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DIRECT COMPRESSION

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<strong>DIRECT</strong> <strong>COMPRESSION</strong><br />

Manufacturing Flowchart [I]<br />

LACTOSE<br />

Active<br />

Material<br />

MICROCRYSTALLINE<br />

CELLULOSE<br />

SUPER<br />

DISINTEGRANTS<br />

Development<br />

Content Uniformity on<br />

unlubricated blend to<br />

establish mixing time<br />

AQUEOUS<br />

FILM COAT<br />

To printing<br />

SDL(30%) - MCC(60%)<br />

Roller mixer<br />

MIX Y-cone<br />

Mill<br />

Where necessary<br />

0.6 -0.8 mm<br />

MIX Y-cone<br />

BLEND STEP<br />

rpm + time<br />

COMPRESS<br />

FLUSH<br />

COATED DC TABLETS<br />

SUITABILITY:<br />

Glibenclamide 5 mg<br />

Selegiline 5 mg<br />

Famotidine 10/20/40 mg<br />

Bromhexine 8 mg<br />

Amitriphyline 10 mg<br />

Lubricant<br />

and Glidant<br />

SIEVE<br />

50 MESH<br />

MIX<br />

rpm + time<br />

IPQC<br />

ID<br />

Assay<br />

Content Uniformity<br />

QC<br />

Weight uniformity<br />

Thickness<br />

Hardness<br />

Disintegration<br />

RELEASE<br />

ID<br />

Assay<br />

Content Uniformity<br />

Dissolution<br />

Lubricant coats<br />

the lactose<br />

providing<br />

greater control<br />

over final<br />

blending stage

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