Solid Dosage Forms

• Uniformity of Dosage Units - USP <905>
• Uniformity of Dosage Units - degree of uniformity in the amount of the drug substance among dosage unit
• Weight Variation - is allowed for hard capsules, uncoated tablets, and film–coated tablets containing 25 mg or more of the drug substance comprising 25% or more of the weight of the dosage unit
• Content Uniformity - based on the assay of the individual content of drug substance(s) in several dosage units to determine whether the individual content is within the limits set; applicable to dosage units with <25 mg or<25% of drug substance
• Disintegration Test USP <701>
• Disintegration - determine whether the tablet, capsule, or granules disintegrate within the prescribed time when placed in liquid medium
• Complete Disintegration - is defined as that in which any residue of the unit remain on the screen of the test apparatus or adhering to the lower surface of the disk, if used, is a soft mass having no palpably firm core
• Dissolution Test USP <711>
• Dissolution - this test is provided to determine compliance with the dissolution parameters for dosage form administered orally
• Different types of dissolution apparatus:

  A) Basket

  
• Different types of dissolution apparatus:

  A) Paddle

  
• Different types of dissolution apparatus:

  A) Reciprocating Cylinder

  
• Different types of dissolution apparatus:

  A) Flow-through Cell

  
• Different types of dissolution apparatus:

  A) Paddle Over Disk

  
• In Vitro Disintegration test - the most reliable predictor of In Vivo performance as it is crucial and is known as the rate-limiting step
• Sink Conditions – sufficient media to ensure un-impaired dissolution
• Friability Test USP <1216>
• Friability - applicable to most tablets, this test supplements other physical measurements, such as Hardness Test
• Tablet Breaking Force USP <1217>
• Tablet Breaking Force - tablets must be able to withstand the rigors of handling and transportation experienced in the manufacturing plant, in the drug distribution system, and in the field at the hands of the end users (patients/consumers)
• Breaking Force - measures the mechanical integrity of the tablet; the force that required to cause them to fail
• Hardness - the crushing strength
• Rule of Thumb - tablet is of proper hardness if it was firm enough to break with a sharp snap when held between 2nd and 3rd fingers, using thumb as fulcrum
• 1.5-4 mPa or 15-40 Newtons - breaking force for tablets
• Equipment used For Tablet Breaking Force:

  A) Stokes Hardness

  
• Equipment used For Tablet Breaking Force:

  A) Strong Cobb

  
• Equipment used For Tablet Breaking Force:

  A) Pfizer Hardness

  
• Equipment used For Tablet Breaking Force:

  A) Erweka Tester

  
• Equipment used For Tablet Breaking Force:

  A) Schleuniger Tester

  
• Thickness and Diameter - measured by Caliper
• Particle Size Distribution - applicable to powders and granules, in the evaluation of the flow property and compressibility
• Sieving - most rapid method in particle size distribution; disadvantage: attrition of particles, breakage of mesh
• Optical microscopy - measures individual part of particles; very tedious
• Electron microscopy - have two types Electron and Scanning EM
• Sedimentation " Free Fall Velocity of Partciles" - may be calculated using Stoke's Law, uses Andreasen Pipette for analysis
• Light scattering technique - uses Coulter Counter
• Angle of Repose - defined maximum possible as the angle between the surface of a pile of powder and the horizontal plane; simple technique for estimating flow properties of the powder
• Water Determination - to determine the amount of water in the drug product
• Microbial Test Limit - the presence of certain microorganisms in solid dosage forms may contribute to the instability of a drug product leading to reduced therapeutic activity or potentially cause adverse effects
• Trypticase Soy Agar (TSA) - Total Aerobic Microbial Count medium