PHA 327 - Exam 2 - Preformulation 1
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. What would you like to do?
What is a drug?
The active ingredient having pharmacological or therapeutic effect
What components does a dosage form have?
- Active ingredients
- Inactive ingredient
- (Purpose for using inactive ingredients is included)
Give an example of a dosage form:
Give an example of a drug:
Describe an optimized drug product:
One that has been designed to release drugs in a way that improves efficacy and reliability
What charcteristics of a dosage form are accounted for by pharmaceutic indgredients?
What are pharmaceutic ingredients?
- Dosage form components that contribute to the shape, form, taste, texture and stability of the product
- stabilizers, bases, diluents, binders, etc.
What is the general purpose of using surfactants as a pharmacutic ingredient?
What is the general purpose of using water as a pharmacutic ingredient?
What five things should you consider what designing a dosage form?
- Characteristics of the drug substance
- Drug and formulation stability
- drug release profile
- prevention against microbes
What are therapeutic considerations for dosage form design?
- Clinical effectiveness
- Route of administration
- Nature or disease
- Age and condition of patient
What are biopharmaceutic consideration of dosage design?
What is Pharmaceutics important?
in-depth understanding of traditional pharmaceutical dosage forms as well as innovative new drug delivery systems
What is preformulation?
- process of optimizing a drug through the determination of its physical and chemical properties
- including: the determination of any possible interactions in the final form
What three properties need to be evaluated in preformulation studies?
What are the chemical properties that need to be studied in preformulation?
What physical features need to be studied in preformulation?
- microscopic and macroscopic properties
- Drug and drug product stability
- General : pKa, solubility, dissolution, polymorphism, partition coefficient
What type of property is studied when you evaluate the pKa, partition coefficient, solubility, dissolution, and polymorphism of a drug product?
What biologic properties are studied during preformulation?
- Ability to get to the site of action
- Ability to elicit a response
What are the five Macroscopic properties listed in class?
- Flow properties
Color, odor, appearance, flow properties and density are what type of property?
What are the three microscopic properties discussed in class?
- Crystal habit
- Particle size
- Size distribution
What type of property are: size distribution, particle size, and crystal habit?
What USP chapter describes federal obligations for Macroscopic properties?
What type of densities measurements exist?
- True density
- Bulk density
- Tapped density
What is true density?
Density of the actual solid material
What is bulk density?
The mass of a powder divided by the volume (includes spaces between particles)
What is the tapped density?
Mass divided by the volume obtained by tapping a cylinder repeatedly (compressing the spaces between the particles)
How is the true density obtained?
- For Non-porous material = volume is obtained by displacement in an insoluble liquid
- For porous material = volume is measured using a helium densitometer
What would you use a helium densiometer for?
To measure the volume of a porous substance to obtain the true density
What type of density is obtained by dividing the bulk mass by the bulk volume (volume is inclusive of the spaces between particles)?
What is the angle of repose?
- The angle of the side of a pile of drug powder/granule
- The steepest angle of the dip of the slope relative to the horizonal
What is the equation for the angle of respose?
- tan (angle of repose) = usus = coeff. of static friction
What is the range of angles or repose?
What would you like to do?
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