DICOM SANAQ SP 204 - DiCOM SANAQ - PHARMATRANS SANAQ AG

Identification & Functionality

Chemical Name: Cellulose, Microcrystalline,
Magnesium Peroxide,
Sodium Carboxymethyl Starch,
Starch,
Starch, Pregelatinized
Pharma & Nutraceuticals Functions: Binder,
Diluent
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Binders & Disintegrants,
Fillers & Diluents
Composition: MCC - MgO2 -Starch -Pregelatizend starch -Sodium starch glycolate

Features & Benefits

Product Highlights: Mixtures with high compressibility,superior diluition properties and fast disitegrating time. The purpose of the excipient is to aid processing during manufacture, enhance stability or bioavailability.
Benefits: Uniform Alkaline protection from all the side.

Compression at high speed with uniform weight and quality attributes.

Enhanced Stability for acid labile APIs.

Better product quality, robust tablet with reduced friability.

Reduced tolling damage because of indirect contact and protection by other excipients in combination. No special coating required on tools...

High bulk density makes this product suitable to formulate high tablet weight capsule fill weight in smaller die / capsule size respectively.

Large Surface area of Light Magnesium Oxide gives enhanced protection / stability to acid labile APIs from a 360° alkaline microenvironment.

Handling and processing with Light Magnesium Oxide is challenging.

DICOM SANAQ-DC SP204 designed in a way for easy handling and maximum protection.

Improper die filling Segregation tendency (leads to weight variation / non-uniform alkaline microenvironment/ unstable formulation)

Light magnesium oxide is very fluffy and difficult to process directly

Tooling damage, in some cases. Special coating required on tools.

Applications & Uses

Markets: Healthcare & Pharma
Applications: Healthcare & Pharma — Drug Delivery & Care Solutions
Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
Pharmaceutical Processing
Dosage Form: Orally Disintegrating Tablets (ODTs),
Tablets
Manufacturing Technology: Direct Compression
Application Fields: LS 004

Diluent - Disintegrant

ML 011

Diluent - Binder

SP 204

Designed for moisture sensitive APIs and where alkaline conditions are needed for stability purpose

SP 205

Designed for moisture sensitive and low bulk density and fluffy API’s formulations.

SP 206

Designed for moisture sensitive and low bulk density and fluffy API’s formulations

SR 300

Designed for modified release, matrix type of tablets

Properties

	Value	Units	Test Method / Conditions
TAMC	max. 1000	CFU/g	USP/NF / JP / Ph. EUR
TYMC	max. 100	CFU/g	USP/NF / JP / Ph. EUR
E. Coli, Pseudomonas Aeruginosa	Negative in 10 g sample	—	USP/NF / JP / Ph. EUR
St. Aureus, Salmonella Species	Negative in 10 g sample	—	USP/NF / JP / Ph. EUR

	Value	Units	Test Method / Conditions
Particle Size	300 - 600	μm	Malvem Method

Regulatory & Compliance

Certifications & Compliance: European Pharmacopeia (Ph. Eur.),
GMP,
ISO 9001,
Japan Pharmacopeia (JP),
National Formulary (NF),
United States Pharmacopeia (USP)
Grade: Pharma Grade

DICOM SANAQ® SP 204

LS 004	Diluent - Disintegrant
ML 011	Diluent - Binder
SP 204	Designed for moisture sensitive APIs and where alkaline conditions are needed for stability purpose
SP 205	Designed for moisture sensitive and low bulk density and fluffy API’s formulations.
SP 206	Designed for moisture sensitive and low bulk density and fluffy API’s formulations
SR 300	Designed for modified release, matrix type of tablets