Description

Malethamer is a high-purity pharmaceutical excipient widely recognized for its versatile functionality in drug formulation. Its primary value lies in its ability to modify the release profile and enhance the bioavailability of active pharmaceutical ingredients (APIs). This makes it a critical component for manufacturers in the pharmaceutical, nutraceutical, and advanced cosmetic industries seeking to develop controlled-release and solubility-enhanced products.

Application

• Pharmaceutical Formulations: As a key matrix former in controlled-release tablets, capsules, and multi-particulate systems to achieve sustained or delayed drug release.
• Solubility Enhancement: Used in solid dispersions and complexes to improve the dissolution rate and oral bioavailability of poorly water-soluble APIs (BCS Class II & IV drugs).
• Film Coating: Serves as a film-forming agent for tablet coatings, providing modified release, taste masking, and moisture barrier properties.
• Bioadhesive Systems: Employed in formulations designed for mucoadhesion, such as buccal, nasal, or vaginal delivery systems, to prolong residence time at the site of absorption.
• Hot-Melt Extrusion (HME): An ideal carrier polymer in HME processes for producing amorphous solid dispersions with enhanced physical stability.
• 3D Printing of Pharmaceuticals: Utilized as a feedstock polymer for fabricating personalized dosage forms with complex geometries and tailored release profiles via fused deposition modeling (FDM).

Basic Information

Item	Details
Product Name	Malethamer
CAS No.	29535-27-1
Molecular Formula	(C6H10O5)n
Molecular Weight	Varies (Polymer)
Synonyms	Methacrylic Acid - Ethyl Acrylate Copolymer (1:1); Methacrylic Acid Ethyl Acrylate Copolymer; Eudragit L 100-55; Kollicoat MAE 100P; Poly(methacrylic acid-co-ethyl acrylate) 1:1; Methacrylic Acid–Ethyl Acrylate Copolymer (1:1); Anionic Methacrylic Copolymer; USP/NF: Methacrylic Acid Copolymer, Type C
EINECS	Contact for details

Quality Control

Our Malethamer is manufactured under strict quality management systems. Each batch is tested to ensure compliance with major pharmacopoeial standards, including USP-NF and Ph. Eur. specifications for Methacrylic Acid Copolymer, Type C. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing key parameters such as assay, residual monomers, viscosity, and acid value to guarantee batch-to-batch consistency and regulatory compliance for your formulations.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed after initial opening to prevent moisture uptake, which can affect physicochemical properties.

Specification

Item	Specification
Appearance	White to off-white powder or granules
Identification (IR)	Conforms
Assay (as methacrylic acid units)	46.0 - 50.6 %
Viscosity (of a 20% dispersion)	3 - 12 mPa·s
Residual Monomers (GC)	NMT 0.1% total
Loss on Drying	NMT 5.0 %
Sulfated Ash	NMT 0.2 %

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.