Introducing the application of F-Melt® for manufacturing oral disintegrating tablets (ODTS) of Simvastatin

See the fifth issue of Fuji Chemical Industries Technical Newsletter. It presents the application of F-Melt® for manufacturing oral disintegrating tablets (ODTS) of Simvastatin.

ORAL DISINTEGRATING TABLETS OF SIMVASTATIN WITH F-MELT®

F-Melt® is a co-processed spray-dried excipient system containing up to five pharmaceutical excipients, such as carbohydrates, disintegrants, and inorganic ingredients.

Simvastatin, 3-hydroxy-3-methyl glutaryl coenzyme, is a reductase inhibitor (HMG-CoA reductase inhibitor) that works to reduce the body’s cholesterol production and reduce the amount of cholesterol and triglycerides moving through the body. Simvastatin is adsorbed from the gastrointestinal tract and hydrolyzed to its active β-hydroxy acid metabolite.

F-Melt® Family

Type M for pharmaceutical ODT applications.

Type C for pharmaceutical, nutraceutical and dietary supplement ODT applications.

F1 for pharmaceutical, dietary supplement and functional food chewable applications.

INTRODUCING THE APPLICATION OF F-MELT® FOR MANUFACTURING ORAL DISINTEGRATING TABLETS (ODTS) OF SIMVASTATIN_Magnesium

Simvastatin ODT Formulation with F-Melt® Type M

Commercial oral Simvastatin tablets provide doses of 5 mg up to 80 mg, of which not more than 7% could reach circulation as active form.

F-Melt® offers a new approach to produce oral Simvastatin tablets as ODTs simply by direct compression.

This drug delivery option can extend the life cycle for original brand manufacturers in addition to a more convenient and patient friendly dosage option.

SIMVASTATIN STABILITY TEST

INTRODUCING THE APPLICATION OF F-MELT® FOR MANUFACTURING ORAL DISINTEGRATING TABLETS (ODTS) OF SIMVASTATIN_Equipment to measure ODTs (Toyama Sangyo Co., Ltd) — Equipment to measure ODTs (Toyama Sangyo Co., Ltd)

INTRODUCING THE APPLICATION OF F-MELT® FOR MANUFACTURING ORAL DISINTEGRATING TABLETS (ODTS) OF SIMVASTATIN_Dissolution Test

Dissolution test condition:
test solution, 900 mL, 0.3% polysorbate 80 37° C, paddle speed 50 rpm, detection at UV 239 nm.

INTRODUCING THE APPLICATION OF F-MELT® FOR MANUFACTURING ORAL DISINTEGRATING TABLETS (ODTS) OF SIMVASTATIN_F-Melt human

High-quality Simvastatin ODTs with good mouth feel can be produced by simple blending with F-Melt® Type M or Type C and a lubricant, followed by direct compression.

INTRODUCING THE APPLICATION OF F-MELT® FOR MANUFACTURING ORAL DISINTEGRATING TABLETS (ODTS) OF SIMVASTATIN_F-Melt Heard

Continue reading and see the full Pharmaceutical Technical Newsletter on “Issue 05 – F-Melt® oral disintegrating tablets Simvastatin” here:

(click the picture to download the technical newsletter)