Term
| Capsules are both solid and semi-solid dosage forms containing a drug substance and/or inert substances. |
|
Definition
| False (they can contain solid or semi-solids) |
|
|
Term
| A capsule shell may be composed of gelatin, HPMC, Pullulan, and Carrageenan? |
|
Definition
|
|
Term
| Hard gelatin capsules may be called as dry to liquid filled capsules. |
|
Definition
|
|
Term
| Soft elastic capsules are liquid filled. |
|
Definition
|
|
Term
| Powdered material is filled into the body of a hard gelatin capsule. |
|
Definition
|
|
Term
| Hard gelatin capsule is unaffected by storage conditions? |
|
Definition
|
|
Term
| Advantages of hard gelatin capsules are elegance, ease of use, portability, provides smooth but rather difficulty in swallowing, and tasteless shell for bitter drugs. |
|
Definition
| False (not difficult to swallow) |
|
|
Term
| Hard shell capsules are limited to use for powdered solids? |
|
Definition
|
|
Term
| Hard shell capsules are ideally suited for blinded clinical trials. |
|
Definition
|
|
Term
| Potential for gelatin cross-linking with a drug substance and decreasing its bio-availability is one of the disadvantages with hard gelatin capsules. |
|
Definition
|
|
Term
BSE disease is associated with which capsule material type among the following?
A. HPMC
B. Pullulan
C. Gelatin |
|
Definition
|
|
Term
| Capsules can be produced at a high speed similar to tablets. |
|
Definition
|
|
Term
| Overall, capsules are less expensive to produce than tablets? |
|
Definition
|
|
Term
| There are three types of gelatin? |
|
Definition
|
|
Term
Gelatin derived from an acid-treated precursor with an isoelectric point of approximate pH 9 is called?
1. Type A
2. Type B |
|
Definition
|
|
Term
| Type B is from neutrally treated precursor with isoelectric point of approx. pH 4.7? |
|
Definition
|
|
Term
| HPMC is the only non-animal based material used for capsules? |
|
Definition
|
|
Term
| HPMC has low moisture content and resists to cross-linking? |
|
Definition
|
|
Term
| Pullulan is a polysaccharide made from starch? |
|
Definition
|
|
Term
| Carrageenan may be used as a substitute for soft gelatin capsule |
|
Definition
|
|
Term
| A capsule formulation may contain bulking agent, lubricants, glidants, and adsorbents along with the drug substance. |
|
Definition
|
|
Term
| Microcrystalline starch may be used as a diluent or adsorbing agent |
|
Definition
|
|
Term
| The only limitation of materials that can be filled in capsules is the amount of the material that can be filled into available (desired) capsule size |
|
Definition
|
|
Term
| A capsule fill capacity depends on the capsule volume and the bulk density of the powder |
|
Definition
|
|
Term
| Capsule filling volume is inversely proportional to the capsule number. |
|
Definition
| True (smaller the capsule nomenclature the more volume it can hold) |
|
|
Term
Which one of the following capsule sizes has lower volume?
A. 000
B. 3
C. 0 |
|
Definition
|
|
Term
| Weight of the powder filled in a capsule, regardless of its material type, is always the same for a given capsule size. |
|
Definition
| False (every powder has differing density) |
|
|
Term
| Soft capsules are soft, globular, and made up of gelatin only |
|
Definition
| False (not only globular in shape) |
|
|
Term
| Soft capsules are primarily used for suspensions. |
|
Definition
|
|
Term
| Soft capsules are desired for highly potent and high melting point components. |
|
Definition
|
|
Term
| Soft capsules provide high degree of fill reproducibility. |
|
Definition
|
|
Term
| Soft capsules are available in globular size only. |
|
Definition
|
|
Term
| Soft elastic capsules are more expensive to produce than tablets. |
|
Definition
|
|
Term
| There is an increased chance of unwanted reactions with the drug material and the soft elastic material? |
|
Definition
|
|
Term
| Disadvantages of soft elastic capsules are higher level of moisture, long drying time, and capital investment. |
|
Definition
|
|
Term
| Lubricant is one of the ingredients in a soft capsule formulation. |
|
Definition
|
|
Term
| Finished product is tested for weight variation, disintegration, content uniformity, and dissolution. |
|
Definition
|
|
Term
| Weight variation, disintegration, content uniformity, and dissolution are all required USP monographs of all capsules |
|
Definition
|
|
Term
| per the USP chapter 905, uniformity of dosage units may be confirmed by weight variation if the amount of API is greater than or equal to 25 mg and/or greater than or equal to 25% in a unit dose |
|
Definition
|
|
Term
| Content uniformity is a USP requirement for soft capsules filled with all material types? |
|
Definition
|
|
Term
| Disintegration test is repeated with 12 additional capsules if 1 or 2 capsules fail to disintegrate completely during the first test? |
|
Definition
|
|
Term
| No less than 1 capsule of the total 18 capsules tested must disintegrate completely in order to pass the disintegration test. |
|
Definition
|
|
Term
| USP <905> Dissolution tests have 3 different acceptance criteria |
|
Definition
| False (USP 905 is content uniformity) <711> is dissolution. |
|
|
Term
| Advantages of sterile products are: drugs are directly delivered to the blood, patients who cannot take medication orally, provides quick onset and accurate control of blood levels. |
|
Definition
|
|
Term
| Disadvantages of sterile products are: cost, inconvenient to use, requires sterility, and drug properties have greater impact on formulation design. |
|
Definition
|
|
Term
| All steps in manufacture of sterile products is to keep sterility paramount to minimize bioburden. |
|
Definition
|
|
Term
| Sterile products must meet sterility assurance level of less than or equal to 10E-6 |
|
Definition
|
|
Term
| Sterilization process must be validate before use. |
|
Definition
|
|
Term
| Selection of a sterilization method depends on the nature of the drug and drug product |
|
Definition
|
|
Term
| Various sterilization methods are: saturated steam, dry heat, ethlyene oxide, hydrogen peroxide, radiation and filtration |
|
Definition
|
|
Term
| Biological indicator used for moist heat sterilization is 'spores of bacilus subtilis' |
|
Definition
| False (bacillus stearothermophillus) |
|
|
Term
| Biological indicator used for dry heat sterilization is spores of bacillus purmilus |
|
Definition
|
|
Term
| Biological indicators used for filtration sterilization are spores of serratia marcescens, brevundimonas diminuta, and stearothermophillus |
|
Definition
|
|
Term
| Most typical cycles for saturated steam sterilization are: 121 C for 15 minutes or 134 C for 3 minutes. |
|
Definition
|
|
Term
| Denaturation and hydrolysis are the typical reactions in hydrated state during saturated steam sterilization |
|
Definition
|
|
Term
| Super-heated steam is not saturated with water; it is less efficient in sterilizing and acts like hot air. |
|
Definition
|
|
Term
| Dry heat sterilization targets both the microorganisms and their by-products. |
|
Definition
|
|
Term
| Depyrogenation destroys fever causing pyrogens. |
|
Definition
|
|
Term
| Dry heat sterilization and depyrogenation destroy microbes and endotoxins by oxidative pathways. |
|
Definition
|
|
Term
| Normal steam sterilization does not depyrogenate |
|
Definition
|
|
Term
| The temperature at which dry heat sterilization is usually carried out is lower than that of depyrogenation |
|
Definition
|
|
Term
| One of the cycles for depyrogenation is at 230 C for 60-90 minutes |
|
Definition
|
|
Term
| Microorganisms are removed rather than destroyed during sterile filtration |
|
Definition
|
|
Term
| Sterile filtration is primarily used for heat sensitive drugs and drug products |
|
Definition
|
|
Term
| Filters with 0.22 micron pore size are used for sterile filtration |
|
Definition
|
|
Term
| Membrane filters are made from various polymers. |
|
Definition
|
|
Term
| membrane filters made from cellulose esters are used for organic solvents |
|
Definition
|
|
Term
| Sterility is achieved by both the membrane and depth filters |
|
Definition
|
|
Term
| Depth filters provide absolute retention |
|
Definition
|
|
Term
| Filter integrity is verified before and after filtration |
|
Definition
|
|
Term
| In sterile processing area, air is monitored for both the viable and non-viable quality. |
|
Definition
|
|
Term
| Microbiological tests are performed to check HEPA filter integrity. |
|
Definition
|
|
Term
| Various parameters are used to certify sterile processing spaces; those are: pressure differentials, air changes per hour from HEPA filters and air quality |
|
Definition
|
|
Term
Whats the ISO number for the US standard (class) of 10,000
A. ISO 7
B. ISO 5
C. ISO 8 |
|
Definition
|
|
Term
What's the maximum number of particles of 0.5 micron or larger per cubic meter is acceptable for ISO 5 class space?
A. 352,000
B. 3520
C. 3,520,000 |
|
Definition
|
|
Term
| Depth filters provide rapid filtration rates than those achieved from the membrane filters |
|
Definition
|
|
Term
| The WHO's clean room classification Grade A and Grade B are the same as the ISO class 5 or US class of 100 |
|
Definition
|
|
Term
| Acceptable environmental monitoring includes compliance to the specifications of viable counts. |
|
Definition
|
|
Term
| IS classes (5, 7, 8, etc) is primarily based on the number of non-viable particle counts of less than 0.5 microns per cubic meter |
|
Definition
|
|
Term
| Higher levels of non-viable particles are allowed in ISO 7 than in ISO 8 classified space? |
|
Definition
| False (the lower the number the more sterile) |
|
|
Term
| Official classification of clean areas is primarily based on monitoring air quality at steady state (At rest) with no production is taking place in those areas. |
|
Definition
|
|
Term
| The ISO 5 clean area must be free from viable particles? |
|
Definition
|
|
Term
| The ISO 5 clean area must have the highest pressure compared to all other adjacent classified areas. |
|
Definition
|
|
Term
|
Definition
|
|
Term
| Sterile water for injection is synonymous to water for injection |
|
Definition
|
|
Term
| Sterile water for injection may contain antimicrobials to keep it sterile |
|
Definition
|
|
Term
| LAL testing is commonly used to determine endotoxin levels in sterile products |
|
Definition
|
|
Term
| Autoclave exposure (temp + time) is usually dependent on the product being sterilized. |
|
Definition
|
|
Term
| Dry heat is more effective than moist heat in killing microbes |
|
Definition
|
|
Term
| To prevent damage of the HEPA filter during depyrogenation, the temperature is increased at a much slower rate of 1-1/1 C/min. |
|
Definition
|
|
Term
| During lyophilization, API (and mannitol) aqueous solution is frozen (at -50 C) and sublimated to remove moisture under vacuum. |
|
Definition
|
|
Term
| Due to its low cost, lyophilization is a preferred method for all powdered injectables |
|
Definition
|
|
Term
| Settling and surface contant plates are used for monitoring of non-viable particulates |
|
Definition
|
|
Term
| Glove finger test is one of the routine air quality monitoring on non-viable particulate counts |
|
Definition
| False (training for viable PPE donning) |
|
|
Term
| Glass vials may be free of endotoxins by rinsing with purified water. |
|
Definition
|
|
Term
| Pyrogen testing, involving the temperature rise in rabbits is a required release test for batches of all sterile products. |
|
Definition
|
|
Term
| Injectable solutions are visually inspected (at random-small sampling) to ensure the batch is free from particulates |
|
Definition
|
|
Term
| Acceptable level of the particle counts is the same for all sizes of injectable solutions |
|
Definition
|
|
Term
| Selection of the type of glass container and stopper is not a major concern for injectable solutions |
|
Definition
|
|
Term
| Type of the tubing material used for IV administration is not important. |
|
Definition
|
|
Term
| All parenterals, including suspensions, are aqueous based. |
|
Definition
|
|
Term
| Tablets are compressed solid unit dosage form containing drug substance with or without excipients. |
|
Definition
|
|
Term
| The advantages (among many others) of tablets are: dose precision, least content variability, easy to swallow, and easiest and cheapest to package and strip. |
|
Definition
|
|
Term
| Disadvantages (among others) of tablets are: difficulty for children and unconscious to swallow, drugs with poor wetting and slow dissolution properties, and offer lesser microbiological stability as compared to other oral dosage forms. |
|
Definition
|
|
Term
| Tablets used in oral cavity are: buccal tablets, sublingual tablets, hypodermic tablets, troches, lozenges. |
|
Definition
|
|
Term
| Tablet excipients are used to improve stability, solubility, enhance bio-availability, increase patient acceptability, and to modify drug release. |
|
Definition
|
|
Term
| Diluents could be used to provide better tablet properties such as cohesion and to promote flow. |
|
Definition
|
|
Term
| Diluents must be non-toxic, physiologically active, physically and chemically stable, but may alter (slightly) bio-availability of the drug. |
|
Definition
|
|
Term
| Binders and adhesives are used in dry form only. |
|
Definition
|
|
Term
| Disintegrant facilities breaking or disintegration of a tablet when it comes in contact with fluids in the GI tract |
|
Definition
|
|
Term
| Superdisintegrants are expensive than regular disintegrant without additional benefits in tablet breaking. |
|
Definition
|
|
Term
| For the most part, lubricants offer the same benefits as glidants and they interchangeable. |
|
Definition
|
|
Term
| Lubricants are intended to prevent adhesion of tablet powder to the surface of the dies and punches. |
|
Definition
|
|
Term
| Glidants are intended to promote flow of tablet powder by reducing the friction between the particles. |
|
Definition
|
|
Term
| Anydrous form of lactose undergoes maillard reaction. |
|
Definition
|
|
Term
| Anhydrous lactose is preferred over the hydrous grade during wet granulation. |
|
Definition
|
|
Term
| Spray dried lactose has good flowability but less compressibility. |
|
Definition
|
|
Term
| Fast flow lactose is more compressible than spray dried lactose |
|
Definition
|
|
Term
| Fast-flow lactose is non-hygroscopic |
|
Definition
|
|
Term
| Starch can be from corn, wheat, or potato source. |
|
Definition
|
|
Term
| Starch has poor flow but desired compression characteristics. |
|
Definition
|
|
Term
| Starches are preferably used in dry granulation. |
|
Definition
|
|
Term
| Sta 1500 is free flowing, self-lubricating, continuing slightly high moisture content. |
|
Definition
|
|
Term
| Sta 1500 does not form hard compacts due to its moisture content. |
|
Definition
|
|
Term
| Sta 1500 is used both as a binder and a disintegrant. |
|
Definition
|
|
Term
| Avicel is microcrystalline cellulose |
|
Definition
|
|
Term
| Avicel is available in two grades: PH101 and PH102 |
|
Definition
|
|
Term
| Avicel is most compressible with highest dilution potential. |
|
Definition
|
|
Term
Which tableting method has the fewest steps:
A. Wet granulation
B. Direct compression
C. Dry Granulation |
|
Definition
|
|
Term
| Powders intended for compression into tablets must be flowable and compressible. |
|
Definition
|
|
Term
| Sluggin is one of the processes used in producing granules for dry granulation. |
|
Definition
|
|
Term
| Slugs are broken into granules with various sizes (large and small) prior to compression |
|
Definition
|
|
Term
| Material of very low density require roller compaction to achieve bulk density sufficient to allow compression |
|
Definition
|
|
Term
| Dry granulation requires drugs or excipients with cohesive properties. |
|
Definition
|
|
Term
| One of the disadvantages of drug granulation is that higher percentage of fines or non-compacted products which could compromise product quality. |
|
Definition
|
|
Term
| Wet granulation is the most popular method for tablet manufacturing processes. |
|
Definition
|
|
Term
| Benefits of wet granulation are: prevents segregation, improve flowability, improve compressibility, and content uniformity. |
|
Definition
|
|
Term
| Wet granulation is suitable for all drugs including those that are heat and moisture sensitive. |
|
Definition
|
|
Term
| Coating makes tablets stronger, tougher and easier to swallow. |
|
Definition
|
|
Term
| Additional benefits of tablet coating are: to provide special characteristics of drug release, and prevent inadvertent contact by non-patients with the drug substance. |
|
Definition
|
|
Term
| Enteric coating is one of the examples of coating methods to modify drug release in GI tract. |
|
Definition
|
|
Term
| Which one is the correct sequence of steps involved in sugar coating. |
|
Definition
| A. Waterproofing and sealing (if needed), subcoating, smoothing and final rounding, finishing and coloring (if desired), polishing. |
|
|
Term
| Waterproofing and sealing is a required step when tablets are sugar coated. |
|
Definition
|
|
Term
| Subcoating is used to bond sugar coating to the tablet and provides rounding. |
|
Definition
|
|
Term
| Blistering, chipping, catering, picking, and pitting are sources of the problems with all types of coating methodologies. |
|
Definition
|
|
Term
| Binding is adhesion of granules to the die wall causing resistance if the tablet to eject the die. |
|
Definition
|
|
Term
| binding is caused due to insufficient glidant in the formula. |
|
Definition
|
|
Term
| Binding may be improved by increasing the moisture content of the granulation. |
|
Definition
|
|
Term
| Sticking occurs when particles adhere to the punch face and die walls. |
|
Definition
|
|
Term
| Sticking is caused due to improperly dried or lubricated granules. |
|
Definition
|
|
Term
When the upper segment of the tablet separates from, the main portion of the tablet and comes offs a cap is called.
A. Lamination
B. Capping |
|
Definition
|
|
Term
| Some of the reasons for capping are: insufficient lubrication, large amount of fines, and/or too dry granules among others. |
|
Definition
|
|
Term
| Tooling is usually the cause for lamination. |
|
Definition
|
|
Term
| Some of the solution to prevent capping and lamination are increasing the binder amount, and certain degree of moisture in granules. |
|
Definition
|
|
Term
| Per USP <905>, content uniformity is required for all tablet formulations regardless of the amount of active ingredient in a formulation. |
|
Definition
|
|
Term
| USP has specification limits for tablets thickness, disintegration, and tablet breaking force. |
|
Definition
|
|
Term
| Disintegration test is not performed for coated, chewable or modified release tablets. |
|
Definition
|
|
Term
| What is the S1 criteria for acetaminophen tablets to pass the dissolution test with NLT 75% (Q) spec? |
|
Definition
| C. Amount of the API dissolved from each of the 6 tablets is not less than Q + 5 (80%) |
|
|
