GPAT-2019- COMMON EXCIPIENTS & THEIR SUGGESTED USE LEVELS IN PHARMACEUTICAL PREPARATION
Binders:
Polyvinylpyrrolidone (PVP) : 0.5-4%
Pregelatinized starch : 5-10% (wet), 5-20% (direct)
Starch paste : 5-25% w/w
Microcrystalline cellulose : 5-25% (wet), 5-25% (direct)
Sucrose : 50-70% solution
Hydroxypropyl cellulose : 4-6%
Ethylcellulose : 5% solution
Methylcellulose : 1-6% solution (depending on viscosity grade)
Solvents:
Purified water
Ethanol
Purified water/ethanol
Other organic solvents (i.e Methnol + Isopropanol)
Fillers/Diluents:
Microcrystalline cellulose.
Lactose monohydrate and anhydrous.
Starch/pregelatinized starch
Di calcium phosphate (According to tablets/capsules size and weight)
Calcium carbonate
Compressible sugars
Mannitol
Sorbitol
Disintegrating Agents:
Sodium starch glycolate : 2-6%
Croscarmellose sodium : 1-6%
Pregelatinized starch : 5-10%
Starch : 5-10%
Microcrystalline cellulose : 5-15%
Crosspovidone : 2-5 %
Glidants/Lubricants/Antiadherents:
Fumed silicon dioxide (glidant) : 0.1-0.5% (anti-adherent) : 1-2%
Talc (anti-adherent) : 1-5%
Magnesium stearate : 0.25-2.0% .
Stearic acid : 0.5-3%
Hydrogenated vegetable oils : 2-5%
Sodium lauryl sulfate : 1-3%
Mineral oil : 1-3%
Others:
Dyes- Usually aluminum lakes: water-soluble dyes precipitated with the hydrous oxide of aluminum.
Sweetening Agents & Flavors’- Compressible sugars/alcohols & various flavoring agents.
Wetting Agents- Sodium lauryl sulfate : 0.1-3%,
Polysorbate 80 : 0.1-3%
Acidifying Agents, Buffers, Stabilizers, etc….
Citric acid : 0.2-2%
Sodium citrate : 0.3-2 % (dihydrate).
Sodium phosphate (monobasic).