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Pharmaceutics Exam 2
Review for Pharmaceutics Exam 2
| Question | Answer |
|---|---|
| Intimate mixtures of dry, finely divided drugs and/or chemicals that may be intended for internal or external use. | Powders |
| How is patient dosing for bulk powders? | requires the patient to measure the dose, reducing convenience and accuracy - enables greater dosing flexibility |
| Bulk powders are typically reserved for ______. | topical application and/or non-potent drugs. |
| __________ are dispensed as unit-dose powders. | Divided powders |
| What are some benefits of divided powders? | Increased dosing accuracy and convenience, better method for orally administering potent drugs |
| What is the drawback to using divided powders? | Less dosing flexibility |
| ___________ require the use of a powder inhaler. | Inhaled Powders |
| What are some potential advantages/disadvantages of inhaled powders? | Advantage: dosing is accurate Disadvantage: not convenient (may require pt. loading the required dose) |
| What are some potential advantages/disadvantages to oral administration of powder? | difficult to mask taste, easier to swallow compared to tablets or capsules. |
| _______ is typically mixed with food or beverages and immediately consumed. | Orally administered powder |
| ________ may be used for locally and sytemically acting drugs. | Orally administered powder |
| ________ is primarily used to deliver locally-acting drugs to the skin and mucous membranes. | Topically administered powder |
| Topically administered powder may be used with a _______ to increase convenience and accuracy. | application device |
| ________ is primarily used to deliver locally-acting drugs to the lungs. | Pulmonary administered poder. |
| In pulmonary administration the drug is also exposed to the _______. | oral cavity and throat. |
| More spherical, larger, and denser particles have better ______. | flowability |
| Flow is improved by _____ or adding ______. | granulating; glidants |
| Flowability is estimated based upon a powder's _________. | angle of repose |
| Porosity is an important determinant of ______. | Bulk Density; appropriate container size |
| Porosity is influenced by ______. | particle packing; rhombus/triangle vs. cubic |
| Larger particles have a tendency to segregate to the ______ of containers, especially when shaken. | top |
| _______ particles may fill-in the void between any _______ particles. | smaller; larger |
| Examples of diluents to add bulk to the powder formulation include: | lactose, starch, and talc |
| Examples of glidants to improve powder flowability include: | magnesium stearate, talc, and colloidal silica |
| Examples of flavors and sweeteners to mask taste and improve palatability include: | mannitol and aspartame |
| The process of reducing the particle size of a particulate solid to a finer state or subdivision | Comminution |
| "Soft" substances undergo _____ deformation. | plastic |
| substances that undergo ______ deformation can never reach the "yield stress" required to fracture the particle. | plastic |
| Brittle substances undergo ____ deformation. | elastic |
| In _____ deformation if the force is removed before yield stress is reached the particle returns to original shape. | elastic |
| _____ mortars and pestles are ideal for reducing particl size. | Wedgewood and porcelain |
| Dyes should not be used in _____ mortars and pestles. | wedgewood and porcelain |
| Powders of very small quantity should not be used in ______ mortars and pestles. | wedgewood and porcelain |
| _______ mortars and pestles are typically smooth, with nonporous interior surfaces. | clear glass |
| Pulverization by intervention is used for _____. | 1. "soft" powders or 2. those with a very hard crystalline structure |
| Describe the process of pulverization by intervention. | the powder is dissolved in a minimal amount of a volatile solvent, such as ethyl alcohol and either mixed with sufficient powder to absorb the solvent or spread thin to allow for evaporation of the solvent. |
| Mills and pulverizers are typically used by _____. | pharmaceutical manufacturers |
| Aggregation/Granulation is a process whereby: | powder materials are made into larger particles (agglomerates or granules) |
| Describe the wet granulation method | The powder formulation is mixed with water to cause particle adhesion, the resulting granules are then dried in the oven; binders may also be included to facilitate particle adhesion. |
| povidone and microcrystalline cellulose are examples of _____. | binders |
| What is the disadvantage of the wet granulation method? | cannot use water or heat sensitive powders |
| Describe the dry granulation method | The powder formulation is compressed into pellets, slugs, or sheets that are milled, or broken down, to the appropriate particle size. |
| What are the disadvantages of the dry granulation method? | the granules are "weak" and have a wide size distribution that can be uneven. |
| Mixing two or more powders until uniform. | Blending |
| Geometric dillution must be used when blending ingredients of significantly ________. | unequal volumes |
| Ensures that any ingredients needed in small quantities are uniformly distributed throughout the preparation in the shortest amount of time. | geometric dilution |
| The preffered method of blending powders because the applied pressure more intimately mixes powders | trituration |
| Powders are blended on a piece of powder paper or an ointment using a spatula. | Spatulation |
| Powders are blended by passing through a powder sifter | Sifting |
| Bulk powders for external use are often dispensed in ________. | sifter-topped or shaker canisters |
| What are some disadvantages of sifter-topped or shaker canisters? | not considered "tight" may create stability concerns (more conservative than the usual 6 month/25% expiration date rule) |
| Bulk powders for internal use are often dispensed in _______. | sealed, wide-mouth containers. |
| What is the do not use beyond date for powder packets? | usually 2X the intended duration of use. |
| By convention, each dose of divided powder charts contains _____ of the appropriate powder formation. | 300 mg |
| How are charulea/charts normally dispensed? | in a hinged powder box or larger polyethylene bag |
| What is the USP preparation requirement for powders for inhalation and powders packaged in unit-dose containers, that contain inactive ingredient mixed with inactive substances? | Content Uniformity |
| _______ may be used in place of content uniformity for solids packaged in unit-dose containers that contain an active ingredient mixed with inactive substances, if the dosage unit contains > 50 mg of drug comprising > 50% of total weight | Weight Variation |
| Dose uniformity over entire contents is required for ______. | multi-dose powder inhalers |
| Is powder or tablets/capsules more stable? | tabs/caps |
| ______ absorb water from the atmosphere. | Hygroscopic and Deliquescent powders |
| Deliquescent and Hygroscopic powders are unique in that they actually absorb enough water to form ____. | solutions |
| How can you increase the stability of Hygroscopic/deliquescent powders? | 1. Store in tight containers 2. use film coatings 3. store id dry environments 4. add descicant |
| _____ powders contain water of hydration. | Efflorescent |
| Whe water of hydration in Efflorescent powders may be released when the powder is exposed to ______. | a dry environment or increased pressures |
| Stability of Efflorescent powders may be increased by ________. | 1. storing in tight containers, 2. using film coatings, 3. using an anhydrous form |
| A mixture of two or more solid materials that melt or liquefy upon mixing at room temperature | Eutectic powders |
| What are some examples of Eutectic powders? | menthol, phenol, and camphor |
| What are some strategies for blending eutectic powders? | 1. Blend the eutectic powders until they liquify then mix with diluent to absorb it into the powder or 2. separately triturate the 2 eutectic forming powders and then gently blend the mixtures using spatulation |
| Micronized powders have a powder size less than ______. | 5micrometers |
| Effervescent mixtures may be used to increase ______. | dissolution rate |
| Examples of effervescent mixtures include _______. | monosodium citrate and sodium bicarbonate |
| In topical administration, effectiveness is dependent on contact area, which is influenced by ______ | particle size |
| Decreased size ________ available contact pointas | increases |
| Decreased particle size enables deeper delivery into the lower lung, _______ effect. | increasing |
| Performance in pulmonary administration is dependent on _______ | inspiratory rate and inhaler function |
| Solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or shell. | Capsules |
| Solid dosage form containing medicinal substances with or without suitable diluents, and classified as either compressed or molded. | Tablets |
| Patient dosing of capsules and tablets is an example of _______ dosing. | Unit |
| What is one disadvantage to capsules and tablets? | There is limited dosing flexibility. |
| What are two situations that would indicate that splitting the tablet is definately not recommended? | If the product is modified release (Extended Release, etc.) or if the product is a combination product. |
| What is by far, the most common route of administration for tablets and capsules? | Oral administration |
| Lodging of a tablet/capsule may result in _____. | Irritation or ulceration |
| Generally, ______ are more difficult to swallow than capsules. | tablets |
| The taste of tablets and capsules is relatively ______ to mask. | easy (very little contact with the taste buds |
| What are some potential benefits/side effects of using disintegrating/disolving tablets? | Advantages: Does not require water Quicker onset of action/avoids 1st pass metabolism, easier to swallow Disadvantages: Masking taste becomes more difficult |
| What are some potential advantages to vaginal/rectal administration of tablets/capsules over suppositories? | Easier to produce, Less stability issues, more convenient administration |
| ______ capsule shells are typically oblong in shape and consist of two pieces (body and cap) | Hard Capsule Shells |
| _______ capsule shells come in multiple shapes and are single enclosed systems. | Soft Capsule Shells |
| What is the most common material used to prepare capsule shells? | Gelatin |
| _______ is a protein obtained by partially hydrolyzing collagen from the skin, connective tissue, and bones of animals. | Gelatin |
| What makes gelatin an ideal exipient for capsule shells? | It is solid at room temperature but rapidly dissolves at body temperature and is easily hydrolyzed by digestive enzymes and an acidic pH. |
| What are some common gelatin substitutes? | Starch and hydroxypropylmethylcellulose |
| Hard shells typically contain ______ % of water. | 13-16% |
| Hard shells have a ______ percentage of water than soft shells. | lower |
| What are the main capsule shell exipients? | 1. Gelatin, 2. Water, 3. Colorants, 4. Plasticizers |
| Red Ferric oxide and FD & C Red No 3 are examples of _______. | Colorants |
| _____ are commonly used to make capsule shells opaque. | Opacifiers |
| _______ is an example of an opacifier. | Titanium oxide |
| ________ increase flexibility to enable preparation of soft capsule shells. | Plasticizers |
| Plasticizers create a _____ and _______ shell surface. | smoother, shinier |
| What are 2 examples of plasticizers used in capsule shell preparation? | polyethylene glycol and glycerin |
| How are hard capsule shells prepared? | Mold pins are submerged in the melted mixture and allowed to dry. |
| How are soft capsule shells prepared? | The drug is added in between two ribbons of capsule shell material that are fused together. |
| What capsule shell sizes are most commonly used for oral administration? | 0, 1, and 2. |
| What capsule shell size is most typically used for rectal or vaginal application? | 000 |
| What is the largest capsule size? | 000 |
| What is the smallest capsule size? | 5 |
| _____ are special hard capsule shells that are tapered at the closed end of the capsule body. | Pulvules |
| ______ are special hard capsule shells that are tapered at both ends. | Spansules |
| What is the perceived benefit of using capsules that are tapered? | easier swallowing |
| What is the difference between snap-fit and coni-snap capsule shells? | both have grooves to minimize tampering and content loss, coni-snap has a tapered body to ease closure. |
| What is coni-snap supro? | coni-snap capsule that has a longer cap that covers most of the capsule body. |
| What are the benefits of using capsules that have grooves? | minimize tampering and content loss. |
| _____ increase the bulk of the formulation and provide cohesion/compressibility, which ensures proper filling of the capsules. | Diluents |
| ______ ensure that the powder formulation flows freely and uniformly. | Glidants |
| ______ promote particle adhesion within the powder formulation and improve compressibility. | Binders |
| ______ decrease the cohesion between the powder formulation and the capsule filling machine. | Lubricants |
| What kinds of liquids can you put into capsules? | non-aqeuous, also make sure that the capsule is sealed or locking. |
| What is the goal in selecting a capsule size? | Select a capsule size that will contain the appropriate amount of drug without significant empty spaces. |
| Capacity charts should only be used as a ____. | guide |
| Explain the "punch" method. | The powder formulation is triturated until uniform, the uniform powder formulation is compressed into a flat bed of uniform thickness using a spatula, the capsule body is pushed into the compressed powder until it feels full, and then checked |
| Anhydrous lactose and microcrystalline cellulose are both diluents that have a good _____. | Flow |
| Hand operated capsule filling machines should be used with ______ to ensure uniformity. | Diluents with good flow and/or glidants |
| Banding seals are made out of ____. | gelatin or gelatin substitute. |
| ______ seals the capsule cap and body by applying heat at a small spot to melt and fuse the two halves. | Heat Welding |
| What are two methods of hard capsule sealing? | Banding and Heat Welding |
| ____ increase the bulk of the formulation and provide cohesion/compressibility, which ensures proper tablet formation. | Diluents |
| _____ ensure that the powder formulation flows freely and uniformly. | Glidants |
| ______ promote particle adhesion within the powder formulation which is critical for maintaining tablet integrity. | Binders |
| _____ decrease the cohesion between the powder formulation and the tablet filling machinery. | Lubricants |
| Describe the production of compressed tablets. | There is an upper punch and a lower punch that compress powder that is in a die cavity, the lower punch moves up and the lower punch moves down to apply pressure to the powder, then the tablet is expeled by the lower punch pushing it out of the die cavity |
| Some ____ allows the powder particles to deform around each other which increases tablet integrity. | Plastic deformation |
| Excessive ______ will cause the powder to fracture and the tablet to crumble. | Elastic deformation |
| Lamination and capping are two examples of what can happen to a tablet when it lacks _____. | Binders and lubricants |
| ___ is striations on the tablet surface. | Lamination |
| _____ is when the top of the tablet separates from the rest of the tablet. | Capping |
| Tablets that are molded are typically _______ and rapidly _______. | soft and rapidly disintegrate |
| In the process of making molded tablets the powder formulation is moistened with a small amount of a ______ mixture. | water alcohol mixture (50:50) |
| What are some potential advantages of using tablet coatings? | Decreased damage during transport and maintenance of tablet integrity, improved stability during storage, protection to handlers of toxic ingredients, pharmaceutical elegance/identity, masks taste odor, smoother surface, modified drug release. |
| What is the usual ingredient used in sugar coating? | sucrose |
| What are some disadvantages to sugar coating? | cannot be used with water sensitive ingredients, offers little resistance to damage, and causes significant increase in tablet size. |
| Sugar coatings have no effect on ______. | dC/dt |
| Geltabs are _____. | tablets dipped into a melted gelatin mixture |
| What are some advantages to geltabs? | Easier to swallow, compressible tablets make for a smaller dosage form compared to capsules, tamperproof |
| What are some disadvantages to geltabs? | Cannot be used with water sensitive ingredients and changes the size moderately. |
| What is the most common type of coating on tablets? | Film Coating |
| ____ is a thin, smooth coating of a polymer material | Film coating |
| What are some benefits of Film coating? | No significant increase in product size, quicker to apply than sugar or gelatin coatings, flexible and highly resistant to damage, and enables alterations in dissolution characteristics. |
| Film former is a olymer material to provide the base of the coating, what are two examples? | cellulose acetate phthalate (nonaqeous), hydroxypropyl methylcellulose (aqeous) |
| _____ provides coating flexibility for tablets. | Plasticizer |
| Castor oil (non-aqeous), glycerin (aqeous), and polyethylene glycol (aqeous) are all examples of ______ | Plasticizers |
| ______ decrease surface tension, which ensures uniform coating. | Sufactants |
| polysorbate 80 is an example of a _____. | surfactant |
| _____ are used to ensure a smooth coating. | Anti-foaming agents |
| ______ is an example of an anti-foaming agent. | simethicone |
| What are the advantages/disadvantages to using water as a solvent to dissolve the coating ingredients for a tablet? | more environmentally friendly, cheaper, extended drying time, and a less smooth surface |
| What are some potential benefits to using alchol-acetone as a solvent in film coating preparation? | Faster drying, less safe, more expensive, smoother surfaces |
| Explain compression coating. | A powder coating is compressed around a tablet, does not require any water or solvents, requires special equipment, and may alter dissolution characteristics, the coating is thin and uniform. |
| What is the do not use beyond date rule for multi-dose capsule vials? | 1 year from dispensing or exp date |
| What is the do not use beyond date rule for med-packs? | 60-days or exp date |
| What is the do not use beyond date rule for unit-dose packs (blister packs)? | 1 year from dispensing or exp date |
| Content Uniformity is required in: | Tablets and hard capsules having at least one dosage strength < 50 mg and all coated tablets |
| Weight Variation may be used in place of content uniformity for : | uncoated tablets and hard capsules if the dosage uint contains > 50 mg of drug comprising > 50% of the total weight. And all soft capsules. |
| Citric acid is an example of an _______ | antioxidant |
| sodium benzoate and methylparaben are examples of ______. | preservatives. |
| Plasticizers within soft shells often act as ______, helping prevent water loss from these capsule shells. | hemectants |
| What factors play into the hardness of a tablet? | Compression pressures used during tableting; powder compresiibility; amount of binders in the powder formulation |
| Capsules usually result in _____ dissolution rates than tablets. | Quicker |
| _______ are used to overcome any substantial cohesion of the powder formulation aftern administration. | Disintegrants |
| Pregelatinized starch, croscarmellose, and sodium starch glycolate are examples of _____ | disintegrants |
| ______ facilitate wetting of the powder formation after administration. | Surfactants |
| sodium lauryl sulfate is an example of a ____. | surfactant |
| ________ provide water solubility and permeability to non-aqeous coatings which ensures dissolution. | Alloying substances |
| One substance used as an alloying substance is ______. | polyethylene glycol |
| _______ increase disintegration and dissolution rates | Effervescent agents |
| Chewable tablets have a slightly _____ onset of action than tablets. | Eariler |
Created by:
chilangberto