Liquid Dosage Forms

• Dosage form - refers to a combination of drug substances and excipients to facilitate dosing, administration, and delivery of the medicine to the patient
• Liquid Dosage forms - are pharmaceutical formulations which contain a mixture of active drug components and nondrug components dissolved or suspended in a suitable solvent or mixtures of solvents; are pourable and designed to provide rapid therapeutic effect
• Sterility Test - a test conducted under aseptic conditions
• Fluid Thioglycolate Medium - primarily intended for anaerobic bacteria; but can also detect aerobic bacteria
• Soybean-Casein Digest Medium - suitable for the culture of the fungi and aerobic bacteria
• Direct Transfer - a test wherein it is used for substances that cannot be tested on membrane filtration
• Membrane Filtration - uses filter paper; nmt 0.45um (filter paper's pores)
• Biological indicators - provide a high level of sterility assurance; used to contain this viable microorganism
• Moist heat and Ethylene oxide - sterilization technique used for Bacillus stearothermophilus
• Dry Heat - sterilization technique used for Bacillus subtilis
• Radiation - sterilization technique used for B. pumilus, B. stearothermophilus, B. Subtilis
• Membrane filtration - sterilization technique used for Pseudomonas diminuta
• Test for Pyrogens - number one concern of parenteral preparations; required for all number one concern of parenteral preparations
• Endotoxin - outer coating of spores/bacteria; fever inducing because they are pyrogens
• Rabbit Pyrogen Test - other name for Pyrogen test
• Limulus Amoebocyte Lysate (LSL) reagent - prepared by lysing amoebocyte blood cells from Limulus polyphemus
• Light Obscuration Particle Count Test - electronic particle counters
• Microscopic Particle Count Test - slow counting and sizing on membrane surface; requires top and bottom lighting to distinguish all particles
• Tip Seal "Bead seal method" - only the tip of the ampule is heated to seal; more prone to leake
• Leaker's Test - negative pressure within incompletely sealed ampule while submerged in dye solution; Dye: 0.5-1% Methylene Blue
• Redispersibility - the amount of the force necessary to redisperse particles, product is subject to shaking for minimum of 10 spm
• Zeta Potential - determines the repulsive forces between particles
• Safety Test

  A) Rat

  B) Ratchitic rat

  C) Male Rat

  D) Female Rat

  E) Pigeon

  F) Cat

  G) Chicken

  H) Dog

  I) Sheep

  J) Rabbit