TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.
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This document summarizes key tests performed on pharmaceutical formulations, including content uniformity, hardness, and dissolution. Content uniformity testing ensures each tablet contains the intended amount of active drug with little variation between tablets. Hardness testing measures a tablet's crushing strength, with limits varying based on the type of tablet. Dissolution testing predicts in vivo drug release profiles using basket or paddle apparatus under set conditions to simulate gastrointestinal fluids. These tests help ensure consistent dosing, sufficient strength, and controlled drug release.
TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.
- 1. TESTS ON FORMULATIONS: Content Uniformity, Hardness, Dissolution.
- 2. Different chemical substances, including the active drug, are combined to produce a final medicinal product.
- 4. To ensure that every tablet contains the amount of drug substance intended with little variation among tablets within a batch.
- 5. Used for testing the consistency Bulk powders Liquid 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.
- 6. Measures crushing strength property defined as compressional force applied diametrically to a tablet which just fracture it.
- 7. Limits: 4 kg is considered to be the minimum for satisfactory tablets. Oral tablets: 4 to 10 kg Hypodermic and chewable tablets: 3 kg. Sustained release tablets: 10 to 20 kg.
- 8. 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
- 9. 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
- 10. BASKET TYPE: Vessel is cylindrical Hight: 100-210mm Inside diameter: 98-106mm Basket position: the distance between the inside of bottom vessel & basket maintained at 25 ± 2mm.
- 11. PADDLE TYPE: Vessel is cylindrical Hight: 160-210mm Inside diameter: 98-160mm. Blade position: distance between the inside bottom of vessel & the blade is maintained at 25 ± 2mm.
- 12. 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.
- 13. Volume Deaeration Examples Of Typical Media
- 15. Above mentioned tests are very essential in order to ensure, • Constant dose of drug • Sufficient mechanical strength • Released in controlled and reproducible way.