TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution

TESTS ON FORMULATIONS: Content Uniformity, Hardness,

Dissolution.

Different chemical substances, including the active drug, are combined to produce a final medicinal product.

To ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.

Used for testing the consistencyBulk powdersLiquid orals Also during filling of powders into capsules or liquids

into vials or ampoules  Amount of active pharmaceutical ingredient within

individual units of tablets or capsules.

Measures crushing strength property defined as compressional force applied diametrically to a tablet which just fracture it.

Limits: 4 kg is considered to be the minimum for satisfactory

tablets. Oral tablets: 4 to 10 kgHypodermic and chewable tablets: 3 kg.Sustained release tablets: 10 to 20 kg.

Why do we measure Hardness:Need for pressure adjustment on the tableting

machine.Affects the disintegration and dissolution

Factors affecting Hardness:Compression of the tablet and compressive force. Amount of binder. (More binder a more hardness) Method of granulation in preparing the tablet

Predict in vivo drug release profiles.Test is intended for a capsule or Tablet.Condition maintained:

Temperature: 37 ± 0.5°C

Speed: 25-150 rpm

BASKET TYPE:Vessel is cylindricalHight: 100-210mmInside diameter: 98-106mmBasket position: the distance between the inside of

bottom vessel & basket maintained at 25 ± 2mm.

PADDLE TYPE:Vessel is cylindricalHight: 160-210mmInside diameter: 98-160mm.Blade position: distance between the inside bottom of

vessel & the blade is maintained at 25 ± 2mm.

Apparatus should be chemically inert.Do not adsorb, react or interfere with

dissolution medium.All metal parts of the apparatus must be

made from stainless steel.

VolumeDeaerationExamples Of Typical Media

Above mentioned tests are very essential in order to ensure,

• Constant dose of drug• Sufficient mechanical strength• Released in controlled and reproducible way.

Bibliography:Indian Pharmacopoeia.

Webliography:www.pharmainfo.net