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164 Cards in this Set
- Front
- Back
____________ are semisolid preparations intended for the external application to the skin or mucous membranes
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Ointments
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Describe 3 uses for ointments.
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1. to protect skin/ mucous membranes and to permit rejuvination
2. provide hydration. emollient effect 3. provide a vehicle fo applying medication (local or systemic) |
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_______ is an agent that softens the skin or soothes irritation in skin or mucous membranes.
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Emollient
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Define "protective".
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a substance that protects injured/exposed skin surfaces from harmful or annoying stimuli.
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_____________ is a substance that promotes retention of water in the skin by forming a hydrophobic barrier that prevents moisture in the skin from evaporating.
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Occlusive
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_________ is a substance that causes water to be retained because of its hygroscopic propertie
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Humectant
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True or False.
A desirable property of a base is free from objectionable odor. |
True
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True or False.
A desirable property of a base is not-toxic, nonsensitizing, and nonirritating |
True
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True or False.
A desirable property of a base is a greasy application. |
False. Bases should be nongreasy.
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True or False.
A desirable property of a base is easy removal. |
True
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True or False.
A desirable property of a base is chemically and physically stable under normal conditions. |
True
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True or False.
A desirable property of a base is reactivity and incompatiblity with other drugs and auxillary agents. |
False. Bases should be nonreactive and compatible.
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List 4 types of Ointment bases.
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1. oleaginous
2. absorption 3. water-removable 4. water- souble |
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________ are also called oleaginouos bases.
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Hydrocarbon bases.
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Describe an oleaginous base.
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1. emollient effect
2. protect escape of moisture 3. effective as occlusive dressings 4. can remain on skin for prolonged periods 5. difficult to wash off 6. can include water and aqueous solvents in small amts 7. can include powdered substances with mineral oil as a levigating agent. |
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What levigating agent would you use to incorporate a powdered substance into a hydrocarbon base?
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mineral oil
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What are 3 disadvantages of oily bases?
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1. greasy nature (pts dont like)
2. not easily removes 3. cannot absorb water, and very little alcoholic sol. |
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List 4 examples of hydrocarbon bases?
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1. petrolatum
2. white petrolatum 3. yellow ointment 4. white ointment |
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Which oily base is described as a purified mixture of semisolid hydrocarbons that has been decolorized?
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white petrolatum
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Which oily base is described as a simple ointment, that is slightly more viscous than plain petrolatum, and is a combination of petrolatum and yellow wax?
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yellow ointment
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Which oily base is describes as a simple ointment made with petrolatum and bleached wax?
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White ointment
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__________ may be used as emollients, but dont provide the degree of occlusion of oily bases.
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Absorption Bases
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Which oily base is useful as asjuncts to incorporate small volumes of aqueous solutions into hydrocarbon bases?
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Absorption Bases
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Give 2 examples of an absorption base?
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1. Hydrophilic petrolatum
2. Lanolin |
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An absorption base that incorporates aqueous solutions forming water-in-oil.
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hydrophilic petrolatum
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An absorption base that is already a water in oil emulsion but allows incorporation of additional aqueos solutions
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Lanolin
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Aquaphor is an example of which base?
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Absorption base: Hydophilic petrolatum
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Cholesterol 30g
Stearyl alcohol 30g white wax 80g white perolatum 860g This formulation describes which type of base? |
Absorption base: Hydrophilic petrolatum
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What are 3 advantage of absorption bases?
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1. mod. good protective, occlusive and emollient properties
2. dont wash easily, hold medication longer 3. can absorb liquids |
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Which base is obtained from the wool of sheep, has been purified, deodorized, decolorized, and contains no more than 0.25% water?
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Absorption base: Lanolin
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An absorption base that is already a water in oil emulsion but allows incorporation of additional aqueos solutions
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Lanolin
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Aquaphor is an example of which base?
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Absorption base: Hydophilic petrolatum
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Cholesteol 30g
Stearyl alcohol 30g white wax 80g white perolatum 860g This formulation describes which type of base? |
Absorption base: Hydophilic petrolatum
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What are 3 advantage of absorption bases?
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1. mod. good protective, occlusive and emollient properties
2. dont wash easily, hold medication longer 3. can absorb liquids |
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Which base is obtained from the wool of sheep, has been purified, deodorized, decolorized, and contains no more than 0.25% water?
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Absorption base: Lanolin
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Lanolin contains no more than ______ water.
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0.25%
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Describe modified lanolin.
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reduced contents of free lanolin alcohols and detergent/ pesticide residues.
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List 5 Water-Removable Base characteristics.
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1. water-washable
2. oil-in-water emuslion cream 3. easily washed 4. can be diluted with water 5. can absorb serous discharge. |
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Hydrophilic ointment, vanishing cream, and dermabase are all examples of this base?
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Water-Removable
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List 4 advantages of Water-Removable Bases?
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1. nongreasy
2. easily washed 3. can absorb water and alcohol 4. allows dissipation of fluids from injury |
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Which base contains no oily cmpds, greaseless, and soften greatly with addition of water?
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Water-Soluble bases
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What are 3 advantages of a water-solucble bases?
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1. easily washed
2. leaves no oil residue 3. can absorb water/ alcohol |
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What are the USP tests required for ointments?
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1. microbial content
2. minimum fill 3. packaging 4. storage and labeling |
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_________ are not required to be sterile.
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Topical applications ( excluding opthalmic)
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Preparations (with/without) water contain more microbial growth.
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with
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What is an example of an auxillary agent?
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fragrance
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True or False.
When incorportaing solids, fine powders are the ideal choice drug form. |
True
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True or False.
When incorporating a solid, particle size should be reduced as far as possible. |
True
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Mineral oil
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Levigating agent
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glycerin
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Levigating agent
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propylene glycol
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Levigating agent
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PEG 400
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Levigating agent
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cottonseed oil
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Levigating agent
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castor oil
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Levigating agent
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Polysorbate (Tween) 80
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Levigating agent
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Methylparaben
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Preservative
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Propylparaben
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Preservative
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Phenols
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Preservative
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Benzoic Acid
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Preservative
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Sorbic Acid
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Preservative
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Quarternary Ammonium Salts
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Preservative
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__________ is the determination of weight or volume of filled containers to ensure proper contents.
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Minimum Fill
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True or False.
Ointments may require opaque or light resistant containers. |
True
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True or False.
There is an additional labeling requirement needed for ointment which includes type of base used. |
True
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True or False.
Viscosity must be considered in ointment formulation |
True
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True or False.
In Vitro drug release doesn't need to be considered in ointment formulation. |
False, it should be considred.
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For nonaqueous formulations of unknown stability, the USP allows for a BUD from ______day to ______ months, depending on source of ingredients.
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30; 6
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Creams are primarliy used for which 3 routes of administration?
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1. topically
2. vaginally 3. rectally |
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Creams or Ointments.
Which is easier to spread and remove? |
Creams
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Semisolid preparations containing one or more medicinal agents dissolved or dispersed in either a water-in-oil emulsion or an oil-in-water emulsion base or in another type of water-washable base
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Creams
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Semisolid systems consisting of dispersions of small or large molecules in an aqueous liquid vehicle rendered jellylike by the addition of a gelling agent
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Gels
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Semisolid preparation that also contains drug substances, solvents, preservatives and/or stabilizers
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Gels
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List 5 routes gels may be administered
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1. eye
2. skin 3. nose 4. vagina 5. rectum |
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List 5 gelling agents
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1.Carbomer 934
2.Carboxymethylcellulose 3.Hydroxypropyl 4. methylcellulose 5.tragacanth |
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____________ are gels in which the macromolecules are uniformly distributed throughout a liquid with no apparent boundaries between the dispersed macromolecules and the liquid
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single phase
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Which gel has a mass consisting of floccules of small distinct particles?
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two phase gels
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Magmas are what type of gel?
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two phase gel
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dimethyl sulfoxide (DMSO)
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penetration enhancer
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ethanol
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penetration enhancer
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propylene glycol
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Penetration enhancers
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glycerin
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Penetration enhancers
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polyethylene glycol
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Penetration enhancers
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sodium lauryl sulfate
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Penetration enhancers
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Tweens, lecithin, terpenes
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Penetration enhancers
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Which semisolid prepartion should not be applied to hairy parts of the body?
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paste
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Which semsolid prepartion remains in place after application and are effectively used to absorb serous secretions?
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Paste
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Semisolid containing a larger proportion of solid materials than ointments and are therefore stiffer
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Paste
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Commonly compounded transdermal preparation which aids in the rapid penetration of many active drugs through the skin
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Pluronic Lecithin Organogel (PLO)
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Solid or semisolid adhesive masses spread on a backing of paper, fabric, moleskin or plastic
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Plasters
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Plastic masses containing gelatin (15%), glycerin (40%), water (35%), and added medicinal substance (10%)
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Glycerogelatins
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Describe a Transdermal Delivery System.
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Drug through the skin for systemic effects.
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List 7 factors that affect Percutaneous Absorption.
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1.Drug Concentration
2.Area of Application 3.Affinity of the Drug for the 4.Skin versus the Vehicle 5.Molecular Weight 6.Skin Hydration 7.Thickness of the Horny Layer 8.Contact Time with the Skin |
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___________increase skin permeability by reversibly damaging or altering the physicochemical nature of the stratum corneum to reduce its diffusional resistance
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Chemical Enhancers
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Chemical enhancers can _________ hydration of the stratum corneum.
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Increase
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If the molecular weight of a drug is greater than 800 g/mL, will this make a good transdermal product?
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No, because the general says that a drug that large will not cross the skin.
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Where is the thinnest layer of horny layer located?
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Lips
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How do you select chemical enhancers for a TDDS?
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-efficacy
-low dermal toxicity -compatibility with other components |
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Acetone
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Chemical Enhancer
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Azone
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Chemical Enhancer
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Dimethyl sulfoxide (DMSO)
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Chemical Enhancer
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Ethanol
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Chemical Enhancer
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Oleic acid
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Chemical Enhancer
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Polyethylene glycol
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Chemical Enhancer
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Propylene glycol
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Chemical Enhancer
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Sodium lauryl sulfate
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Chemical Enhancer
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The delivery of a charged chemical compound across the skin membrane using an electrical field.
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Iontophoresis
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The high frequency ultrasound to enhance transdermal drug delivery.
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Sonophoresis
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True or False.
Chemical Enhancers can changes thre structure of lipids? |
True
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Which TDDS system incorporates a drug matrix layer between backing and frontal layers?
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Monolithic systems
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Which TDDS system contains a drug reservoir or pouch, a rate controlling membrane, and backing, adhesive and protective layers
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Membrane-Controlled Systems
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If the drug is delivered to the stratum corneum at a rate less than the absorption capacity, the _________is the rate-controlling factor
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Device
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If the drug is delivered to the skin area to saturation, the ________ is the rate-controlling factor
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Skin
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What are 2 disadvantages of TDDS?
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1. Only relatively potent drugs
2. Contact dermatitis |
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What is the ideal shelf life of a TDDS?
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up to 2 years
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Whats is the ideal patch size of a TDDS?
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< 40 cm2
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Whats is the ideal dosing frequency of a TDDS?
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once a day to once a week
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Whats is the ideal aesthetic appeal of a TDDS?
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Clear, tan or white color
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What is the ideal packagin of a TDDS?
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Easy removal of release liner and minimum number of steps required to apply
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What is the ideal skin adhesion property of a TDDS?
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No fall-off during dosing
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What is the ideal skin reaction of a TDDS?
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Nonirritating and nonsensitizing
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Which is not a quality control method of TDDS?
A.Stability of the assembled system B.Release profile C. In vitro assessment of TDDS using diffusion cells D.Adhesion and Matrix profiles E.In vivo assessment of TDDS |
D
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Topical products are used more for ________effects, as oppose to Transdermal products which have a ______effect.
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local; systemic
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What is the biggest barrier which considering TDDS?
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Stratum Corneum
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True or False
Controlled drug release is an advantage of TDDS. |
True
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Which is not an advantage of TDDS?
a.Avoid first-pass effect b.Location of product c.Noninavsive d.Provide extended therapy |
B. Location of product
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True or False.
TDDS are subject to GI effects |
False; TDDS avoid GI effects
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Which of the following is an advantage of TDDS?
A.Provide extended therapy B.Extend activity of drugs with short half-life C.Rapid termination of therapy D.Easily identified E. All of the above |
E. All of the above
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True or False
Controlled drug release is an advantage of TDDS. |
True
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Which is not an advantage of TDDS?
a.Avoid first-pass effect b.Location of product c.Noninavsive d.Provide extended therapy |
B. Location of product
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True or False.
TDDS are subject to GI effects |
False; TDDS avoid GI effects
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Which of the following is an advantage of TDDS?
A.Provide extended therapy B.Extend activity of drugs with short half-life C.Rapid termination of therapy D.Easily identified E. All of the above |
E. All of the above
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______________ is a solid dosage form intended for insertion into a body orifice where it melts, softens or dissolves and exerts local or systemic effects
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Suppository
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Which is not an advantage of suppository?
A.By-passes the first-pass effect B.Large dose drugs C.Can be crushed for smaller dose D.Can control duration of action |
C
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Which of the following is a disadvantage to suppositories?
A.Leakage B.Unpredictable drug absorption C.Potential for irritation D.Upward movement can increase first pass metabolism E. All of the above |
E
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True or False
Uniform distribution of active ingredient throughout the dosage form is an ideal property for a suppository |
True
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What factors affect rectal absorption?
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1.colonic content
2. circulation route 3. pH 4. lack of buffering capacity |
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The rectum is approximately ________ long.
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15-20 cm
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True or False.
Particle size affects rectal absorption. |
True
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True or False.
Solubility has no affect on rectal absorption. |
False. Lipid-Water solubility DOES affect absorption.
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What are three classes of suppository bases?
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1. Fatty base
2. Water-soluble or water-miscible polymers 3. Miscellaneous |
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What are 3 fatty bases used for suppository formulation?
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1. Cocoa Butter
2. Fattibase 3. Witepsol base |
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Which fatty base used for suppository formulation has a problem with polymorphism?
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Cocoa Butter
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Which fatty base used in suppository formulation is made of a combination of oils?
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Fattibase
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Fatty Bases________ to release drugs, as oppose to water-soluble/water miscible polymers which ________ to release drug.
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melt; dissolve
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List 2 Water-Soluble and Water-Miscible Suppository Bases.
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1. glycerinated gelatin
2. polyethylene glycols |
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___________ are mixtures of oleaginous and water-soluble or water-miscible materials used to make suppositories
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Miscellaneous Bases
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Miscellaneous Bases used in suppository formulation release drug by ___________.
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softening
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What would you expect the drug release rate to be given the following:
Oil-soluble drug with oily base |
Slow release; poor escaping tendency
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What would you expect the drug release rate to be given the following:
Water-soluble drug with oily base |
Rapid release
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What would you expect the drug release rate to be given the following:
Oil-soluble drug with water miscible base |
Moderate release rate- depends more on base--- dissolution
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What would you expect the drug release rate to be given the following:
Water-miscible drug with water miscible base |
Moderate release; based on diffusion; all water soluble
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What are three methods used in making suppositories?
|
Compression
Hand Rolling Molding ( fusion) |
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Which suppository method is limited to cocoa butter as a base, doesnt require any calculations, and lacks an elegant apperance?
|
Hand Rolling
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Which supossitory method allows most bases for molding,
requires lubrication and calibration and can be used for both small and large scale manufacturing? |
Molding ( fusion)
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if the quantity of the active ingredient is less than_________, then the volume occupied by the powder is insignificant
|
100 mg
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Which suppository method is rarely used at the small scale level, used greatly for heat-labile products, and eliminates the likelihood of insoluble components settling during manufacture?
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Compression
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What are 3 methods used in determining the amount od base needed in the formulation of a suppository?
|
1.Dosage Replacement Factor Method
2.Density Factor 3.Occupied Volume Method |
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If your prescription calls for 6 suppositories, how many should you make?
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7-8; allow for excess
|
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What packaging and storing conditions should be considred with Glycerinated gelatin suppositories
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Packaging must protect product from moisture and can be stored at RT
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What packaging and storing conditions should be considred with Cocoa butter suppositories
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Must be kept in constant cool place to prevent melting.
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What packaging and storing conditions should be considred with Polyethylene suppositories
|
Packaging must protect product from moisture and can be stored at RT. However,very incompatible with many things, especially plastic.
|
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True or False
Layering of a suppository is acceptable. |
False. Layering should not occur
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True or False.
One qualitity control measure for a suppository is visual inspection. |
True
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Which of the following in not a consideration in suppository formulation?
A. Viscosity B. Stability C. Presence of water D. Color |
D. color
|