Ceutics exam 2
Sorbitol is used in Sandimmune® (Cyclosporine) soft capsules as: A. main capsule shell material B. colorant C. opacifier D. plasticizer
d
For each of the tablet processing problem listed below, SELECT/MATCH the most likely reason for the condition. A) Excessive moisture in the granulation B) Entrapment of air C) Tablet friability D) Degraded drug E) Tablet hardness
10-A. Picking 11-D. Mottling 12-B. Capping 13-A. Sticking
MATCH the lettered formulation design that best describes the mechanism of drug release from each of the following sustained-release drug delivery systems A) Encapsulated dissolution B) Ion-exchange C) Matrix diffusion D) Matrix dissolution E) Osmotic pumping
14-B. Drug is bound to a resin and released due to changes in pH 15-D. Drug is compressed into tablets with a slowly soluble polymer 16-C. Drug is compressed into tablets with an insoluble polymer 17-E. Drug is compressed into tablets with semipermeable membrane and a laser drilled hole through which drug is transported out by convective flow.
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
I and II
True statements, about the function of excipients used in tablet formulations include: I. binders promote granulation during the wet granulation process. II. glidants help to promote the flow of the tablet granulation during manufacture. III. lubricants help the patient to swallow the tablets.
I and II
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
I and II
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
II and III
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
II and III
The prime purpose for which of the following types of coating may be to mask the bitter taste of an orally administered drug? I. Enteric II. Film III. Sugar
II and III
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
II and III
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
III
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
III
gents that might be used to coat enteric-coated tablets include: I. hydroxypropyl methylcellulose (HPMC) II. carboxymethylcellulose (CMC) III. phthalate esters such as cellulose acetate (CAP) and polyacrylate copolymers
III
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
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
In Tylenol® (Acetaminophen) tablets, magnesium stearate is used as: A. lubricant B. disintegrant C. colorant D. binder E. filler
a
Magnesium stearate is used in Depakote® (Divalproex sodium) hard capsule sprinkle as: A. lubricant B. binder C. filler D. disintegrant
a
Silicon dioxide is used in Nitrostat® (nitroglycerin) sublingual tablet as: A. glidant B. diluent C. disintegrant D. binder
a
The shells of soft gelatin capsules may be made elastic or plastic-like by the addition of A) sorbitol B) povidone C) polyethylene glycol (PEG) D) lactose E) hydroxypropyl methylcellulose (HPMC)
a
What is the ingredient croscarmellose sodium used for in making Tylenol® (acetaminophen) tablets? A. Disintegrant B. Filler C. Solubilizer D. Coloring Agent
a
What is the main polymeric component of Mirena® (Levonorgestrel) IUD drug reservoir ? A. Polydimethysiloxane B. Polyethylene C. Polylactide D. Polyglycolide
a
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
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
Advantages to the manufacturer for tablet film coating when compared to sugar coating include: I. shorter production times II. less gross weight III. lower incidence in coat chipping
all
What is an advantage of Lamprene® (Clofazimine) dosage form (soft gelatin capsule)? I. Less expense to formulate II. Increased bioavailability III. Increased stability
all
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
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
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
Dose dumping is a problem in the formulation of A) compressed tablets B) modified-release drug products C) hard gelatin capsules D) soft gelatin capsules E) suppositories
b
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
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
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
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
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
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
What is the role of sodium chloride in Concerta® (methylphenidate HCl) ER tablet? A. Film coating B. Osmotic agent C. Plasticizer D. Opacifier
b
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
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
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
A pharmacist receives a prescription for 15 mg piroxicam capsules, qty. 48. A #1 capsule filled with piroxicam weighs 245 mg; a capsule filled with lactose weighs 180 mg. How much piroxicam and lactose are required for the prescription? Prepare sufficient powder for 50 capsules (2 extra). A. 15 mg piroxicam + 165 mg lactose B. 750 mg piroxicam + 9.00 g lactose C. 750 mg piroxicam + 8.45g lactose D. 15 mg piroxicam + 230 mg lactose E. None of the above
c
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
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
Dicalcium Phosphate Anhydrous is used in DSUVIA®(sufentanyl) sublingual tablet as: A. binder B. disintegrant C. filler D. lubricant
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
If the API of 125 mg tablet decays by zero-order kinetics with a reaction rate constant kinetic of 0.5 mg per hour, what is the amount of intact drug remaining after 3 days (72 hours)? A. 0.89 mg B. 8.9 mg C. 89 mg D. 890 mg
c
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
Sesame oil (antioxidant/solubilizer) is used in the Marinol® (Dronabinol) soft capsules as: A. opacifier B. lubricant C. solubilizer D. Pigment
c
The United States Pharmacopeia (USP) content uniformity test for tablets is used to ensure which of the following qualities? A) Bioequivalency B) Dissolution C) Potency D) Purity E) Toxicity
c
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
United States Pharmacopeia (USP) tests for ensuring the quality of drug products in tablet form include all of the following EXCEPT. A) disintegration B) dissolution C) hardness and friability D) content uniformity E) weight variation
c
What is the role of propylene glycol in Imvexxy® (estradiol) vaginal insert? A.) Plasticizer B.) Lubricant C.) Preservative D.) Suppository Base
c
Which flavoring is used in the Zofran® (Ondansetron HCl) ODT tablet? A. Mint B. Orange C. Strawberry D. Ghost Pepper E. Attack Helicopter
c
Which ingredient is responsible for the delayed release effect of Cardizem® (Diltiazem HCl) CD capsules? A. Diltiazem 15 B. Talc C. Eudragit RL 30 D D. Simethicone emulsion, USP
c
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
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
Which of the following is NOT a function of the lubricant in a tablet formulation? A) Improving flow properties of granules B) Reducing powder adhesion onto the dies and punches C) Improving tablet wetting in the stomach D) Reducing punch and die wear E) Facilitating tablet ejection from the die
c
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
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
he rectal route of administration of drug may be preferred over the oral route for some systemic-action because A) the drug does not have to be absorbed B) absorption is predictable and complete C) a portion of the absorbed drug does not pass through the liver before entering the systemic circulation D) inert binders, diluents, and excipients cannot interfere with absorption E) the dissolution process is avoided.
c
A satisfactory suppository base must meet all of the following criteria EXCEPT A) it should have a narrow melting range B) it should be nonirritating and nonsensitizing C) it should dissolve or disintegrate rapidly in the body cavity D) it should melt below 30 degrees C E) it should be inert
d
A sweetener that is widely employed in chewable tablet formulas is A) aspartame B) glucose C) lactose D) mannitol E) sucrose
d
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
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
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
How is Cleocin® (Clindamycin phosphate) vaginal suppository formulated? A. Film coating method B. Wet granulation C. Hard gelatin capsule D. Fusion molding
d
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
If a bottle of tablets has an expiration date of "Dec 2022", the pharmacist may continue to dispense the product A) up to 1 year after the expiration date B) only through January 31, 2022 C) only through December 15, 2022 D) only through December 31, 2022 E) if the pharmacist informs the patient to discard unused tablets in 6 months
d
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
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
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
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
The respective amount of zinc oxide and cocoa butter required to make these 12 suppositories is: A) ZnO: 0.36 grams Cocoa butter: 2.3 grams B) ZnO: 3.6 grams Cocoa butter: 2.3 grams C) ZnO: 0.36 grams Cocoa butter: 23 grams D) ZnO: 3.6 grams Cocoa butter: 23 grams E) ZnO: 3.6 grams Cocoa butter: 24 grams
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
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
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
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
Which one of the following statements concerning tablet dissolution is NOT true? A) Disintegration precedes dissolution B) In vivo disintegration is usually a good predictor of dissolution C) Changing a drug's crystalline state may change dissolution rates D) Increasing tablet compression force will increase dissolution E) Micronization of drug powder will decrease dissolution time
d
Croscarmellose sodium is used in Zubsolv® (buprenorphine/naloxone) sublingual tablets as: A) diluent B) lubricant C) binder D) sweetener E) superdisintegrant
e
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
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
Which of the following capsules sizes has the largest capacity? A) 5 B) 4 C) 1 D) 0 E) 000
e
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
Most commercial vaginal suppositories use a base of A) Beewax B) Cocoa butter C) Glycerin D) glycerinated gelatin A) Polyethylene glycols
polyethylene glycols