets

Appearance
White redispersible powder
Odor
Faint characteristic odor
Soluble in
dilute alkaline solutions
Composition
ValueUnitsTest Method / Conditions
Sodium Lauryl Sulfate0.7%—
Polysorbate 802.3%—

Regulatory & Compliance

Certifications & Compliance

ECOVADIS,

EXCiPACT,

European Pharmacopeia (Ph. Eur.),

ISO 14001,

ISO 9001,

International Standards For Phytosanitary Measures No. 15 (ISPM 15) Compliant,

Japanese Pharmaceutical Excipients (JPE),

National Formulary (NF),

OHSAS,

REACH Exempt (Europe),

RSPO MassBalance Certified,

United States Pharmacopeia (USP),

cGMP

Chemical Inventories

TSCA Exempt (USA)

Grade

Pharma Grade

Packaging & Availability

Packaging Type

Boxes,

Drums

Packaging Information
  • 0.5KG Plastic bottle (Sample)
  • 1KG Plastic bottle (Sample)
  • 20KG Fibreboard boxes

Storage & Handling

Storage Information & Retest Period
  • Store below 25°C
  • Retest Period : 18 months