Pharmaceutics ll Exam 2 Practice

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• Which statement best distinguishes diffusion-controlled release in polymeric matrices from erosion-controlled release?
• The two USP dissolution apparatuses are Basket system Type 1 and Paddle system Type 2.
• Which type of tablet is not used in the oral cavity?
• What defines Level A IVIVC in formulation development?
• Which of the following is a typical example of a critical quality attribute (CQA) in pharmaceutical product development?
• Burst release is characterized by which phenomenon?
• Cracking in emulsions is irreversible.
• Effervescent tablets dissolve in water and release carbon dioxide.
• In a tablet manufacturing context, what action do the punches perform to the powder to form a tablet in a rotary press?
• A suspension is composed of which of the following?
• An angle of repose less than 25 degrees indicates what powder flow?
• Acacia is very sticky.
• If a patient takes 0.5 g of calcium carbonate three times daily, how much elemental calcium is provided per day?
• Which statement about zero-order release is true?
• In wet granulation, making the powder heavier makes for easier compression.
• What is the mesh size required for a very fine powder?
• How does moisture sorption influence pharmaceutical stability and how is it quantified?
• In the same powder, how many grams of caffeine are present?
• Which of the following is NOT a route of administration for composite tablets?
• The hydrophilic-lipophilic value (HLV) of an oil-in-water emulsifying agent is in which range?
• What is the primary difference between transdermal patches and topical gels in terms of mechanism and drug properties?
• Which parameter is used to assess weight uniformity of tablets?
• Explain the difference between chemical stability and physical stability in drugs.
• Which statement best describes an emulsion?
• Describe the autoclave cycles used in moist heat sterilization with typical parameters.
• What does CQA stand for in pharmaceutical product development?
• Which statement best describes the primary outcome of wet granulation in tablet formulation?
• In a patient receiving hydromorphone PCA at 0.2 mg/hour basal, demand dose 0.1 mg, lock-out 6 minutes, hourly limit 2.2 mg, who used 5 on-demand bolus doses in 24 hours, how many milligrams of hydromorphone were delivered in 24 hours?
• What does Cs represent in the Noyes-Whitney dissolution rate equation dM/dt = D·A/h·(Cs − Cb)?
• Container-closure integrity refers to which essential property for sterile products?
• Explain wet granulation and dry granulation and when each is used.
• Aseptic processing entails certain critical control parameters. Which of the following is NOT a critical control parameter?
• What is ICH Q1A(R2) and what does it cover?
• Direct compression can have uniformity problems.
• An angle of repose less than 25 degrees indicates good flowability.
• If 3.17 kg of a drug is used to make 50,000 tablets, how many milligrams will 30 tablets contain?
• Which method is typically used to sterilize heat-labile liquids?
• Mean Dissolution Time (MDT) is defined as which of the following?
• Which warfarin tablet strength comes in a blue tablet?
• Direct compression can be used for hyathymine sufate 1.25 mg.
• Polymorphism refers to the existence of multiple crystalline forms of a drug. What is the consequence?
• HLB value is a measure to categorize surfactants based on balance between hydrophilic and lipophilic properties.
• Which statement about co-solvents, surfactants, and solid dispersions is true?
• Preservatives are used in emulsions.
• What is buffer capacity and why is it important in parenteral formulations?
• HLB for oil in water emulsions
• What is the most important factor of any dosage form?
• What is the role of Avicel in a capsule formulation?
• An emulsion is best described as which of the following?
• Compare multiparticulate and single-unit controlled-release systems and list advantages of multiparticulates.
• Polymorph screening in early drug development serves to:
• What labeling is required for packaging suspensions?
• Direct compression is NOT suitable for which type of drug?
• Two well-known superdisintegrants are Acusol and Expotab.
• In the 1.255 kg powder with aspirin 6 parts, phenacetin 3 parts, and caffeine 1 part, how many grams of phenacetin are present?
• A 45-year-old mechanically ventilated patient receives propofol 200 mg/h in a 10 mg/mL formulation in a 10% lipid emulsion. How many calories per day does this provide?
• Dissolution testing is related to bioavailability because it measures what?
• Which factors influence selection of a salt form to improve solubility?
• Which of the following is NOT an advantage of hard gelatin capsules?
• Which of the following is NOT typically included in method validation criteria?
• Surfactants used to enhance dissolution can have which potential drawback?
• Elemental calcium makes up approximately what percentage of calcium carbonate by weight?
• An order initiates Propofol at 10 mcg/kg/min for a 180 lb patient using a 1000 mg/100 mL lipid emulsion. What is the rate in mL/hr?
• Which test measures how quickly a tablet disintegrates in a liquid?
• Which polymer provides a hydrophobic diffusion barrier in oral controlled-release matrices?
• Which statement about regulatory flexibility provided by operating within a design space is correct?
• Which statement correctly describes the relative sizes of No. 000 and No. 5 capsules?
• Which of the following is a sign of growth of microorganisms in emulsions?
• A 22 kg child is treated with amoxicillin 90 mg/kg/day in two divided doses for 5 days. What is the total amount of amoxicillin required for the course in grams?
• What excipient is commonly found in chewable tablets?
• Which of the following is a standard in vitro test for tablets that measures drug release over time?
• Content uniformity specification for tablets typically requires the active ingredient to lie within what range of the labeled value?
• Shelf-life is the period during which a DS and DP remains within the approved specifications, provided that it is stored under the approved conditions in the approved packaging.
• The Higuchi model applies under which conditions?
• Which of the following is not listed as a method to control suspensions in pharmaceutics?
• How many milligrams are present in 60 mL of a 5% w/v triamcinolone preparation?
• Which law is commonly used to predict the sedimentation rate of particles in a suspension?
• Waterproof sunscreen is a W/O emulsion because it is oil based.
• Stokes is the most important law for pharmaceutical suspensions.
• What is the moisture content in a soft gelatin capsule?
• In a single-punch tablet press, the shoe moves which of the following?
• Which statement about powder weight and compression in wet granulation is correct?
• Organoleptic properties of drugs are color, odor, taste.
• Which statement correctly differentiates content uniformity and dosage unit uniformity?
• What is an advantage of wet granulation?
• Effervescent tablets are composed of
• Which storage statement is correct after reconstitution?
• Which statement correctly contrasts BCS Class II and Class IV drugs regarding dissolution strategies?
• What does bioequivalence (BE) require for Cmax and AUC in typical oral BE studies?
• When designing a sterile injectable suspension, which set of considerations is most comprehensive?
• Which option best summarizes the definitions used in the FDA framework for new drugs?
• How can shelf-life (t90) be estimated from stability data collected at elevated temperatures?
• Explain the role of pH-dependent enteric coatings and the function of Eudragit polymers.
• How is F (bioavailability) calculated from AUC values and dose?
• For water-in-oil emulsions, a lower HLB value is typically suitable.
• CMC or acacia can be used in suspensions for external use.
• In a water-in-oil (W/O) emulsion, the continuous phase is oil.
• MDT provides a concise summary measure of dissolution performance; which statement best reflects this concept?
• Buccal tablets are placed under the tongue and are subject to first-pass metabolism.
• Larger sieve number, _______ the particle size
• Acrylic polymers (e.g., Eudragit) can form coatings with diffusion- or dissolution-controlled release. Which polymer is an example of this class?
• An amoxicillin 400 mg/5 mL suspension; a 4-year-old child requires amoxicillin 90 mg/kg/day in divided doses every 12 hours for 5 days. What bottle size should be dispensed?
• For slab geometry in Korsmeyer-Peppas, what does n ≈ 0.5 indicate?
• State Fick's first law and its role in transdermal drug delivery.
• An osmotic pump is best described as which type of controlled-release system?
• Soft gelatin capsules are flexible because they contain plasticizers.
• Which USP dissolution apparatus is used for tablets and granules?
• HLB stands for
• Which dissolution apparatus is best for poorly soluble or controlled-release forms?
• A suspension is composed of which of the following?
• The lower punch movement in a single-punch tablet press is which of the following?
• Why is isotonicity important in parenteral formulations and how is it achieved?
• Natural gums such as karaya and alginate modulate release via gel formation and swelling. Which natural gum is cited?
• What is the smallest standard size for human-use capsules?
• What is the role of disintegration and dissolution testing in tablet quality control?
• What is the total hydromorphone delivered in 24 hours when including both basal and on-demand boluses?
• Which HLB range is suitable for stabilizing oil-in-water emulsions?
• Magnesium stearate must be below what percentage in tablets and capsules?
• Which component is commonly used as a plasticizer to increase flexibility of soft gelatin capsule shells?
• Which capsule sizes are listed as used for veterinary use?
• Describe the concept of dissolution media selection and the role of sink conditions in dissolution testing.
• Friability testing is primarily associated with which dosage form?
• Medications are rarely just made up of the drugs alone, but require excipients.
• Which set of ICH guidelines supports a risk-based, science-led approach with regulatory flexibility within a defined design space?
• Which statement about isotonicity in injectable formulations is true?
• The shell of a soft gelatin capsule may be made more flexible by adding ______.
• What is the Higuchi release equation and when does it apply?
• What percentage by weight of the 1.255 kg powder is aspirin?
• Mean Dissolution Time (MDT) is defined as which of the following?
• A powder is prepared from a mixture with aspirin 6 parts, phenacetin 3 parts, and caffeine 1 part. If the total powder mass is 1.255 kg, how many grams of aspirin are required?
• A pharmacist adds grams of hydrocortisone to 150 g of a 2.5% hydrocortisone ointment. What is the amount of hydrocortisone present in the finished product in grams?
• Which statement about particle size distribution and dissolution is correct?
• When selecting preservatives for ophthalmic and topical formulations, which factors are considered?
• DP stands for Drug Product.
• What property is particularly important for drugs formulated in transdermal patches?
• Which statement best describes Level A IVIVC relative to Level B?
• How does pH influence dissolution and solubility of weak acids and bases?
• Sublingual and buccal routes bypass first-pass metabolism.
• How many milligrams of triamcinolone are required to prepare 60 mL of a 5% w/v preparation?
• What are the general steps involved in pharmaceutical stability testing under ICH guidelines?
• How does rheology influence the mouthfeel and release of semi-solid dosage forms?
• Which describes a monolithic matrix release system?
• Which of the following is a preformulation property to assess?
• Which is the standard size range for human-use capsules?
• IVIVC Level B correlation versus Level A correlation: which statement correctly differentiates their relationship to in vivo data?
• Which statement best describes the difference between ophthalmic solutions and ointments in terms of corneal penetration and residence time?
• If 5 on-demand bolus doses of 0.1 mg are given, how much hydromorphone is delivered via boluses in 24 hours?
• Which sterilization method is preferred for heat-sensitive items?
• Which dissolution apparatus is used for insoluble or highly permeable compounds and non-traditional dosage forms?
• Acusol and Expotab are examples of which type of excipients?
• What is zeta-potential?
• Aqueous coating is the most popular film type coating.
• Which statement best describes diffusion-controlled release (Higuchi) in polymer matrices?
• Which of the following is a purpose of preformulation studies?
• Amphiphilic characteristics are good for emulsifying suspensions.
• In the context of pharmaceutical standards, USP stands for which organization?
• Dry heat is preferred for which type of products?
• Which polymer forms swelling gels that slow diffusion in oral controlled-release matrices?
• An evaluation test used for tablets, not capsules?
• What is the combined mass (in grams) of the non-aspirin components (phenacetin and caffeine) in the 1.255 kg powder?
• Which of the following best defines thixotropy in semi-solid dosage forms?
• Which guidelines underpin Quality by Design (QbD) and design space concepts, and what is their regulatory significance?
• A patient takes 1 g of calcium carbonate salt three times daily. How much elemental calcium is provided in 24 hours?
• HLB for water in oil emulsions
• How many sizes exist for human-use capsules?
• Which of the following factors are involved in media selection for dissolution testing?
• What is the filled volume of a size 2 hard gelatin capsule?
• Describe osmotic pump mechanisms and how they achieve near-zero-order release.
• In Korsmeyer-Peppas, what does 0.5 < n < 1 indicate?
• Which is a strategy to improve solubility for BCS II/IV and its rationale?
• Which statement best describes how salt formation improves solubility and the role of pKa in selecting a salt form?
• Which of the following is a possible preformulation consideration to assess crystal forms?
• In a rotary tablet press, both upper and lower punches do what to the powder to form the tablet?
• Which statement is true about sieve size and particle size?
• What is the total hydromorphone delivered by the basal rate alone over 24 hours?
• Define design space in QbD and its significance for regulatory flexibility.
• From 3.17 kg used to make 50,000 tablets, the exact milligram strength per tablet is closest to which value?
• Dynamic Vapor Sorption (DVS) measures what?
• Stokes' law is most closely associated with which phenomenon in suspensions?
• DS stands for Drug Substance.