Definition : Diluents are inactive substances to increase bulk and convert in the compressible form,

when drug material is potent or inadequate to

provide a suitable shape and size to tablet.

They are also known as fillers and the range of diluent is 5% to 80%.

1. 2.

They must be non-toxic They must be commercially available in acceptable

grade.
3. 4. 5.

Their cost must be low. They must be physiologically inert. They must be physically and chemically stable by themselves and with drugs.

6. They must be free from microbial contamination. 7. They do not alter the bioavailability of the drug.
8.

They must be color compatible.

These are the various properties that an ideal diluent must possess.

Lactose anhydrous and spray dried lactose Directly compressible starch-sta Rx 1500

Hydrolysed starch-emdex and celutab

Microcrystalline cellulose Avicel (PH 101 and PH 102). Dibasic calcium phosphate dihydrate Calcium sulphate dihydrate

Mannitol Sorbitol

Calcium carbonate
Dextrose Sucrose- sugartab dipac nutab

Two ways to classify diluents

1. 2.

Based on type of material Based on solubility

TYPE organic

EXAMPLES sugars , starches, celluloses

Inorganic
Co-processed

Calcium phosphates
Fast flo lactose, dipac, sugartab, nutab

INSOLUBLE TABLET FILLERS OR DILUENTS Starch

Powdered cellulose Microcrystalline cellulose

SOLUBLE TABLET FILLERS OR DILUENTS Lactose

Sucrose Mannitol

Calcium phosphates, etc. Sorbitol, etc.

NAME OF THE DILUENT Alpha-lactose monohydrate (pharmatose, respitose )

CHARACTERISTICS Used in wet granulation

Responsible for maillard reaction Spray dried lactose(spray process Directly compressible diluent, 315) compressibility adversely affected if dried below 3% moisture

Anhydrous lactose(pharmatose DCL 21)

Darkening in presence of amines due to furaldehyde Directly compressible

Pick up moisture at elevated humidity Directly compressible Good binding and disintegrant properties

Pregelatinised starch(starch 1500 LM)

Sucrose

Requires high machine pressures

Good binding property and hygroscopic

Mannitol(parteck M/pearlitol/mannogem) Sorbitol(sorbifin/neosorb) MCC Widely used in chewable tablets Non-hygroscopic Highly compressible diluent Hygroscopic in nature Most widely used directly compressible tablet diluent. Plastic deformation on compression. Calcium phosphates Directly compressible, produce hard tablets and abrasive in nature. Alkalinity is the major source of instability.

Selection of direct compression diluent is extremely critical, because the success or failure of direct

compression formulation completely depends on

characteristics of diluents.

There are number of factors playing key role in selection of optimum diluent.

Factors like- Primary properties of API (particle size and shape, bulk density, solubility).

The characteristics needed for processing

(flowability, compressibity).

Factors affecting stability (moisture, light, and other

environmental factors).

Economical approach and availability of material.

Raymond c rowe, Paul j sherkey, Sian c owen: hand book of pharmaceutical excipients, 5th edition.

http://www.pharmainfo.net/tablet-ruling-

dosage-form-years/formulation-tablets