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What is a drug?
The active ingredient having pharmacological or therapeutic effect
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What components does a dosage form have?
- Active ingredients
- Inactive ingredient
- (Purpose for using inactive ingredients is included)
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Give an example of a dosage form:
- tablet
- capsule
- suspension
- emulsion
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Give an example of a drug:
- ibuprofen
- asprin
- hypdrocodone
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Describe an optimized drug product:
One that has been designed to release drugs in a way that improves efficacy and reliability
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What charcteristics of a dosage form are accounted for by pharmaceutic indgredients?
- appearance
- texture
- stability
- taste
- form
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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.
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What is the general purpose of using surfactants as a pharmacutic ingredient?
Solubilize
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What is the general purpose of using water as a pharmacutic ingredient?
Dilute
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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
- Appearance
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What are therapeutic considerations for dosage form design?
- Clinical effectiveness
- Route of administration
- Nature or disease
- Age and condition of patient
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What are biopharmaceutic consideration of dosage design?
- Biopharmaceutics
- Bioavailability
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What is Pharmaceutics important?
in-depth understanding of traditional pharmaceutical dosage forms as well as innovative new drug delivery systems
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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
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What three properties need to be evaluated in preformulation studies?
- chemical
- physical
- biological
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What are the chemical properties that need to be studied in preformulation?
- structure
- form
- purity
- reactivity
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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
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What type of property is studied when you evaluate the pKa, partition coefficient, solubility, dissolution, and polymorphism of a drug product?
Physical properties
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What biologic properties are studied during preformulation?
- Ability to get to the site of action
- Ability to elicit a response
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What are the five Macroscopic properties listed in class?
- Color
- Odor
- Appearance
- Density
- Flow properties
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Color, odor, appearance, flow properties and density are what type of property?
Macroscopic
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What are the three microscopic properties discussed in class?
- Crystal habit
- Particle size
- Size distribution
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What type of property are: size distribution, particle size, and crystal habit?
Microscopic properties
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What USP chapter describes federal obligations for Macroscopic properties?
616
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What type of densities measurements exist?
- True density
- Bulk density
- Tapped density
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What is true density?
Density of the actual solid material
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What is bulk density?
The mass of a powder divided by the volume (includes spaces between particles)
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What is the tapped density?
Mass divided by the volume obtained by tapping a cylinder repeatedly (compressing the spaces between the particles)
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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
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What would you use a helium densiometer for?
To measure the volume of a porous substance to obtain the true density
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What type of density is obtained by dividing the bulk mass by the bulk volume (volume is inclusive of the spaces between particles)?
Bulk density
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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
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What is the equation for the angle of respose?
- tan (angle of repose) = us
- us = coeff. of static friction
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What is the range of angles or repose?
0-90 degrees
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