DICOM SANAQ SP 206 - DiCOM SANAQ - PHARMATRANS SANAQ AG

Identification & Functionality

Chemical Name: Cellulose, Microcrystalline,
Polyvinyl Pyrrolidone Copolymer,
Silicon Dioxide,
Silicon Dioxide, Colloidal ,
Sodium Carboxymethyl Starch
Pharma & Nutraceuticals Functions: Diluent
Technologies: Pharmaceuticals & Nutraceuticals
Product Families: Pharmaceuticals & Nutraceuticals — Excipients
Fillers & Diluents
Composition: MCC - Colloidal silicon dioxide - Polyvinyl pyrrolidone - 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: Processing of Colloidal Silicon Dioxide at high concentration (upto 15%) is difficult, But SP205 and SP206 gives advantage of process ease and uniform quality

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

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 206

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