Classification of Pharmaceutical Excipients

Classification of Pharmaceutical Excipients

1. Diluents (Fillers/Bulking agent)
2. Binders
3. Granulating agents
4. Disintegrating agents
5. Lubricants
6. Glidants
7. Antioxidants
8. Sweetening agents
9. Preservatives
10. Flavoring agents
11. Colouring agents
12. Ointment Base
13. Solvent & Co-solvent
14. Chelating agents
15. Surface active agents
16. Viscosity enhancers
17. Buffering agents
18. Sorbents
19. Humectants
20. Coating agents 

Microcrystalline Cellulose

“Excipient” is derived from the Latin word “Excipere”, which means ‘Other Than’. An excipient is usually an inert substance and becomes a vehicle/carrier for a pharmaceutical active entity.

Microcrystalline Cellulose

The most common excipient ‘Microcrystalline Cellulose” available in different grades plays the role of binder, disintegrant, diluent, absorbant, lubricant, anti-adherent, etc. in tablet dosage form. Microcrystalline cellulose was discovered in 1955. MCC is widely used for the direct compression process.

Official Names/Non-proprietary Names

USP-NF: Microcrystalline Cellulose

IP: Microcrystalline Cellulose

PhEur: Cellulose, Microcrystalline

BP: Microcrystalline Cellulose

IUPAC Name:

2-{[4,5-dihydroxy-2-(hydroxymethyl)-6-methoxyoxan-3-yl]oxy}-6-(hydroxymethyl)-5-methoxyoxane-3,4-diol

CAS Number

Cellulose [9004-34-6]

Empirical formula and molecular weight: (C₆H₁₀O₅)n, 370.35

Physical & Chemical Description

MCC occurs as a white odorless, tasteless, crystalline porous particles and chemically depolymerized cellulose.

Applications in Pharmaceutical Development

-Binder/Diluent in oral tablet & Capsule

-Used in wet-granulation and direct compression process

-Additional lubricant & disintegrant property

Commercially available grades of MCC

Avicel PH-101, 102, 103, 105, 112, 113, 200, 301, 302

Celex 101

Ceolus KG-802

Esmocel 50M, 90M

MCC Sanaq 101, 200, 301, 302, 002

Vivapur 101, 102, 12

Safety

-Generally regarded as non-toxic and non-irritant material.

-The laxative effect observed after consumption in large quantity

Storage: Store protected from moisture

Regulatory Status: GRAS listed

 

References:

Indian Pharmacopoeia, United States Pharmacopoeia, Handbook of Pharmaceutical excipients by R. C. Rowe (6^th Edition), Pubchem.