Formulation Handbook: Guaifenesin Direct Compression
Formulation Handbook: Guaifenesin Direct Compression
Formulation Handbook: Guaifenesin Direct Compression
Summary
Guaifenesin is a fluffy, low-melting-point expectorant. It is tablet with excellent formulation and tableting characteristics.
poorly flowing and poorly compressible and is typically granu- In a comparison study, PROSOLV ® SMCC HD 90 provided
lated prior to solid dosage form manufacture. The typical harder, smaller tablets at lower compaction forces than
dosage of Guaifenesin is a 200 mg/tablet. PROSOLV ® SMCC comparable high-density Microcrystalline Cellulose
HD 90 faciliated a directly compressible, quickly disintegrating formulations.
Formulation
Active content [mg] mg/tablet Contribution [%]
Guaifenesin 200.0 200.0 40.0
PROSOLV ® SMCC HD 90 (Silicified Microcrystalline Cellulose) 295.0 59.0
Talcum 5.0 1.0
Total 500.0 100.0
Procedure
Blending:
PROSOLV ® SMCC HD 90 and Talcum were dispensed to the correct masses and transferred to a Patterson-Kelly twin-shell
V-blender. Guafenesin was sieved and transferred into the V-blender. The powders were blended for 5 minutes. The powder
mixture was ready for direct compression.
Equipment:
Blender: Patterson-Kelly twin-shell V-blender
Flowability Apparatus: Hanson Research Flodex™
Tablet Press: Riva Piccola instrumented rotary tablet press
Hardness Tester: Key HT-500
Disintegration Tester: GlobePharma ED-2L
Friability Tester: GlobePharma FT-400
Tablet Characteristics
Tablet Weight: 500 mg
Crushing Strength: 120 N
Compaction Force: 8.5 kN
Tablet Disintegration Time: 10 s
WORLDWIDE HEADQUARTERS
JRS PHARMA GMBH & CO. KG
73494 Rosenberg (Germany)
Phone: + 49 (0) 7967 / 152 312 [email protected]
Fax: + 49 (0) 7967 / 152 345 www.jrs.de
280
200
160
120
80
40
0 2 4 6 8 10 12 14 16 18 20 22
Compression Force [kN]
Diagram 2: Tablet Hardness as a Function of Compaction Force
Disclaimer: The information provided is based on thorough research and is believed to be completely reliable. Application suggestions are
given to assist our customers, but are for guidance only. Circumstances in which our material is used vary and are beyond our control.
Therefore, we cannot assume any responsibility for risks or liabilities, which may result from the use of this technical advice.
WORLDWIDE HEADQUARTERS
JRS PHARMA GMBH & CO. KG
73494 Rosenberg (Germany)
Phone: + 49 (0) 7967 / 152 312 [email protected]
Fax: + 49 (0) 7967 / 152 345 www.jrs.de