Pharmaceutical Excipients and Their Suggested Quantity : Pharmaceutical Guidelines

Pharmaceutical Excipients and Their Suggested Quantity

Learn how much the excipients are used and their category in pharmaceuticals.
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
    •  Di calcium 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





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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