Ceutics case study practice questions exam 2

Question #11 In Tylenol® (Acetaminophen) tablets, magnesium stearate is used as: A.lubricant B.disintegrant C.colorant D.binder E.filler

A. lubricant

Question #3 Which of the following is the active ingredient of Methylin® (Methylphenidate HCl) Chewable IR tablets? A.Methylphenidate HCl B.Aspartame C.Microcrystalline Cellulose D.All of the Above

A. methylphenidate HCl

What is the main polymeric component of Mirena® (Levonorgestrel) IUD drug reservoir? A.Polydimethysiloxane B.Polyethylene C.Polylactide D.Polyglycolide

A. polydimethysiloxane

Ethyl parahydroxybenzoate sodium and Propyl parahydroxybenzoate sodium (parabens) are used in Lamprene® (Clofazimine) soft capsules as: A.Preservative agents B.Moistuizing agents C.Levigating agents D.Opacifying agents

A. preservative agents

Question #29 What is the role of sodium chloride in Concerta® (methylphenidate HCl) ER tablet? A.Film coating B.Osmotic agent C.Plasticizer D.Opacifier

B. osmotic agent

What is an advantage of Lamprene® (Clofazimine) dosage form (soft gelatin capsule)? I.Less expense to formulate II.Increased bioavailability III.Increased stability

all 3

Question #18 Aspartame (methyl ester of the aspartic acid/phenylalanine dipeptide, brand names such as NutraSweet® and Equal® is used in Singulair® (Monteluskat sodium) chewable tablets as: A.alternative sweetener B.alternative binder C.alternative diluent D.alternative lubricant

A. alternative sweetener

Question #10 What is the ingredient croscarmellose sodium used for in making Tylenol® (acetaminophen) tablets? A.Disintegrant B.Filler C.Solubilizer D.Coloring Agent

A. disintegrant

Question #17 Silicon dioxide is used in Nitrostat® (nitroglycerin) sublingual tablet as: A.glidant B.diluent C.disintegrant D.binder

A. glidant

Magnesium stearate is used in Depakote® (Divalproex sodium) hard capsule sprinkle as: A.lubricant B.binder C.filler D.disintegrant

A. lubricant

It is important to keep Prostin® E2 (Prostanglandin E2) vaginal suppository drug in the freezer at no higher than -20 degrees Celsius and warm it immediately to room temperature before its administration because: I.The API is thermally unstable II.Glycerides and Fatty acid are suppository bases that melt III.Glycerides and Fatty acid are suppository bases that are watersoluble

1 and 2

Question #19 Which of the following is an abuse deterrent agent in Oxecta® (Oxycodone HCl) abuse deterrent tablets? I.Oxycodone II.Polyethylene oxide III.Sodium lauryl sulfate

1 and 2

Which of the following statements about Silicone elastomers used for drug release rate control in Annovera® (Segesterone acetate/Etinyl estradiol) vaginal ring, is correct? I.They are biocompatible polymers II.They are nonbiodegradable polymers III.They are biodegradable polymers

1 and 2

Question #22 In the Fentora® (fentanyl citrate) buccal tablet formulation, citric acid is used: I.to mainly increase buccal pH II.to form API citrate salt to increase watersolubility III.to promote effervescence based on OraVescent® technology

2 and 3

Question #27 Spritam® (Levetiracetam) Rapidly Disintegrating Oral 3D printed Tablet disintegrate between 2 and 27 seconds, with the average tablet disintegrating in 11 seconds in the mouth when taken with a sip of liquid. This is due to: I.The manufacturing process using direct compression II.The high solubility of the API and inactive ingredient III.The manufacturing process using 3D printing

2 and 3

In tablet Tamifu® (Oseltamivir phosphate) tablet formulation, which of the following statement is NOT TRUE I.pregelatinized starch is used drug powder filler II.Gelatin is used as for capsule shell formation III.Both pregelatinized starch and gelatin are consitutent of the capsule shell

3

Question #20 How much of the 50 mg scored Purinethol® (mercaptopurine) scored tablets would you give to a poor metabolizer of Mercaptopurine, assuming that average patient would need 1 tablet. I.Half tablet II.One tablet III.Two tablets

3 two tablets

Question #7 Which two ingredients serve as both glidants and anti-adherent agents in Nucynta® (Tapentdol) tablets? A.talc and magnesium stearate B.polyethylene glycol and titanium dioxide C.microcrystalline cellulose and Lactose monohydrate D.croscarmellose sodium and providone (PVP)

A. talc and magnesium stearate

What purpose does Barium Sulfate ((BaSO4, contrast agent) have in the ParaGard T 380A Copper Intra Unterine Device (IUD)? I.Changes uterine environment to inhibit sperm survival. II.Aids in the viewing of the Paraguard T 380A IUD on X-ray scans. III.Composes T-frame of device and aids in detection/removal of the device.

All 3

Why is Metadate® CD (methylphenidate HCl) preferred over IR Formulations of Methylphenidate HCl? I.Higher adherence II.Once a day dosing instead of multiple dose per day III.Less fluctuation of plasma drug concentration

All 3

Question #6 Hypromellose 2208 is an ingredient in all Glucophage® (Metformin) XR tablets. If this ingredient was removed from the medication what can we expect to change in the therapeutic effect or manufacturing process of Glucophage XR? A.Product would stick to machinery when being manufactured, causing an array of issues. B.The release of Glucophage XR when taken would be less controlled and result in a quicker release of the drug, removing the extended release effects. C.Product may cake and will struggle to freely flow during manufacturing. D.No therapeutic or manufacturing effect will be noticed.

B.

Vaginal rings such as NuvaRing® (etonogestrel/ethinyl estradiol) should NOT be stored in a freezer, thus avoiding loss of the ring flexibility (e.g. cracking) and intended drug release kinetics due to? A. High glass transition temperature (Tg) of the main ethylene-vinyl acetate (EVA) rate controlling copolymer component. B. Low glass transition temperature (Tg) of the main ethylene-vinyl acetate (EVA) rate controlling copolymeric component. C. High melting temperature (Tm) of the main ethylene-vinyl acetate (EVA) rate controlling copolymer component. D. Low melting temperature (Tm) of the main ethylene-vinyl acetate (EVA) rate controlling copolymer component.

B.

In tablet Tamifu® (Oseltamivir phosphate) tablet formulation, Sodium stearyl fumarate is used as: A.alternative binder B.alternative lubricant C.alternative disintegrant D.alternative filler

B. alternative lubricant

Question #16 Acesulfame potassium (potassium salt of 6-methyl-1,2,3-oxathiazine-4(3H)-one 2,2-dioxide, acesulfame K or Ace K, a synthetic calorie-free sugar substitute often marketed under the trade names Sunett and Sweet One) is used in Suboxone® (buprenorphine/naloxone) sublingual films as: A.alternative binder B.alternative sweetener C.alternative diluent D.alternative colorant

B. alternative sweetner

What is the main role of the sugar spheres in Metadate® (Methylphenidate HCl) CD capsules? A.API B.Filler C.Disintegrant D.Solution binder

B. filler

Question #28 The COVERA-HS® (Verapamil hydrochloride) Extended Release Film Coated Tablet, Controlled Onset, drug release mechanism is: A)matrix dissolution B)osmotic pumping C)ion exchange D)matrix diffusion E)Ionic exchange

B. osmotic pumping

Question #13 Which of the following statement is NOT TRUE about the administration of Oravig® (Miconazole) buccal tablet A.Patients do not swallow the tablet B.Patients does swallow the tablet C.The tablet can be placed on upper gum D.Patients can eat and drink while tablet is on gum E.Tablets can be administered to unconscious patients

B. patients does swallow the tablet

Question #21 Which of the following is an advantage of the new Fentora® (fentanyl) buccal formulation? A.longer onset of action B.shorter onset of action C.increased drug excretion D.decreased transmucosal absorption

B. shorter onset of action

Question #12 What is the primary purpose of enteric coating of individual pellets within the Eryc® (Erythromycin) capsules? A.To improve taste B.To avoid inactivation by gastric acidity C.To release drug immediately in the mouth D.To delay drug release until the large intestine

B. to avoid inactivation by gastric acidity

A 15-year old patient with ADHD who had been stable on a dose of 10 mg BID (Bis in Die, Twice a day) Focalin® (Dimethylphenidate HCl) is transitioning to Focalin® XR 20 mg QD (Quaque Die, Once a day). After 2 weeks, he returns to the doctor complaining of distractedness during school, a jittery feeling in the morning an hour or two after taking his medication. When asked how he is taking his medication, he states that due to difficulty swallowing, he has been opening the capsules of Focalin XR and mixing them with chunky applesauce, which he chews before swallowing. Which of the following statement is CORRECT. A.The new dose of Focalin XR is too high and should be reduced. B.The patient is experiencing dose-dumping because he is opening the capsules. C.The patient is experiencing dose-dumping because he is chewing the capsules content with applesauce. D.The severity of the patient's ADHD has increased and he is suffering from a new onset anxiety disorder. E.The patient is experiencing dose dumping because the capsules contents are interacting with the applesauce.

C.

How should Canasa® (Mesalamine) rectal suppository containing fatty base be stored? A.Below 35°C and avoid direct heat, humidity and light B.Above 40°C and avoid direct heat, humidity and light C.Below 25°C and avoid direct heat, humidity and light D.Above 30°C and avoid direct heat, humidity and light.

C.

Which ingredient is responsible for the delayed release effect of Cardizem® (Diltiazem HCl) CD capsules? A.Diltiazem B.Talc C.Eudragit RL 30 D D.Simethicone emulsion, USP

C. Eudragit RL 30 D

Question #8 Which of the following is not a coating agent used for Rilutek® (Riluzone) film coated tablets? A.Hypromellose (HPMC) B.Polyethylene Glycol 6000 C.Hypromellose Phthalate (HPMCP) D.Titanium Dioxide

C. HPMCP

Cocoa butter used in Phenergan® (Promethazine HCl) rectal suppositories is a typical example of: A.base that dissolves B.base that is highly hydrophilic C.base that melts D.base that is inorganic

C. base that melts

Question #9 The ingredients "titanium dioxide" and "yellow ferric oxide" act as in the formulation of Avigan® (Favipiravir) film coated tablets. A.Surfactants B.Sweeteners C.Colorants D.Plasticizers

C. colorants

Which of the following ingredients is used as diluent in Vagifem® (estradiol) vaginal tablets? A.Hypromellose B.Estradiol C.Lactose monohydrate D.Dicalcium phosphate

C. lactose monohydrate

Ammonio methacrylate copolymer and Methacrylic acid copolymer are used in Focalin® (Dimethyphenidate HCl) XR Capsules as: A.enzyme sensitive polymers to ensure bi-modal drug release profile B.light sensitive polymers to bi-modal drug release profile C.pH sensitive polymers bi-modal drug release profile D.temperature sensitive polymers bi-modal drug release

C. pH sensitive polymers Bi-modal drug release profile

Question #30 In Oxycontin® (Oxycodone HCl) ER film coated tablet, the abuse deterrent agent (Polyethylene Oxide) has the following effect: A)agonist/antagonist B)prodrug effect C)physicochemical barrier effect D)aversion effect/unpleasant taste effect

C. physicochemical barrier effect

Which of the following is used as plasticizer in Norvir® (Ritonavir) soft capsules? A.Ritonavir B.Gelatin C.Polyoxyl 35 castor oil D.Titanium dioxide

C. polyoxyl 35 castor oil

What is the role of propylene glycol in Imvexxy® (estradiol) vaginal insert? A.)Plasticizer B.)Lubricant C.)Preservative D.)Suppository Base

C. preservative

Sesame oil (antioxidant/solubilizer) is used in the Marinol® (Dronabinol) soft capsules as: A.opacifier B.lubricant C.solubilizer D.Pigment

C. solubilizer

Which of the following describes proper storage techniques for Annovera® (Segesterone acetate/Etinyl estradiol) vaginal ring? A.Store in direct sunlight B.Store in a freezer or refrigerator C.Store at room temperature D.Store very high temperatures

C. store at room temperature

Question #26 Which of the following statement is NOT TRUE about ALBENZA® (Albendazol) tablets: A)It is taken orally and it comes in 200 mg tablets and 200 mg chewable tablets. B)The chewable tablets are for kids, whereas, the regular tablets are for patient over 60 kg. C)Patients will either take the regular tablet as a whole, crushed, or chewed with water and a meal. D)Children will take ALBENZA® 400 mg twice a day, while for adults it's 15 mg/kg/day.

D

What abuse deterrent formulation strategy was used in Embeda® (Morphine/Naltrexone) Capsules A.Physico/Chemical effect B.Aversion/Unpleasant effect C.Prodrug/Implant effect D.Agonist/Antagonist

D. agonist/antagonist

Question #12 Sucralose (Trichlorosucrose, Splenda brand name) and mannitol (Resectisol®, Osmitrol®) are used in Vyvanse® (Lisdexamfetamine dimesylate) chewable tablets as A.alternative diluents B.alternative lubricants C.alternative binders D.alternative sweeteners E.alternative disintegrants

D. alternative sweetners

Question #15 What are the advantages to using Suboxone® (buprenorphine/naloxone) sublingual films? A.They have increased bioavailability as compared to the SL tablets B.You can take a much lower dose when switching from SL tablets C.They help to deter abuse D.Both A and C are correct answers

D. both A and C are correct

Question #23 All of the following about Zubsolv (buprenorphine/naloxone) sublingual tablets are true EXCEPT: A.Zubsolv has better bioavailability than Suboxone B.The active ingredients are water soluble C.Buprenorphine and Naloxone do not affect each other during absorption or their pharmacokinetics D.Buprenorphine is a partial opioid antagonist of mu receptors E.Sublingual tablet

D. buprenorphine is a partial opioid antagonist of mu receptors

Focalin® (Dimethylphenidate HCl) XR Capsules are available in: A.one strength (5 mg) B.two strengths (5 and 40 mg) C.Four strengths (5, 10, 20 and 40 mg) D.Eight strengths (5 to 40 mg)

D. eight strengths

How is Cleocin® (Clindamycin phosphate) vaginal suppository formulated? A.Film coating method B.Wet granulation C.Hard gelatin capsule D.Fusion molding

D. fusion molding

Question #32 Coumadin® (Warfarin sodium) IR Tablets are FDA approved for: A.one strength only (10 mg) B.two strengths (1 mg, 10 mg) C.three strengths (1 mg, 6 mg, 10 mg) D.nine strengths (1 mg to 10 mg) E.eightheen strengths (1 mg to 10 mg)

D. nine strengths

How is NuvaRing® (etonogestrel/ethinyl estradiol) vaginal ring to be used? A)Worn around the wrist B)Only inserted into the vagina prior to intercourse C)Inserted into the vagina and left in for 21 days D)Once a day for 21 days

D. once a day for 21 days

Sorbitol is used in Sandimmune® (Cyclosporine) soft capsules as: A.main capsule shell material B.colorant C.opacifier D.plasticizer

D. plasticizer

Question #31 In Oxycontin® (Oxycodone HCl) ER film coated tablet, Polyethylene Glycol 400 (low molecular weight) is used: A.Main polymeric coating agent B.Tablet core diluent C.Tablet core lubricant D.Plasticizer/pore forming coating agent

D. plasticizer/pore forming coating agent

Question #14 Prevacid Solutab® (Lansoprazole) orally disintegrating (ODT) delayed release tablet was made possible mainly due to the incorporation of the following pH sensitive inactive ingredient: A.Mannitol B.Crospovidone C.Lactose D.Polyacrylate

D. polyacrylate

What purpose does hydrogenated palm oil serve in Anusol-HC® (Hydrocortisone acetate) suppository ? A. Viscosity agent B. Surfactant C. Levigating agent D. Suppository base

D. suppository base

What is a reason why rectal suppository formulation of an NSAID such as INDOCIN® (Indomethacin) would be preferred for a patient? A.Rectal suppositories offer less therapeutic response than other formulations B.Patient is unconscious C.Patient is alert, aware, and able to swallow pills or capsules D.Patient is experiencing nausea/vomiting E.Both B and D

E. both B and D

Question #25 In In CETYLEV® (Acetyl cysteine) effervescent tablets, the effervescence due to carbon dioxide generation is mainly due to the chemical interaction between sodium bicarbonate and A)sucralose B)maltodextrin C)edetate sodium D)peppermint E)lemon juice

E. lemon juice

Question #24 Croscarmellose sodium is used in Zubsolv® (buprenorphine/naloxone) sublingual tablets as: A)diluent B)lubricant C)binder D)sweetener E)superdisintegrant

E. superdisintegrant

Question #2 Which of the following is not an ingredient(s) in Motrin® (ibuprofen) film coated tablets: A.Maltose B.Lactose C.Croscarmellose sodium D.Colloidal silicon dioxide E.Hot Butter F.A and E G.B and C H.None of the Above

F. A and E

Question #4 Dicalcium Phosphate Anhydrous is used in DSUVIA®(sufentanyl) sublingual tablet as: A.binder B.disintegrant C.filler D.lubricant

c. filler

Question #5 Which flavoring is used in the Zofran® (Ondansetron HCl) ODT tablet? A.Mint B.Orange C.Strawberry D.Ghost Pepper E.Attack Helicopter

c. strawberry

Question #1 Starch is the main disintegrant ingredient in the Decadron® (Dexamethasone) IR tablet formulation. The primary purpose of starch is to: A.Promote particle aggregation/cohesion in liquid state B.Prevent sticking to die and punch C.Facilitate flow of granules from hopper D.Promote break down of particle aggregates

d. promote break down of particle aggregates