配方类型:

DRUG PRODUCTS

配方说明:

配方组成:

"avicel" PH-102/20.0
ascorbic acid (90% roche)/95.0
stearic acid/40.0
magnesium stearate/2.5
FD&C yellow #6 lake (jet milled)/1.0
orange flavor firmenich (57.399TP)/7.4
sugar tab/511.1
"syloid" 74/4.0
sodium ascorbate AG/199.0
sorbitol (tablet type)/120.0

配制方法:

1) mix the sodium ascorbate AG, FD&C yellow #6 lake (jet milled), and "syloid" 74 in a pony mixer for 5 min.
mill through a fitzpatrick fitted with a #0 plate, with hammers forward at medium speed.
2) add the following materials to 1: ascorbic acid (90% granulation), firmenich flavor (57.399TP), sorbitol, sugar tab, and "avicel" PH102. mix for 5 min and mill the material through a fitzpatrick using knives forward, at medium speed with a #1 plate.
3) make a premix of stearic acid and the magnesium stearate with a small portion of the above mix; screen through #20 mesh screen and add. mix the entire batch in a suitable blender (such as P.K.) for 10 min.
4) compress at 6.5 SCU. punch size 1/2 in. S.C.
NOTE: 1) prolonged exposure to high humidity (e.g., 55% and above) conditions during preparation of the mix sdhould be held to a minimum as material is hgroscopic.
2)compression of the product should not be done above 50% R.H.