METOLOSE® SR 90SH-4000SR

Identification & Functionality

Chemical Name

Hydroxypropyl Methylcellulose

Pharma & Nutraceuticals Functions

Binder,

Controlled Release Agent,

Sustained Release Agent

CAS No.

9004-65-3

EC No.

618-389-6

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Modified & Controlled Release

Structure

 

Features & Benefits

Labeling Claims

BSE-free,

Kosher,

Non-GMO,

Solvent-free,

TSE-free

Features

• For Hydrophilic matrix formulation of API and METOLOSE® SR to extend the dissolution. The dosage forms can be obtained by direct compression or granulation process.
• METOLOSE® SR has specifications of particle size which can be suitable for sustained release application.
• Dissolution profile can be easily adjusted by selecting appropriate grade.
• Recommendable amount of METOLOSE® SR is more than 20% in the formulation in order to form the stable gel layer.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Healthcare & Pharma — Pharmaceutical Manufacturing

Excipients & Coatings

Dosage Form

Tablets

Manufacturing Technology

Direct Compression,

Granulation,

Tablet Coating

Properties

Physical Form

Powder,

Solid

Typical Properties

	Value	Units	Test Method / Conditions
Hydroxypropoxy Content	8.5 - 10.5	%	-
Methoxy Content	22.0 - 24.0	%	-
Viscosity	3000 - 5600	-	-

Particle Size Distribution

	Value	Units	Test Method / Conditions
Particle Size at D20	20 - 40	µm	-
Particle Size at D50	50 - 80	µm	-
Particle Size at D80	100 - 160	µm

Note

*Values in the table are viscosities of 2 w/w % aqueous solution at 20°C

Regulatory & Compliance

Certifications & Compliance

DMF Type IV,

European Pharmacopeia (Ph. Eur.),

FDA Compliant,

GMP,

Generally Recognized As Safe (GRAS),

JECFA (FAO/WHO),

Japan Pharmacopeia (JP),

Kosher,

The Food Allergen Labeling & Consumer Protection Act of 2004 (FALCPA),

United States Pharmacopeia (USP)

Grade

Pharma Grade

Technical Details & Test Data

Drug Release from Matrix Tablets with Metolose® SR (Viscosity Grade)

 

Packaging & Availability

Packaging Type

Bags,

Drums,

Totes (IBC)

Package

• Packaging material: Double-layered polyethylene bag in fiber drum
• Net weight: Depending on grades

Storage & Handling

Storage

Keep dry. Store away from excess heat and sunlight. Store in sealed containers.