DISPENSING Flashcards
The capability of a particular formulation to remain within its physical, chemical, microbiological, therapeutic and toxicological specifications
Drug stability
Usually conducted throughout the clinical trial and during the filing period
Pre-market stability
Continuous assurance on the post-approval batches for long-term stability monitoring on the drug product
Commercial stability
Manifested by the drug’s molecular structure, chemical change results to different drug molecule, and each active ingredient should retain its chemical integrity and labeled potency within specified limits
Chemical stability
Properties of drugs and dosage forms that can be seen or tested by physical means
Physical stability
It involves the assessment of flavor, odor, appearance and mouthfeel of a product
Organoleptic testing
Sterility or resistance to microbial growth is retained according to the specified requirements
Microbiological stability
The therapeutic effect remains unchanged
Therapeutic stability
No significant increase in toxicity occurs
Toxicological stability
Problem which could occur as a result of interaction between two or more drugs or chemicals
Drug instability/Incompatibility
Physical or chemical interaction that leads to visible recognizable change
Physical incompatibilities
Remedy for insolubility of components
Suspension
Remedy for immiscibility of components
Emulsion
Solute which is originally dissolved in the solvent is thrown out of solution
Salting out process
The solubility of most drugs __ as the temperature of the solution __
Decreases, decreases
Remedy for salting out
Use another solvent
Notorious to liquefaction
Efflorescent powders
Absorbs moisture but does not dissolve
Hygroscopic
Absorbs moisture and dissolves
Deliquescence
Liquefaction of solids mixed in dry state
Eutexia
Molecules are concentrating at the interface
Adsorption
Molecules being absorbed are penetrating into the capillary spaces of the absorbing surface
Absorption
Drugs that are __ or __ have greater tendency to sorb to PCV to dissolve in its plasticizer
Poor water-soluble, lipophilic
Based on study in animals, drugs that contain surfactants or cosolvents can cause cancer
True
Process of liberation of the active ingredients. Other term is volatilization
Vaporization
Common in liquid dosage form
Loss of water
Visible change in the reaction is not necessarily observed but can be determined by analytical method
Chemical incompatibilities
The chemical interactions can be corrected by changing the order of mixing
Tolerated incompatibility
Change in the formulation is needed with a compound having equal therapeutic value
Adjusted incompatibilities
Tolerated and adjusted incompatibilities
Chemical interactions
Immediate and delayed incompatibilities
Nature of chemical interactions
Chemical reaction takes place immediately after combining the prescription ingredients
Immediate incompatibilities
Chemical reaction proceeds at a very slow rate and no appreciable visible change occurs which may develop on keeping the product for a long time
Delayed incompatibilities
Occurs when one drug losses electron to the other; VILEORA
Oxidation
Most common type of incompatibility and drug degradation. Triggered by presence of water, acids, bases, and catalyst
Hydrolysis
Commonly caused by sodium bicarbonate and carbonate buffers that cause effervescence
Evolution of gas