Exam 2 Dissolution Flashcards
T or F: Dissolution is defined as the process by which a solid is transformed from aggregates of molecules or ions into a dissolved state (i.e. enters into solution)
True
The rate of solution is determined by the rate of _______ of the dissolved substance through a thin layer that forms instantaneously around the solid particles
Diffusion
T or F: In the late 1960s, dissolution testing of solid dosage forms became a mandatory requirement for several drugs
True
T or F: The dissolution test is a simple and inexpensive measure of the physical consistency of the dosage form being evaluated
True
In case of variation in dissolution results, one must investigate the causative sources, which are _________, ________, or ________
Raw material, formulation, or process
T or F: Dissolution is the process by which a solid substance dissolves
True
Dissolution is controlled by the ______ between the solid substance and the solvent
Affinity
Factors that influence the dissolution rate
- Physical characteristics of the dosage form
- Wettability of dosage unit
- Ability of the dissolution medium to penetrate the dosage form
- Swelling process
- Disintegration and deaggregation of dosage form
The speed of wetting is dependent on the _______ ______ between the solid surface and dissolution medium
interfacial tension
Hydrophobic lubricants such as ____ and ______ ______ slow the penetration rate of the medium; thus slowing the __________ of the granules
talc, magnesium stearate; deaggregation
Absorption rate-limiting step for freely-soluble drugs
Diffusion across the GI membrane
Absorption rate limiting step for poorly-soluble drugs
Dissolution of the drug
Physical parameters that control the rate at which a substance dissolves
- Surface area at a given time
- Shape of the particles
- Nature of the solid/liquid interface
- Solubility of the solid in the dissolution medium
Mathematic equation of the rate of dissoltion
dM/dt = KA (Cs - C) M = mass of the substance dissolved during time t A = area exposed to the dissolution medium Cs = solubility of the drug C = concentration of drug in solution at time t K = intrinsic dissolution rate constant
dM/dt = KACs is known as what equation?
Sink-condition equation
The intrinsic rate of dissolution is determined by using either the ____ disk system, or the ____ disk system
rotating; stationary
Flux equation
J = (dM/dt) * (1/A)
Factors related to the physiochemical properties of the drug (2)
- Solubility
- Particle Size
The major factor that determines the rate of dissolution and can be used as a rough predictor of bioavailability
Solubility
T or F: Increasing the particle size results into larger surface area, and subsequently faster dissolution
False: Decreasing the particle size increases surface area
The surface area accessible by the medium is known as
Effective surface area
T or F: It is assumed that the solubility of the drug is dependent on particle size
False: solubility is independent of particle size