Pharmaceutical Excipients and Their Suggested Quantity

Following are some of the most common excipients and their suggested use levels in pharmaceutical preparations.

1. 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)

Related: Binders and Their Concentration in Manufacturing

2. Solvents:

    •  Purified water

    •  Ethanol

    •  Purified water/ethanol

    •  Other organic solvents (i.e Methnol + Isopropanol)

3. Fillers/Diluents:

    •  Microcrystalline cellulose.

    •  Lactose monohydrate and anhydrous.

    •  Starch/pregelatinized starch

    •  Dicalcium phosphate (According to tablets/capsules size and weight)

    •  Calcium carbonate

    •  Compressible sugars

    •  Mannitol

    •  Sorbitol

4. 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 %

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%

6. 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).

Submitted by:

Basel Hejazi.

Senior formulator drugs Pharmacist.

Pharma international – R&D Labs.

Jordan.

E-mail - bh-1980@hotmail.com