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Pharmaceutics II > Exam 4 > Flashcards

Exam 4 Flashcards

1
Q

sticky mixture, secretions of the sebaceous and sweat glands (ear canal is skin), hydrophobic protective covering, components (shed skin cells with keratin, sebum –> long chain fatty acids both saturated and unsaturated/alcohols/squalene/cholesterol)

A

ear wax, cerumen

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2
Q

why are ear infections common in children?

A

still developing immune system, small eustachian tube

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3
Q

allows drainage of fluid from middle ear, maintains middle ear pressure, most of the time it’s in a collapsed/closed form which prevents bacteria from entering middle ear, ear infection common after sore throat/cold

A

eustachian tube

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4
Q

poor systemic absorption from the ear canal because covered with skin, low surface area, and cerumen barrier, middle/inner ear are inaccessible using topical delivery (tympanic membrane impermeable unless perforated or damaged or tympanostomy tube AKA grommet)

A

drug delivery to ears

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5
Q

solution/suspension/oil solution, most are sterile, preserved because multidose, isotonic because ear is sensitive/easily infected/protect eardrum/relatively enclosed environment, capacity is 4 drops in adults/2-3 in children

A

otic formulations

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6
Q

lack of sufficient contact time (hard to keep product in ear canal), cerumen (semisolid, sticky, solid mass, poor diffusion), eardrum (impermeable barrier), poor drug absorption through the skin, small surface area for absorption, less blood supply to skin

A

challenges in otic delivery

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7
Q

increase viscosity (formulation strategy), inserting cotton wick into the ear canal and saturating the cotton periodically with medication (topical application technique), patient counseling (keep head in horizontal/lie down position, clean the ear canal by removing ear wax)

A

strategies to improve otic delivery

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8
Q

occurs when ear is unable to clear cerumen due to an overproduction/narrow convoluted canal/inappropriate ear cleaning, symptoms include mild earache or pain/discomfort, tinnitus or ringing in the ear, ear fullness/plugged feeling, dizziness/vertigo, reduced or loss of hearing, treatment includes physical removal following cerumen softeners (flushing, suction, glycerin, baby oil, mineral oil) or cerumenolytic agent (carbamide peroxide)

A

cerumen impaction

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9
Q

cerumenolytic agent, contains hydrogen peroxide (in presence of catalase releases water and O2 creating an effervescent foam to soften the cerumen) and urea (antiseptic and also assists in softening the wax), dispensed with droppers and bulb, examples are Clearcanal Ear Wax Softener, Clinere Ear Wax Removal Kit, GoodSense Ear Wax Removal, FT Ear Wax Removal Kit

A

carbamide peroxide (6.5%) otic solution

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10
Q

inflammation/infection of the outer ear, can be treated with otic corticosteroids (hydrocortisone, dexamethasone, fluocinolone acetonide), otic antibiotics (ciprofloxacin, polymyxin B, neomycin, ofloxacin, colistin), combination of antibiotics and steroids, 2% acetic acid with or without HC as an anti-infective

A

otitis externa/swimmer’s ear

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11
Q

Acetasol HC (acetic acid, propylene glycol, hydrocortisone) otic solution, acetic acid otic solution, Cetraxal (ciprofloxacin) otic solution, ofloxacin otic solution, neomycin sulfate/polymyxin B/hydrocortisone otic solution or suspension, Cortisporin-TC (neomycin, colistin, hydrocortisone, thonzonium bromide - surfactant) otic suspension, Cipro HC (ciprofloxacin and hydrocortisone), ciprofloxacin and dexamethasone otic suspension

A

otic products for otitis externa/swimmer’s ear

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12
Q

otic antibiotic/corticosteroid, neomycin sulfate (interferes with bacterial protein synthesis, aminoglycoside antibiotic, ototoxic), colistin sulfate (disrupts bacterial cell membrane, colistimethate, polypeptide antibiotic), hydrocortisone acetate (decreases inflammation), thonzonium bromide (surface active agent that promotes tissue contact by dispersion and penetration of the cellular debris and exudate, now considered and active ingredient)

A

Cortisporin-TC otic suspension

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13
Q

during the early stages of otitis externa/swimmer’s ear water clogs in the ear canal leading to maceration and infection, clogging could be due to excessive cerumen or narrow/convoluted ear canal, otic products contain excipients that help to drain and dry the ear such as_______, _________, _________, and ________

A

propylene glycol, isopropyl alcohol, glycerin, boric acid (all are ear drying products)

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14
Q

otic corticosteroid (ear drops) for the treatment of chronic eczematous external otitis, 5 drops in affected ear(s) twice daily for 7-14 days, blend of oils (isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, fragrances, refined peanut oil - risk for allergic reactions)

A

fluocinolone acetonide otic oil (DermOtic, Flac)

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15
Q

foam that stays within ear, provide better contact and extend drug release, provide metered dose, in clinical trials - no approved products yet

A

otic foam

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16
Q

infection in the middle ear, common in childhood, possible causes of infection (blockage of eustachian tube, respiratory infection, damaged/ruptured eardrum), symptoms (pain, fever, inflammation), cannot be treated topically (systemic treatment/oral antibiotics, treatment via tympanostomy tube - for recurrent ear infections fluid buildup in middle ear leading to hearing loss)

A

otitis media

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17
Q

steroid injection for sudden hearing loss (Meniere’s disease), fluid collects in inner ear and the pressure damages some delicate structure in the inner ear which affects both hearing and balance leading to severe vertigo), injection through tympanic membrane provides local and high concentrations of the drug into the middle ear, after injection keep the ear turned up, don’t frequently swallow, don’t pop the ears, don’t yawn, don’t blow nose

A

intratympanic injection

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18
Q

incision into the tympanic membrane for draining middle ear effusions (pressure equalization tubes), offers disease-free time and improved hearing, limitations (highly invasive, otorrhea which is discharge from the external ear, persistent perforation of tympanic membrane)

A

tympanostomy tube (grommet), myringotomy is the incision

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19
Q

acute otitis media treatment, Otovel (ciprofloxacin and fluocinolone otic solution), Ofloxacin otic solution, ciprofloxacin and dexamethasone otic suspension, gently pump the tragus to facilitate penetration of medication into the middle ear

A

intratympanic administration through tympanostomy tubes/grommet

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20
Q

many antibiotics have the potential to do this (aminoglycosides, macrolides, salicylates, chemotherapeutic agents, loop diuretics, antimalarials), damage to cochlear hair cells, hearing loss/tinnitus, low incidence of this with topical otic products unless there is damaged perforated eardrum, tympanostomy tube, excessive skin abrasion

A

ototoxicity

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21
Q

no blood supply to the ______ of the skin

A

epidermis

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22
Q

most difficult epidermal barrier for drugs to cross, brick and mortar model, composed of corneocytes (keratin and water, barrier for lipophilic drugs) and intracellular lipids (barrier for hydrophilic drugs, holds cells together, keeps skin elastic and pliable)

A

stratum corneum

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23
Q

ways drugs can be delivered through the skin (passive diffusion) and which does most of the drug absorption occur?

A

through the hair follicular duct, sweat glands, and epidermis –> epidermis is where most of the drug absorption takes place because large surface area

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24
Q

skin produces less oil and/or abnormal water loss from stratum corneum (could be due to low humidity that is weather related, improper formation of lipids due to aging or eczema, excessive removal of lipids due to exposure to solvent or soap, corneocyte shrink due to skin injury or infection), more difficult for drug absorption and penetration when this occurs

A

dry skin

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25
Q

prevent the loss of water –> types of this (occlusive which cover the skin to prevent water loss, emollient which add oil to the lipid layer which also prevents the evaporation of water, humectant which penetrates the stratum corneum and keeps the moisture to reduce water loss), add moisture to the epidermis –> types of this (water containing products that can hydrate the skin, creams), hydrated skin increases drug absorption and penetration

A

skin moisturizers

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26
Q

example of water soluble base for ointments

A

polyethylene glycols (PEGs)

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27
Q

example of oleaginous base for ointments

A

hydrocarbons/oils

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28
Q

examples of anhydrous base for ointments

A

hydrocarbons and surfactant (HLB < 6)

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29
Q

examples of w/o emulsion base for ointments

A

hydrocarbons and water (less than 45% w/w) and surfactant (HLB < 6)

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30
Q

examples of o/w emulsion base for ointments

A

hydrocarbons and water (greater than 45% w/w) and surfactant (HLB > 8)

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31
Q

ability to form an impermeable barrier to moisture (occlusiveness), ability to soften skin and make it pliable (emolliency), greaseless and easily rinsed off with water without the use of soap (water rinsability and washability), ability to spread readily on the skin (spreadability), no irritation to the skin

A

properties of ointment bases

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32
Q

chemical stability of the drug (is the drug stable in the base or in presence of water?), what is suitable base for a drug/patient/clinical condition (irritation, occlusiveness, emolliency), is the drug dissolved or suspended in the base (rate of release, drug penetration, grittiness)

A

formulation of dermatologicals

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33
Q

what type of base should be used for dry skin?

A

occlusive and emollient base

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34
Q

what type of base should be used for wet skin?

A

non-occlusive base, absorption base is preferred if there is exudate

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35
Q

apply product only to indicated area, do not apply to large surface area (larger area means more penetration), do not apply to damaged skin, do not occlude skin unless indicated, avoid excess rubbing and heating of the area, stop using if skin gets irritated, wash hands after application and avoid touching other body parts before washing hands

A

how to minimize systemic adverse effects of dermal products

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36
Q

gentamicin, mupirocin, retapamulin, silver sulfadiazine, metronidazole, mafenide

A

topical antibiotics for dermatologic infections, impetigo, burns

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37
Q

nystatin, ciclopirox, luliconazole, clotrimazole, econazole, ketoconazole, naftifine, oxiconazole, sertaconazole, sulconazole

A

topical antifungal agents for tinea, candidiasis, dandruff

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38
Q

acyclovir, penciclovir, docosanol

A

topical antivirals for herpes, HSV cold sores, genital herpes

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39
Q

triamcinolone, clocortolone, fluocinolone, alclometasone, betamethasone, desoximetasone, fluticasone, hydrocortisone, mometasone, diflorasone, amcinonide, fluocinonide, halcinonide, desonide, clobetasol, halobetasol

A

topical corticosteroids for inflammation

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40
Q

retinoic acid derivatives (adapalene, tretinoin, tazarotene, trifarotene), azelaic acid and benzoyl peroxide, combination with antibiotics (clindamycin, adapalene, benzoyl peroxide)

A

dermatological products for acne and rosacea

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41
Q

tacrolimus, sirolimus, pimecrolimus

A

dermatological products that are immune system modifiers/immunosuppressants for dermatitis, psoriasis, eczema, vitiligo

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42
Q

ruxolitinib (Opzelura)

A

janus kinase inhibitor (JAKs) for vitiligo

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43
Q

calcitriol, calcipotriene

A

Vitamin D analogs for plaque psoriasis

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44
Q

soften and exfoliate the horny layer of the epidermis, acne, seborrheic dermatitis, dandruff, warts (genital or perianal), anthralin, salicylic acid, cantharidin, podophyllum, resin, podofilox, sinecatechins, urea

A

keratolytics

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45
Q

head lice, scabicide agents, ivermectin, permethrin, malathion, pyrethrins and piperonyl butoxide, spinosad, lindane

A

topical antiparasitic agents, pediculicides

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46
Q

fluorouracil, ruxolitinib (vitiligo also), imiquimod (genital warts also), actinic keratosis, carcinoma

A

antineoplastic agents

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47
Q

Tapinarof (Vtama), plaque psoriasis

A

AhR (aryl hydrocarbon receptor) agonist

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48
Q

ointments, creams, pastes, gels, aerosol foams

A

semisolid dermatological products

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49
Q

lotions, oils, shampoos, solutions, suspensions, sprays

A

liquid dermatological products

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50
Q

powders (dusting powders), sponges, swabs, topical systems (patches), tapes

A

solid dermatological products

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51
Q

used for skin treatment due to its moisturizing properties, w/o cream that contains mineral oil, white wax and cetyl ester wax (emulsifying agent sodium salts of free fatty acids from waxes), sodium borate (preservative is boric acid –> reaction in free fatty acid to create boric acid from sodium borate), water

A

cold cream

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52
Q

which is preferred for the face, Zovirax cream or ointment?

A

cream

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53
Q

which is preferred for genital area, Zovirax cream or ointment?

A

ointment

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54
Q

for the treatment of recurrent herpes labialis, cold sores, fever blisters, excipients are white petrolatum, cetostearyl alcohol, mineral oil, poloxamer (surfactant), propylene glycol, sodium lauryl sulfate (surfactant, water washable), water, and buffer

A

Zovirax (acyclovir) cream and ointment, Xerese (acyclovir and hydrocortisone) cream

55
Q

OTC, saturated fatty alcohol, used traditionally as an emollient, emulsifier, and thickener in cosmetics, antiviral activity, treat cold sores/fever blisters on the face or lips, shorten the duration of symptoms like tingling/pain/itching/burning, penetrate deep and block the virus replication

A

Abreva (docosanol) cream

56
Q

topical treatment of acne and rosacea

A

clindamycin and benzoyl peroxide gel (Acanya, Neuac, Onexton)

57
Q

treatment of acne vulgaris, excipients are diethylene glycol monoethyl ether (polar solvent), methylparaben (preservative), acrylamide copolymer and water (determine that this is a gel), isohexadecane (hydrocarbon and texture enhancer), polysorbate 80 (wetting agent)

A

Aczone (dapsone) gel

58
Q

combination therapy (vitamin D analog and corticosteroid) for the topical treatment of plaque psoriasis, propellant is dimethyl ether and butane

A

Enstilar (calcipotriene and betamethasone) topical foam

59
Q

for treatment of acne vulgaris and rosacea, dosage forms are foam, gel, lotion, pledget/swab, solution

A

clindamycin topical –> Clindacin (foam), Clindagel (gel) Cleocin T (lotion), Clindacin ETZ or Clindacin-P (pledget/swab), solution is generic

60
Q

which clindamycin topical product has the following excipients: isopropyl alcohol, propylene glycol, purified water

A

solution (generic)

61
Q

which clindamycin topical product has the following excipients: allantoin, carbomer 934P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, purified water

A

gel (Clindagel)

62
Q

which clindamycin topical product has the following excipients: cetostearyl alcohol, glycerin, glyceryl stearate SE, isostearyl alcohol, methylparaben, sodium lauryl sarcosine, stearic acid, purified water

A

lotion (Cleocin-T)

63
Q

which clindamycin topical product has the following excipients: cetyl alcohol, ethanol, polysorbate 60, propylene glycol, stearyl alcohol, propane, butane, purified water

A

foam (Clindacin)

64
Q

body oil, scalp oil, blend of oils that contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF, fragrances

A

Derma-Smoothe FS (fluocinolone acetonide) external body/scalp oil

65
Q

for treatment of dandruff, scalp psoriasis, scalp seborrheic dermatitis, Anti-Dandruff (selenium sulfide), Clobex/Clodan (clobetasol propionate), Ciclopirox, Ketoconazole

A

shampoos

66
Q

for fungal infections (cutaneous and mucocutaneous), dusting powder

A

nystatin (Klayesta, Nyamyc, Nystop) external powder

67
Q

PRE-OP (hexachlorophene, topical antibiotic used for surgical scrub and as bacteriostatic skin cleanser), Bioscrub (chlorhexidine gluconate, topical surgical scrub), Duraprep (iodine povacrylex, isopropyl alcohol), E-Z Scrub (povidone-iodine)

A

sponges

68
Q

apply medication or absorb discharges, Clindacin ETZ/Clindamycin-P for treatment of acne vulgaris, Ery (erythromycin for treatment of acne vulgaris), Chlorhexidine gluconate (topical antiseptic)

A

swabs/pledgets/pads

69
Q

Licart (diclofenac epolamine, for local analgesia for minor strains/sprains, local plasma concentration), Qutenza (capsaicin, for neuropathic pain associated with postherpetic neuralgia/PHN, shingles, diabetic neuropathic pain), if necessary clip the hair around the treatment area but do not shave, TOPICAL not transdermal

A

patches

70
Q

substances that control oozing/discharge/bleeding, calamine lotion/suspension, aluminum acetate cream/packet (powder)/solution, witch hazel liquid or pad for hemorrhoids or anorectal pain, used for weeping wounds, minor skin irritations, insect bites, minor rashes, coagulates proteins (protein precipitate acts as protective coat and allows new cells to grow underneath)

A

astringents

71
Q

cells filled with hard keratin much thicker than stratum corneum, impermeable to topical drugs (onychomycosis or nail fungus, infections of the nail plate), difficulty in retaining formulations here (ointments, creams, gels, polish or lacquer provides better efficacy), occlusive covering helps penetration (like covering with a bandage), system therapy if topical not working like oral or parenteral

A

nails

72
Q

which is faster transcellular route or intercellular route and why?

A

intercellular because the drug only has to undergo diffusion, not diffusion and partition (don’t worry about partition because not going from oil to water or vice versa since not entering cells)

73
Q

which formulation wants to enter cells since it is water soluble and is used in buccal and parenteral formulations, fentanyl or fentanyl citrate?

A

fentanyl citrate

74
Q

which formulation doesn’t want to go into cells/takes intercellular route since it is lipophilic and is used in TD patches, fentanyl or fentanyl citrate?

A

fentanyl

75
Q

drug properties (lipophilicity, ionization, size of molecule, dose/potency, non-irritating), dosage form properties (release rate, surface area/size of dosage form, drug concentration in the system), skin/stratum corneum properties (thickness, perfusion to dermis, skin hydration, temperature, massage, occlusion)

A

factors affecting drug absorption through the skin

76
Q
  • semisolids (ointments/gels) and liquids (solution) –> difficult to maintain dose uniformity because not unit dosage forms
  • patches/films (transdermal therapeutic system TTS) –> control the drug release accurately, drug reservoir system with or without membrane, easy to use
  • device and novel forms/systems –> iontophoresis, phonophoresis, microneedles
A

transdermal dosage forms

77
Q

type of patch where membrane controls drug release and absorption, suitable for fast-penetrating and potent drugs

A

membrane-type patch

78
Q

type of patch that has no membrane, stratum corneum controls the absorption rate giving the skin the responsibility to control absorption, for slow-penetrating drugs

A

matrix patch

79
Q

type of patch that has multiple drug layers, multiphasic delivery is possible (loading and maintenance doses)

A

matrix-membrane combination patch

80
Q

flexible film/laminate that is polymer based, protects the patch, prevents transfer of drug to others, provides occlusive property, serves as product identification, can provide a cosmetic nature, caution because some patches contain metallic components (aluminum, Catapres-TTS)

A

patch backing layer

81
Q

keep the patch securely attached to skin, Bioclusive or Tegaderm, transparent/breathable/flexible/adhesive film dressing, need to consider drug being delivered, duration of wear and skin sensitivity, examples that can use this are Fentanyl Transdermal Patch, Butrans (buprenorphine) transdermal patch

A

adhesive dressings

82
Q

controlled release, lag time between application to skin and appearance of drug in the blood that depends on release from this/penetration of the drug/diffusion through the stratum corneum, not suitable for acute/emergency situations, skin acts as drug-reservoir leading to accumulation of the drug in stratum corneum, drug persists in the body/blood after removed

A

pharmacokinetics of transdermal delivery systems

83
Q

used for prevention of angina, not for acute angina, apply once a day for 12-14 hours and then remove, apply patch around same time each day, zero order drug delivery

A

Nitro-Dur (nitroglycerin) transdermal 24 hour patch

84
Q

antihypertensive alpha 2 adrenergic agonist, free base of drug, controlled release once a week (0.1mg/day/week), therapeutic level is reached after 2-3 days (that’s the lag time), after removal therapeutic levels maintained for 8 hours, half life of oral tablets is 12 hours so BID dosing so this is a significant advantage for patient compliance

A

Catapres-TTS (clonidine)

85
Q

absorption varies from site to site so stick to manufacturer’s specified sites because of skin thickness variation, recommended locations are based on convenience/product design/penetration, large patient to patient variability in stratum corneum due to age/gender/environmental conditions/skin disease if any, firm and complete contact with skin (clean/wash the site with water and no soap because possible irritation and removal of skin fat, remove large hairs but don’t shave, adhesive dressing could be used), rotate the sites of application (possible irritation and lag time issue), if patch removal is difficult an oil based product like petroleum jelly or olive oil may be applied to edges to aid removal

A

transdermal drug systems site of application information

86
Q

where is Transderm-Scop (scopolamine) patch applied?

A

behind the ear

87
Q

where is Butrans (buprenorphine) patch applied?

A

upper arm, chest, back

88
Q

where is Daytrana (methylphenidate) patch applied?

A

hip area avoiding the waistline

89
Q

where is Xulane (ethinyl estradiol and norelgestromin) patch applied?

A

buttock, lower abdomen

90
Q

suited for extender release, non-invasive, avoids the risks and inconveniences of parenteral therapy, alternative option to oral drug delivery for patients unable to take oral meds/to avoid first pass metabolism/GI tract problems like nausea and vomiting, easily identified/removed if dose termination is required (rapid termination but blood level may persist for a while)

A

advantages of TDS

91
Q

few drugs penetrate stratum corneum sufficiently (mostly suitable for lipophilic/potent drugs), many drugs and excipients can irritate the skin (patient acceptance could be a problem, irritation may change nature of stratum corneum and therefore absorption), therapeutic blood level attained slowly (lag time, not suitable for acute effect)

A

limitations of TDS

92
Q
  • apply only to clean, dry, non-irritated skin
  • use only recommended sites of application
  • remove the protective liner just before use
  • press the patch firmly to the skin
  • rotate sites of application as recommended and watch for skin irritation (report if any)
  • avoid applying on skin where friction is likely
  • dispose securely and properly because lots of drug remaining in patch
  • wash hands after application
  • be aware of swimming, showering, or engaging in vigorous activity
  • avoid heating the site of application
  • advise what to do if edges of patch peel away or patch does not stick well
  • discuss need to take an intermediate dose at beginning if necessary
A

patient counseling on TDS

93
Q

gels and ointments for systemic applications, nitroglycerin ointment (Nitro-Bid), testosterone gel (AndroGel, Fortesta, Testim, Vogelxo, Vogelxo Pump), estradiol gel (Divigel, Estrogel), Gelnique (oxybutynin chloride gel for overactive bladder), applied with suitable applicators (measuring device), cost effective and suitable for patients with allergic reactions to alternative, suitable to titrate the dose for personalized therapy

A

transdermal semisolid dosage forms

94
Q

solution for actuation/sprays, Evamist (estradiol), testosterone solution

A

transdermal solutions

95
Q

temporarily alter the nature of stratum corneum, provide moisture, loosen and delaminate stratum corneum, examples are ethanol, dimethyl sulfoxide, urea, oleic acid, propylene glycol

A

penetration enhancers

96
Q

ultrasound pulses through a probe into the skin to enhance drug delivery, fluidize the lipid barrier (cavitation force), commonly used in physical therapy/chiropractic, topical steroids for deep local action

A

phonophoresis/sonophoresis

97
Q

driven by electric field, useful for ionizable molecules, hair follicles and sweat ducts, provide deeper local action or systemic effect, Ionsys (fentanyl) Iontophoretic Transdermal System (discontinued), decrease the patient to patient variability because stratum corneum is not rate limiting step, as needed delivery that is patient controlled, eliminates the problem of a long lag time, has no accumulation of drug in stratum corneum, delivery programs can be preprogrammed for dose adjustment

A

iontophoresis

98
Q

painless injection, delivery of large molecules, no lag, no persistence, questions about safety because may increase susceptibility to infections, design (this followed by drug reservoir or this coated with drug/integrated)

A

microneedles

99
Q

prohibited the interstate commerce in adulterated and misbranded food and drugs, established FDA to regulate food and drug

A

Pure Food and Drug Act

100
Q

all marketed drug products must be safe and pure as of stated strength, companies are required to submit a new drug application (NDA)

A

Federal Food, Drug, and Cosmetic Act

101
Q

all marketed products must be safe and effective, required to conduct clinical trials, phases 1/2/3

A

Kefauver-Harris Amendments to Food Drug and Cosmetic Act

102
Q

created an abbreviated mechanism for approval of generic copies of all drugs approved after 1962 by stating that preclinical trials and clinical testing does not have to be repeated for generics (ANDA), gave companies greater access to market for generic prescription drugs and innovator companies’ greater patent life

A

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)

103
Q

created an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA licensed reference biological product, part of Affordable Care Act

A

Biologics Price Competition and Innovation Act

104
Q
  • drug products that are identical or comparable to brand name products in terms of drug substance (active ingredient), dosage form, strength, route of administration, quality, performance characteristics, intended use
  • work the same as brand name medications, must meet high standards to receive FDA approval, approved medications are generally sold only after patents and exclusivities protecting brand name version end, COST less than brand names (whole point of them!)
A

generic drug products

105
Q

cost saving therapeutic alternatives that reduce costs, increase drug use, and prevent drug shortages, there for social and economic justifications not therapeutic justification, may not be appropriate for all drugs (hormones because of personalized dose, drug with critical dose and narrow therapeutic ratio)

A

generic substitution

106
Q

generic must be therapeutically equivalent (TE), meet the same requirements for identity/strength/purity/quality (pharmaceutically equivalent PE), be manufactured under the same strict standards of FDA’s good manufacturing practice regulations required for brand products

A

have to meet this to have FDA approval

107
Q

what is the FDA’s bioequivalence range?

A

80-125%

108
Q

Cmax, tmax, and AUC are part of this type of equivalence, compares the rate and extent of absorption between products

A

bioequivalence (BE)

109
Q

list of approved drug products with TE evaluations that is approved based on safety and efficacy from an NDA or ANDA, helps to identify multi-source products (products that are available in more than one TE product), helps to determine products that are TE to each other (TE codes –> A__ is yes, B___ is no), assists the generic company in identifying reference products (RLD and RS)

A

FDA’s Orange Book

110
Q

RS or RLD is given for in vivo bioequivalence studies

A

RS

111
Q

multi-source drug products with two or more reference listed drugs coded how?

A

AB1, AB2, AB3….

112
Q

what code means that two products are TE and passed a bioequivalence test and we can assume the two products are equally safe and effective?

A

AB

113
Q

substitution of drug products that contain different chemical entities but should produce similar treatment effects/same pharmacological action, example is celecoxib for ibuprofen or fentanyl for morphine

A

therapeutic substitution

114
Q

products that are NOT PE, for example same API but different routes of administration/dosage forms/strengths/salts, NOT compared for TE so generic products cannot submit ANDA for these products and are not part of generic substitution

A

pharmaceutical alternatives

115
Q

one small PK study, less than 30 normal healthy adults that are volunteers, single dose (two treatment crossover study design), collect data of [plasma drug] at various times, AUC, Cmax, test results should be within the 80-125%, if yes than products are PE, BE, TE and get an AB code

A

human PK trial

116
Q

blood levels may not be seen/relevant, need to assess local bioavailability of the test (generic) to the reference (brand), drug release, clinical therapeutic effect, case by case basis

A

BE of topical products

117
Q

granted for Class I (high solubility high permeability) immediate release oral drug products because no anticipated absorption problems, human PK study not required, generic manufacturers can do an in vitro dissolution study to compare their product to reference/brand (if both are similar in vitro dissolution profiles then they are BE and get an AB code, some don’t need either PK or dissolution study –> Class I solutions - liquid dosage form - using similar solvents, products are PE, drug is already dissolved, solvents are similar, test and reference assumed to be BE)

A

FDA waivers

118
Q

products in conventional dosage forms not presenting BE problems code

A

AA

119
Q

injectable aqueous solutions and in certain situations intravenous non-aqueous code

A

AP

120
Q

injectable oil solutions code (type of oil should be identical)

A

AO

121
Q

solutions and powders for aerosolization code

A

AN

122
Q

topical products code

A

AT

123
Q

drug products that FDA at this time considers not TE to other PE products

A

B codes

124
Q

extended release products that aren’t BE code

A

BC

125
Q

drugs with documented BE problems code

A

BD

126
Q

delayed release (enteric coated) products B code

A

BE

127
Q

products in aerosol-nebulizer drug delivery systems B code

A

BN

128
Q

potential BE problems code

A

BP

129
Q

rectal dosage forms for systemic delivery B code

A

BR

130
Q

topical products with BE issues code

A

BT

131
Q

insufficient data submitted code

A

BX

132
Q

products having drug standard deficiencies code

A

BS

133
Q

biologics with same mechanism of action, control of manufacturing process, extensive lab testing, animal safety studies, human safety/potency studies, human immunogenicity studies, clinical efficacy and safety

A

biosimilarity

Pharmaceutics II (4 decks)

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